SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA
FACULTY OF MECHANICAL ENGINEERING
Implementation of new ISO 17025 standard into temperature
calibration laboratory
Diploma thesis
SjF-163615-99745
June, 2020
Mr. Zafarulla Shariff
SLOVAK UNIVERSITY OF TECHNOLOGY IN BRATISLAVA
FACULTY OF MECHANICAL ENGINEERING
Implementation of new ISO 17025 standard into temperature
calibration laboratory
Diploma thesis
SjF-163615-99745
Study programme :
Manufacturing Systems and Quality Management(​in English Language)
Field of study:
99745
Training workplace:
ÚAMAI SjF STU v Bratislava
Supervisor:
prof. Ing. Pavlásek, PhD.
Consultant:
prof. Ing. Stanislav Ďuriš, Phd.
Bratislava, June 2020.
1
Mr. Zafarulla Shariff
2
Declaration
I, Zafarulla Shariff, pursuing Masters Course in Manufacturing Systems and Quality
Management at Slovak Technical University, hereby solemnly declare that this diploma work
was completed by me independently with the aid of some legal references.
Bratislava, June 2020
…………………………
Signature
3
Acknowledgement
I sincerely thank ​prof. Ing. Pavlásek, PhD for giving me the opportunity to work under his
guidance. The time and effort he put into helping me finish the diploma thesis is very much
appreciated.
I would like to extend my gratitude to ​prof. Ing. Stanislav Ďuriš​, Phd for all his efforts as
well.
Special thanks to all the professors and faculty members of ​Slovenská Technická
Univerzita, Bratislava ​for all their efforts in helping me complete my Masters in
Manufacturing Systems and Quality Management (in English Language).
4
Title of the thesis: ​Implementation of new ISO 17025 standard into temperature calibration
laboratory
Key words: ​Quality Manual, ISO/IEC 17025, Calibration, Metrology, Measurement.
Abstract: ​Accreditation according to the ISO 17025 standard is to endorse the
cooperation and partnership between laboratories and other institutions with the aim
of exchanging information promoting the harmonization and standardization of
procedures and standards. A laboratory accreditation strengthens the organization
performance through better control of laboratory procedures and thereby increases
their potential due to increased customer satisfaction.
5
Contents
Introduction ​
Measurement
9
Measurement Units
9
Birth of International system of units
10
History
12
Evolution of ISO standard
14
Key changes
15
About the new Standard
16
Transition from ISO/IEC 17025:2005 to ISO/IEC 17025:2017
26
Importance of ISO 17025:2017
26
Benefits to the customer
28
Quality Manual
29
Foreword
30
Introduction
3​1
1.​Main Objective of Company/Calibration Laboratory
​3​2
2.Puropse of Quality Manual
33
3.Organisation Structure
33
3.1 ​Organisation ​Information
33
​3.2 Organisation Structure​
33
3.3 Area and scope of activities performed within the Company/Calibration lab
34
​3.4 Authorization of responsibilities
3​7
3.5 Laboratory Infrastructure
37
3.6 Human Resources
38
3.6.1 Key Personals of Calibration Laboratory
39
​3.6.2 General criteria for selection of employees of the Calibration laboratory
39
​3.6.4 Qualifications of Company / Calibration laboratory employees
4​1
​3.6.3 Training of employees
4​0
3.6.5 Employees Supervision
41
3.6.6 Monitoring of the Employees competence
42
​3.6.7 Communication
4​2
​3.7 Quality Management System
4​3
3.7.1 Outline of the Management System
43
​3.7.2 Quality Policy​
43
​3.7.3 Management Statement​
6
9
44
4. Impartiality
44
5. Confidentiality
46
6. Document and Record Management
47
​7. Equipment and environmental conditions
7.1 Environmental conditions monitoring and recording
47
7.2 Equipment conditions
47
​7.3 Equipments availability​
48
7.4 Equipments requirement,storage,handling,transport and maintenance
48
7.4.1
​7.4.2
​7.4.3
​Verification of meeting specified requirements by a device​
7.5.1
50
Device accuracy and uncertainty requirements​
50
​Equipment calibration labelling​
​7.7 Reference values and correction factors of used equipment​
51
​7.8 Preventing the unintended adjustment of equipment​
52
​7.9 Used equipment/device records and information​
52
​8. Metrological traceability
53
​9.Process requirements
54
Foreword
General Principles​
Conduct in Relation to the Public​
Conduct of Employees in Relation to Employers or Clients​
Certification​
Conflict of Interest and Confidentiality Guideline
Foreword
Introduction​
Objective​
Indemnification​
CONTROL OF DOCUMENTS AND RECORDS
Foreword
Change Request Form​
Calibration procedure for temperature indication devices performed in climatic
chamber
1. Introduction
7
51
51
Code of Ethics
●
●
50
7.6 ​Non-functioning or devices with unusual behaviour​
​9.1 Review of requests, tenders and contracts​
●
●
●
●
49
General requirement on used devices​
7.5 ​Used equipment calibration​
●
●
●
●
●
47
54
56
57
58
58
59
60
6​1
62
63
63
63
6​4
65
76
77
7​8
2. ​Used standards recommendations and regulations
7​9
3. ​Abbreviations and symbols
80
4. ​Technical requirements
80
​4.1 Requirements on the laboratory environment
80
​4.2 Requirements on the laboratory equipment
80
​4.3 Used equipment calibration
8​1
​4.4 Measurement scheme
8​1
​4.5 Requirements on software
8​1
5. ​Calibration method
​5.1 Devices necessary for calibration process
8​2
8​3
6. Measurement preparatory steps
83
7. ​Calibration procedure
8​4
8. ​Calibration protocol
8​5
9. ​Elaborating of calibration results
8​5
​9.1. Measurement evaluation
8​7
Uncertainty assigned to the temperature indication device of reference thermometer
(𝜹𝒓𝒆𝒇𝟏):
8​7
Resolution of the temperature indication device of reference thermometer (𝜹𝒓𝒆𝒇𝟐): 8​8
8
Temperature homogeneity of the climatic chamber (𝜹𝒉𝒐𝒎):
8​9
Temperature stability of the climatic chamber (𝜹𝒔𝒕𝒂𝒃):
8​9
Temperature difference between the temperature indicated by the device under
calibration and the temperature reference (∆𝒕):
8​9
Resolution of the device under calibration (𝜹𝒅𝒖𝒄𝟏):
8​9
10. ​Traceability
90
11. ​Measurement uncertainty determination
90
11.1 ​Measurement uncertainty calculation
9​1
11.2 ​Measurement uncertainty budget
9​2
12. ​Statement of calibration result
9​2
Introduction
Metrology is a branch of engineering science involved in measurement, units of
measurement, methods and means of measurement, as well as in principles of
measurement results processing, in order to assure the uniformity and correctness of
measurements in various fields of human activities. The legal metrology concerns
the measurements that have an influence on transparency of business transactions,
consumer’s protection, and protection of health, safety, environment, or law
enforcement.[1]
Measurement
The process of associating numbers with physical quantities and phenomena.
Measurement is fundamental to sciences; to engineering, construction and other
technical fields; and to almost all everyday activities​.
For this reason the elements, conditions, limitations and theoretical foundations of
measurements have been studied.
Measurement always begins with a definition of the quantity that is to be measured
and it always involves comparisons with some known physical quantity of the same
kind. If the object or quantity is not accessible by direct comparison, it is converted or
transduced into an analogous measurement signal.​[1]
Measurement units
Real scalar quantity, defined and adopted by quantity by convention, with which any
other physical quantity of the same kind can be compared to express the ratio of two
quantities as a number. With so many languages and systems in use we have
different systems of measurement units such as the metric ​system​, the imperial
system​, and United States customary units. ​[1]
Let us have a look at how these different systems in use have created confusions
and grave errors which sometimes lead to loss of life and property.
1.Korean Air Cargo, flight No. 6316 (in 1999) Flight from Shanghai to Seoul
On departure from Shanghai, the crew was ordered to climb to "1500", with the
control tower thinking of height in meters and the crew in feet. During the subsequent
maneuver, the aircraft crashed as it was too low. Eight people died.​[1]
2.Air Canada, flight 143 (in 1983) Flight from Montreal to Edmonton
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When departing from Montreal, the computer system of the all-new Boeing 767
worked with kilograms of fuel, while the ground crew worked in pounds (1 pound is
approximately 0.45 kg). The aircraft crew was informed that the ground crew
refueled "23,000" and entered it into the computer. In fact, the aircraft had only about
half the fuel that occurred during the flight. After a gliding flight, the plane landed
happily in Gimli. After the repair, the aircraft continued its service in Air Canada.​[1]
3.Mars Climate Orbiter
Manufactured by Lockheed Martin, operated by NASA spacecraft took off in 1998,
arriving at Mars in September 1999. There it turned on its engine, bringing it into
alignment behind Mars. No connection was later established with spacecraft. The
investigation found that the spacecraft manufacturer programmed the main engine to
work with English units (its thrust was reported in pounds) while NASA
communicated with the spacecraft in metric units (thrust was reported in Newtons).
Because of this, the spacecraft was only 57 km away from the planet's surface
instead of the planned 140 to 150 km. But the atmosphere burned it somewhere
between 80 and 90 km from the surface.​[1]
It is clear from the examples, there was a desperate need for a unique measurement
unit to be established with least variation which could be adopted and converted to
any system of units.
Birth of The International System of Units
[2]The General Conference on Weights and Measures (CGPM) has responsibility. In
1960 the 11th CGPM formally defined and established the SI (The International
System of Units, universally known as the SI (from the FrenchSystème international
d’unités), and has subsequently revised it from time to time in response to the
requirements of users and advances in science and technology.
The most recent and perhaps the most significant revision of the SI since its
establishment was made by the 26th CGPM (2018) and is documented in this 9th
edition of the SI Brochure. The SI is a consistent system of units for use in all
aspects of life, including international trade, manufacturing, security, health and
safety, protection of the environment, and in the basic science that underpins all of
these. The system of quantities underlying the SI and the equations relating them
are based on the present description of nature and are familiar to all scientists,
technologists and engineers. The definition of the SI units is established in terms of a
set of seven defining constants. The complete system of units can be derived from
the fixed values of these defining constants, expressed in the units of the SI. These
seven defining constants are the most fundamental feature of the definition of the
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entire system of units. These particular constants were chosen after having been
identified as being the best choice, taking into account the previous definition of the
SI, which was based on seven base units, and progress in science.A variety of
experimental methods described by the CIPM Consultative Committees may be
used to realize the definitions. Descriptions of these realizations are also referred to
as “mises en pratique”. Realizations may be revised whenever new experiments are
developed.[2]
ISO (International Organization for Standardization)​ is an independent,
non-governmental organization with a membership of 162* national standards
bodies. Through its members, ISO brings together experts to share knowledge and
develop voluntary, consensus-based, market-relevant International Standards that
support innovation and provide solutions to global challenges.ISO has published
more than 21500* International Standards and related documents, covering almost
every industry, from technology to food safety, agriculture and healthcare. It also
provides guidelines for Quality management.
*Q
​ uality management is the act of overseeing all activities and tasks needed to maintain a desired
level of excellence. This includes the determination of a quality policy, creating and implementing
quality planning and assurance, and quality control and quality improvement.[​ 2]
The following are clauses related to Measurement and their systems.
Clause 7.1.5.1 ● Determine and provide the resources for valid and reliable results.
● When monitoring or measuring is used to verify the conformity of the products
or services to requirements.
● Ensure that the resources provided are suitable for specific types of
monitoring and measurement activities being undertaken.
● Maintained to ensure their continued fitness for their purpose.
Clause 7.2.5.2 Where measurement traceability is a requirement or considered to be an essential
part of providing confidence in the validity of the measurement results.
To achieve the above. Measuring instruments must be;
● Calibrated or verified or both
● At specific intervals or
● Prior to use against measurement standards traceable to International or
national measurement standards.
11
● Retain the basis used for calibration or verification as documented information
if no such standards exist.
● Instruments must be identical in order to determine their status.
● Safeguarded from adjustments, damage or deterioration that would invalidate
calibration status and subsequent measurement results.
● Determine if the validity of previous measurement results is found to be unfit
for the purpose and take appropriate actions as necessary.
The definition of accreditation according to the ISO 17000 standard is the “third party
attestation related to a conformity assessment body, which is a formal recognition of
their competence to perform specific activities of conformity assessment.”[2]
One of the most important benefits of accreditation according to the ISO 17025
standard is to endorse the cooperation and partnership between laboratories and
other institutions with the aim of exchanging information promoting the harmonization
and standardization of procedures and standards. A laboratory accreditation
strengthens the organization performance through better control of laboratory
procedures and thereby increases their potential due to increased customer
satisfaction.
Accreditation is also an effective marketing tool for calibration or for testing, because
it is a “passport” for companies and organizations that require reliable and
independent laboratories. One of the most important ISO 17025 benefits is to reduce
the number of audits and evaluations by customers, since it is periodically audited by
an accreditation body. Additionally, one important accreditation benefit is that any
test or calibration certificate issued by an accredited laboratory that is a signatory of
the Mutual Recognition Agreement (MRA), is accepted in any country signatory of
the Agreement.
History
ISO/IEC 17025 was first issued in 1999 by the International Organization for
Standardization (ISO) and the International Electro-technical Commission (IEC). It is
the single most important standard for calibration and testing laboratories around the
world, with more than 50.000 laboratories accredited, globally.
At the International Laboratory Accreditation Cooperation (ILAC) General Assembly
in ​October 2013​ the Laboratory Committee (which is composed of stakeholder
representatives of accredited testing and calibration) recommended that ILAC
request that ISO/CASCO establish a new work item to comprehensively revise
ISO/IEC 17025:2005. CASCO is the ISO committee that works on issues relating to
conformity assessment. CASCO develops policy and publishes standards related to
12
conformity assessment; it does not perform conformity assessment activities.
CASCO's standards development activities are carried out by working groups made
up of experts put forward by the ISO member bodies. The experts are individuals
who possess specific knowledge relating to the activities to be undertaken by the
working group. The 6th ISO/CASCO WG 44 meeting was held on ​July 10-12, 2017
in ISO Central Secretariat, Geneva. The deliverable of this meeting was the FDIS
version of the new ISO/IEC 17025 version. The document is expected to proceed to
publication, planned for end ​November/December 2017​. [3]
13
Evolution of the ISO standard
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry
out tests and/or calibrations, including sampling. It covers testing and calibration
performed using standard methods, non-standard methods, and
laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These
include, for example, first-, second- and third-party laboratories, and laboratories
where testing and/or calibration forms part of inspection and product certification.
ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of
personnel or the extent of the scope of testing and/or calibration activities. When a
laboratory does not undertake one or more of the activities covered by ISO/IEC
17025:2005, such as sampling and the design/development of new methods, the
requirements of those clauses do not apply.
ISO/IEC 17025:2005 is for use by laboratories in developing their management
system for quality, administrative and technical operations. Laboratory customers,
regulatory authorities and accreditation bodies may also use it in confirming or
recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to
be used as the basis for certification of laboratories.
Compliance with regulatory and safety requirements on the operation of laboratories
is not covered by ISO/IEC 17025:2005.
SO/IEC 17025:2017 specifies the general requirements for the competence,
impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory
activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using
peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in
confirming or recognizing the competence of laboratories.
14
Key changes
ISO/IEC 17025:2017 takes into consideration the new ways of working in
laboratories today. The most substantive changes are as follows :
•The scope has been revised to cover all laboratory activities, including testing,
calibration and the sampling associated with subsequent calibration and testing.
• A new structure has been adopted to align the standard with the other exist-ing
ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on
conformity assessment.
• The process approach now matches that of newer standards such as ISO 9001
(quality management), ISO 15189 (quality of medical labora-tories) and the ISO/IEC
17000 series (standards for conformity assessment activities), putting the emphasis
on the results of a process instead of the detailed description of its tasks and steps.
• The standard has a stronger focus on information technologies. In recogni-tion of
the fact that hard-copy manuals, records and reports are slowly being phased out in
favour of electronic ver-sions, it incorporates the use of com-puter systems,
electronic records and the production of electronic results and reports.
• A new section has been added intro-ducing the concept of risk-based thinking and
describes the com-monalities with the new version of ISO 9001:2015, Quality
management systems – Requirements
The terminology has been updated. Examples include changes to the Inter-national
Vocabulary of Metrology (VIM) and alignment with ISO/IEC terminol-ogy, which has
a set of common terms and definitions for all standards dedi-cated to conformity
assessment.
15
About the New Standard
General Information
According to the International Accreditation Forum (IAF) and the International
Laboratory Accreditation Cooperation (ILAC), accreditation is defined as “the
independent evaluation of conformity assessment bodies against recognized
standards to ensure their impartiality and competence.”
This standard was developed with the objective of promoting confidence in the
operation of laboratories and contains requirements for laboratories to enable them
to demonstrate that they operate in a competent and impartial way and that they are
able to provide valid results.
During its development phase it has tried to align the standard with the principles of
ISO 9001, although this was not always practically possible. Still it is a fair statement
to make that the laboratories complying with the standard will also, in general,
comply with the principles of ISO 9001.
The standard can be used for accreditation purposes, for self-assessment of the
laboratories and for second party assessments by laboratory customers, regulatory
authorities, organizations and schemes using peer-assessment.
Its requirements are applicable to any organization that performs the activities of
testing and/or calibration and/or sampling associated with subsequent testing or
calibration. Therefore, accreditation to the new standard can be also achieved by
organizations offering sampling associated with subsequent testing or calibration.
When the standard uses the term “laboratory” it refers to any of the 3 options
mentioned above (testing, calibration, and sampling).
The potential of performing only sampling activities is a new element in the standard.
If, for example, a laboratory is performing tests and takes samples by its own
capacity, it should meet all requirements related to both: sampling and testing. On
the other hand, if any organization performs only sampling and then the samples are
forwarded to a laboratory for testing, then this organization should comply with new
standard requirements regarding sampling and its management system should
ensure that the sampling activity doesn’t affect negatively on test results.
Requirements for sampling organizations are similar to testing and calibration
laboratories: personnel shall be competent, equipment has to be maintained and
calibrated, sampling procedure has to be validated, quality of sampling has to be
assured etc. Confirmation of competence of organization to provide sampling can be
provided through accreditation against the new ISO/IEC 17025:2017.
16
Guide 99 ISO/IEC, International vocabulary of metrology — basic and general
concepts and associated terms (VIM), is referenced in the standard as a normative
reference. The definitions also given in ISO/IEC The new ISO/IEC 17025:20173 |
Page17000 are applicable. In addition, the standard provides the detailed definitions
of the terms impartiality, complaint, interlaboratory comparison, interlaboratory
comparison, proficiency testing, laboratory, decision rule.
The format of the new standard has been significantly changed to be more in line
with new ISO formatting guidelines. The basic format is similar to other new
standards such as ISO/IEC 17020 and ISO/IEC 17065. The new standard is now
structured as follows:
Clause 1.Scope
This document specifies the general requirements for the competence, impartiality
and consistent operation of laboratories.
This document is applicable to all organizations performing laboratory activities,
regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using
peer-assessment, accreditation bodies, and others use this document in confirming
or recognizing the competence of laboratories.
Clause 2.Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
● ISO/IEC Guide 99, International vocabulary of metrology — Basic and general
concepts and associated terms (VIM)
● ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
Clause 3.Terms and definitions
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
● ISO/IEC Guide 99, International vocabulary of metrology — Basic and general
concepts and associated terms (VIM)
17
● ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
● International Temperature Scale of 1990 (ITS-90)
The International Temperature Scale adopted in 1990 (ITS-90) is an
internationally accepted document enabling the realization of the
temperature scale.
● Interpolation device
The interpolation device ensures the realization of the temperature scale
between the definition temperature points in accordance with the
relationships given in ITS-90. E.g. The interpolation device ITS-90 is a
standard resistance temperature sensor for the temperature range up to
660 ° C.
● Measurement standard
Realization of the definition of a given quantity, with stated quantity value
and associated measurement uncertainty, used as a reference (ISO/IEC
Guide 99, JCGM 100, p.5.1).
● Reference measurement standard
Measurement standard designated for the calibration of other measurement
standards for quantities of a given kind in a given organization or at a given
location (ISO/IEC Guide 99, JCGM 100, p.5.6).
● Secondary measurement standard
Measurement standard established through calibration with respect to a
primary measurement standard for a quantity of the same kind (ISO/IEC
Guide 99, JCGM 100, p.5.5).
● Calibration
Operation that, under specified conditions, in a first step, establishes a
relation between the quantity values with measurement uncertainties
provided by measurement standards and corresponding indications with
associated measurement uncertainties and, in a second step, uses this
information to establish a relation for obtaining a measurement result from
an indication (ISO/IEC Guide 99, JCGM 100, p.2.39).
● Measurement uncertainty
Non-negative parameter characterizing the dispersion of the quantity values
18
being attributed to a measure, based on the information used (ISO/IEC
Guide 99, JCGM 100, p.2.39).
● Measurement reproducibility
Measurement precision under reproducibility conditions of measurement
(ISO/IEC Guide 99, JCGM 100, p.2.25).
● Measurement repeatability
Measurement precision under a set of repeatability conditions of
measurement (ISO/IEC Guide 99, JCGM 100, p.2.21).
The Standard introduces its main requirements throughout the clauses 4 to 8.
Clause 4 - General requirements
Impartiality and Confidentiality requirements are discussed in clause 4. The
risk-based thinking is evident throughout the standard. It should be noted that the
new standard expects from the laboratory to plan and implement actions to address
risks and opportunities. Although addressing risks and opportunities is the
laboratory's responsibility, the standard sets specific requirements. The first
requirement of such risks and opportunities that is needed to be addressed is
mentioned in clause 4, where the laboratory is required to identify and eliminate or
minimize risks related to impartiality, on an on-going basis. The confidentiality
requirements include, among others, the responsibility of the laboratory to informits
customer in advance of the information it intends to place in the public domain. It is
also discussing how to handle the release of confidential information required by law
or authorized by contractual arrangements. The confidentiality requirement is also
extended to laboratory personnel,including any committee members, contractors,
personnel of external bodies, or individuals acting on the laboratory's behalf, even in
the case that information is obtained from sources other than the customer (e.g.
complainant, regulators).
Clause 5 - Structural requirements
In clause 5, main requirements are defined, including: Legal status of the laboratory,
organization and management structure, identification of management, range of
laboratory activities, documenting its procedures, availability of personnel
responsible for the implementation and maintaining the integrity of the management
system.It should be noted that the new standard clearly requires (see clause 5.3)
that the laboratory shall only claim conformity with this document for this range of
laboratory activities, which excludes externally provided laboratory activities on an
ongoing basis. This means that the laboratory is expected to be accredited, and
19
include in the scope of accreditation only testing/calibration/sampling activities that is
providing by utilizing its own resources.In its 2005 version the standard allowed to
subcontract tests and calibrations in the case that the laboratory was not in position
to perform them. According to the new standard the laboratory can be accredited
only for those laboratory activities, for which it is competent. Subcontracting is
allowed only for outstanding situations, like overload of work, sickness of personnel,
maintenance of equipment or other similar cases.
Clause 6 - Resource requirements
Resource requirements are considered to include personnel, facilities, equipment,
systems and support services necessary to manage and perform the laboratory
activities. It is expected that all internal or external personnel of the laboratory shall
be competent and act impartially. The standard doesn’t refer to this clause to ALL
personnel, but only to personnel who could influence the results of laboratory
activities. This is not only personnel who are directly involved in
testing/calibration/sampling activities, but also personnel who are indirectly involved,
like technical personnel. For example, it can be personnel that perform maintenance
of the equipment, or management system personnel, who evaluate suppliers and/or
maintain the management system including internal auditing activities.
The competence requirements, which are expected to be documented, include
education, qualification,training, technical knowledge, skills (like capacity to evaluate
the significance of laboratory activities deviations) and experience. In addition,
procedure and records are expected for selection, training, supervision, authorization
and monitoring of competence of personnel. The standard also defines the cases
where it is expected for the laboratory to authorized personnel to perform specific
laboratory activities.
It is expected for the requirements for facilities and environmental conditions suitable
for the laboratory activities to be documented, including the conditions related to
monitoring, controlling and recording environmental conditions. The standard sets
requirements to those environmental conditions which can affect the results of
laboratory activities. Depending on the nature of laboratory activities the same
parameter can be or cannot be important for the testing results. For example, the
value of the relative humidity that can be critical and shall be controlled during some
textile testing, it is usually not critical during routine mechanical tests of plastics.
Measures to control facilities may include access to and use of areas affecting
laboratory activities, prevention of contamination and effective area separation,
including sites or facilities outside of laboratory’s permanent control. A procedure for
handling, transport, storage, use and planned maintenance of equipment is required.
20
Equipment requirements are applicable to hardware, software, measurement
standards, reference materials, reference data, reagents, consumables or auxiliary
apparatus – whatever is required for achieving correct results during laboratory
activities. It is also expected that the equipment used for measurement should
achieve the required measurement accuracy or measurement uncertainty. The
calibration requirements are described in detail in clauses 6.4.6-6.4.13 including the
requirements for relevant records.The standard is giving great attention to
metrological traceability issues. In addition to the main requirements which are
described in detail in clause 6.5, an informative annex (Annex A) is available
providing additional information, including guidance on how to establish and
demonstrate metrological traceability.
Requirements related to the control of and communication with external
organizations providing products and services affecting laboratory activities are
described in clause 6.6. Procedure and records are required to define, review and
approve the laboratory’s requirements for externally provided products and services
(purchasing requirements), setting the criteria for evaluation, selection of
performance and re-evaluation of the external providers, ensuring that they conform
to requirements and taking appropriate actions in the case that they don’t.
21
Clause 7 - Process requirements
An example of a possible schematic representation of the operational processes of a
laboratory as described in Clause 7 is presented in informative Annex B:
Fig.1.Schematic representation of the operational processes [5]
Process requirements are deployed as follows:
7.1 Review of requests, tenders and contracts
A procedure is required to address issues such as the level of understanding of
requirements; laboratory’s capability and resources to meet the requirements;
implementation of appropriate control over external providers used (if any); and
selection of appropriate methods to meet the customers' requirements. It is expected
that the laboratory shall inform the customer when the required
testing/calibration/sampling method is considered to be inappropriate or out of date.
When a statement of conformity to a specification or standard is required, the
decision rule (which specifies pass/fail criteria) selected shall be communicated to,
22
and agreed with, the customer. Contract review procedure shall be applied also for
any changes in the contract/tender/request. Relative review records are required.
7.2 Selection, verification and validation of methods
The term “method” in the standard is used to identify calibration method,
testing/measurement procedure, sampling procedure. The laboratory is expected to
ensure that it uses the latest valid version of a method, unless it is not appropriate or
possible to do so. Methods used can include methods published in international,
regional or national standards, or by reputable technical organizations, or in relevant
scientific texts or journals, or as specified by the manufacturer of the equipment or
laboratory-developed or laboratory-modified methods. The laboratory shall verify that
it can properly perform selected methods. Deviations from methods shall occur only
if the deviation has been documented, technically justified, authorized, and accepted
by the customer. Non-standard methods, laboratory-developed methods and
modified standard methods are expected to be validated, and relevant records are
expected to be kept.
7.3 Sampling
The requirements of this clause are applicable to the laboratories which perform just
sampling activities as well as for testing and calibration laboratories which are
responsible also for sampling. A sampling plan and a sampling method are expected
to be available and implemented when the laboratory carries out sampling of
substances, materials or products for subsequent testing or calibration. Records of
sampling data should be retained per standard requirements.
7.4 Handling of test or calibration items
A procedure for the transportation, receipt, handling, protection, storage, retention,
and disposal or return of test or calibration items should be drafted including a
system for the identification of test or calibration items. Deviations from specified
conditions are expected to be recorded and the customer to be consulted for next
steps. In the case that some items have to be stored or conditioned under specified
environmental conditions, these conditions shall be maintained, monitored and
recorded.
7.5 Technical records
Requirements to retain technical records are in place to ensure the traceability of
laboratory activities and to provide information for potential decision making.The
technical records are expected to contain the results, report and sufficient
information to facilitate, if possible, identification of factors affecting the
23
measurement result and its associated measurement uncertainty and enable the
repetition of the laboratory activity if required, providing traceability to previous
versions or to original observations if amended.
7.6 Evaluation of measurement uncertainty
For testing laboratories it is expected to evaluate measurement uncertainty
considering all contributions which are of significance, including those arising from
sampling. It is noted in the standard that for a particular method, where the
measurement uncertainty of the results has been established and verified, there is
no need to evaluate measurement uncertainty for each result, if the laboratory can
demonstrate that the identified critical influencing factors are under control. For
calibration laboratories it is expected to evaluate the measurement uncertainty for all
calibrations considering all contributions which are of significance, including those
arising from sampling.
7.7 Assuring the validity of results
A procedure and records are required for monitoring the validity of results, which can
include, among others: use of reference materials or QC materials; use of alternative
traceable instrumentation; functional checks; use of standards with control charts;
intermediate checks; replicate tests or calibrations; retesting or recalibration;
correlation of results; review of reported results; intra-laboratory comparisons; testing
of blind samples. Participating in PT’s (Proficiency Tests) and/or ILC’s
(interlaboratory comparisons) is expected where available and appropriate. Such
activities, according to the standard, must be planned and reviewed.
7.8 Reporting of results
Laboratory activity results shall be reported. The standard sets requirements for
results review and authorization as retained in the relative technical records. The
common information required to be included in the test, calibration or sampling
reports is presented in details in clause 7.8.2. In addition, the specific information for
test reports is presented in clause 7.8.3, for calibration certificates in clause 7.8.4, for
reporting sampling in clause 7.8.5, for reporting statements of conformity in clause
7.8.6, for reporting opinions and interpretations in clause 7.8.7 and for amendments
to reports in clause 7.8.8.
7.9. Complaints
A documented process is required for receiving, evaluating and making decisions on
complaints. This process is expected to be available to any interested party upon
request. The outcomes to be communicated to the complainant shall be made by, or
24
reviewed and approved by, the individual(s) not involved in the original laboratory
activities in question.
7.10 Nonconforming work
A Nonconforming work procedure is expected to be in place ensuring that the
responsibilities and authorities for the management of nonconforming workare
defined, subsequent actions are taken considering the risk levels; an evaluation is
made of the significance of the nonconforming work; a decision is taken on the
acceptability of the nonconforming work; the customer is notified, if possible; work is
recalled, if needed; and the responsibility for authorizing the resumption of work is
defined. Halting or repeating of work and withholding of reports, as necessary can be
considered among the required actions. Records of nonconforming work and relative
actions are expected to me retained.
7.11 Control of data – Information management
This clause sets requirements for the laboratory information management system(s)
used for the collection, processing, recording, reporting, storage or retrieval of data.
Clause 8 – Management System requirements
The laboratory can choose between implementing a management system in
accordance with option A or option B.
Option A lists the minimum requirements for implementation of a management
system in a laboratory. Care has been taken to incorporate all those requirements of
ISO 9001 that are relevant to the scope of laboratory activities that are covered by
the management system.
Option B allows laboratories to establish and maintain a management system in
accordance with the requirements of ISO 9001. Laboratories that implement option B
will therefore also operate in accordance with ISO 9001.
Conformity of a laboratory to the requirements of ISO 9001 does NOT, by itself,
demonstrate the competence of the laboratory to produce technically valid data and
results. This is accomplished only through compliance to ISO/IEC 17025.
The requirements for documentation have been significantly reduced in clause 8.
The documentation requirements related to the operation of the management system
per clause 8 are:
•Management System policies and objectives (8.2.1)
25
•Analysis of Customer feedback (8.6.2)
•Corrective actions, non-conformities related records (8.7.3)
•Internal audit and results records (8.8.2)
•Management review input and output record (8.9.2)
It should be noted that there are no requirements any more for documented
procedures related to management system activities referred in clause 8. There is
also no requirement for Quality Manual.
By introducing the risk-based thinking in the standard some reduction in prescriptive
requirements and their replacement by performance-based requirements was
possible. Clause 8.5 that is dedicated to actions to address risks and opportunities is
a new element added in the recent revision of the standard. This clause requires the
laboratory to consider the risks and opportunities associated with the laboratory
activities. These activities are described throughout the standard and include risks
related to impartiality (4.1.4), statements of conformity (7.8.6), nonconforming work
(7.10.1), and corrective actions (8.7.1). It should be noted that the standard doesn’t
require a formal/specific method for risk management or a documented risk
management process. Useful information can be found in ISO 31000, Risk
management - Principles and guidelines, which is included as a reference in the
bibliography.
Transition from ISO/IEC 17025:2015 to ISO/IEC 17025:2017
Once the new standard’s final version is published, expected by the end of 2017,
there will be a three year transition period. Accreditation bodies will need to have all
laboratories assessed to the new standard by the end of 2020. Of course this doesn’t
mean that laboratories should wait for action until the end of the three years period. It
is suggested to plan and initiate the transition process much earlier.
The main transition steps to follow are:
● Decide on the overall timeline;
● Train the lab personnel who will be responsible for transition and
implementation;
● Learn how to read, interpret and implement the new standard requirements;
● Conduct a gap analysis between the existing quality system and the
requirements in the revised standard;
● Update management system’s documentation.
26
(This includes updates to existing policies and procedures as required, plus the
removal/modification/addition of policies and procedures.)
Importance of ISO 17025:2017
It is an undeniable fact that, in our contemporary world, being competitive is the key
to success for any company. Competitiveness involves delighting the customer and
exceeding his expectations and to achieve these goals, there is a need for quality.
The benefit attached to the quality of products is the reputation it brings to the
company. In addition, the search for quality drives companies towards continual
improvement of their management system and development of efficient ways to
meet customer satisfaction. Moreover, the impact of quality on cost should not be
neglected and this is explained by Deming’s philosophy (Deming 2009) which says
that as quality increases costs tend to fall over time as shown in Figure
Fig. 2. Deming’s Philosophy.[6]
A QMS in a testing laboratory is a way of showing that the quality of the final test
results can be relied upon. The presence of quality assurance, through the use of
appropriate procedures and management methods, guarantees clients that errors in
test results, are minimised. The QMS provides the laboratory with measurement
traceability, the opportunity of error prevention by the use of preventive actions and
the possibility of initiating corrective action when errors are detected.
ISO/IEC 17025 accreditation is the single most important standard for calibration and
testing laboratories around the world. ISO 17025 accredited laboratories have
demonstrated that they are technically proficient and able to produce precise and
27
accurate test and calibration data. This is a voluntary, third party-reviewed process
that ensures a laboratory’s quality management system is thoroughly evaluated on a
regular basis to guarantee continued technical competence and compliance with ISO
17025. It also helps facilitate cooperation between laboratories and other bodies by
generating wider acceptance of results between countries. Test reports and
certificates can be accepted from one country to another without the need for further
testing, which, in turn, improves international trade.
Laboratory accreditation bodies use the ISO 17025 standard specifically to assess
factors relevant to a laboratory’s ability to produce precise, accurate test and
calibration data; including:
●
●
●
●
●
●
●
Traceability of measurements and calibrations to national standards
Technical competence of staff
Maintenance of test equipment
Quality assurance of test and calibration data
Validity and appropriateness of test methods
Appropriate handling and transportation of test items
Quality of testing environment and sampling
To ensure continued compliance, accredited laboratories are regularly re-assessed
to check that they are maintaining their standard of technical expertise. These
laboratories are also required to participate in regular proficiency testing programs as
an ongoing demonstration of their competence.
Benefit for the customer
ISO/IEC 17025 accreditation helps you minimize risk by ensuring that you are
choosing a technically competent lab that has a sound quality system in place. This
also allows you to avoid expensive retesting, which enhances your confidence in our
product by assuring that it has been thoroughly evaluated by an independent,
competent testing or calibration laboratory that has been assessed by a third party.
28
Quality Manual
29
Foreword
The Quality Manual is the document ​stating the company's intentions for operating the
processes within the quality management system. All the processes and procedures
outlined in the Quality manual are based on the guidelines outlined by ISO
17025:2017.
The Quality manual is created for a Company/Calibration laboratory specifically
designed for internal calibration services of temperature indicating devices(
Thermometers).
30
Introduction
The specific temperature calibration laboratory is the part/structure of a
Company/calibration laboratory aiming to perform internal calibrations and provide
calibration services to customers, accredited as per ISO 17025 standards. The
calibration services provided by the calibration laboratory is limited to temperature
sensors with indicative function.
The values are the foundations of the Company/Calibration Laboratory and guide all
corporate, commercial and technical operations:
●
●
Technical and Operational Integrity: ​metrological​ ​services are
valued because of adherence to technically valid processes in the
search for objective results. This integrity is backed by business
practices which include transparency, honesty, and prevention or
mitigation of any real or perceived conflict of interest.
Technical Innovation: ​is constantly seeking improvements in
technical metrological processes and makes use of continual
improvement tools to identify areas where innovation can be
implemented.
Laboratory Quality management system policies, programs, procedures and
guidelines within the scope of ISO / IEC 17025:2017 requirements are described in
the Metrology Laboratory Quality Manual.
The Quality Policy consists of:
●
●
●
●
●
31
Company/Calibration Laboratory ensures the health, welfare
and safety of all employees and visitors.
Company/Calibration Laboratory delivers technically valid test
and inspection results as part of a sustainable business.
Company/Calibration Laboratory exercises appropriate and
reasonable care to eliminate harmful environmental impacts.
Company/Calibration Laboratory ensures maximum customer
satisfaction.
Company/Calibration Laboratory provides meteorological
calibration and control methods for the Company.
1.
Main Objective of Company/Calibration Laboratory
The Company/Calibration Laboratory delivers value to its people, its customers, and
those industries it serves:
● By providing metrological control and calibration services;
● By maintaining and ensuring Quality management systems.
● By continuously improving metrological procedures and management
systems.
The objective of the Company / Calibration laboratory is to perform internal
calibration services of thermometers with indication function within a climatic
chamber.
Methods Used - Comparative calibration techniques by using a reference resistance
thermometer. A more detailed description of the calibration procedure can be found
in the document CP-01: Calibration procedure for temperature indication devices
performed in climatic chamber.
All of the activities outlined in this document together with its appendices, customer
requirement and relevant supervisory authority must be done with accordance to the
set requirements.
2.
Purpose of Quality Manual
The Quality manual of the Company/Calibration lab describes the process
procedures and Quality systems to be implemented in accordance with the ISO
17025:2017 standard. It focuses on metrological activities related to laboratory
activities with emphasis on traceability of performed measurements and calibration.
Through this document the laboratory ensures that all of the devices and equipment
that are used for the purpose of calibration are calibrated and can demonstrate
traceability to the basic SI unit.
The Quality manual is the main control document of the Company/Calibration lab. It
outlines the structure and the need for a Quality management system. The Quality
manual is printed and distributed in electronic form in accordance with the
distribution list.
The Quality Manager of the Company/Calibration lab is responsible for creating,
updating and reviewing the Quality manual in cooperation with all members of the
lab. Through the Quality Management System Board, changes and modifications are
proposed by the technical staff that is responsible for calibration of the
32
thermometers. Changes are made and documented as per the guidelines by
DRM1-Document and Record Management.
3.
Organisation Structure
​ 3.1 Organisation Information
Name of organization: Company / calibration lab.
Address: ​Karloveská 63, 841 04 Bratislava
Business ID: ​SMU​\0000111
Tel.: 02/602 94 13
Bank account: xxxxxx , IBAN: xxxxxx
BIC: xxxxx
Web page: https://www.smu.sk/
3.2 Organisation Structure
Figure 1. Basic Structure of the Company/Calibration Laboratory
The Basic structure is provided by the Director of the Company/Calibration
Laboratory which is described in Figure 1.
33
Legal Designation : Company/Calibration Laboratory.
The Selection criteria for employment of people for the Company/Calibration
Laboratory is described in section 3.6.2.
Head of Calibration Lab/ Quality Manager​ - (Name Surname) : Report directly to
the Director of the Company/Calibration laboratory. He/She is the person responsible
for overall duties of the Calibration lab.
Deputy Head of the Calibration Lab/ Jr Quality manager​ - (Name Surname) : Is
the second in command to the Quality manager. His/Her role is to act as the Quality
manager in his/her absence.
Senior Laboratory Officer/Senior Quality specialist​ - (Name Surname) : Is the
subordinate of the Quality manager.
Junior Laboratory Officer/Junior Quality specialist​ - (Name Surname) : Is the
second in command to the Senior lab officer. His/Her role is to act as the Quality
officer in his/her absence.
Laboratory Technicians​ - (Name Surname) : Are subordinates of the Head of the
Calibration lab and the laboratory officers. They perform all the laboratory activities.
(Only in relevant areas are connected to Quality).
3.3 Area and scope of activities performed within the Company / Calibration
laboratory
Type of activities performed in the calibration laboratory includes the following:
1.
2.
3.
4.
Calibration of temperature indication devices performed in climatic chamber
Calibration uncertainty evaluation
Calibration data evaluation
Consultations related to the measurement and calibration in climatic chamber
Table 1.Individual employee responsibilities within the Company / calibration lab. calibration
laboratory.
Name of Employee and
position
34
Activity for which the
employee is
responsible
Relevant procedure
Name Surname
Head of Calibration Lab/
Quality Manager
Name Surname
(​Senior Laboratory
Officer/Senior
Quality specialist​)
35
Calibration of temperature
indication devices performed
in climatic chamber,
Calibration uncertainty
evaluation, Calibration data
evaluation, Consultations
related to the measurement
and calibration in climatic
chamber, Supervision of
calibration/measurement
processes as well as the
final verification of the
performed measurements
and evaluation of data and
uncertainties, is obliged to
clearly and before the active
participation on measurement
/
calibration process to outline
each employees
responsibilities and
competences, development,
modification, verification and
validation of methods, report
of unusual behavior of
equipment, to report of
possible shortages of
equipment outside the listed
devices in the section 5.1 of
CP-01 document
responsible for the quality
aspects of the laboratory
together with their
implementation and
adherence to the quality
system of metrology
laboratories
CP-01: ​Calibration
procedure for
temperature indication
devices performed in
climatic chamber
Quality manual
and its
annexes
Name Surname
(​Junior Laboratory
Officer/Junior Quality
specialist​)
Name Surname
(​Laboratory technicians​)
36
Is responsible for
implementation and
adherence to the quality
system of metrology
laboratories.
Manages the list of
employees that are
responsible for metrological
activities within the
laboratory.
This list includes the work
specification of each
individual staff (job
description) determines the
competences and
responsibilities of each
laboratory worker for the
performance of their duties,
for identifying and
minimizing deviations from
the quality system and
metrological procedures.
Calibration of temperature
indication devices performed
in climatic chamber,
Calibration data evaluation,
report of unusual behavior of
equipment, to report of
possible shortages of
equipment outside the listed
devices in the section 5.1 of
CP-01 document
Quality manual
and its
annexes
CP-01: ​Calibration
procedure for
temperature indication
devices performed in
climatic chamber
3.4. Authorization of responsibilities
Each employee of the Company / Calibration laboratory will adhere to a specific job
profile.
The Job description of every employee will be documented and stored.
The responsible personals will be updated and their confirmation by signature will be
as documented and stored.
3.5 Laboratory Infrastructure
The Calibration Laboratory management system manages all the activities of the
Laboratory as per the Management System Infrastructure document.
The Head Of the Calibration Laboratory/Quality Manager regularly monitors the
compliance of the ​work environment in terms of following the procedures, documents
and safety​ in the laboratory and is responsible for their correction in case of
deficiencies.
All Employes are trained and well acquainted with the Laboratory conditions and are
obligated to comply with them.
Calibration laboratory premises to provide full safety and technical infrastructure for
correct and reliable performance of activities outlined in document CP-01: ​Calibration
procedure for temperature indication devices performed in climatic chamber.​
37
■
Laboratory controls its environments in a manner specified to
ensure the health and safety of employees to ensure the
appropriate technical operations..
■
Laboratory prohibits consumption of food, narcotic and psychotropic
substances, smoking within the laboratory premises.
■
Laboratory has smoke detectors in every room to protect against
fires. The conditions and the way of monitoring the environment for
individual activities are stated in the relevant work/calibration
procedures.
■
Laboratory ceases any testing, calibration, inspection or certification
activity, in the event that environmental conditions or other factors
could compromise the outcome. When the incompatible
circumstance is remedied, the Laboratory implements appropriate
procedures to restart the work.
3.6 Human Resources
The Calibration Laboratory Managers and Officers are experts, who introduce,
maintain and improve the Quality Management System of the Laboratory with a
particular emphasis on Metrological activities of the Laboratory. They are appointed
as per the criteria outlined in the Human Resources Management documentation.
The required confidentiality of each employee is stated within the job description of
each individual. This confidentiality requirement shall be ensured and applies on all
information which he received during the course of his work. This confidentiality
ensures solely the protection of customers' information and property rights.
Protection of electronic data storage and transmission is ensured by password
protection of individual computers or files.
The Supervision of every personal associated with metrological activities, including
trainees shall be undertaken by relevant managers. Training details and completion
is documented and stored together with the specific person’s information file.
3.6.1 Key Personals of Calibration Laboratory.
Quality Manager ​: Has overall responsibility for the professional activities and for
ensuring the resources necessary to ensure the required quality of laboratory work.
This includes the supervision of calibration/measurement processes as well as the
final verification of the performed measurements, evaluation of data and
uncertainties, report of unusual behavior of equipment, regular checks of used
equipment for their functionally, to report of possible shortages of equipment outside
the listed devices in the section 5.1 of CP-01 document. Is furthermore responsible
for implementation and adherence to the quality system of metrology laboratories.
Has direct access to senior management. Is obliged to clearly and before the active
participation in the measurement / calibration process to outline each employee's
responsibilities and competences. Part of the activities will consist of development,
modification, verification and validation of methods that will expand, improve the
currently used ones.
Deputy Head of the Calibration Lab/ Jr Quality manager : Is the second in command
to the Quality manager. His/Her role is to act as the Quality manager in his/her
absence.
Senior Laboratory Officer/Senior Quality specialist - Has direct access to top
38
management and is responsible for the quality aspects of the laboratory together
with their implementation and adherence to the quality system of metrology
laboratories.
Junior Laboratory Officer/Junior Quality specialist : Is responsible for implementation
and adherence to the quality system of metrology laboratories. Manages the list of
employees that are responsible for metrological activities within the laboratory. This
list includes the work specification of each individual staff (job description)
determines the competences and responsibilities of each laboratory worker for the
performance of their duties, for identifying and minimizing deviations from the quality
system and metrological procedures.
Laboratory Technicians - are responsible for technical, metrological quality aspects
within the Calibration Laboratory with their specific competences and work
responsibilities listed in the list of employee responsibilities.
3.6.2 General criteria for selection of employees of the Calibration laboratory
All employees that will work for the Calibration Laboratory have to meet a set of
criteria for each job profile outlined in the table 2.
Table 2.Specific minimum criteria on the employees of the Company / calibration lab.
calibration laboratory.
Designation
Head of Calibration Lab/
Quality Manager
Qualification
University degree or higher
with technical background
Senior Laboratory
Officer/Senior Quality specialist
University degree or higher
with technical background
Junior Laboratory
Officer/Junior Quality
specialist
Secondary school or higher
with technical background
Laboratory technicians
Secondary school or higher
with technical background
.
39
Certification or proven praxis
Experience in uncertainty
evaluation, data evaluation,
calibration and measurement
practices, basic management
skills
Experience in quality
management, ISO 17025
Basic experience in quality
management
Data evaluation, calibration
and measurement practices
experience
Years of documented
experience in the relevant
field
5
4
2
1
3.6.3 Training of employees
In order to maintain a high level of efficiency and adherence to quality, all the new
recruits undergo a training session and attend seminars on measurement techniques
and methods. The training and professional growth takes place as per the annual
plan prepared by the Quality officer of the Laboratory. Depending on the situation,
the plan can be modified as per requirement.
The trainee is obligated to share relevant content of the training with other
employees.
The effectiveness of the training is evaluated by the Head of Calibration Lab/ Quality
Manager during the annual meeting. The results of evaluation are available to the
Senior Laboratory Officer/Senior Quality specialist which is used to create an annual
training plan.
The following measures ensures that all employees are qualified,
1. By establishing necessary qualifications and adhering to a certain level of
professional development for all workers.
2. By providing information concerning professional activities derived from
international metrology regulations and working materials.
3. Facilitating the participation of workers in domestic or international
professional events (seminars, conferences, symposia, congresses) related to
the scope.
The individual progress of employees is systematically monitored and stored.
Each employee is obliged to submit a copy of the evidence of their qualifications
(diploma, certificate, training (also abroad), etc.) to his/her supervisor according to
the organizational structure of the Calibration Laboratory.
40
3.6.4 Qualifications of Company / calibration lab. calibration laboratory
employees
Within this section, relevant qualifications, training, participations, language skills,
highest education and years of documented experience of each individual employee
of the Calibration laboratory is presented.
Name and
Designation
Highest level of
education
Language skills
Qualifications and
training
participations
Years of
documented
experience in the
relevant field
Name Surname
Name Surname
3.6.5 Employees supervision
Head of Calibration Lab/ Quality Manager or Alternatively employee with the highest
qualification or designation will supervise the activities of all the personals in the
Laboratory.
For an Employee
● With <1 year of work experience, regular checks of performed
measurement/calibration by the Supervisor of the Calibration Laboratory.
● With >1 and <2 years of work experience, check of his every
measurement/calibration by means of data and evaluation by Head of
Calibration Lab/ Quality Manager or Alternatively employee with the highest
qualification or designation.
● With >2 years of work experience, random check of his
measurement/calibration by Head of Calibration Lab/ Quality Manager or
Alternatively employee with the highest qualification or designation.
Supervision includes the recording of data, their use and treatment and the
measurement/calibration procedure performed by the employee.
3.6.6 Monitoring of the employees competence
41
The competence of Calibration laboratory employees will be validated and verified by
the means of annual(at least once per year) check of their measurement / calibration
performance in terms of,
● Following the internal guidelines (CP-01:​Calibration procedure for
temperature indication devices performed in climatic chamber​).
● Customer complains.
● Random audits/inspection of used measurement procedures.
3.6.7 Communication
The Calibration Laboratory uses the intranet of the company for internal
communication.
Telephones((Personal/Company) or emails(Personal/Company email) are the main
communications tools.
Annual meetings are held between the management at least 6 times a year. The
meetings are held to discuss about the following two aspects,
1. Improvement of the Management System.
2. Current technical realization of measurement / calibration, improvement of the
activities with regard to customer demand and suggestions
All the documents are available on the internal server and are accessible to every
personnel with specific designation, further discussion on access and protection of
data is illustrated in section 6 referenced DRM1-Document and record management.
The Top management of the Calibration Laboratory ensures that there is adequate
communication between the employees for smooth and effective running of the
Management system.
External communications(vendors, authorities, etc) take place via Email, Fax and
telephone. Negotiations also take place in written form.
42
3.7 Quality Management System
3.7.1 Outline of the Management System
The management system covers all the metrological activities within
Temperature/Calibration Laboratory, including:
All aspects regarding the health, safety and welfare of
Laboratory employees, and visitors to Laboratory facilities;
●
Ensures the continual improvement of meteorological parameters of used
devices, as well as used methods;
●
The acquisition and use of expertise with the requisite skills and
knowledge required for all aspects of the metrological activities;
●
The use of facilities and equipment in support of all operations to
provide the best customer satisfaction;
●
All activities related to the quality control (QC) and quality
assurance (QA) of technical and supporting operations;
●
All supporting operations of the business, including HR,
Finance, Purchasing, IT and Marketing, and
●
Continuous improvement of metrological activities.
●
3.7.2 Quality Policy
The Calibration Laboratory maintains a management system appropriate to the
needs of metrological activities being performed and allows Laboratory to
demonstrate conformance to the customer requirements, and the following standard:
●
ISO/IEC 17025:2017 – General requirements for the
competence of testing and calibration
The documented system, methods, and procedures incorporate adequate safety
controls and quality control/quality assurance at all levels of the business. They are
based on regulatory requirements, industry standards or best practice, as
appropriate. Records are maintained of the implementation and the outcomes. All
Laboratory systems and processes are continually monitored for improvement.
Each laboratory and section within Laboratory is required to conform to the
requirements of this management system and implement it within their area,
although some aspects of the management system may need to be tailored to suit
the specific operational needs of some areas Tailoring is at the discretion of the
applicable manager, but requires consensus with the GM and QM.
All management system documentation is published on the Laboratory’s intranet.
43
3.7.3 Management Statement
The Management of the Calibration Laboratory undertakes the responsibility to
create appropriate conditions for its employees which will enable them to implement
the quality policy and achieve the criteria laid out as per ISO 17025:2017 standard.
The Director of the Calibration Laboratory will provide,
1. The precondition for the Laboratory to assure professional performance of
metrological services.
2. The required organisational and economic conditions to provide adequate
quality results.
Based on the statement by The Director of the Calibration Laboratory, The
employees of the Calibration Laboratory are committed to Developing, Implementing,
and continuously improving the management systems in accordance with the ISO
17025:2017.
Management of the Calibration Laboratory ensures the integrity of the management
systems, even in case of updates.
4. Impartiality (Refer Pol-002 and Pol-003)
● Impartiality is essential for the Temperature lab to deliver appropriate
conformity assessment services that provide confidence.
● All personnel are engaged to ensure independence, impartiality and
objectivity in the provision of conformity assessment services.
● The Head of the Company/Calibration Laboratory and the management
implements the Temperature labs’s Code of Ethics and all management and
staff demonstrate commitment to this policy by recording their signatures on
such a Contract (POL-002).
● All laboratory activities will be performed in a manner that will safeguard the
impartiality of set activities. This shall be done by means of laboratory
structure and its management. The Laboratory is structured in such a way that
any outside influence is elemented by virtue of design. Organizational
integration is embedded into the design.
● Laboratory management and personnel are free from any undue internal or
external commercial, financial or other pressures that may adversely affect
their impartiality and integrity with respect to the activities performed. This is
44
enforced by financial detachment of the Laboratory from its parent company
and any other department dealing with customers from the Laboratory. This
includes no commission from sales and any inducements from the customer
to the employees,
● The Laboratory identifies potential risk to its impartiality on an ongoing basis.
The risk to impartiality is identified in these areas of Laboratory activities and
employee’s relationship with the laboratory . If a risk is identified, the
management is notified and specific measures are taken to remove the risk.
The identification and precautions are well documented,
It is the Temperature lab’s policy to assure and effectively manage impartiality.
Laboratory does not supply or design products other than Thermometers or
testing or providing any other products or services that could compromise the
confidentiality, objectivity or impartiality of testing processes and decisions.
It is Laboratory policy that:
Laboratory does not collude or falsify results of participation in proficiency
testing schemes. This is enforced by guidelines outlined in the data management
document. The data is stored and evaluated automatically by a software. The results
are checked and verified by the head of the Company/Calibration lab. Without the
signature of the Head the certificate is considered void.
●
Laboratory proficiency testing schemes are designed, wherever possible, to
minimize the possibility of collusion and falsification of results from participants.
●
Laboratory has a zero tolerance policy with respect to the acceptance of gifts
and inducements as detailed in HR policies and procedures.
●
Laboratory personnel declare any potential conflicts of interest on recruitment
and throughout their employment as applicable. All identified potential conflicts of
interest are assessed and, where a threat to impartiality is confirmed, effective and
timely eliminating or mitigating action is taken
●
Laboratory testing, calibration, consultancy and advisory activities are not
allowed to compromise the impartiality, integrity and objectivity of any Laboratory
activities, processes, procedures and decisions.
●
Laboratory personnel do not engage in any activities that could diminish
confidence in the competence, impartiality, judgment or operational integrity of any
business activities.
●
When an Impartiality is Identified
In Case Impartiality is Identified, a well summarized report with the problem
statement, the nature of the Impartiality with the measures taken to remove are
clearly stated.
45
It is the Laboratory’s responsibility to monitor and minimize the risk to Impartially on
continuous basis and the identification and precautions must be well documented,
All of the actions that are necessary to remove the impartiality should be executed
as soon as possible after the approval by the laboratory management.
5. Confidentiality (Refer Pol-003 for detailed guidelines)
It is the Calibration laboratory’s policy to maintain employee confidentiality in relation
to all business activities. To ensure confidentiality, all staff (permanent or contract)
are required to sign confidentiality agreements on appointment.
Should a third party request information pertaining to any member of Laboratory, no
information will be disclosed without the full written consent of the employee.
In the event where the business is legally obliged to disclose information to a third
party, or an authority having jurisdiction, The laboratory will comply with the law.
The Business ensures that records, data and documentation pertaining to customers
are maintained in confidence. Laboratory publishes procedures regarding the
protection of customer confidentiality and access to facilities. This includes the
protection of electronic data.
6. Document and Record Management
Management maintains adequate data management procedures that incorporate
appropriate security, recording, calculation, validation, authorization, transmittal,
storage and disposal of all operational, technical, and supporting data and related
records.
The Data is stored in two separate storage units indicating the following,
●
●
●
●
Date of the start of the calibration / measurement
Full name of the customer
Calibration / measurement specification range and quantity
Company / Calibration laboratory employees who
has realized the calibration / measurement
Test and calibration results, procedures and inspection reports, product certifications
and the certification of management systems are reported in accordance with
applicable standards, regulatory and client requirements.
Laboratory reports are authorized prior to release by The Head of the Calibration
46
Laboratory or appropriately qualified person and records are maintained to
demonstrate this.
7. ​Equipment and environmental conditions
7.1 Environmental conditions
Laboratory controls its environments in the manner specified for the health and
safety of employees and for the conduct of technical operations for calibrating the
thermometers in climatic chamber.
The Environmental conditions are as follows,
Temperature - 23°C ± 3 °C
Humidity - <70%
Precautions are taken by the Company/Calibration laboratory to avoid excessive
heating during calibrations. If the temperature increases above prescribed level the
calibration has to be stopped ​or may not start until the defined conditions are met
and the environment conditions have to be reset.
7.1.1 Environmental conditions monitoring and recording
Laboratory maintains and records environmental conditions that may have an
influence on the quality of technical operations (testing, inspection, proficiency
testing, and certification) or may have an influence on the health and safety of
Laboratory
employees or visitors. Such controls and their records include
temperature, humidity and supporting services wherever necessary to ensure that
facilities are maintained at the specified conditions for the safe and correct
performance of calibrations, testing, proficiency testing sample preparation,
research, development, consultancy, and training.
7.2 Equipments conditions
All equipment used in the provision of the Company/Calibration Laboratory services
is fit for purpose; uniquely labeled; traceable to the SI; and maintained, stored,
transported and operated in accordance with documented procedures and
instructions. Environmental and equipment operating conditions support the integrity
of the data generated. This includes reference standards, reference materials and
equipment used for subsidiary measurements (such as environmental conditions)
and to equipment used for access and similar uses in facilities or on site.
The Company/Calibration Laboratory ensures the continued capability of its
equipment through preventive maintenance, servicing, inspection and calibration as
appropriate.
47
In the event that existing fixed equipment used for testing or calibration services is
moved from one environment to another or where new equipment is procured for
accredited testing or calibration services, the Company/Calibration Laboratory
informs the appropriate Accreditation Body.
7.3 Equipments availability
All equipment used in the provision of the Company/Calibration Laboratory services
is fit for purpose, uniquely labeled, traceable to the SI.
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber.
The equipment/devices of the Company/Calibration Laboratory are validated and
recalibrated every 3 months. If any discrepancies are found, they are recorded,
documented and a necessary corrective plan is suggested to the management.
If the equipment/devices don’t conform to the guidelines, Calibration process cannot
proceed until these devices operate under the outlined conditions.
The equipment/devices in 5.1 of the document CP-01: Calibration procedure for
temperature indication devices performed in climatic chamber, are available to
designated employees of the Company/Calibration Laboratory.
It is the responsibility of every employee of the Company/Calibration Laboratory to
report any shortage/missing of equipment/devices in order to refill the inventory.
7.4 Equipments requirements, storage, handling, transport and maintenance
The Company/Calibration Laboratory handles and maintains the equipment/devices
as per the guidelines of the manufacturer or the User manual of the
equipment/Device.
Specific manufacturer’s guidance on individual device storage, handling, transport
and maintenance can be found in the following documents
Device name
Purpose of
use
Manufacturer
Model
Serial
No.
Used
Software
version
Relevant
document
DM 01​:
Climatic
48
XXX
Climatic
chamber
Reference
PRT
(Platinum
Resistance
Thermometer
)
Multimeter
Calibration
XXXX
XXXX
XXXX
Chamber
Bedienungsan
leitung​, ​DM
02:​Climatic
Chamber
Betriebsanleitu
ng CTSTouchscreen-B
edienteil
DM 01​:
Calibration
XXXX
XXXX
XXXX
XXX
Calibration
XXXX
XXXX
XXXX
XXX
Climatic
Chamber
Bedienungsan
leitung​, ​DM
02:​Climatic
Chamber
Betriebsanleitu
ng CTSTouchscreen-B
edienteil
DM 03​:
Environmenta
l monitoring
FLUKE1620A
In Case no Guidelines or User manual is available, Then the equipment/devices will
be operated with Environmental conditions,
● Temperature - 23°C ± 3 °C
● Humidity - <70%
The equipment/devices are operated in a stationary position. In case the device
requires transportation, adequate measures are taken to avoid mishandling and
damages to these equipment/devices. And the environmental conditions are reset as
per the guidelines.
In case no User manual or guidelines by the Company/Calibration Laboratory are
stated, the equipment/device shouldn’t be used until the documents are created.
7.4.1
Verification of meeting specified requirements by a device
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
49
chamber are tested and verified before operation.
The equipment/devices are verified initially with test/measurements within a specified
limit.
If the equipment/device fails initial test/measurements it is serviced and retested.
7.4.2
General requirement on used devices
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber are fit for purpose, uniquely labeled, traceable to the SI, fully functional
before being used for calibration/measurement.
The equipment/devices must have a valid calibration certificate.
All of the equipment/devices uncertainty parameters that contribute to the
uncertainty budget have to be determined or provided by the calibration certificate.
The list of devices uncertainty parameters is provided in the section 5.1 of the CP-01
document.
7.4.3
Device accuracy and uncertainty requirements
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber, must be characterised in accordance with the document sections 9.1 and
11.2.
The declared accuracy/uncertainty of devices under use will be ensured by their
individual uncertainty components listed in CP-01 documents section 11.2 that were
determined by the specific calculations listed in section 9.1. These must be stated on
the calibration certificate.
More detailed requirements can be found in the document CP-01.
7.5
Used equipment calibration
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber are fit for purpose, uniquely labeled, traceable to the SI, fully functional and
have a valid calibration certificate.
Every device is verified and recalibrated at least 3 times a year or on a regular basis
depending on the application.
50
7.5.1
Equipment calibration labelling
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber, that were calibrated are uniquely labeled with the information as follows,
● Date of the last calibration
● Date of the next planned calibration
7.6.1 Non-functioning or devices with unusual behaviour
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic
chamber, that are not functioning as per the guidelines SDR-01: ​Specific device
requirements shall be removed from use. The equipment/device is clearly labeled
stating the reason for taking it out of use.
If there is evidence of mishandling(mechanical damage, wrong operation,
overloading etc) of the equipment/devices, an investigation will take place to
determine the actual cause of damage.
Devices that meet the outlined conditions in point 7.6 of the quality manual
document and the document SDR-01: ​Specific device requirements w
​ ill be labelled
with regard to the following points:
● The label will be placed on a clearly visible space on the device
● The label will state the following: “Caution - Not Fit for use”
7.6.2 ​Non-functioning
reintroduction
equipments/devices
with
unusual
behaviour
When a device after non conformity is investigated and the root causes are found
and validated. The device can go back to use only if tested and fit for use in intended
areas and are recalibrated.
7.7 Reference values and correction factors of used equipment
All of the used reference values or correction factors that are listed in the document
CP-01: ​Calibration procedure for temperature indication devices performed in
51
climatic chamber ​(specifically sections 9. and 11.) will be updated regularly with
respect to the calibration period defined by the document DCP- 01:​Device calibration
programme.​
7.8 Preventing the unintended adjustment of equipment
To avoid mishandling and unintended changes to the available equipment/devices
are listed in section 5.1 of the document CP-01: Calibration procedure for
temperature indication devices performed in climatic chamber, the following
measures are taken:
● The initial setup of equipment/device parameters can be done by The Head of
the laboratory or by the technical staff under his supervision.
● The parameters can be changed in unavoidable circumstances by the highest
designated employee available at that time, condition being the changes have
to be verified and validated by The Head of the laboratory/.
● The initial parameters of equipment/devices are recorded before starting
calibration/measurement operations.
● The list of parameters to check are as follows,
● Temperature set points values
● Humidity set points values
● The temperature increase with time
● The total equilibrium time necessary for stabilisation
● Orientation and placement of reference measurement devices
7.9 Used equipment/device records and information
The Company/Calibration Laboratory maintains adequate data management
procedures that incorporate appropriate security, recording, calculation, validation,
authorization, transmittal, storage and disposal of all operational, technical, and
supporting data and related records.
The Data is stored in two separate storage units. One as a printed document and the
other as data on the internal server of the Company/Calibration Laboratory.
Test and calibration results, procedures and inspection reports, product certifications
and the certification of management systems are reported in accordance with
applicable standards, regulatory and client requirements.
The equipment records and information will include the following:
1. Equipment type and name
2. Manufacturers name
52
3. Software and firmware versions
4. Equipment serial number or equivalent
5. Specific equipment calibration certificate (includes calibration dates,
results, calibration interval)
6. Specific equipment manual
7. Location
8. Maintenance plan for specific equipment
9. Damage, malfunction, modification, repair report of specific equipment
Points 1 to 4 :
Are included in this documents section 7.4 as well as in the document CP-01
section 5.1.
Point 5 to 7 :
Are provided in paper form in the data management repository and digitally on the
Company / calibration lab. calibration laboratory server / drive. The specific
calibration intervals for specific devices are provided in the document
DCP-01:​Device calibration programme​.
Point 8 :
Each equipment maintenance plan is provided in the document DMP-01: ​Device
maintenance plan​.
Point 9 :
Incidents connected with equipment that include damage, malfunction, modification
or repair will be recorded in a report that will include the following information:
● Full identification of the affected equipment (Equipment type and
name,manufacturers name, serial number or equivalent)
● Full date and if possible time of the incident
● Full description of the nature of the incident
● Description of the effect on calibration / measurement capabilities of the
device
8. Metrological traceability
The Company/Calibration Laboratory
measurements are traceable to the
International System of Units (SI) (Système international d’unités) wherever the
53
concept is applicable. The Company/Calibration laboratories establish this level of
traceability of their measuring instruments by means of an unbroken chain of
calibrations linking them to relevant primary standards of measurement of
Temperature.
The Traceability is ensured by calibration of each listed measurement device.
Calibrations are done on a regular basis in scheduled intervals listed within the
DCP-01:​Device calibration programme document.
The Company/Calibration Laboratory delivers technically valid results using
approaches and environments that meet or exceed all applicable regulatory
specifications. The Company/Calibration Laboratory reinforces this reputation
through the maintenance of formal third-party recognition schemes, including
accreditations from ILAC-recognized accreditation bodies, approval from designated
regulatory authorities, and formal recognitions of proficiency from accredited
proficiency testing providers.
9.Process requirements
The Company / Calibration laboratory provides metrology services for internal and
external customers.
9.1 Review of requests, tenders and contracts
The review of the product supplied to the customer takes place as in accordance
with the procedure PS-10 Provision of metrological services.
The Head of the Calibration Laboratory with the cooperation of the Employees of the
Company/Calibration Laboratory shall assess the Laboratory’s ability to perform the
specified metrological task before starting the operations.
The Head of the Calibration Laboratory with the cooperation of the Employees of the
Company/Calibration Laboratory selects the latest and validated methods to carry
out the metrological activities to meet the customer requirements.
If there are any issues between the customer needs and Company/Calibration
Laboratory guidelines, This has to be sorted by The Head of the Calibration
Laboratory before starting the metrological activities.
A contract is signed between the customer and the Company/Calibration Laboratory
enabling a legally bound agreement.
54
The Document/Data pertaining to request, review and contracts are stored in two
separate formats. One as a printed document and the other as data on the internal
server of the Company/Calibration Laboratory.
Mutual and signed agreement has to be reached between the customer and
Company/Calibration Laboratory before starting any activity.
55
Code of Ethics
56
Foreword
A code of ethics document outlines the mission and values of the
Company/Calibration Laboratory, how personals are supposed to approach
problems, the ethical principles based on the Company/Calibration Laboratory’s core
values, and the standards to which the professional is held.
Having a code of ethics for the Company/Calibration laboratory isn't simply a good
idea from a moral perspective. It also helps build trust and credibility among the
stakeholders, and enhances the overall brand.
57
Code of Ethics
General Principles
1.
Each employee and partner organisation shall be guided by the highest
standards of ethics, personal honour, engineering or scientific integrity
and professional conduct.
2.
Honesty, integrity, loyalty, fairness, impartiality, candour, fidelity to trust,
and inviolability of confidence, except when required by law, are
incumbent upon the professional conduct of all persons and
organisations associated with the temperature laboratory..
Conduct in Relation to the Public
3.
58
All persons and organisations associated with Temperature Lab:
a.
Shall avoid and discourage sensational, exaggerated and
unwarranted statements with regard to professional matters
and shall not participate in an unsound or illegitimate
undertaking.
b.
Shall not knowingly permit the publication of his/her articles or
reports for an unsound or illegitimate undertaking.
c.
Shall not give a professional opinion, make a report, or give legal
testimony without being as thoroughly informed as might reasonably
be expected considering the purpose for which the opinion, report or
testimony is desired, and the degree of completeness of the
information upon which it is based should be made clear.
d.
Shall not knowingly issue a false statement or false information
even if directed to do so by employer or client.
e.
Shall not falsely or maliciously attempt to injure the
reputation or business of another person or organisation.
f.
Shall freely give credit for work done by others to whom the credit is
due and shall refrain from plagiarism in oral and written
communications, and shall not knowingly accept credit rightfully due
to another.
g.
Shall endeavour to cooperate with others and will encourage
the ethical dissemination of useful knowledge.
h.
Shall not only strive to uphold these standards of ethics in
precept and by example, but also, where necessary, to
encourage by counsel and advice to other persons their
adherence to such standards.
i.
Shall not conduct themselves in any manner that would bring the
temperature Lab into disrepute.
Conduct of Employees in Relation to Employers or Clients
4.
59
All persons employed by the Laboratory or by organisations
associated with Lab:
a.
Shall protect the interest of his/her employer or client so far as it is
consistent with the public welfare and his/her professional
obligations and ethics.
b.
Shall consider alternatives if they find that their obligations to their
employer or client conflicts with their professional obligations or
ethics. They may choose alternatives to have such objectionable
conditions corrected or resign.
c.
Shall disclose to their prospective employer or client the existence of
any interest which they hold, either directly or indirectly, having
pertinent bearing on such employment.
d.
Shall not use, directly or indirectly, any employer's or client's
confidential information in any way which is competitive, adverse or
detrimental to the interests of the employer or client.
e.
Shall not, if retained by one client, accept, without the client's
consent, an engagement by another where there is likely to be a
conflict of interest.
f.
Shall not seek to profit economically from the information gained, if
they have made an investigation for any employer or client, unless
permission to do so is granted, or until it is clear that there can no
longer be a conflict of interest with the original employer or client.
g.
Shall not divulge information provided to him/her in confidence, except
when required to do so by law. Persons employed by organizations
associated with temperature labs which are also regulatory agencies
and “authorities having jurisdiction” within the public sector, may be
required by law to report any contravention of the laws they are
duty-bound to enforce.
h.
Shall engage, or advise their employer or client to engage, and
cooperate with, other experts and specialists whenever the
employer's or client's interest would be best served by such
service.
i.
Shall not accept a concealed fee for referring a client or employer
to a specialist or for recommending professional services other
than their own.
Certification
5.
This is to certify that I have read and understand the above Code and
agree to observe the Code while carrying out duties on behalf of the
Temperature Laboratory. I also agree to abide and uphold the Conflict
of Interest and Confidentiality Guideline.
Name
Witness
Signature
Signature (Witness)
Date
60
Date
Conflict of Interest and Confidentiality
Guideline
61
Conflict of Interest and Confidentiality Guideline
Introduction
1.
This Guideline for The Company/Calibration Laboratory represents
conditions for employees carrying out responsibilities on behalf of The
Company/Calibration Laboratory that could place the individual in a
position of conflict of interest, and/or give them access to confidential
information.
2.
For the purpose of the Guideline, "official" means all persons whose
conduct is affected by this Guideline:
a)
b)
An employee of The Company/Calibration the Company/Calibration
Laboratory;
Any individual under contract, including a personal service contract,
with the Company/Calibration Laboratory
Objective
3.
The objectives of the Guideline are to enhance confidence in the integrity of
individuals representing The Company/Calibration Laboratory:
a)
b)
c)
d)
While encouraging the use of the Company/Calibration Laboratory
expertise
While facilitating interchange between the the Company/Calibration
Laboratory and clients, regulatory agencies, other stakeholders, and
the public;
By establishing clear rules of conduct respecting conflict of interest
applicable to all The Company/Calibration Laboratory
representatives, and
By promoting adherence to the the Company/Calibration Laboratory
Code of Ethics.
4.
Every official shall conform to the The Company/Calibration Laboratory
Code of Ethics and the following principles that articulate the complete
Guideline for The Company/Calibration Laboratory Officials.
5.
Officials shall ensure that they are free from any commercial, financial,
internal and external pressures. They shall also ensure that they do not
take part in any activities that might diminish confidence in The
Company/Calibration Laboratory’s competence, impartiality, judgment or
operational integrity, and that they will not allow any such pressures to
adversely affect the quality of their work
62
6.
Officials shall not knowingly take advantage of, or benefit from,
information that is obtained in the course of their official duties and
responsibilities and that is not generally available to The
Company/Calibration Laboratory employees, clients, or the general
public.
7.
Officials shall avoid commercial or contractual conflicts with the
performance of their duties for The Company/Calibration Laboratory, and
shall disclose to the The Company/Calibration Laboratory General
Manager all involvement in personal, commercial, or professional
activities or contracts that could put them in a position of a real, potential,
or apparent conflict of interest with the performance of their duties.
8.
Officials shall return to the The Company/Calibration Laboratory all
documents and copies relating to the evaluation, assessment or audit of
an organization.
9.
Officials agree that The Company/Calibration Laboratory may disclose to
client’s officials, their involvement in outside activity, that in The
Company/Calibration Laboratory 's opinion, represents a real or apparent
conflict of interest.
10.
Officials agree that if a finding of real or apparent conflict of interest is
made, the official will absent himself/herself from deliberations that relate
to the evaluation, assessment, or audit of an organization.
11.
Officials shall respect and safeguard the confidentiality of all information
obtained in the conduct of their duties, including documents provided by
The Company/Calibration Laboratory and any information personally
observed or obtained, and shall not
disclose any such information to any person without the express written permission
of The Company/Calibration Laboratory or the client, except where required by law.
Indemnification
12.
63
Officials agree that any official responsible for any breach of
confidentiality with respect to information received in their capacity as
“official” shall indemnify The Company/Calibration Laboratory fully for any
damages or loss suffered by The Company/Calibration Laboratory as a
result of said breach.
CONTROL OF DOCUMENTS AND RECORDS
64
Foreword
Document control is the process used to maintain documents that control the design,
operation, maintenance, and configuration of the Company/Calibration laboratory.
Records management is the process for providing evidence of those activities.
65
CONTROL OF DOCUMENTS AND RECORDS
1. Purpose
The Document describes the procedures for the Company / calibration Laboratory to
●
●
●
●
●
●
●
●
Create
Update
Change
Review
Approve
Distribute
Storage and
disposal
Of the documents and records.
This document formally defines the policy to be adhered by all the Employees of the
Company/Calibration Laboratory, when creating and maintaining controlled documents.
The Director of the Company/Calibration laboratory develops the guidelines for this document.
The Head of the Company/Calibration Laboratory creates the procedures in cooperation with
the Management System of the Company/Calibration Laboratory.
Further details are given to ensure:• Sufficient guidance on which documentation is needed to satisfy external regulators
• Documents that may be subject to investigation by external audit teams or regulatory
bodies are ​not ​altered or destroyed.
• Employees have access to the relevant documents.
2. Scope
The procedures described in this document apply to all the standard documents issued by
the Company/Calibration Laboratory. This standard applies to all records required in order to
achieve quality control.
66
3. Roles/Responsibilities
The guidelines are to be followed by every employee of the Company/Calibration Laboratory,
as everyone is involved in the use of documents.
Responsibility for writing controlled documentation is with the Head of the Company /
Calibration Laboratory / Quality manager. Update on the control documents must be approved
by the Head of the Company / Calibration Laboratory / Quality manager.
It is the responsibility of Senior Laboratory Officer/Senior Quality specialist​ ​to:• Assign document and version numbers.
• Organize signature approval.
• Store the document.
• Upload the document on the internal server.
The following personnel/department are responsible for:
● Preparation: Laboratory Offices in cooperation with the Technicians of the
Company/Calibration Laboratory.
● Review : Senior Laboratory Officer/Senior Quality specialist.
● Approval:Head of the Company / Calibration Laboratory / Quality manager or The
Director of the Company/Calibration Laboratory
● Distribution: Junior Laboratory Officer/Junior Quality specialist
The Documents are stored in two separate formats. Signed original documents in a
designated area in Company/Calibration Laboratory and the other as data on the internal
server of the Company/Calibration Laboratory.
Each personal of the Company/Calibration Laboratory is responsible for filing, storage and
maintenance of the records under their charge.
67
4. Processes
4.1. Documents that must be controlled
Formally controlled and approved documentation must be created by the Head of the
Company/Calibration Laboratory and maintained by all the employees of the
Company/Calibration Laboratory for all processes that contribute to the metrological activity.
Relevant processes are defined as – “Any process which influences the metrological activities
of the Company/Calibration Laboratory and can be shown to affect the quality of
calibration/measurement”.
These processes are those which may be subject to action by the Regulatory Authorities, or
are covered by mandatory Quality Standards of the Company / calibration laboratory.
For example;
• Calibration/measurement processes.
• Human resource processes.
• Processes connected to the Supply Chain and correct storage and transportation of
equipment/devices.
• Processes that ensure metrological traceability.
• Tenders,requests and contract processes.
• Training of employees.
• etc
Any documents specifically required by the Quality Standard ISO 17025:2017 or any legal
requirements that specify documents must be produced in a controlled manner.
Risk Analysis: HIGH ​– failing to properly control documents in this category could result in;
• Regulatory action from the Director of the Company/Calibration Laboratory
• Potential Non-Conformities raised by Quality Teams
• Potential threat to ISO 17025:2017 Quality Accreditation
• Legal Action
68
4.2. Documents that may be controlled
Other documentation ​may ​be controlled in this way in order to provide a documentary record
of legal compliance (except where the legal framework outlines specific documentary
requirements) and ensure consistency of method between employees or departments of the
Company/Calibration Laboratory.
The decision on whether to adopt this approach is with the Head of the Company/Calibration
Laboratory based on advice from Legal and Quality Management representatives.
Risk Analysis: MEDIUM ​– Potential for risks as listed in 4.1 above but this is far less likely for
non relevant processes. Not controlling documented processes for key business operations
may lead to lack of clarity and control.
4.3. Documents that do not need to be controlled
Letters and forms using a standard layout to provide a consistent format may be important to
the metrological activities but do not usually need to be controlled. Where the use of a
standard format is mandatory a copy should be included within the process in which it is used.
Risk Analysis: LOW – ​Little risk of regulatory or audit action.
4.4. Summary and Examples
Must be controlled
Category
Relevant processes.
Legal requirements for control
of specific documents.
Documents needed under
ISO 17025:2017.
Documents needed to
demonstrate compliance to
Quality Standards.
Examples
Processes covering the
Supply Chain calibration/measurement
69
May be controlled
Category
SOPs or Work Instructions that
are not relevant. i.e. do not
have an affect on the
calibration/measurement.
Processes that are controlled
to aid consistent methodology
or to demonstrate legal
compliance as decided by the
Directory of the
Company/Calibration
Laboratory.
Examples
Non relevant Company
Policies.
Do not need to be controlled
Category
Documents produced for
convenience that do not
influence the outcome of the
metrological activities.
Examples
Standard letters.
Quote
templates.
integrity and batch
traceability.
Processes covering
sales, marketing and
finance functions.
Forms.
Checklists.
All processes involved in
complaint management.
Training procedures
and records for relevant
processes
Please note examples are not a comprehensive list.
4.5. Naming of the Company/Calibration Laboratory Documents
All mandatory procedures as determined by the ISO 17025 guideline, Company / calibration
Laboratory.
Quality standards, and regulations will be named by the Head of the Company / Calibration
Laboratory as a acronym of the process followed by the relevant number for the procedure
and the name of the process, e.g. Detailed description of the calibration procedure can be
found in the document CP-01: Calibration procedure for temperature indication devices
performed in climatic chamber.
.
All divisional work instructions will be named the Head of the Company / Calibration
Laboratory acronym of type of process followed by the relevant divisions/department’s
abbreviated name for identification purposes.
4.6. Issuing/distributing Company / Calibration Laboratory procedures
Each standard is reviewed and signed by the Head of the Company / Calibration Laboratory
for each employee affected by this standard.
After review and approval is obtained, the standard is issued with a date of issue and a date of
validity. The time between issue and validity is provided to give time for local training of the
employees of the Company / Calibration Laboratory and is dependent on the complexity and
the urgency of the standard in question.
The approved versions of standards are published in the Company / Calibration Laboratory’s
intranet in a password-protected environment. When printed out from the Intranet, the
standards contain a warning that this document is only valid at the time of the printout and that
prior to any official use the Company / Calibration Laboratory intranet has to be checked to
70
verify that it is the current approved document.
In case of a new version, a change history including the changes made from the latest version
are indicated in the “Document Change History” paragraph of the standard.
4.7. Change Control
Requests for changes to standard can be made by anyone. Change-requests must be made
in writing to the Head of the Company / Calibration Laboratory using the CR-001: Change
request form (Appendix I) available on the intranet Document Management system.
The change-request is evaluated and approved or rejected. The decision is communicated in
writing to the person requesting the change.
Depending on the significance and/or urgency of an approved change, a new version of the
corresponding standard is then issued (same procedure as for the original standard) or
several approved changes may be included before a new version is issued.
4.8. Version Control
Management of the Company / Calibration Laboratory in conjunction with the IT Department is
responsible for version control of the standards. The existence of a new version is
communicated via email to all units affected and the new version is published on the
Company / Calibration Laboratory intranet Document Management System.
4.9. Archiving Standards
Retired/obsolete standards are archived by Document Management System and Hard copies
of original SOPs are archived in the Quality Department for 5 years.
4.10. Control of Records
The following records are maintained readily available and stored for the defined time
period.
Name of document
71
Storage location
Retention time
5 years – employee files
1.
Training records
2.
Contracts in force
Management systems
3.
Customer Purchase
Order
Customer Invoice
Custom Documents
Management systems
The Head of the Company /
Calibration Laboratory will keep
a record of training that
employees have attended for 5
years post departure.
Agreements - indefinite
All others - 3 years after
expiration
7 years
Management systems
Management systems
7 years
7 years
Customer Survey
Results
HR
5 years
Quality
Management systems
5 years
HR department
4.
5.
6.
7.
8.
Management Review
Reports
Management Meeting
Minutes
9.
Disposal Records
10.
Return Records
11.
Product Advice
Notices, Product
Safety Notices, Field
Safety Corrective
Action
The Head of the
Company / Calibration
Laboratory Office
Quality
Management systems
Quality
Management systems
Quality
Management systems
5 years
7 years
2 year after expiry of the product
7 years
For all records listed above, the individual storage location must be defined.
The records are to be stored safely and in a protected manner. Safely means that only an
authorized person has the access to the records. Protected manner means the records are
legible and are stored to minimize the deterioration and to prevent loss.
72
Those records stored in an automated data processing system shall have a back-up.
All calibration/ measurement related records listed in the table above are retained for a period
of time equivalent to the design and expected life of the device.
All other records will be retained for a period of time at least equivalent to the lifetime of the
calibration/measurement device as defined in each specific department procedure, but not
less than two years from the date of the calibration/measurement .
4.11. Controlling Adherence to and Effectiveness of Standards
The Head of the Company / Calibration Laboratory with the higher management performs
audits including adherence to and effectiveness of the described standards.
When deficiencies or non-adherence is observed a corrective action plan is requested from
the audited unit and the implementation of the corrective actions is reviewed by checking the
documents or performing a re-audit.
73
Change Request Form
PROJECT DETAILS
Project Name:
Name of the project
against which the change is being requested
Project Manager:
Name of the project
manager responsible for implementing the change
CHANGE DETAILS​©
Change No:
Unique identifier for the
change (as per Change Register)
Change Requester:
Name of person who is
requesting the change
Change Request Date: Date on which this form is
completed
Change Urgency:​ ©
Urgency for undertaking
the change
Change Description:
Brief description of the change requested
Risk Analysis:
List any drivers which necessitate this change
Change Benefits:
Change Costs:
Describe the benefits associated with the change Describe the costs associated with the change
IMPACT DETAILS
Project Impact:
Describe the impact on the project if this change is
/ not implemented
APPROVAL DETAILS​©
Supporting Documentation:
Reference any supporting documentation used to
substantiate this change
The Director or the Head of the Company / Calibration
Laboratory​ ​will create the implementation plan with required documents.
74
Guide to assessing Risk Category
Risk category
Criteria
1 Minor risk / priority
No negative impact on specifications or calibration/measurement
of metrological activities
No risk to the health or safety of the employees of the
Company/Calibration Laboratory
Error is readily apparent to the technician of the
Company/Calibration Laboratory; represents an isolated case, i.e.,
only limited calibration/measurements are affected
Audit recommendation (suggestion for improvement, not
necessarily related to a failure to meet specifications); an audit
observation associated with low risk (isolated deviation regarding a
calibration process or documentation with no further relevance for
the QM system)
2 Major risk / priority
Negative impact on performance characteristics, specifications or
calibration/measurement of metrological activities, but not
categorized as "potentially critical."
Error is difficult or impossible to detect, either by the Laboratory
technician or through internal tests; represents an isolated case,
i.e., only one calibration/measurements is affected
May have an influence on the calibration/measurement of
metrological activities and/or reliability of a
calibration/measurement of metrological activities but no
foreseeable risk to the health or safety of employees.
Audit observations associated with a high risk (individual QM
system elements are not effective, interdepartmental problem,
cumulative or repeated occurrence of minor deviations),
observations by external auditors that do not call certificate into
question
3 Critical risk / priority
Negative impact on performance characteristics, specifications or
calibration/measurement of metrological activities; impact
categorized as "potentially critical" or "critical."
Poses a risk to the health or safety of the employees of the
Company/Calibration Laboratory
75
Error is difficult or impossible to detect, either by the technician or
through internal tests; does not represent an isolated case but is
instead a fundamental quality problem affecting various
products/batches.
Market recall or correction required
Audit observations categorized as critical (the QM system is not
effective, risk of a "warning letter" from authorities or loss of
certification, cumulative or repeated occurrence of major
deviations).
76
Calibration procedure for temperature
indication devices performed in climatic
chamber
77
1.
Introduction
The calibration procedure was specifically developed for the requirements of the
Company/Calibration laboratory. This procedure is designed to be used for internal
calibration services that include the calibration of thermometers with indication function within
a climatic chamber.
●
Method - Comparative calibration by using a reference resistance thermometer. This
calibration procedure respects the measurement methods specified in ISO 17025:2017
standard, metrological recommendations and regulations, including all operations necessary
for the measurement result, including the evaluation of the uncertainty of the calibration
result.
2.
Used standards recommendations and regulations
ISO/IEC Guide 99
International vocabulary of metrology — Basic and general
concepts
and associated terms (VIM)
IEC 60068-3-11:2007
Environmental testing - Part 3-11: Supporting documentation and
guidance - Calculation of uncertainty of conditions in climatic test chambers
IEC 60751:2008
temperature sensors
Industrial platinum resistance thermometers and platinum
JCGM 100:2008
Evaluation of measurement data – Guide to the expression of
uncertainty in measurement
ISO/IEC GUIDE 98-1
Uncertainty of measurement — Part 1: Introduction to the
expression of uncertainty in measurement
ISO/IEC GUIDE 98-3
Uncertainty of measurement — Part 3: Guide to the expression of
uncertainty in measurement
EA-4/02
Expression of the Uncertainty of Measurement in Calibration
EURAMET cg-11
Guidelines on the Calibration of Temperature Indicators and
Simulators by Electrical Simulation and Measurement
OIML R 84
Platinum, copper, and nickel resistance thermometers (for industrial
and commercial use)
OIML G 8
78
Guide to practical temperature measurement
3. Abbreviations and symbols
t
temperature in °C
T
temperature in K
u​A
standard
uncertainty
using
A
method ​u​B
standard uncertainty using
B method ​u​C
combined
standard
uncertainty
U
expanded measurement uncertainty
k
coverage factor
PRT platinum resistance thermometer
4.
Technical requirements
All of the listed technical requirements are related to the internal calibration of temperature
sensors with indication function that displays the temperature value (dominantly in °C) in
electric resistance (Ω) or both. These sensors will be calibrated within a climatic chamber in
the required temperature range.
4.1 Requirements on the laboratory environment
Temperature sensors with indication function are calibrated,
●
●
At the surrounding temperature of 23°C ​±​ ​3 °C
Air humidity should not exceed 70%.
Temperature and humidity is monitored during the calibration process.
When optimal temperature can’t be maintained or exceeds the maximum set level the
calibration process must be stopped and continued after the prescribed temperature conditions
are reached.
Precaution must be taken to avoid any radiation heat from light sources to affect the results.
This can be done by shielding the light source or by covering the climatic chamber window (if
applicable). If there is no transparent opening on the climatic chamber this point is not
relevant and can be omitted.
4.2 Requirements on the laboratory equipment
All ​equipment​/devices used in the provision of the Company/Calibration Laboratory
services should fit for purpose, uniquely labeled, traceable to the SI.
All of the laboratory equipment​/devices ​that are involved in the calibration procedure and
have a measuring function must be calibrated and have a valid calibration certificate.
All of the equipment/devices uncertainty parameters that contribute to the uncertainty
79
budget have to be determined or provided by the calibration certificate. The list of
devices uncertainty parameters is provided in the section 5.1
All of the used ​equipment/devices ​combined with type B uncertainty (see equation 15) that
are used for the calibration / measurement process with respect to the uncertainty budget
provided in section 11.2 should not exceed the value of 0.2 °C.
4.3 Used equipment calibration
The available equipment/devices are listed in section 5.1 of the document CP-01:
Calibration procedure for temperature indication devices performed in climatic chamber
are fit for purpose, uniquely labeled, traceable to the SI, fully functional before being
used for calibration/measurement. ​Each individual device must be calibrated on a regular
basis in accordance with the ​Device calibration programme​.
4.4 Measurement scheme
The scheme of the measurement representing all the used devices with their relation to each
other is presented in the following figure:
Fig.1 Measurement scheme of calibration in climatic chamber
4.5 Requirements on software
The Company/Calibration laboratory results are obtained from analysing gathered data that
was treated by calculation performed by the Excel software.
The detailed calculations and the excel spreadsheets are presented in the Annex 01 of the
document.
All of the calculations by the excel software have been validated by a known set of data
80
against manually calculated results.
5. Calibration method
1.
Calibration of temperature sensors with indication function is done by a comparison
calibration against a reference Platinum Resistance Thermometer (that has an up to date
calibration in the relevant temperature range) in a climatic chamber.
2.
Alternatively calibration can be performed solely by the climatic chamber if its
temperature indicator has a higher resolution than the devices under test and the
temperature sensor was calibrated individually.
The sensor needs to demonstrate that its measurement precision is higher than the sensors
under calibration or its uncertainty contributing to the overall uncertainty budget will not result
in the overstepping of desired expanded calibration uncertainty value (expressed in section
11).
3.
The climatic chambers temperature homogeneity and stability was determined within
its calibration.
5.1 Devices necessary for calibration process
1.
Device
Name
Measurement devices:
Nominal
resistor
value (Ω)
Temperatur
e Range
(℃)
Man
ufact
urer
Model
Serial
No.
Used
Software
Version
Location
2. Devices for the creation of thermostatic environment
Device
Name
Nominal
resistor
value (Ω)
Temperatur
e Range
(℃)
Man
ufact
urer
Model
Serial
No.
Used
Software
Version
Location
Man
ufact
urer
Model
Serial
No.
Used
Software
Version
Location
3. Additional devices
Device
Name
81
Purpose
of Use
Temperatur
e Range
(℃)
6.
Measurement preparatory steps
Preparatory steps prior to measurement:
1.
Evaluate the environmental conditions within the laboratory. Further details listed in
section 4.1.
2.
Evaluation of calibration certificates validity of equipment​/devices​ devices necessary for
the calibration process.
If the calibration certificate of a equipment​/device ​necessary for the calibration process is out
of date it should not be used until it is calibrated.
3.
Verify the equipment​/devices ​for mechanical damage of devices necessary for the
calibration process and devices under calibration.
●
If the equipment​/devices ​necessary for calibration shows any sign of damage it
should be subject to further investigation for internal functionality and indication check. The
failure needs to be reported in the calibration protocol with exact indication to which device
has exhibited the damage.
●
In case of suspicious behaviour about the devices functionally or indication it should
be subject to calibration or repair.
4.
Inspect Fluid levels necessary for proper function of devices necessary for the
calibration process.
5.
Checking and cleaning of dust and moisture condensation on devices necessary for
the calibration process and devices under calibration.
6.
Functionality check of devices necessary for calibration process.
7.
Correct indication check of the reference sensor (PRT or climatic chamber
temperature sensor under conditions listed in section 5. point 2.).
The inspection is done by introducing the sensor to a known temperature and comparing this
temperature to the sensor indication. If the deviation from the known temperature (for
example ice point – which is a mixture of distilled water and crushed ice made also from
distilled water that reproduces 0 °C) is within ±0.5 °C the check is considered as positive and
the reference device can be used.
8.
Connection and communication check of devices necessary for calibration process.
Communication connections for all devices necessary for the calibration process and for all
devices under calibration need to be tested. Usually a test recording over a short period of
time is done together with controlling orders to the relevant devices.
82
Electric connections of all devices necessary for the calibration process and for all devices
under calibration are checked.
7.
Calibration procedure
This calibration procedure can be used only if all of the point 1.to7.of section 6. were properly
addressed.
1.
The equipment/devices that are going to undergo calibration are placed into the
climatic chamber in such a manner that they are not in contact with one another and an air
gap of at least 1.5 cm (from each side) is created.
If a PRT is used as a temperature reference indicator it is placed as well into the climatic
chamber in a position that avoids contact of its sensing element with the body of the climatic
chamber or any other object in it. Its position should be generally identical (ideally in the
center of the chamber working space) during all performed calibration. If the reference sensor
is moved this should be mentioned in the calibration protocol.
2.
After chambers closure the desired calibration temperature is set. The temperature
calibration point should be arranged from the lowest to the highest in order to achieve the
shortest stabilisation times. The set temperature on the climatic chamber controller (display)
should be set as closed to the desired calibration temperature and with regard to the current
calibration certificate of the chamber.
3.
After the climatic chamber controller (display) indication shows a stable temperature
and humidity a stabilization time of 30 min [1] or alternatively based on the inserted devices
under calibration should be applied. The temperature and humidity stabilisation of the
devices under calibration within the climatic chamber can be checked by the temperature
output of the set devices. If an additional reference temperature or humidity sensor is used in
the calibration its indication should be used to determine the stabilisation.
4.
After the temperature and humidity stabilisation is reached for both the sensor under
calibration and of the climatic chamber the recording of the temperature indication from the
reference (either the built in sensor of the climatic chamber or a dedicated reference
temperature sensor) and devices under calibration can begin. The recording should be done
simultaneously for all devices under calibration and for the reference sensor.
The minimum number of measured points for each device after stabilized conditions is 15
recordings.The frequency of recording is set for a minimum of 5s if the devices under
calibration cannot meet this requirement it should be stated in the certificate.
5.
When the measurement at a desired temperature and humidity point is done the point 2.
To
4. are repeated.
83
8.
Calibration protocol
The calibration protocol is a crucial part of the calibration process and must be done for all
calibrations with assigned certificates. The calibration protocol should include the following
information:
▪
▪
▪
▪
▪
▪
▪
▪
etc.)
▪
▪
▪
▪
▪
▪
▪
Measurement identification (eg Calibration of digital thermometers)
Customer for whom the calibration is being realized
Page designation
Text "Confidential" should be visible on the document
Total number of pages
Date of calibration
Calibration conditions (ambient temperature, humidity)
Identification of device under calibration (type of measuring instrument, serial number,
9.
Elaborating of calibration results
Used equipment, its identification (serial numbers, type of equipment, used standards)
Used methodology (calibration procedure name or number)
Measured values and calculations or link where they are located (file name etc.)
Name of the person performing the calibration
Name of the person who evaluated the calibration
Name of the person who reviewed the calibration
Certificate number and assigned calibration mark number (if applicable)
The result of the temperature calibration of devices with indication performed in climatic
chamber is represented by the following equation:
∆𝑡 = 𝑡​𝑑𝑢𝑐 ​− 𝑡​𝑟𝑒𝑓
(1)
where:
𝒕​𝒅𝒖𝒄​–​temperature indicated (in °C or K) by the device under calibration in specific calibration
temperature point calculated from the mean value of recorded data.
𝒕​𝒓𝒆𝒇 ​- temperature indicated (in °C or K) by the temperature reference in specific calibration
temperature point calculated from the mean value of recorded data.
∆𝒕 ​– temperature difference (in °C or K) between the temperature indicated by the device
under calibration and the temperature reference (reference thermometer). This value is
calculated for each individual temperature calibration point individually.
The mean value of recorded data is calculated is by using the following equation:
n
t = 1/n ∑ tix
i=1
84
(2)
where:
𝒕​𝒙​–​mean value of measured temperature data
𝒕​𝒊𝒙​–​individual temperature measurement (applicable for ​𝒕​𝒓𝒆𝒇​or ​𝒕​𝒅𝒖𝒄​)
𝒏​–​total number of temperature measurements
The calibration results based on the calculation presented in this section should be presented
in the calibration certificate according to the following example:
Activi
ty
*​
**​
S/N of
Devic
es
Result
s
Unit
s
Temperature
of the
reference tref *
Temperature
indicated by a
device
*
tduc
𝝙t
U **
,
K=2
Reference
Standard
Used
- ​The indicated value represents a mean value ​t ​of n individual measurements​ ​.
-​Expanded measurement uncertainty with the coverage factor of k=2 that corresponds to a 95% confidence
interval.
When for the determination of ​𝒕​𝒓𝒆𝒇 ​a PRT (Platinum Resistance Thermometer) is used the
temperature indication can be obtained directly by indication device (when temperature
indication is possible) or alternatively it can be calculated from the resistance indication
device from according to IEC 60751:2008. The equations used to convert the PRT resistance
in a specific calibration point to temperature follow:
for measuring range from -200 °C to 0 °C the temperature characteristic of resistance
thermometer is:
𝑅​𝑡 =
​
𝑅​0[​ 1 + 𝐴𝑡 + 𝐵𝑡​2​ + 𝐶(𝑡 − 100°𝐶)𝑡​3​]
(3) and for a measuring range from 0 °C to 850 °C the temperature characteristic is:
𝑅​ =
​
𝑅​0​(1 + 𝐴𝑡 + 𝐵𝑡​2​)
where:
𝑹​𝒕​–​resistance of the PRT at temperature ​t i​ n °C
𝑹​𝟎​–​resistance of the PRT at 0°C
A,B,C​–​PRT constants obtained from calibration
t​–​temperature in °C
85
(4)
9.1.
Measurement evaluation
The measurement made in the course of calibration process in a climatic chamber
composes of two steps:
1.
2.
Determination of temperature within the climatic chamber
Determination of temperature indicated by the device under
calibration Both of the presented steps follow the respected
measurement models:
▪
Measurement model for the determination of temperature within the climatic chamber:
𝑡​
where:
= 𝑡​
𝑐𝑐ℎ ​
𝛿​
+ 𝛿​
𝑟𝑒𝑓​(​ 𝑟𝑒𝑓1 ​
𝑟𝑒𝑓2​)
+ 𝛿​ + 𝛿​
​ ℎ𝑜𝑚 ​ 𝑠𝑡𝑎𝑏
(5)
𝒕​𝒄𝒄𝒉​– temperature within the calibration chamber
𝒕​𝒓𝒆𝒇​– temperature indicated (in °C or K) by the temperature reference in specific
calibration temperature point calculated from the mean value of recorded data.
𝜹​𝒓𝒆𝒇𝟏​– uncertainty assigned to the temperature indication device of reference thermometer
𝜹​𝒓𝒆𝒇𝟐​– resolution of the temperature indication device of reference thermometer
𝜹​𝒉𝒐𝒎​– temperature homogeneity of the climatic chamber
𝜹​𝒔𝒕𝒂𝒃​– temperature stability of the climatic chamber
Uncertainty assigned to the temperature indication device of reference thermometer
(​𝜹𝒓​ 𝒆𝒇𝟏​):
This information is obtained from the calibration certificate assigned to the indication device.
We assume this uncertainty component has a normal distribution. The uncertainty
contribution of this component is calculated according to the following equation:
u( δ ref 1 ) = ucl1 ÷ k1
(6)
​
where:
𝑼​𝑪𝑰𝟏​–​expanded uncertainty of the indication device of the reference thermometer
𝒌​𝟏 ​- value of the coverage factor for normal distribution (​𝑘​1 ​= 1​)
Resolution of the temperature indication device of reference thermometer (​𝜹​𝒓𝒆𝒇𝟐​):
86
This contribution is calculated from the maximum resolution of the temperature indication
device. We assume this uncertainty component has a rectangular distribution.The uncertainty
contribution of this component is calculated according to the following equation:
u( δ ref 1 ) =
0.5Rez Ref
k1
(7)
where:
𝑹𝒆𝒛​𝒓𝒆𝒇 ​- temperature indication device of the reference thermometer resolution (last significant
digit)
𝒌​𝟐​ ​- value of the coverage factor for rectangular distribution (​𝑘​2​ = √3​)
Temperature homogeneity of the climatic chamber (​𝜹​𝒉𝒐𝒎​):
This contribution is obtained from experimental measurements in the climatic chamber (under
same or similar as possible conditions as during calibration) or from a calibration certificate of
the climatic chamber (if temperature homogeneity information is present). The experimental
measurements are realized by two calibrated sensors that one is stationary (placed in the
middle of the climatic chamber volume) and the second one is moved into the climatic
chamber space in axial and radial positions (including the furthest distance from the
stationary sensor). The contribution to the uncertainty budget is taken as the largest
difference from the temperature reading of the first and the second sensor. We assume this
uncertainty component has a rectangular distribution.The uncertainty contribution of this
component is calculated according to the following equations:
​u( δhom ) = ucl2 ÷ k2
(8)
alternatively:
​u(
δ ref 1 ) = Δtmax ÷ k2
(9)
where:
𝑼​𝑪𝑰𝟐​–​expanded uncertainty of the climatic chamber temperature homogeneity
∆𝒕​𝒎𝒂𝒙​–​maximal temperature difference between the stationary and moved sensor temperature
indication
𝒌​𝟐​ ​- value of the coverage factor for rectangular distribution (​𝑘​2​ = √3​)
Temperature stability of the climatic chamber (​𝜹​𝒔𝒕𝒂𝒃​):
This contribution is obtained from experimental measurements in the climatic chamber (under
87
same or similar as possible conditions as during calibration) or from a calibration certificate of
the climatic chamber (if temperature stability information is present). The experimental
measurements are realized by using one stationary calibrated sensor placed in the middle of
the work space of the climatic chamber. The temperature changes in time are monitored (at
least for 2 hours after obvious temperature stabilisation). The contribution to the uncertainty
budget is taken as the difference of the largest temperature measurement points. We
assume this uncertainty component has a rectangular distribution.The uncertainty
contribution of this component is calculated according to the following equations:
alternatively:
where:
​u( δstab ) = ucl3 ÷ k3
(10)
​u( δstab ) = Δtmax ÷ k2
(11)
𝑼​𝑪𝑰𝟑​–​expanded uncertainty of the climatic chamber temperature stability
∆𝒕​𝒕𝒎𝒂𝒙​–​maximal temperature changes in time are monitored (at least for 2 hours after obvious
temperature stabilisation)
𝒌​𝟐​ ​- value of the coverage factor for rectangular distribution (​𝑘​2​ = √3​)
▪
Measurement model for the determination of temperature indicated by the device
under calibration:
𝑡​𝑟𝑑𝑢𝑐 ​= 𝑡​𝑑𝑢𝑐 ​+ ∆𝑡 + 𝛿​𝑑𝑢𝑐1
(12)
where:
𝒕​𝒓𝒅𝒖𝒄​– temperature indicated by the device under calibration taking into account most relevant
influential factors.
𝒕​𝒅𝒖𝒄​– temperature indicated (in °C or K) by the device under calibration in specific calibration
temperature point calculated from the mean value of recorded data.
∆𝒕 ​– temperature difference between the temperature indicated by the device under calibration
and the temperature reference (reference thermometer).
𝜹​𝒅𝒖𝒄𝟏​– resolution of the device under calibration
Temperature difference between the temperature indicated by the device under
calibration and the temperature reference (​∆𝒕​):
This value is calculated for each individual temperature calibration point individually.
Resolution of the device under calibration (​𝜹​𝒅𝒖𝒄𝟏​):
This contribution is calculated from the maximum resolution of the device under calibration.
We assume this uncertainty component has a rectangular distribution.The uncertainty
contribution of this component is calculated according to the following equation:
88
u( δ duc ) =
0.5Rez duc
k1
(13)
where:
𝑹𝒆𝒛​𝒅𝒖𝒄 ​– resolution of the device under calibration (last significant digit)
𝒌​𝟐​ ​- value of the coverage factor for rectangular distribution (​𝑘​2​ = √3​)
10.
Traceability
Traceability of the measurements performed for the purpose of calibration of temperature
indication devices realized in a climatic chamber is ensured by calibration of each listed
measurement device. Calibrations are done on a regular basis in scheduled intervals and are
performed by
laboratories that can demonstrate their calibration and measurement
capabilities provided by national metrology institutes and designated institutes that have been
subject to suitable peer-review processes conducted under the CIPMMRA (International
Committee for Weights and Measures Mutual Recognition Arrangement) or by laboratories
that have been accredited by an accreditation body subject to the ILAC (International
Laboratory Accreditation Cooperation) Arrangement or to Regional Arrangements recognized
by ILAC have demonstrated metrological traceability.
11.
Measurement uncertainty determination
Determination of measurement uncertainty represents the inclusion of the most relevant
influential factors that affect the indicated value by the devices under calibration. These
uncertainty sources are taken from the whole measurement chain that includes all the
devices necessary for the calibration process that are listed in Tables 1. - 3. in section 5.1
and from the effects that influence these devices.
The measurement uncertainty is evaluated in accordance with the document EA-4/02 and it
is expressed in a form of an expanded uncertainty ​U (k=2​), that defines an interval having a
level of confidence of approximately 95 %.
The type A uncertainty corresponds to the standard deviation of the sample average of the
measured values and shall be determined by the relation:
uA =
√
1
n−(n−1)
n
∑ (tix − tx )2
i=1
​
(14)
The type B uncertainty shall be determined by the following equation:
89
uB =
√
n
2
∑ uBi
(15)
i=1
where:
𝒖​𝑩𝒊 ​– individual component of the type B uncertainty
The combined standard uncertainty ​𝑢​𝐶 ​is calculated by the equation:
uc =
√u
2
A
− uB2
(16)
The expanded calibration uncertainty shall be determined by the upcoming equation:
𝑈 = 𝑢​𝐶​. 𝑘
​(17)
where:
𝒌 ​– coverage factor for this specific procedure k=2.
11.1. Measurement uncertainty calculation
The measurement uncertainty of temperature within the climatic chamber measured by a
reference thermometer can be expressed by the following measuring equation:
𝑢(𝑡​𝑐𝑐ℎ​) = √𝑢(𝑡​𝑟𝑒𝑓​)​2​ + 𝑢(𝛿​𝑟𝑒𝑓1​)​2​ + 𝑢(𝛿​𝑟𝑒𝑓2​)​2​ + 𝑢(𝛿​ℎ𝑜𝑚​)​2​ + 𝑢(𝛿​𝑠𝑡𝑎𝑏​)​2
(18)
The measurement uncertainty of a calibration of devices in a climatic chamber can be
expressed by the following measuring equation:
(𝑡​𝑟𝑑𝑢𝑐​) = √𝑢(𝑡​𝑑𝑢𝑐​)​2​ + 𝑢(∆𝑡)​2​ + 𝑢(𝛿​𝑑𝑢𝑐1​)​2
90
(19)
11.2. Measurement uncertainty budget
Table of uncertainty budget for the climatic chamber temperature measured by a
reference thermometer
Stan
dard
unc
ertai
nty
Deg
rees
of
free
dom
Prob
abilit
y
Distr
ibuti
on
Sen
sitivi
ty
Coe
ffici
ent
Unce
rtaint
y
Contr
ibutio
n
𝒙​𝒊
𝒖(𝒙​𝒊​)
𝒗
-
𝑪​𝒊
𝒖​𝒊​(𝒚)
-
[°C]
[°C]
-
-
[°C]
𝑟𝑒𝑓
{𝑡​𝑟𝑒𝑓
}
𝑢(𝑡​𝑟𝑒𝑓​)
0
𝑢(𝛿​𝑟𝑒𝑓1
)
Qu
ant
ity
Esti
mati
on
𝑿​𝒊
𝑡​
𝛿​
𝑟𝑒𝑓
1
𝛿​
𝑟𝑒𝑓
0
2
𝛿​
ℎ𝑜
0
𝑚
𝛿​
𝑠𝑡𝑎
0
𝑏
𝑡​
𝑐𝑐ℎ
-
N​1
Nor
mal
1
∞
Nor
mal
1
𝑢(𝛿​𝑟𝑒𝑓
2​)
∞
Rect
angu
lar
√
3
𝑢(𝛿
𝑢(𝛿​ℎ𝑜
𝑚​)
∞
Rect
angu
lar
√
3
𝑢(𝛿
𝑢(𝛿​𝑠𝑡𝑎𝑏
)
∞
Rect
angu
lar
√
3
𝑢(𝛿
{𝑡​𝑐𝑐ℎ
}
𝑢(𝑡​𝑟𝑒𝑓​)
𝑢(𝛿
𝑟𝑒𝑓1​)
𝑟𝑒𝑓2
)
ℎ𝑜𝑚
)
𝑠𝑡𝑎𝑏
)
√𝑢​2​(
𝑡​𝑐𝑐ℎ​)
{𝑣
}
Table of uncertainty budget for devices calibrated in a climatic chamber
Stan
dard
unc
ertai
nty
Deg
rees
of
free
dom
Prob
abilit
y
Distr
ibuti
on
𝒙​𝒊
𝒖(𝒙​𝒊​)
𝒗
-
[°C]
[°C]
-
𝑑𝑢𝑐
{𝑡​𝑑𝑢𝑐
𝑢(𝑡​𝑑𝑢𝑐
N​-
Qu
ant
ity
Esti
mati
on
𝑿​𝒊
𝑡​
91
Sen
sitivi
ty
Coe
ffici
ent
Unce
rtaint
y
Contr
ibutio
n
-
𝑪​𝒊
𝒖​𝒊​(𝒚)
-
-
[°C]
Nor
1
𝑢(𝑡​𝑑𝑢𝑐
}
∆𝑡
𝛿​
𝑑𝑢𝑐
𝑟𝑑𝑢
𝑐
)
mal
𝑢(∆𝑡)
∞
Rect
angu
lar
√3
𝑢(∆𝑡)
0
𝑢(𝛿​𝑑𝑢
𝑐1​)
∞
Rect
angu
lar
√3
𝑢(𝛿​𝑑𝑢
𝑐1​)
{𝑡​
𝑟𝑑𝑢
}
𝑐​
1
0
1
𝑡​
)
{𝑣
}
√𝑢​2​(𝑡
𝑟𝑑𝑢𝑐​)
The presented uncertainty budget tables should be part of the calibration process for each
individual device under calibration.
12.
Statement of calibration result
The expressed measuring results in the calibration certificate that is presented in section 9.
determines the calibration temperature by means of measured temperature reference​𝑡​𝑟𝑒𝑓 ​that
was done by specific reference standard.
The results furthermore establish the indicated temperature by the device under test and the
difference ​∆𝑡 ​from the temperature reference​𝑡​𝑟𝑒𝑓​.
Expressed expanded measurement uncertainty U is determined by multiplying the combined
standard measurement uncertainty by an expansion coefficient k = 2, which for normal
distribution corresponds to a coverage probability of approximately 95%. The standard
measurement uncertainty was determined in accordance with EA-4/02 M: 2013 and GUM
(BIPM / IEC / ISO / OIML, JCGM 100:2008). The expanded measurement uncertainty takes
into account all the relevant influential factors on the calibration process.
92
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