Accreditation – ISO/IEC 17025
Rüdiger Kaus
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
What is Accreditation ?
(According to ISO/IEC 17025)
 Confirmation of competence of a testing or
calibration laboratory by an independent
third party, the accreditation body
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Accreditation Body
 Usually there are national regulations for one
or several accreditation bodies in each
country
 There is cooperation between accreditation
bodies in international organisations
 Europe: European Accreditation Cooperation (EA)
 Worldwide: International Laboratory Accrediation
Cooperation (ILAC)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
International Multilateral Agreement
Between Accreditation Bodies
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Accreditation Procedure
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Application to the accreditation body
Contract with the accreditation body
Nomination and commissioning of assessors
Technical audit of the application documents
On-site laboratory assessment
If necessary proficiency testing
Assessment report
Inspection of the report in the sectoral
committee
 Accreditation decision
 Publication
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
ISO/IEC 17025
“General requirements for the
competence of testing and
calibration laboratories”
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
ISO/IEC 17025:1999
 addresses the technical competence of
laboratories to carry out specific tests
and is used by laboratory accreditation
bodies world wide as the core
requirements for the accreditation of
laboratories.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Contents of ISO 17025 - I
Foreword
1 Scope
2 Normative references
3 Terms and definitions
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Contents of ISO 17025 - II
4 Management requirements
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
Organization
Quality System
Document control
Review of requests, tenders and contracts
Subcontracting of tests and calibrations
Purchasing Services and supplies
Service to the client
Complaints
Control of nonconforming testing and/or calibration work
Corrective action
Preventive action
Control of records
Internal audits
Management reviews
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Contents of ISO 17025 - III
5 Technical requirements
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Contents of ISO 17025 - IV
Annex A (informative)
Nominal Cross-references to ISO 9001 :1994
and ISO 9002 :1994
Annex B (informative)
Guidelines for establishing applications for
specific fields
Bibliography
Annex ZA (normative)
Normative references to international
publications with their relevant European
publications
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Chapter 1 of ISO 17025: Scope
 A laboratory may apply quality assurance
procedures according to ISO/IEC 17025 to all
(or part) of its operations.
 Where a laboratory claims compliance
against or certification or accreditation to a
particular standard, it is important to be clear
to what this compliance, certification or
accreditation applies.
 The formal statement of the activities, which
have been certified against ISO 9001, or
accredited against ISO 17025 is known as the
"scope".
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Scope of ISO/IEC 17025 - I
 Quality management is supported by a
clear statement of activities,
 which ideally should define the range of
work covered,
 without restricting the laboratory's
operation.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Scope of ISO/IEC 17025 - II
 is typically defined in terms of:
 range of products, materials or sample
types
 measurements (or types of measurements)
 specification or
method/equipment/technique
 concentration range and uncertainty
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Chapter 4 of ISO 17025
“Management requirements”
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization (Ch. 4.1)
 legal responsibility (4.1.1)
 meeting the requirements of this International
Standard, satisfying the needs of the client,
the regulatory authorities or organizations
providing recognition (4.1.2)
 The management system shall cover work
carried out in all facilities:
 laboratory's permanent facilities,
 at sites away from its permanent facilities,
 or in associated temporary or mobile facilities
(4.1.3)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization (Ch. 4.1)
 Responsibilities of key personnel shall
be defined in order to identify potential
conflicts of interest (4.1.4)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization (Ch. 4.1)
 Requirements on the laboratory (4.1.5) (1 of 3)
 managerial and technical personnel with the
authority and resources needed to carry out their
duties …
 management and personnel free from any undue
internal and external commercial, financial and
other pressures and influences that may adversely
affect the quality of their work
 policies and procedures to ensure the protection
of its clients' confidential Information and
proprietary rights…
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization (Ch. 4.1)
 Requirements on the laboratory (4.1.5) (2 of 3)
 policies and procedures to avoid involvement in
any activities that would diminish confidence in its
competence, impartiality judgement or operational
integrity
 define the organization and management structure
of the laboratory, its place in any parent
organization, and the relationships between
quality management, technical operations and
support services
 specify the responsibility, authority and
interrelationships of all personnel who manage,
perform or verify work affecting the quality of the
tests and/or calibrations
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Organization (Ch. 4.1)
 Requirements on the laboratory (4.1.5) (3 of 3)
 adequate supervision of testing and calibration
staff, …
 technical management with overall responsibility
for the technical operations …
 appoint a member of staff as quality manager …
 appoint deputies for key managerial personnel
Individuals may have more than one function and it may be
impractical to appoint deputies for every function.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality System (Ch. 4.2)
 Establishing, implementing and maintaining a
quality system appropriate to the scope of its
activities.
 Documenting its policies, systems,
programmes, procedures and instructions to
the extent necessary to assure the quality of
the test and/or calibration results.
 The system's documentation shall be
communicated to, understood by, available to,
and implemented by the appropriate
personnel. (4.2.1)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality System (Ch. 4.2)
 Quality manual (4.2.2)
 The laboratory's quality system policies
and objectives shall be defined in a quality
manual (however named).
 Quality policy statement
(4.2.2)
 The overall objectives shall be documented
in a quality policy statement. The quality
policy statement shall be issued under the
authority of the chief executive.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality System (Ch. 4.2)
 Contents of the quality policy statement
(4.2.2) (1 of 3)
It shall include at least the following:
 the laboratory management's commitment
to good Professional practice and to the
quality of its testing and calibration in
servicing its clients
 the management‘s Statement of the
laboratory's Standard of Service
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality System (Ch. 4.2)
 Contents of the quality policy statement (4.2.2)
(2 of 3)
 the objectives of the quality system;
 a requirement that all personnel concerned with
testing and calibration activities within the
laboratory familiarize themselves with the quality
documentation and implement the policies and
procedures in their work; and
 the laboratory management's commitment to
compliance with this International Standard.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality System (Ch. 4.2)
 Contents of the quality policy statement (4.2.2)
(3 of 3)
 The quality policy statement should be concise
and may include the requirement that tests and/or
calibrations shall always be carried out in
accordance with stated methods and clients'
requirements.
 When the test and/or calibration laboratory is part
of a larger organization, some quality policy
elements may be in other documents.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Quality Manual (Ch. 4.2.3 and 4.2.4)
 The quality manual shall include or make
reference to the supporting procedures
including technical procedures.
 It shall outline the structure of the
documentation used in the quality system.
 The roles and responsibilities of technical
management and the quality manager,
including their responsibility for ensuring
compliance with this International Standard,
shall be defined in the quality manual.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Control (Ch. 4.3)
 General (4.3.1)
(1 of 2)
 The laboratory shall establish and maintain
procedures to control all documents that
form part of its quality system  Master list
(internally generated or from external sources)
 such as regulations, standards, other
normative documents, test and/or
calibration methods, as well as drawings,
software, specifications, instructions and
manuals.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Control (Ch. 4.3)
 General (4.3.1) (2 of 2)
 In this context "document" could be policy
statements, procedures, specifications, calibration
tables, charts, text books, posters, notices,
memoranda, software, drawings, plans, etc.
 These may be on various media, whether
hardcopy or electronic, and they may be digital,
analog, photographic or written.
 The control of data related to testing and
calibration is covered in 5.4.7. The control of
records is covered in 4.12.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Basis Documents  Proof Documents
Differences
 Basis Documents
(4.2.3 quality manual and
4.3 Document control)
 Requirements or
prerequisites
 Target
 Changeable
 Valid for a longer
period
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
 Proof Documents
(4.12 Control of records)
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Proof
Actual stock
Not changeable
Valid for a single
incident
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Approval and Issue
(Ch. 4.3.2)
 Review of the documents (4.3.2.1)
 The procedure(s) adopted shall ensure that:
 authorized editions of appropriate documents are
available at all locations where operations essential to
the effective functioning of the laboratory are performed;
 documents are periodically reviewed and, where
necessary, revised to ensure continuing suitability and
compliance with applicable requirements;
 invalid or obsolete documents are promptly removed
from all points of issue or use, or otherwise assured
against unintended use;
 obsolete documents retained for either legal or
knowledge preservation purposes are suitably
marked. (4.3.2.2)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Document Control (Ch. 4.3)
 Quality system documents generated by
the laboratory shall be uniquely
identified (4.3.2.3)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Review of Requests, Tenders
and Contracts (Ch. 4.4)
 Policies and procedures (4.4.1)
 Records of reviews (4.4.2)
 Review for repetitive routine tasks
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Subcontracting of Tests and
Calibrations (4.5)
Purchasing Services and
Supplies (4.6)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Service to the Client (Ch. 4.7)
 The laboratory shall afford clients and
their representatives cooperation to
clarify the client's request and to
monitor the laboratory's performance
relation to the work performed,
 provided that the laboratory ensures
confidentiality to other clients.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Ensuring the Quality
 Complaints (4.8)
 Control of nonconforming testing and/or
calibration work (4.9)
 Corrective action (4.10)
 Preventive action (4.11)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Control of Records (Ch. 4.12)
 The laboratory shall establish and maintain
procedures for identification, collection,
indexing, access, fixing, storage,
maintenance and disposal of quality and
technical records. (4.12.1.1)
 Quality records shall include reports from
internal audits and management reviews as
well as records of corrective and preventive
actions.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Internal Audits (Ch. 4.13)
 The laboratory shall periodically and in
accordance with a predetermined
schedule and procedure
 conduct internal audits of its activity
 to verify that its operations continue comply
with the requirements of the quality system
and this International Standard. … (4.13.1)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Management Reviews (Ch. 4.14)
 Laboratory's executive management
shall periodically conduct a review
about the laboratory's quality system
testing and/or calibration activities:
ensure their continuing suitability
effectiveness, and to introduce
necessary changes or improvements.
(4.14.1)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Management Reviews (Ch. 4.14)
 Review shall take into account (4.14.1):
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the suitability of policies and procedures
reports from managerial and surveyor personnel
the outcome of recent internal audits
corrective and preventive actions
assessments by external bodies
the results of interlaboratory comparisons or
proficiency tests
changes in the volume and type of the work
client feedback
complaints
other relevant factors, such as quality control
activities, resources and staff training.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Management Reviews (Ch. 4.14)
 A typical period for conducting a management review
is once every 12 months.
 Results should feed into the laboratory planning
system and should include the goals, objectives and
action plans for the coming year.
 A management review includes consideration of
related subjects at regular management meetings.
 Findings from management reviews and the actions
that arise from them shall be recorded. The
management shall ensure that those actions are
carried out within an appropriate and agreed
timescale. (4.14.2)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Chapter 5 of ISO 17025
“Technical Requirements”
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
General (Ch. 5.1)
 Factors which determine the correctness and
reliability of the tests and/or calibrations
performed by a laboratory (5.1.1)
 human factors (5.2)
 accommodation and environmental conditions (5.3)
 test and calibration methods and method
validation (5.4)
 equipment (5.5)
 measurement traceability (5.6)
 sampling (5.7)
 the handling of test and calibration items (5.8)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
General (Ch. 5.1)
 Influence to the total uncertainty (5.1.2)
 The extent to which the factors contribute to the
total uncertainty of measurement differs
considerably between (types of) tests and
between (types of) calibrations.
 The laboratory shall take account of these factors
in developing test and calibration methods and
procedures, in the training and qualification of
personnel, and in the selection and calibration of
the equipment it uses.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Personnel (Ch. 5.2)
 Requirements for personnel (5.2.1)
 Ensuring the competence of all who operate
specific equipment, perform tests and/or
calibrations, evaluate results, and sign test
reports and calibration certificates.
 Personnel certification: the laboratory is
responsible for fulfilling specified personnel
certification requirements.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Personnel (Ch. 5.2)
 Training programme (5.2.2)
 Supervising additional personnel (5.2.3)
 Authorization (5.2.5)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Accommodation and
Environmental Conditions (Ch. 5.3)
 Laboratory facilities (5.3.1)
 Monitoring the environmental conditions
(5.3.2)
 Tests and calibrations shall be stopped when the
environmental conditions jeopardize the results of
the tests and/or calibrations.
 (Remember: “No data is better than poor data”)
 Preventing cross-contimination (5.3.3)
 Access to the laboratory (5.3.4)
 Good housekeeping (5.3.5)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Test and Calibration Methods
and Method Validation (Ch. 5.4)
 General (5.4.1)
 Using appropriate methods and procedures for all
tests and/or calibrations within its scope.
 The laboratory shall have instructions on the use
and operation of all relevant equipment, and on
the handling and preparation of items for testing
and/or calibration,
 shall be kept up to date and shall be made readily
available to personnel
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Test and Calibration Methods
and Method Validation (Ch. 5.4)
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Selection of methods (5.4.2)
Laboratory developed methods (5.4.3)
Non-standard methods (5.4.4)
Validation of methods (5.4.5)
Estimation of uncertainty of
measurement (5.4.6)
 Control of data (5.4.7)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Equipment (Ch. 5.5)
Records of Equipment (5.5.5)
The records shall include at least the following:
 the identity of the item of equipment and its software
 the manufacturer's name, type identification, and serial number
or other unique identification
 checks that equipment complies with the specification
 the current location, where appropriate
 the manufacturer's instructions, if available, or reference to their
location
 dates, results and copies of reports and certificates of all
calibrations, adjustments, acceptance criteria, and the due date
of next calibration
 the maintenance plan, where appropriate, and maintenance
carried out to date
 any damage, malfunction, modification or repair to the
equipment
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Measurement Traceability (Ch. 5.6)
 The laboratory shall have an established
programme and procedure for the calibration
of its equipment.
 Such a programme should include a system
for selecting, using, calibrating, checking,
controlling and maintaining measurement
standards, reference materials used as
measurement standards, and measuring and
test equipment used to perform tests and
calibrations. …
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Measurement Traceability (Ch. 5.6)
 Specific requirements
(5.6.2)
 for calibration laboratories
 traceable to the International System of Units
(SI) (Systeme international d'unites). (5.6.2.1.1)
 Testing (5.6.2.2)
 Reference standards and reference
materials (5.6.3)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Further Chapters
 Sampling (Ch. 5.7)
 Handling of test and calibration items
(Ch. 5.8)
 Assuring the quality of test and
calibration results (Ch. 5.9)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
shall be reported
 accurately,
 clearly,
 unambiguously
 objectively
 in accordance with any specific
instructions in the test or calibration
methods.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Test Reports and Calibration Certificates
(5.10.2) (1 of 2)
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Each test report or calibration certificate shall include at least
the following information, unless the laboratory has valid
reasons for not doing so:
a title (e.g. "Test Report" or "Calibration Certificate")
the name and address of the laboratory, and the location where
the tests and/or calibrations were carried out, if different from the
address of the laboratory
unique identification of the test report or calibration certificate
(such as the serial number), and an each page an identification
in order to ensure that the page is recognized as a part of the
test report or calibration certificate, and a clear identification of
the end of the test report or calibration certificate
the name and address of the client
identification of the method used
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Test Reports and Calibration Certificates
(5.10.2) (2 of 2)
 a description of, the condition of, and unambiguous identification
of the item(s) tested or calibrated
 the date of receipt of the test or calibration item(s) where this is
critical to the validity and application of the results, and the
date(s) of performance of the test or calibration
 reference to the sampling plan and procedures used by the
laboratory or other bodies where these are relevant to the
validity or application of the results
 the test or calibration results with, where appropriate, the units
of measurement
 the name(s), function(s) and signature(s) or equivalent
identification of person(s) authorizing the test report or
calibration certificate
 where relevant, a statement to the effect that the results relate
only to the items tested or calibrated
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Test Reports and Calibration Certificates
(5.10.2) (1 of 2)
 Hard copies of test reports and calibration
certificates should also include the page
number and total number of pages.
 It is recommended that laboratories include a
statement specifying that the test report or
calibration certificate shall not be reproduced
except in full, without written approval of the
laboratory
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Test Reports (5.10.3)
 In addition to the requirements listed in 5.10.2, test
reports shall, where necessary for the interpretation
of the test results, include the following:
 deviations from, additions to, or exclusions from the test
method, and information an specific test conditions, such as
environmental conditions;
 Where relevant, a statement of compliance/non-compliance
with requirements and/or specifications; where applicable, a
statement on the estimated uncertainty of measurement;
information on uncertainty is needed in test reports when it is
relevant to the validity or application of the test results, when
a client's instruction so requires, or when the uncertainty
affects compliance to a specification limit; where appropriate
and needed, opinions and interpretations (see 5.10.5);
 additional information which may be required by specific
methods, clients or groups of clients. (5.10.3.1)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Test Reports (5.10.3)
 the results of sampling shall include the following,
where necessary for the interpretation of test results:
 the date of sampling
 unambiguous identification of the substance, material or
product sampled (including the name of the manufacturer,
the model or type of designation and serial numbers as
appropriate)
 the location of sampling, including any diagrams, sketches or
photographs
 a reference to the sampling plan and procedures used
 details of any environmental conditions during sampling that
may affect the interpretation of the test results
 any standard or other specification for the sampling method
or procedure, and deviations, additions to or exclusions from
the specification concerned. (5.10.3.2)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Calibration Certificates (5.10.4)
 shall include:
 the conditions (e.g. environmental) under which
the calibrations were made that have an influence
an the measurement results
 the uncertainty of measurement and/or a
statement of compliance with an identified
metrological specification or clauses thereof
 evidence that the measurements are traceable
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Opinions and Interpretations (5.10.5)
 Documenting the basis upon which the
opinions and interpretations have been
made
 Opinions and interpretations shall be
clearly marked as such in a test report.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Opinions and Interpretations (5.10.5)
 No confusion with inspections and product
certifications as intended in ISO/IEC 17020
and ISO/IEC Guide 65 (5.10.5 Note 1)
 Possible contents:
 an opinion on the statement of compliance/noncompliance of the results with requirements
 fulfilment of contractual requirements
 recommendations and how to use the results
 guidance to be used for improvements (5.10.5 Note 2)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
 Testing and calibration results obtained
from subcontractors (5.10.6)
 Clear Identification
 Electronic transmission of results (5.10.7)
 Requirements of this International
Standard shall be met (see also 5.4.7)
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Format of Reports and Certificates
(5.10.8)
 Accommodating each type of test or
calibration carried out
 Minimizing the possibility of
misunderstanding or misuse.
 Headings should be standardized as far
as possible.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Reporting the Results (Ch. 5.10)
Amendments to Test Reports and
Calibration Certificates (5.10.9)
 Material amendments should include the
statement:
 "Supplement to Test Report [or Calibration
Certificate], serial number ... [or as otherwise
identified]", …
 When it is necessary to issue a complete new
test report or calibration certificate, this shall
be uniquely identified and shall contain a
reference to the original that it replaces
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching
Summary
 Accreditation according to ISO/IEC
17025 is not an easy task, especially
when done for the first time. But it
assures most customers a feeling of
quality and correct procedures.
Kaus, R.: Accreditation – ISO/IEC 17025
In: Wenclawiak, Koch, Hadjicostas (eds.)
© Springer-Verlag Berlin Heidelberg 2003
Quality Assurance in Analytical Chemistry – Training and Teaching