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TECHNICAL REQUIREMENTS
of
ISO/IEC 17025:2005
Organisation’s
SANAS No/s.
Date/s of
evaluation
Assessor/s &
Observers
Laboratory
Area / field of
operation
Laboratory
Representative
This report covers the following:
Document Review only
Implementation on
Site Visit only
Document Review
Other
and Site Visit
Compliance = C, Non-compliance = NC, Not applicable = NA C
C l a u s e REQUIREMENTS & COMMENTS.
NC
NB1: Comment below on adequacy of how requirements have been addressed, documented and/or
NA
implemented. References to ISO/IEC 17025: 2005 are in italics & indicated as Std. The order of assessment
need not follow the order of the checklist. Assessors are expected to know & have the standard, this
worksheet is designed as guidance to prompt detailed recording of the process.
NB2: Where a clause is marked as NA, reason must be provided as to why it’s not applicable.
REFER TO ISO/IEC 17025: 2005 FOR DETAIL AND FOR CLARIFICATION NOTES.
TECHNICAL REQUIREMENTS
Personnel: How are the following addressed/implemented?
Competence of all who operate specific equipment, perform tests/calibrations, evaluate results,
Note Std sign reports/ certificates. Qualified on basis of appropriate education, training, experience and/or
demonstrated skills. Appropriate supervision of trainees.
5.2.2
Goals education, training, skills. ID training needs, provide training. Evaluate effectiveness of
training. Programme relevant to tasks.
5.2.3
Employed by/under contract. Supervised, competent, work in accordance with lab’s management
system.
5.2.4
Current job descriptions for managerial, technical, key support personnel involved in
Note Std tests/calibrations
5.2.5
Authorize specific personnel to: perform particular types of sampling, test, calibration; issue reports
certificates; give opinions, interpretations; operate particular types of equipment.
Records of authorisation(s), competence, educational, professional qualifications, training, skills,
experience of all technical personnel, including contracted personnel. Dated, readily available.
4.3.2.1 Are personnel who review and approve documents issued as part of the management system
&
authorized to do so?
ILAC
Do the personnel who undertake development and modification of methods have the necessary
G18
technical understanding and knowledge of the technology used?
5
5.2
5.2.1
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5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
Accommodation and Environmental Conditions: How are the following addressed/implemented?
Not invalidate/adversely affect results. Permanent lab/other sites. Requirements documented.
Monitor, control, record where quality of results influenced. Stop work when results jeopardised.
Effective separations between incompatible activities. Measures to prevent cross-contamination.
Access to areas affecting quality of tests/calibrations controlled based on particular circumstances.
Measures taken to ensure good housekeeping. Special procedures prepared where necessary.
4.6 Purchasing of Supplies (e.g. Reference Materials, critical consumables etc.)
4.6.2
Supplies verified prior to use to meet QC requirements prior to use
4.6
System ensures supplies for the uninterrupted performance of work documented and effective –
e.g. stock control, requisitioning, ordering and storage
Test & Calibration Methods & Method Validation: How are the following addressed/implemented?
General. Appropriate for scope. Include sampling, handling, transport, storage, preparation,
Note Std use/operation of equipment. Estimation of measurement uncertainty & statistic techniques for
& See 4.3
analysis of data, where their absence could jeopardize results. Up-to-date and readily available.
Deviations documented, technically justified, authorized, accepted by customer
Selection of methods: How are the following addressed/implemented?
5.4.2
Meet needs of customer, appropriate for tests/calibrations. Prefer international, regional, national
stds. Latest valid edition. Supplements to ensure consistency. By reputable technical
organisations/in relevant scientific texts/journals or specified by the manufacturer of the equipment
Laboratory developed method/s appropriate for intended use and validated.
Customer informed as to the method chosen.
Confirm that it can properly operate standard methods before introducing the tests/calibrations.
Confirmation repeated if standard method changes.
Customer informed when method proposed by customer is considered to be inappropriate or out
of date.
5.4
5.4.1
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Laboratory developed methods: How are the following addressed/implemented?
Introduction of method planned, assigned to qualified persons equipped with adequate resources.
Plans up-dated as development proceeds, effective communication amongst all persons involved.
Non-standard methods: How are the following addressed/implemented?
5.4.4
Note in
Agreement with the customer, include clear specification of the customer’s requirements and the
Std
purpose of the test and/or calibration. Validated appropriately before use.
Validation of methods: Confirmation by examination and provision of objective evidence that
5.4.5
5.4.5.1 particular requirements for specific intended uses are fulfilled.
5.4.5.2 Validate non-standard methods; laboratory-developed methods; standard methods used outside
Notes Std intended scope; amplifications/modifications of standard methods. As extensive as is necessary
for application/field of application. Record results, procedure, statement of fitness for intended use.
5.4.5.3 Range and accuracy as assessed for the intended use relevant to the customer’s needs. (e.g. the
Notes Std uncertainty, detection limit, selectivity, linearity, repeatability, reproducibility, robustness )
5.4.3
Estimation of Uncertainty of Measurement: How are the following addressed/implemented?
Test & calibration labs; uncertainty procedure for all calibrations and types of calibrations.
Testing laboratories, identification of all the components of uncertainty & reasonable estimation is
NB Notes attempted. Reporting of results do not give wrong impression of uncertainty. Estimation based on
in Std
knowledge of performance of method, measurement scope, and validation data.
5.4.6.3 All uncertainty components of importance in the given situation taken into account using
Notes Std appropriate methods of analysis.
5.4.6
5.4.6.1
5.4.6.2
Control of data: How are the following addressed/implemented?
Calculations and data transfers subject to appropriate checks in a systematic manner. (Eg.
Scientific notation & rounding-off policy)
5.4.7.2 Electronic equipment for acquisition, processing, recording, reporting, storage or retrieval of data
a)
software developed by user documented in sufficient detail, suitably validated as adequate for use.
b)
procedures for integrity & confidentiality of data entry, collection, storage, transmission, processing
c)NoteStd computers/automated equipment, proper functioning, conditions to maintain the integrity of data.
5.4.7
5.4.7.1
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5.5
5.5.1
5.5.2
See 5.6
5.5.3
5.5.4
5.5.5
a)
b)
c)
d)
e)
f)
g)
h)
5.5.6
Note Std
5.5.7
see 4.9
5.5.8
5.5.9
5.5.10
5.5.11
5.5.12
Equipment: How are the following addressed/implemented?
All required equipment & its software, including that outside its permanent control available.
Capable of achieving accuracy required, comply with relevant specifications. Calibration
programmes for key quantities having significant effect on results. Calibrated/checked before use
Operated by authorized personnel. Up-to-date instructions use, maintenance readily available.
Each item significant to the result, when practicable, uniquely identified.
Records maintained of each item significant to the tests and/or calibrations performed.
the identity of the item of equipment and its software
the manufacture’s name, type identification, and serial number or other unique identification
checks that equipment complies with the specification(see 5.5.2);
the current location, where appropriate
the manufacturers instructions, if available, or reference to their location
dates, results, reports/certificates, adjustments, acceptance criteria, 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
Procedures for safe handling, transport, storage, use and planned maintenance of measuring
equipment to ensure proper functioning and in order to prevent contamination or deterioration.
Defective Equipment, prevented from use until shown by calibration or test to perform correctly.
Examine effect of defect on previous tests/calibrations, Control non-conforming work procedure.
When practicable identified to indicate calibration status, date last calibrated, re-calibration due.
Outside direct control, ensure function & calibration checked, satisfactory before returned to use.
Intermediate checks to maintain confidence in calibration status carried out to defined procedure.
Calibrations' correction factors, procedures to ensure copies (eg in software) are correctly updated
Equipment, hardware and software, safeguarded from adjustments, which would invalidate results.
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5.6
5.6.1
Note Std
5.6.2
5.6.2.1
5.6.2.1.1
Notes in
Std
See also
5.10.4.2
5.6.2.1.2
5.6.2.2
5.6.2.2.1
Note Std
5.6.2.2.2
Measurement Traceability: How are the following addressed/implemented?
General All equipment, including for subsidiary measurements having a significant effect on
validity of results, calibrated before being put into service.
Established programme and procedure for the calibration of its equipment.
Specific requirements
Calibration: How are the following addressed/implemented?
Calibration laboratories, programme to ensure traceablility to International System of Units (SI).
Stds & instruments to SI by unbroken chain of comparisons link to primary standards.
Use laboratories demonstrating competence, measurement capability and traceability.
Certificates contain results, uncertainty / statement of compliance with identified metrological spec.
Calibration providing confidence in measurement by establishing traceability to standards such as:
Certified reference materials provided by a competent supplier
Specified methods and/or consensus standards that are clearly described, agreed by all parties.
Participation in a suitable programme of inter-laboratory comparisons where possible.
Testing: How are the following addressed/implemented?
Measuring & test equipment with measuring functions apply 5.6.2.1, unless calibration contributes
little to total uncertainty of test result. Equipment providing uncertainty of measurement needed.
SI not possible, then certified reference materials, agreed methods, consensus standards, 5.6.2.1.2
Reference standards and reference materials: How are the following addressed/implemented?
Reference standards. Programme & procedure for calibration, traceable. Used for calibration only
unless not invalidated. Calibrated before and after any adjustment
5.6.3.2 Reference materials. Traceable to SI units/to certified reference materials. Internal checked
5.6.3.3 Intermediate cheeks. Checks to maintain confidence in calibration status of reference, primary,
transfer/working standards, reference materials according to defined procedures and schedules
5.6.3.4 Transport and storage. Procedures for safe handling, transport, storage and use in order to
Note Std prevent contamination or deterioration and to protect their integrity
5.6.3
5.6.3.1
Sampling: How are the following addressed/implemented?
Sampling plan & procedures available at the location where sampling is undertaken.
Notes Std Based on appropriate statistical methods, address factors to control to ensure validity of results.
5.7.2
Customer required deviations, recorded in detail with sampling data, results, communicated to all
staff.
5.7.3
Records of data & operations, procedure, sampler, environmental conditions, location, statistics
5.7
5.7.1
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Handling of Test and Calibration Items: How are the following addressed/implemented?
Transport, receipt, handling, protection, storage, retention, disposal, protect integrity/ interests
Identify, for life of item, not confuse, accommodate sub-division and transfer of items.
Departures recorded on receipt. Where doubt consult customer before proceeding and record
Avoid deterioration, loss/damage storage, handling, preparation. Follow instruction. Environmental
Notes Std conditions maintained, monitored, recorded. Storage secure, protect condition and integrity.
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.9
5.9.1
Assuring the Quality of Test & Calibration Results: How are the following addressed/implemented?
QC procedures to monitor validity of results, data recorded, trends, statistics. Planned & reviewed:
Note Std
a)
b)
c)
d)
e)
5.9.2
regular use of certified reference materials and/or secondary reference materials.
participation in inter-laboratory comparison or proficiency-testing programmes.
replicate tests or calibrations using the same or different methods.
re-testing or re-calibration of retained items.
correlation of results for different characteristics of an item.
QC data analysis. Action plan for incorrect results. Preventing the reporting of incorrect results.
Reporting the Results: How are the following addressed/implemented?
General
Notes Std Accurate, clear, unambiguous, objective, in accordance with specific instructions in methods.
Information requested by client & for interpretation of results Refer 5.10.2, and 5.10.3 or 5.10.4.
Internal customers/written agreement, report simplified. Information 5.10.2 to 5.10.4 readily
available
5.10
5.10.1
Signed :
Lead/Technical
Assessor
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Date
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