Comparison of accreditation requirements between ISO/IEC 17025 and
ANSI/NCSL Z540.3
National Cooperation for Laboratory National Cooperation for Laboratory AccreditationAccreditation
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Ryan Fischer Calibration Program ManagerLaboratory Accreditation Bureau
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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T opics to be covered•Finding L aboratories in com pliance w ith 5.3
of Z540.3 w ith IS O /IEC 17025 Accreditation•U sing Appendix F of the Handbook•P rogram R equirem ents for an AB•Cooperation for Consistency•T hird P arty N ational R ecognition
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• Accreditation is defined as a third-party attestation related to a conform ity assessm ent body conveying form al dem onstration of its com petence to carry out specific conform ity assessm ent tasks
• Accreditation Bodies (ABs) are authoritative bodies that perform s accreditation
• ABs attest that the laboratories they assess are technically com petent for the item s they calibrate or test on their scope.
Accreditationdefinitions derived from IS O /IEC 17000
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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• Accreditation Bodies (ABs) currently accredit labs to a defined scope per param eter/item /device, etc. • In recognition of a successful assessm ent , L A BO R AT O R Y N AM E has been accredited to IS O /IEC
17025:2005 and found in com pliance w ith AN S I/N CS L Z540.3 – 2006 to perform the follow ing Calibrations:
• Additionally the AB m ay develop sector specific and/or supplem ental requirem ents (or standards) to find the laboratory(s) in conform ance w ith, external to 17025 (i.e. Z540.3, etc), to m eet laboratories, S pecifiers, and/or R egulators needs.
• AB’s have done this for years, Z540-1 is one of them .
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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N ACL A (N ational Cooperation for L aboratory Accreditation) is a third party national recognition body specified by R egulators and S pecifiers w ith national accreditation interests. N ACL A w as asked to
Establish a N ACL A evaluation procedure for the recognition of organizations (e.g. accreditation bodies or other organizations,such as registrars, etc.) that seek to provide statem ents of conform ity for calibration system s found to be in com pliance w ith the N ational S tandard, AN S I/N CS L Z540.3.
N ACL A form ed a Z540.3 T echnical Com m ittee for all stakeholders to m eet the needs of the request from a S pecifier
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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U sing the A ppendix F of the Handbook to develop P rogram R equirem ents
T o develop P rogram R equirem ents, ABs typically do a “cross-w alk” of the root standard (IS O /IEC 17025 to the S upplem ental requirem ents)T he Com m ittee has done this and identified for the w hole Z540.3 (over 17025):•19 Clauses are Additional R equirem ent•3 Clauses m ay be Additional R equirem ents•1 Clause m ay not be an Additional R equirem ent•52 Clauses are not additional R equirem ents•11 N otes (N ot requirem ents)
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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ANSI/NCSL Z540.3-2006 Sub-clause 5.3 Topics ANS/ISO/IEC 17025 Relevant Sub-clauses and171 Committee Comments
5.3 Calibration of measuring and test equipmentCalibration of measuring and test equipment shall be in accordance with the requirements of this National Standard. Calibration may be performed within or outside a designated calibration facility, e.g., in situ, on-site, or at a customer’s facility, provided compliance with the requirements of this National Standard is maintained. The scope of the calibration capability shall be consistent with the calibration requirements and provide levels of measurement decision risk acceptable to both the customer and supplier.
For the purpose of this comparison, the customer is the organization submitting the M&TE and the supplier is the calibration laboratory.
17025 is a test and calibration laboratory competency demonstration requirement.
Z540.3 is a technical requirements document that applies to M&TE used by an organization, including the calibration component which may be an internal or external calibration laboratory.
The application of Z540.3 to the calibration laboratory may be by contractual agreement with the customer or be self-imposed by the laboratory itself. (Note: This applies throughout this analysis)
The calibration laboratory is to demonstrate their capability todetermine measurement decision risk () for a specific calibration scope. This capability may be self imposed and requires assessment before it can be placed on a scope of accreditation.
This is an additional requirement.
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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T he com m ittee also identified the significant requirem ents (those requiring “additional know ledge, clarification and assessm ent effort”) for laboratories and ABs.• S ub-clauses 5.3 and 5.3b (decision risk, false accept, T U R evaluation,
param eter calculation, etc.)• S ub-clauses 5.3 and 5.3.4 (calibration system concept, requirem ents,and
application to cal lab standards, etc.)• S ub-clauses 5.3 and 5.3.4 (cal interval evaluation and m easurem ent reliability
and uncertainty requirem ents)
U sing the Appendix F of the Handbook
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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U sing the Appendix F of the HandbookT he Com m ittee has provided a detailed analysis of S ub-Clause 5.3 T opics w ith Com m ittee Com m ents related to the cross-w alk to IS O /IEC 17025•First … . T hank you•S econd … W e still have to do the w ork ourselves and have identified the differences betw een w hat w e believe and w hat the com m ittee believes.•T hird … not m any differences but the know ledge gained for us as an AB is w orth the exercise. •Fourth … . Good Job … the cooperative effort w ill im prove the calibration of M easuring and T est Equipm ent
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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Program Requirements for an ABT o bring P rogram R equirem ents to the point to of accreditation, an AB m ust:• Consider the S pecifiers R equirem ents and intent• W ork w ith the S pecifier to confirm how they recognize them to perform the
Accreditation w ith the additional requirem ents (direct, N ational, International)
• W rite the P rogram R equirem ents utilizing the cross-w alk, standards, S pecifier requirem ents, and guidance documents (handbooks)
• Assure these requirem ents are acceptable to the S pecifier
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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Program Requirements for an ABIS O /IEC 17025
P roficiency T estingM easurem ent T raceability
U ncertainty of M easurem ent
AN S I/N CS L Z540.3Calibration S ystem , Calibration P rogram
M easurem ent Decision R iskM easurem ent Assurance P rocess
M easurem ent U ncertaintyM easurem ent T raceability
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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Cooperation for Consistency• W hile AB’s develop their ow n P rogram R equirem ents based on
the standards, cross-w alks, and w orkbooks• T hey cooperate w ith stakeholders through N ational, R egional
and International organizations on:• R ecognition requirem ents for AB’s• T raining requirem ents for evaluators• Accreditation requirem ents for labs, N IS T traceability, or other
N M I…• T raining requirem ents for assessors
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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T hird P arty N ational R ecognition
ISO/IEC 17025 vs. ANSI/NCSL Z540.3
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T HAN K YO U Ryan Fischer
Calibration Program ManagerLaboratory Accreditation Bureau
