Fluke Calibration

Web Seminar Series

Introduction to ISO/IEC 17025:2017

January 31, 2018

©2018 Fluke Corporation 1

ISO/IEC 17025:2017
Your Presenter:
Jeff Gust
Chief Corporate Metrologist

Your Host:
Bruce Fuller
©2018 Fluke Corporation 2
What is ISO/IEC 17025?

•General requirements for the

competence of testing and calibration
laboratories
• Contains all requirements that testing and
calibration laboratories have to meet if they wish to
demonstrate:
• Operate a management system
• Technically competent
• Able to generate technically valid results

©2018 Fluke Corporation 3

17025 vs 9001- why bother having 17025?

“Conformity of the management system

within which the laboratory operates to
the requirements of ISO 9001 does not of
itself demonstrate the competence of the
laboratory to produce technically valid
data and results. This is accomplished
through compliance with clauses 4 to 7 of
ISO/IEC 17025.”

©2018 Fluke Corporation 4

Why is ISO 17025 Important?

• International
Laboratory
Accreditation
Cooperation (ILAC)
• Measured once,
accepted everywhere
• Mutual Recognition
Arrangement

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What are the general requirements?

• Technical competence to get the right result

• Organization, structure and people to have integrity
and consistency
• Clear output to the client
• Documentation and ability to demonstrate all the
above

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History

• 1990 – ISO Guide 25

• 1999 – ISO 17025 first released
• 2005 – ISO 17025 has minor revisions to align to ISO
9001:2000

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What has been happening lately -
CASCO WG 44 Work Plan
Feb 2015 1st meeting Workplan
June 2015 2nd meeting WD (working draft)
Aug 2015 3rd meeting CD (committee draft)
Sep 2015 Ballot on CD Voting by Members
Oct 2015 Comment Collation 2600 comments
Feb 2016 4th Meeting CD2 DIS
Mar 2016 Ballot on CD2 Voting by Members
Sep 2016 5th Meeting Compiling DIS
Dec 2016 Ballot on DIS Voting by Members for 3 m
May 2017 Drafting Group Final Draft for WG Consideration
July 2017 6th Meeting Compiling FDIS
Aug 2017 FDIS for voting Two months YES/NO only
Nov 2017 Published Standard ISO 17025:2017

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FDIS Approval

• FDIS Vote Closed on 9 Oct 2017

• 90 out of 91 voting members voted yes
• Voting members are nations
• NCSLI and ILAC are liaisons – no vote
• Many submitted identified editorial errors

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Next Steps

• ISO/IEC 17025:2017 was published on December 1,

2017
• Released on the same day as ISO 17011 (the
standard that accreditation bodies work to)
• ILAC has approved a 3 year transition period to the
2017 standard
• Check with your AB for their specific policy
• Most likely, AB’s will be able to do assessments to
2017 soon for labs that want to change quickly
• Probably won’t be required to do 2017 for 18 – 24
months

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 Headlines of Changes

• Major restructure from 2005 version; clauses and order

changed
• Very few changes in requirements
• Allows use of ISO 9001 as basis for management system
• Confirmed that ISO/ILAC/IAF tripartite agreement is
renewed
• Clarification for inclusion of “Stand-alone” Sampling
• New term “Decision Rule” for deciding pass/fail decisions
• Consideration of “Risk and Opportunity” throughout
• Informative annex on traceability

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Change in Approach

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Completely Restructured

For a laboratory, in line with the other 17000 series

standards:
Structure: “What it looks like”

Resource: “What it needs to have”

Process: “What it needs to do”

Some mandatory text (esp Options A and B)

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A Revised Definition
Definition of Laboratory:

“Laboratory:
A body that performs one or more of the
following activities:
Calibration
Testing
Sampling, associated with subsequent
calibration and testing”

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Main Issues likely to need attention by Assessors

• Assessing Option B (ISO 9001) Management System

• needs to cover 17025 technical clauses
• Decision Rules; any sensible ones to be agreed
• risks of false accept etc
• reporting of decision rule used
• Risks and Opportunities to be considered
• measures necessary in a given lab therefore vary
• 2nd person for complaint handling (small labs)

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Management System Options

Option A – Using ISO 17025 directly, as before

Option B – Using ISO 9001 but ensuring that the MS meets

the technical needs of 17025

The difference? Not a lot, as the new 17025 has largely

been aligned with 9001 for requirements and terms

AB’s assess that the system covers the 17025 requirements

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 Management System Option A

1.2 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 laboratory's management system. Laboratories
that comply with clauses 4 to 7 of ISO/IEC 17025
and implement option A of clause 8 will therefore
also operate in accordance with the principles of ISO
9001.”

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 Management System Option B

1.3 Option B allows laboratories to establish

and maintain a management system in
accordance with the requirements of ISO 9001
in a manner that supports and demonstrates
the consistent fulfillment of clauses 4 to 7 of
ISO/IEC 17025. Laboratories that implement
option B of clause 8 will therefore also operate
in accordance with ISO 9001.

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The Important Clauses are 4 to 7
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Structural requirements
6 Resource requirements
7 Process requirements
8 Management requirements
Annex A
Annex B
Bibliography

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Clauses 4 to 6

4 General requirements
4.1 Impartiality
4.2 Confidentiality
5 Structural requirements
6 Resource requirements
6.1 General
6.2 Personnel
6.3 Laboratory facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services

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 Clause 7

7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Assuring the quality of results
7.8 Reporting of results
7.9 Complaints
7.10 Management of nonconforming work
7.11 Control of data – Information management

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Less Prescriptive? Example clause
ISO 17025:2005
• Lab shall have policies and
procedures to ensure
protection of confidential
information… including
electronic storage and
transmission of results
Less focus on prescriptive requirements, more focus on the outcome of
results
©2018 Fluke Corporation
FDIS 17025:2017
• The lab shall ensure the
protection of confidential
information…. including
electronic storage and
transmission of results
22
Decision Rules (Pass/Fail Criteria)

Previously, 17025 simply stated that a statement of compliance

(pass/fail) takes uncertainties into account.

Uncertainty – Limits of possible results Result

PASS Mark

Clear Pass Pass Likely Fail Likely Clear Fail

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Decision Rules

Now we have a need to agree and specify the “decision rule”

used

7.8.5.1 When a statement of conformity to a

specification or standard is provided, the laboratory shall
document the decision rule employed, taking into account the
level of risk (such as false accept and false reject and
statistical assumptions) associated with the decision rule
employed and apply the decision rule.

NOTE Where the decision rule is prescribed by the

customer, regulations or normative documents, a further
consideration of the level of risk is not necessary.

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Decision Rule Choices

To be agreed with client, taking risk level into account:

• ISO 14253
• Simple pass/fail
• N:1 rules
• By legislation
• Documented by method
• Industry expectation
• Client required
• Specified risk (e.g. PFA)
• Others

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Risks and Opportunities

• Not much different than we do today

• Can use formal methods like FMEA
• Can use informal methods
• e.g. amount of detail that the lab puts into a calibration procedure

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Conclusion

• DON’T PANIC
• Resources available from AB’s and NCSLI
• Training classes
• Crosswalk from 2017 to 2005 and vice versa
• Tech Exchange
• “Roadshow”
• Conference Tutorial
• Document for Implementing 2017
• Handbook for the application of 2017

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