ISO/IEC 17025:2017 – What’s new
IAEA – SSDL and Quality
Management Training
December 20, 2018
Stephen M. KEOCHAKIAN
New structure
ISO/IEC 17025:2005 ISO/IEC 17025:2017
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Management requirements 4. General requirements
5. Technical requirements 5. Structural requirements
6. Resource requirements
Annex A – Nominal cross- 7. Process requirements
references to ISO 9001:2000 8. Management requirements
Annex B – Guidelines for Annex A – Metrological
establishing applications for traceability
specific fields Annex B – Management system
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Why revise 17025?
Align structure and content with other recently
revised ISO standards
To give laboratories more flexibility
Update language to reflect current practices and
technologies
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What is different
Different structure
But many requirements are unchanged
New: You must manage your “risks”
New flexibility:
“What to do and not how to do it” is no longer the intention
Disappeared:
“quality manual”, “quality manager”,
“subcontracting”, etc.)
You can still use them!
This talk will cover some of the major changes
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New structure
ISO/IEC 17025:2005 ISO/IEC 17025:2017
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Management requirements 4. General requirements
5. Technical requirements 5. Structural requirements
6. Resource requirements
Annex A – Nominal cross- 7. Process requirements
references to ISO 9001:2000 8. Management requirements
Annex B – Guidelines for Annex A – Metrological
establishing applications for traceability
specific fields Annex B – Management system
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New terms
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New terms
3.6 Laboratory
“Laboratory”/“Laboratory activities”
used throughout the document and refers to testing,
calibration and sampling…
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New terms
3.4 intralaboratory comparison
tests on the same or similar items, within the
same laboratory
Relates to 7.7, Ensuring the validity of results
3.7 decision rule
how to determine “Pass” or “Fail” taking into
account uncertainties
Relates to 7.8.6, Reporting statements of conformity
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New items
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Risk & Opportunities NEW
Risks and opportunities associated with the laboratory activities
must be considered in order to:
give assurance the management system achieves its intended
results;
enhance opportunities to achieve the purpose and objectives
of the laboratory;
prevent or reduce negative impacts and potential failures in
the laboratory activities;
achieves improvement.
What does this mean for you?
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4 Impartiality NEW
4.1.4 The laboratory shall …
On an ongoing basis, the laboratory must
identify risks to impartiality, including those
arising from its activities or relationships or the
relationships of its personnel.
What does this mean for you?
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4 Confidentiality Major
Stronger emphasis on confidentiality
New clauses
Laboratories are to advise customers of the
information they will make publically available.
Are you publishing reports and not telling the customer?
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6.2 Your Staff
Your staff (either internal or
external) must be “SQEP”
Suitably Qualified and Experienced Person
This was already found in the 1705:2005 version
New: Emphasis is now on staff’s ability to not only identify
departures from procedures, but also to evaluate the
significance of these.
New: Staff must be authorized to validate a procedure, etc. as
well as following a procedure
New: Competence must be monitored continuously
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6.2 Monitoring staff competence
How do you do this?
• Witnessed measurements
• Results from participation in intra-laboratory
comparisons
• Results from participation in inter-laboratory
comparisons
• Measuring test samples/instruments
• Findings from internal audits
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Traceability
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6.5 Metrological traceability
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Questions?
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Helpful links:
UKAS Assessor tutorial:
https://www.ukas.com/download/general_docume
nts/UKAS-January-2018-training-v9.pdf
NATA Gap Analysis template:
https://www.nata.com.au/phocadownload/gen-
accreditation-criteria/17025-2017-Gap-analysis.pdf
UKAS Transition template:
https://www.ukas.com/download/publications/pub
lications-relating-to-laboratory-accreditation/ISO-
IEC-17025-2017-Transition-Template.docx
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Stephen Keochakian
Bureau International Poids et Mesures
Quality, Health, Safety, Environment
Sèvres, France
Office: +33 1 45076258
Mobile: +33 7 89440933
[email protected]
www.bipm.org
