Documente Academic
Documente Profesional
Documente Cultură
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
2
Why revise 17025?
Align structure and content with other recently
revised ISO standards
3
What is different
Different structure
But many requirements are unchanged
New flexibility:
“What to do and not how to do it” is no longer the intention
Disappeared:
“quality manual”, “quality manager”,
“subcontracting”, etc.)
4
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
5
New terms
6
New terms
3.6 Laboratory
“Laboratory”/“Laboratory activities”
7
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
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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 …
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4 Confidentiality Major
Stronger emphasis on confidentiality
New clauses
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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
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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
stephen.keochakian@bipm.org
www.bipm.org