New ISO/IEC 17025 Standard - cdn.ymaws.com · Risk Management for the New ISO/IEC 17025 Standard...
Transcript of New ISO/IEC 17025 Standard - cdn.ymaws.com · Risk Management for the New ISO/IEC 17025 Standard...
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Risk Management for the
New ISO/IEC 17025 Standard
RogerM.BrauningerAmericanAssociationforLaboratoryAccreditation
Frederick,MarylandApril20,2017
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Don’tPanic.
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ISO/IEC 17025Major Changes
• Obligatory changes by CPC*• Structure• Philosophy• New Definitions
*Chairman’s Policy Coordination Group
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ISO Process Flow
20Preparatory
30Committee
40Inquiry
50Approval
TransitionEvent
Aug2015OutputCD1
OCT2015CD1 Ballot
Jun2015OutputWD2&3
Feb2015OutputofWD1
Feb2016OutputCD2
MAR2016CD2Ballot
OCT2016Translation
FDISOptional
MAY2017DG
OCT2017RELEASE?
JUL2017FDIS?
DEC2016DISBallot
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The Basic Format• Similar to other new standards \
§ e.g., ISO/IEC 17020 and ISO/IEC 17065.• Will be aligned to ISO 9001:2015 principles on
resources and process. • Follows the new ISO 9001 philosophy
§ Requires less documented procedures and policies§ Focuses more on the outcomes of a process.
• Example: no longer required to maintain a current job description (2005 – 5.2.4) but focuses on communicating to each person their duties, responsibilities and authorities (CD2 – 6.2.4)
•
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ISO Obligatory Changes• CPC Proc/33
§ Impartiality• General (4.1), Resource (6.2)
§ Confidentiality• General (4.2)
§ Complaints• Process (7.9)
§ Management System (8)• Option A : 17025:2005 section 4• Option B : 9001 Registered/Certified Bodies
*ISO/CASCO Chairman’s Policy and Coordination Group
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Structure
1Scope2NormativeReferences3Terms&Definitions
4ManagementRequirements5TechnicalRequirements
AnnexA– 9001CrossReferences
AnnexB– GuidelinesforApplications
Bibliography
1Scope2NormativeReferences3Terms&Definitions
4GeneralRequirements5StructuralRequirements6ResourceRequirements7ProcessRequirements8ManagementRequirements
AnnexA– MetrologicalTraceability
AnnexB– ManagementSystem
Bibliography
17025:201X
This doesn’t mean you have to change your
Quality Manuals!*
17025:2005
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4.1 Impartiality4.2 Confidentiality
5.1 Legal entity (4.1)5.2 Management (4.2)5.3 Responsible for activities5.4 Defined range of activities5.5 Authority and resource availability5.6 Communication & integrity
6.1 General6.2 Personnel (5.2)6.3 Laboratory & Environment (5.3)6.4 Equipment (5.5)6.5 External Products & Services (4.6)6.6 Metrological Traceability (5.6)
Structure4GeneralRequirements
5StructuralRequirements
6ResourceRequirements
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Structure7.1 Review of RTC (4.4)7.2 Selection of Methods (5.4)7.3 Sampling (5.7)7.4 Handling of Customer Items (5.8)7.5 Technical Records (4.13)7.6 Evaluation of MU (5.4.6)7.7 Quality Control (5.9)7.8 Reporting of Results (5.10)7.9 Complaints (4.8)7.10 Nonconforming Work (4.9)7.11 Control of Data (4.13)
7ProcessRequirements
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Structure
8.1 Options (A & B) 8.2 Option A – Management System Documentation (4.2)8.3 Option A – Control of Documents (4.3)8.4 Option A – Records (4.13)8.5 Option A – Risks & Opportunities (4.10)8.6 Option A – Improvement (4.10, 4.12)8.7 Option A – Corrective Action (4.11)8.8 Option A – Internal Audits (4.14)8.9 Option A – Management Reviews (4.15)
8ManagementRequirements
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Mapping (1/2)17025:2005
§ 4 – Management4.1 Organization . . . . . . . . . . . . . . . 4.2 Management System . . . . . . . .4.3 Document Control . . . . . . . . . . .4.4 Requests & Tenders . . . . . . . . .4.5 Subcontracting . . . . . . . . . . . . . 4.6 Purchasing . . . . . . . . . . . . . . . . 4.7 Service to Customer . . . . . . . . .4.8 Complaints . . . . . . . . . . . . . . . . 4.9 NCW . . . . . . . . . . . . . . . . . . . . .4.10 Improvement . . . . . . . . . . . . . . 4.11 Corrective Action . . . . . . . . . . .4.12 Preventive Action . . . . . . . . . . .4.13 Records . . . . . . . . . . . . . . . . . .4.14 Internal Audits . . . . . . . . . . . . .4.15 Management Review . . . . . . . .
17025DIS
> §5Structural> 8.2> 8.3> 7.1> 6.5> 6.6> Entire document> 7.9> 7.10> 8.5,8.6> 8.7> Removed> 7.5,7.11,8.4> 8.8> 8.9
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Mapping (2/2)17025:2005
§ 5 – Technical5.2 Personnel . . . . . . . . . . . . . . . .5.3 Accom. & Environ . . . . . . . . . .5.4 Methods . . . . . . . . . . . . . . . . .5.5 Equipment . . . . . . . . . . . . . . .5.6 Traceability . . . . . . . . . . . . . . . 5.7 Sampling . . . . . . . . . . . . . . . . 5.8 Handling of UUT . . . . . . . . . . .5.9 Quality Assurance . . . . . . . . .5.10 Reporting . . . . . . . . . . . . . . .
17025DIS
> 6.2> 6.3> 7.2> 6.4> 6.6,7.6> 7.3> 7.4> 7.7> 7.8
> New> 8.6Risks &Opportunities
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Risk management
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Risk management
§ Requires the laboratory to plan and implement actions to address risks and opportunities.
• Establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.
§ The laboratory is responsible for deciding which risks and opportunities need to be addressed
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What Does this Mean for You?
Identify:Whatcanhappen,when,wherewhyandhow.Assess: Determineexistingcontrols,determinelikelihoodandconsequencesleadingtoestimatelevelofrisk.Evaluate: Compareagainstcriteria,Identifyandweighoptions,Decideonresponseandestablishpriorities.Control&Monitor:Mitigatebymodifyprocess,documentoutcomes
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Philosophical Changes• ISO 9001 Principles
§ Risk management (9001)• Impartiality, Confidentiality, Complaints
§ Managed Processes to Process Management§ “Fit for Use/Purpose” – Validation
• Conformity vs. Compliance§ Added statements of conformity in 7.8.5
• Shall, Must, Should, Where . . .§ Requirements = shall§ Should and Where __ =
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Philosophical Changes (cont)
• “Test and/or calibration”§ Replaced with laboratory to reduce
confusion§ Where appropriate, it was left in the
Standard
• Notes§ If the NOTE did not provide value it was
removed, moved to an Annex, otherwise it was moved to a requirement
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Impartiality (4.1)
• Safeguard against lack of…
• Establish structure
• Mitigate pressures
• Identify & manage risks (ongoing basis)
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Confidentiality (4.2)
• Legally enforceable commitment
• Inform customer of if public exposure of information
• 3rd party communication requirement
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Complaints (7.9)
• Documented process to receive, evaluate and make decisions
• Description of the handling process available to any interested party
• Acknowledge receipt, provide progress reports and the outcome
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Annex A, metrological traceability
• Traceability established by:§ Definition of the measurand§ Unbroken chain of comparisons/cals§ Measurement uncertainty§ Performed in accordance with
documented information§ Competence
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Annex A, Metrological traceability
• Demonstration of Traceability§ Evaluate the technical competence of the
calibration provider and claimed metrological traceability as per the requirements of this standard
§ CMCs peer reviewed by international arrangement – CIPM MRA or ILAC
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8 Management requirements
• Option A § At a minimum the laboratory addresses
8.2 – 8.9• Option B
§ A laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of clauses 4 to 7 of ISO/IEC 17025
§ Also fulfils at least the intent of the management system section requirements (8.2 - 8.9)
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Next Steps
• Writing group subcommittee meeting in May 2017
• 6th Meeting scheduled for week of 10 July 2017
• Anticipate FDIS in fall of 2017• Approval of FDIS by end of 2017• 3 year implementation period from the
time of publication
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For Further Information
Contact:RogerM.BrauningerPhone:3016443233
Email:[email protected]
AmericanAssociationforLaboratoryAccreditation5202PresidentsCourt,Suite220
Frederick,MD21703
www.a2la.org