Risk Management for the

New ISO/IEC 17025 Standard

RogerM.BrauningerAmericanAssociationforLaboratoryAccreditation

Frederick,MarylandApril20,2017

Don’tPanic.

ISO/IEC 17025Major Changes

• Obligatory changes by CPC*• Structure• Philosophy• New Definitions

*Chairman’s Policy Coordination Group

ISO Process Flow

20Preparatory

30Committee

40Inquiry

50Approval

TransitionEvent

Aug2015OutputCD1

OCT2015CD1 Ballot

Jun2015OutputWD2&3

Feb2015OutputofWD1

Feb2016OutputCD2

MAR2016CD2Ballot

OCT2016Translation

FDISOptional

MAY2017DG

OCT2017RELEASE?

JUL2017FDIS?

DEC2016DISBallot

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)

•

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

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

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

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

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

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

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

Risk management

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

What Does this Mean for You?

Identify:Whatcanhappen,when,wherewhyandhow.Assess: Determineexistingcontrols,determinelikelihoodandconsequencesleadingtoestimatelevelofrisk.Evaluate: Compareagainstcriteria,Identifyandweighoptions,Decideonresponseandestablishpriorities.Control&Monitor:Mitigatebymodifyprocess,documentoutcomes

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 __ =

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

Impartiality (4.1)

• Safeguard against lack of…

• Establish structure

• Mitigate pressures

• Identify & manage risks (ongoing basis)

Confidentiality (4.2)

• Legally enforceable commitment

• Inform customer of if public exposure of information

• 3rd party communication requirement

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

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

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

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)

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

For Further Information

Contact:RogerM.BrauningerPhone:3016443233

Email:rbrauninger@a2la.org

AmericanAssociationforLaboratoryAccreditation5202PresidentsCourt,Suite220

Frederick,MD21703

www.a2la.org