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EUROLAB-CH International Seminar, 28th September 2016 REVISION OF ISO/IEC 17025DIRECT VOICE FROM THE STANDARDIZATION GROUP Dr. Gabriele Dudek Bunde...
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EUROLAB-CH International Seminar, 28th September 2016

REVISION OF ISO/IEC 17025DIRECT VOICE FROM THE STANDARDIZATION GROUP

Dr. Gabriele Dudek

Bundesanstalt für Materialforschung und –prüfung (BAM), Berlin, Germany

Dipl.-Ing. Christian Müller-Schöll Mettler Toledo GmbH, Greifensee, Switzerland

Overview Part I

 International Standardization on general aspects of conformity assessment What happens in the ISO CASCO toolbox?  Standard development in ISO CASCO

 Revision of ISO/IEC 17025- Aims and main focus, timeline  The impact of ISO 9001  ISO/IEC 17025 in the context of other CASCO standards The Common Elements  Structure and process approach  The Scope 28.09.2016

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Overview Part II

 New clauses and important technical changes (2nd committee draft):     

Terms and Definitions General an structural requirements Resource requirements Process requirements Management requirements

 Risk-based approach: Risks and Opportunities

 Still under Discussion- The hot potatoes!  Outlook

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Part I

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Standards' development work

 CASCO is the ISO committee that works on issues relating to conformity assessment  CASCO develops policy and publishes standards related to conformity assessment  It does not perform conformity assessment activities  Membership in CASCO is open to full and correspondent members

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Standards for conformity assessmentThe ISO CASCO Toolbox

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What happens in the Toolbox? CASCO Road Map  Standards under development: ISO/IEC 17011 (Accreditation bodies) ISO/IEC 17021-x (e.g. x=2, x=3 und x=9 (Certification bodies for UMS, QMS, Anti-bribery MS) ISO/IEC 17025 (Testing and calibration laboratories) ISO 17034 (Reference material producers) ISO/IEC TR 17028 (Model scheme for certification bodies for services)

 New work item proposal 2016: ISO/IEC 17029 Conformity assessment – General requirements for bodies performing validation and verification activities important with regard to ISO 14065 approved: August 2016 28.09.2016

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ISO/IEC 17025 Historical development

? 1999

2005

1st edition

Adaption to ISO 9001

2010

 Section 5 “Technical requirements” unchanged since 1999  Have laboratories, testing and calibration laboratories changed??

Document control and processing

Graphiken: m. freundl. Genehmigung von H. Schorn (I2PS)

ISO/IEC 17025 The New work item proposal  In Germany and Switzerland: only minor problems in application  Last review in 2010; text of the standard obsolete  Further development of standardization on conformity assessment (structure, management requirements, etc.) Proposal on revision :

 Submitted in summer 2014 (ILAC and SABS)  Survey among ILAC members revealed the following result: 84% approval (DAkkS: rejection)  Foundation of ISO CASCO WG 44  Convenors: Warren Merkel (ILAC), Steve Sydney (SABS) , Heribert Schorn (IEC)  ~140 experts reported  high percentage from emerging and developing countries

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The old standardClauses in need for change 5.4 5.5 5.6 5.7 5.9

5.10

Test and calibration methods and method validation Equipment (possibly) Measurement traceability (Inclusion of the ILAC documents P9, P10 and P14) Sampling Assuring the quality of test and calibration results Reporting the results

- ISO/IEC 17025:2005 was obsolete (structure and terminology) - Revision of ISO 9001 (compatibility is important) - Accreditors wanted an early revision 28.09.2016

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ISO/IEC 17025 – Timeline of Revision October 2014

August 2015

May 2016

December 2016

End 2017

NWIP

Adoption

Publication

Working draft (WD 1, WD 2)

Committee draft (CD1)

Committee draft (CD2)

Draft (DIS)

Final Draft (FDIS)

 Commenting on the 2nd Committee Draft completed internationally  WG will prepare the publication of the DIS,  Publication of the DIS expected in Dec 2016/Jan 2017  Total time of the revision: 36 months  FDIS is basically optional, but probable 28.09.2016

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Vote on ISO/IEC CD2 17025 and further action  89 countries participated in the vote  Proceeding to the next stage (CD2 -> DIS)  Result: YES YES with comments NO Abstain

- More than 2300 comments were discussed in September 2016 (20 -23 Sept 2016)

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New ISO 9001:2015

 5th edition, German-English version, November 2015  New structure: High Level Structure  Important changes include in particular the following topics:

       

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Context of the organization Commitment of top management Interested parties Process approach Quality manager Risk-based approach Knowledge Documented information

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ISO 9001:2015 - Impact on the ISO CASCO Toolbox  New structure: High Level Structure and new terminology (e. g. products -> products and services)  Reinforcing the process-based approach: Processes related to product quality and customer satisfaction more strongly emphasized  Strengthening the responsibility of leadership  responsibility for effectiveness of the QMS  No obligation to formally appoint a quality manager, instead obligation to employ, instruct and support appropriate persons  Promoting the risk-based approach: especially in the context of planning  Risk analysis and emergency planning as well as consideration/use of opportunities arising  Documented information  Classic Quality Manual no further explicitly required  Sufficient flexibility in handling the documentation (electronic, paperbased, etc.) 28.09.2016

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Impact of the new ISO 9001 on ISO/IEC 17025 ‒ Process-based approach and structure  Separation of the requirements for structure, resources and testing or calibration process  split of the processes in core processes and supporting processes --> difficult to handle and therefore not included

‒ Risk-based thinking and acting  In principle, nothing new  More flexibility in the process requirements and in the extent of documentation  Consider risks and opportunities ©www.kweaus.com

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The Common Elements

 Former ISO/PAS documents 17001-17005 written on an understandig of some common elements:  impartiality,  confidentiality,  complaints and appeals,  use of management systems  intended for use by ISO/CASCO WGs in the development of ISO/CASCO standards  two categories of requirements:  obligatory text: element has to be addressed, without modification, except for substitution of more specific terms  recommended text: working groups (WGs) may use if they wished to have a greater degree of specification on the particular topic  general, structural and resource requirements 28.09.2016

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Requirements for management systems  ISO/CASCO working groups shall not write management system requirements that contradict these established requirements where they exist (e. g. ISO 9001, ISO 14001)  MS is an internal mechanism to assure consistent fulfilment of requirements  Bodies that choose to have a QMS that fulfils all of the requirements of ISO 9001 shall gain benefit from this fulfilment (no conflicts!) Options A und B

Option A: minimum management system requirements shall be addressed in the standard Option B: management system, in accordance with ISO 9001 that is capable of supporting/demonstrating the consistent fulfilment of the requirements of clauses 4 to 7 of ISO/IEC 17025 28.09.2016

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Implementation of COMMON ELEMENTS Results of discussion in the working group:  No types of independency A, B, C (such as for inspection bodies)  More emphasis on the importance of impartiality  Appeals: have no relevance in the daily laboratory work - deletion  Management system requirements: Keep connection to the latest ISO 9001

Consider principles of ISO 9001 Options A and B have to be integrated

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The new structure

Scope Normative references Terms and definitions General requirements Structural requirements

Resource requirements Process requirements Management system requirements Annexes 28.09.2016

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The Process Approach

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The Scope

Basic requirements for the competence of all organizations that carry out laboratory activities Laboratory activities are :  tests  calibrations  sampling associated with subsequent calibration or testing Activities using standardized and non-standardized methods (in-house methods) Applicable to all forms of organizations, without distinction in terms of the organizational independence Independent of the size of the company Difference to ISO 9001: technical competence requirements! 28.09.2016

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Part II

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Terms and Definitions – Changes New Terms/Definitions: • Laboratory • Intralaboratory comparison • Decision rule • Impartiality Obsolete Terms: • Quality manager • Technical manager • Accomodation -> Facility • Preventive actions -> risk and opportunities Still under Discussion: • Method/procedure

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"General" and "Structural" Requirements General: • Mostly based on common elements • Adoption of mandatory requirements which are unchanged Structural: • Nothing new but influenced by new ISO 9001:2015; • e. g. establishement of communication processes Provision to cover liabilities: Clause 5.4: The laboratory shall have adequate provision (e.g. insurance or reserves) to cover liabilities arising from its activities) No competence criterion! It concerns liability … (previous ISO/IEC 17025 clause 4.1.1) CLAUSE DELETED 28.09.2016

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Definition of Impartiality

impartiality presence of objectivity Note 1 to entry: Objectivity is understood to mean that conflicts of interest do not exist, or are resolved so as not to adversely influence the activities of the laboratory. Note 2 to entry: Other terms that are useful in conveying the element of impartiality are freedom from conflicts of interest, freedom from bias, freedom from prejudice, neutrality, fairness, open-mindedness, evenhandedness, detachment and balance. [SOURCE: ISO/IEC 17021-1:2015, 3.2] 28.09.2016

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Impartiality

(Obligatory wording, adapted to laboratories)  The laboratory shall not allow commercial, financial or other pressures to compromise impartiality  Laboratory activities shall be structured and managed so as to safeguard impartiality  all personnel of the laboratory, either internal or external, that could influence the conformity assessment activities, shall act impartially

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Resource Requirements Externally Provided Products and Services Basic idea: - Procurement and subcontracting are considered as externally provided services, in conformity with ISO 9001:2015 - No explicit reference to "subcontracting" anymore - External testing and calibration services are basically treated like external services - summarized in one section. Therefore: Requirements also for control of the ext. provider and communication to the customer (acceptance criteria are to be communicated to the customer) Definition of criteria for reviewing external products and services is needed

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5.4 Range of laboratories activities

Range of laboratory activities

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Subcontracting

Externally provided products and services on ongoing basis

Own personnel + equipment = competence

Claim conformity with this International Standard

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Metrological traceability (I)

 In revision of ISO/IEC 17025, accreditors require an appropriate alignment with the ILAC policy (ILAC P10) -> Prioritizing the traceability paths  Text held deliberately shorter than previously  If technically possible  traceability to SI System through comparative measurement or use of certified RM  If technically not possible  traceability to another suitable reference (certified RM, reference methods, consensus-based standards etc.)  Provision of calibrations through competent actors  Explanations in an informative Annex A  Annex A consists mainly of current "NOTEs" 28.09.2016

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Metrological traceability (II)

Main points of Discussion:  Prioritization from ILAC P10 not fully implemented  Text in the new ISO/IEC 17025 is more flexible and risk based  Not everything is traceable to SI with a reasonable effort, this is possible  Consensus-based standards or reference methods shall be accepted by duly authorized bodies

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Process Requirements Fundamental considerations

 Greater involvement of the customer, especially in case of changes during the process and when including external bodies  Validation is always used in the context of „Validation of methods“  Much discussed question: Sampling can be a stand alone activity (provided it is associated with testing or calibration)

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Sampling as a stand alone activity (I) Problem:  "External samplers" are often no "laboratories" (separation from laboratory activity)  Applicability of ISO/IEC 17025 outside the laboratory is questioned  No international harmonization in accreditations Discussion results so far:  Scope of the standard: laboratories connection to the process in the laboratory that produces the results is important  Possibly separate standard for other organizations (special expertise)?  Worldwide survey started in 2015 (as input for the working group)

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Sampling as a stand alone activity (II) Worldwide survey(09-11/2015):  80 countries and 8 organizations got involved  Question: "Should the revised ISO/IEC 17025 be explicitly applicable to organizations that perform sampling without the subsequent testing or calibration?“  Result: 41 x YES; 39 x NO Justifications (excerpts): Supported because :  Sampling is essential for the whole testing and calibration process  Applicability of ISO/IEC 17025 for sampling organizations needs to be improved  ISO/IEC 17025 should be t h e standard for sampling

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Rejected because : - Sampling activity is not a conformity assessment - Sampling is carried out also in connection with other conformity assessment activities (ISO/IEC 17020, ISO 17034, ISO/IEC 17065) - Modification of the scope was no intention of the revision - better an own standard

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Requirements for sampling – 2nd CD  laboratory shall have a sampling plan and documented procedures for sampling  analyzed as received:

• Disclaimer, where the laboratory has not been responsible for the sampling stage • it shall be stated in the report (testing labs)

 Record of relevant data: the laboratory shall detail all parameters to be recorded

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Statements of Conformity

 Laboratories often make statements on conformity of the results with certain specifications (compliance with limits, test passed (yes/no), etc.)  Clear decision rules are to be communicated, documented and to be applied  Decision rules have to relate to associated risks

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Foto: © JrCasas

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Opinions and interpretations

 Opinions and interpretations shall be clearly identified  Always keep reference to the result of the tested or calibrated item  To be given only by authorized personnel (experience)  Bases for the statements made have to be documented  Clear dissociation from assessments/evaluations in the context of inspections and product certifications has to be required

Duck or rabbit? 28.09.2016

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Quality assurance of the results  Laboratory shall have procedures for regular monitoring of the effectiveness of QA measures  Selection of surveillance measures:     

Use of reference materials Intermediate checks Repetition of tests and calibrations Internal comparisons Blind tests

 Comparisons with other laboratories (e. g. PT and comparative tests): whenever available and suitable  Results shall be analyzed to achieve improvements (interaction)

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Reporting of results

 Content given by the customer shall be identified  No "signature" required anymore (but an "identification" of a person authorising the report)  Texts on "statement of conformity" now in this section together with "opinions and interpretations"

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Documentation

 Determine necessary degree of documentation  Stronger link to electronic data (data protection, monitoring changes, storage)  Requirements for information management systems (interfaces, verification of functionality, etc.), target: data integrity  Software changes: Modification of commercially available systems requires validation, authorization and documentation  Technical records shall be maintained in a way which allows the repetition of laboratory activities  A "procedure" can be documented or not (ISO 9001, based on risk etc.)

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Management System Requirements "Quality Management prinicples" are generally implemented: -

Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making - Relationship management

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Minimum management system requirements of the laboratory (Option A): - management system documentation - control of management system documents - control of records - actions to address risks and opportunities - improvement - corrective action - internal audits - management review

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Risk based approach – (I) Actions to address risks and opportunities Objectives:  give assurance that the management system can achieve its intended results  enhance opportunities to achieve purpose and objectives  prevent, or reduce, undesired impacts and potential failures  achieve improvement Actions:  shall be planned and evaluated  shall be proportionate to the potential impact  shall be updated when a nonconformity occurs

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Risk based approach (II)

Options to Address:  identifying and avoiding threats,  taking risk in order to pursue an opportunity,  eliminating the risk source,  changing the likelihood or consequences,  sharing the risk or retaining risk by informed decision Consequences:  „preventive measures“ no longer explicitly stated, because prevention is a core task of quality management and risk based approach  No formalized risk management required  Expression of measurement uncertainty as conceptual basis for dealing with the risk of a measurement result  Accreditation: difficult to assess

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Summary/Key points

• Scope: laboratory activities • Emphasis on "impartiality" • Process orientation: Results of processes instead of process steps and how something needs to be done • Emphasis on the competence of staff • Identical rules for “externally provided services” and “subcontracting” • Risks and opportunities (no risk management!) • IT: risk assessment, data integrity, data security, data protection, confidentiality, software and their validation • Allowing "electronic documents" • Metrological traceability incl. measurement uncertainty • "Decision rules" for passed/not passed {statement of conformity}

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Outlook

Publication expected for end 2017 There is still some time left, but: Substantial impact on many other standards: more than 300 ISO standards reference to ISO/IEC 17025  Transitional period for accreditation will be determined by ILAC (usually 2 years, possibly 3 years), harmonized worldwide  Training will be needed  Adaptation of many international (ILAC and EA) and national documents (accred.-bodies) is to be expected

 Due to risk concepts, less "black and white" and more "grey" -> challenge for accreditors

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Thank you for your attention!

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