endstream endobj 197 0 obj <. It is expected internal or that all <> Clause 4.2.2 may well have some implications with forensic cases and this will need to be assessed on a case by case basis. Clause Comparison of ISO/IEC 17025:2017 to ISO/IEC 17025:2005 CLAUSE ISO/IEC 17025:2017 ISO/IEC 17025:2005 Comments 1 SCOPE 2 NORMATIVE REFERENCES 3 TERMS AND DEFINITIONS Added nine (9) laboratory-specific definitions. Agenda Welcome . This will be accomplished through compliance with clauses 4 to 7 of ISO/IEC 17025. 4 GENERAL REQUIREMENTS 4.1 … PDF | This is part of the training modules to help laboratories to migrate from ISO 17025:2005 to ISO 17025:2017. %%EOF ISO 17025 and ISO 15189 are standards written by laboratory people experienced in what can go wrong. Suggestions on how to implement the novelties • Regarding impartiality (4.1) Mandatory documents for ISO 17025:2017. Description. ISO/IEC 17025:2017 In this presentation: Explanation New requirement Interpretation / Examples / Questions. A second edition of this International Standard, aimed at more closely aligning it with a second edition of ISO/IEC 17025 and with ISO 9001:2000, is anticipated. The concept in the new requirement (clause 8.5.1) about action on risks and opportunity comes from ISO 9001:2016, which has a strong customer focus. This clause covers requirements for the laboratory information management system(s) used for the accumulation, handling, recording, reporting, storage, and recovery of data. GAP ANALYSIS ISO/IEC 17025:2017 -7- (3) NEW CLAUSE ADDED TO THE STANDARD ISO/IEC 17025:2017 Clause No. Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4) <> 0 endobj 2 0 obj ISO/IEC 17025:2017, HKAS 002, HKAS Supplementary Criteria No. The first edition referred to ISO 9001:1994 and ISO 9002:1994. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories. endstream endobj startxref 4: Not addressed under ISO/IEC 17020 or ILAC/IAF A4 5: 7.8 and 9.14 6: Not specifically addressed but alluded to in several Clauses 7: 15 Some others you need to watch: Clauses 6.2, 6.3, 8.2, 8.3, 10 (whole section, especially 10.8), and make sure you have your list of Authorized Signatories and the records of evaluating inspectors in the field. hÞb```¢ù¬‚‚ ÈÀeaà˜ÀÀȐÀð`SkczÃ?‡ ù†)‰@%{:wÎ= SÎ3}ó|ŽKN¤(p⥝ G›³•Kš Oßä‡)»çs´8ïíx´¾ÅIñÞ±R­> ’Œ;3@< ‹ÁÈôè 1 0 obj stream 7.11 Control of Data – Information Management . ACKNOWLEDGEMENTS This guidebook on ISO/IEC 17025 (2017) is published by the United Nations Industrial Development ... clause by clause a description of the requirements along with further clarification and advice on the Resource requirements are considered to include personnel, facilities, equipment, systems and support services necessary to manage and perform the laboratory activities. %PDF-1.7 The relationship between ISO/IEC 17025:2017 and ISO 9001:2015 is … <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 18 0 R 20 0 R 21 0 R 24 0 R 25 0 R 26 0 R 27 0 R 28 0 R 31 0 R 32 0 R 33 0 R 34 0 R 35 0 R 38 0 R 39 0 R 40 0 R 48 0 R 49 0 R 52 0 R 53 0 R 54 0 R 55 0 R 56 0 R] /MediaBox[ 0 0 792 612] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Option A – Follow management . 234 0 obj <>stream The laboratory shall indicate in the ‘MS Clause’ column, for every 1. Recapping what we’ve tackled in the first part, the new ISO/IEC 17025:2017 requirements apply to all organizations conducting laboratory activities. ISO/IEC 17025:2017 Checklist (Internal Audit) An ISO 17025:2017 checklist is a tool used to determine a laboratory’s competency in testing and calibration according to the requirements set by the ISO 17025:2017 standard.This iso 17025 template contains 5 main sections according to the standard’s requirements: general, structural, resource, process, and management system requirements. ISO/IEC 17025:2017 • Change overview • Clause overview • Transition plan 2. Note 1 to clause 8.5.3 (ISO/IEC 17025:2017) refers to more than one options to address risks, namely •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 The clauses in ISO/IEC 17025:2017 are used to improve the competence of calibration laboratories and testing laboratories which in connection with this research are carried out through a process approach principle found in ISO 9001:2015. <>/Metadata 5176 0 R/ViewerPreferences 5177 0 R>> CLAUSE ISO/IEC 17025:2017 REQUIREMENTS How are the following addressed / implemented CAB’s COMMENTS C/ NC ASSESSOR’s COMMENTS 8.2.2 Address competence, impartiality and consistent operation of the laboratory in policies and objectives. The lab is responsible for the management of all information obtained or created during laboratory activities and is held responsible by legal enforcement. •Specific sub clauses of under the new clause 4 now provide for independence and impartiality. However, such relationships do not necessarily Keep in mind that if you exclude some of the clauses from the scope of your implementation, then documents for those clauses will not be required for your lab. Subject Amend ment No. For further information, please refer to the corresponding document and clause as listed in the second column. Clause Ref. Page No. These standards have been superseded by ISO 9001:2000 , which made an alignment of ISO/IEC 17025 necessary. However, this does not demonstrate the competence of a laboratory to produce technically valid data and results. Clause 4.2 of ISO/IEC 17025:2017 discusses the requirements involving confidentiality. The latter allows for laboratories that already have ISO 9001 management systems in place and can show that they consistently fulfill the requirements of clauses 4 to 7 to have inherently satisfied clause 8. Corresponding ISO/IEC 17025:2005 Clause No. RISK IN ISO/IEC 17025:2017 CLAUSES Clause Details 4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis. Clause-by-clause explanation of ISO 17025:2017 Download a complimentary white paper (PDF) This white paper explains each clause of the ISO 17025:2017 standard, while providing guidelines on what needs to be done to meet each requirement. 6 6. 7.2 In ISO 17025:2017, clause 7.2, covers the selection, verification, and validation of methods & corresponds to ISO 17025:2005 clause 5.4 test and calibration methods and method validation. ISO 9001 comply with similar requirements outlined in the new ISO/IEC 17025:2017. Instruments • Measuring and Test Equipment (M&TE) – This comprises all of the measuring instruments, measurement standards, reference materials, and auxiliary apparatus The ISO/IEC 17025:2017 Awareness and Auditor Training Kit is designed to develop your understanding of ISO/IEC 17025:2017 laboratory management system and help you understand how to plan and lead an ISO/IEC 17025 assessment. 4.1.4, 4.1.5 b ,d,e,f ISO/IEC 17025:2017 there is a new section 4.1 dealing with impartiality Highlights • The laboratory management shall be committed to impartiality • The laboratory shall identify risks to its impartiality on an on-going @$Wüß8‘ è’`°©Lþg`rø` éY ... Comparitive Review of 17025 2017 2005.pdf. ISO/IEC 17025:2017 expects laboratories to keep records of non-conforming work and relative actions. Reporting of opinions and interpretations 3. ... clauses in ISO 17025:2017. endobj CLAUSE ISO/IEC 17025:2017 REQUIREMENTS How are the following addressed / implemented CAB’s COMMENTS C/ NC ASSESSOR’s COMMENTS 6 RESOURCE REQUIREMENTS 6.1 Availability of personnel, facilities, equipment, systems and support services necessary for the management and performance laboratory activities. This third edition cancels and replaces the second edition ( ISO/IEC 17025:2005 ), which has … The documents listed below are must-haves according to ISO 17025:2017. The Management System Requirements of clause 8 in ISO/IEC 17025:2017 is now divided into Option A and Option B. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. ISO/IEC 17025:2017 Executive Overview Page 7 7/18 ISO/IEC 17025:2017-ISO 9001:2015 Comparison Chart ISO 9001:2015 ISO/IEC 17025:2017 Clause 1 Clause 1 Clause 2 Clause 2 Clause 3 Clause 3 4.1 Understanding the organization and its context 4.1, 4.2 4.2 Understanding the needs and expectations of interested parties 7.1 6and HOKLAS Supplementary Criteria No. Reporting statements of conformity (Decision rules) 2. Emphasis of Change Summary of text/extract from ISO/IEC 17025:2017 Comments NEW OLD NEW 4.1 Impartiality 4.1.4 Spell out impartiality dalam risk assessment 1New On an ongoing basis, the %���� 3 0 obj Option B using ISO 9001 “8.1.3 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, also fulfils at least the intent of the management Procedure Document the information (in a document P-720 endobj In ISO 17025:2005 Impartiality mostly mentioned in notes and conflict of interest is only mentioned once. Chapter ISO/IEC No. x��=ko�8���?�۵c��DRY�i;�ݙi����E1X8q�z7�\?����{�˒���i�زD�. between the clauses and subclauses of this first edition of ISO 15189 and those of ISO 9001:2000 and of ISO/IEC 17025:1999 is detailed in Annex A of this International Standard. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001:2000 . In short, if your laboratory is certified to ISO 9001:2015, you may choose Option B. A comparitive review covering all the clauses of the new and the old ISO 17025. IlN 1–ôv -Ä`‘~&!Ñ This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel. CROSS-REFERENCES ISO/IEC 17025 2017–2005..... 66. ¾Å+‡‹™Ù¬xHœ0LHzPАþôï{áy¦É˜—3ä0‚˜#ÅÀRÅË Î ÍÈÀtƒË¤C`.£@€ *hMv ISO/IEC 17025:2017 ISO/IEC 17025:2005 Clause Title Clause Title 4.1 Impartiality 4.1.4/4.1.5 Organization 4.2 Confidentiality 4.1.5 c) Organization Identification of changes New harmonized text has been included, so these are completely new clauses. They are more detailed than the equivalent clauses in the 2005 edition •Externally provided products and services cover both services and supplies, and subcontracting 21-22 February 2019 Critical issues of the ISO/IEC 17025 and ISO 15189 11 Specific topics: 1. 17025 1 Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation) ... D119 DEMO OF ISO/IEC 17025:2017 LABORATORY ACCREDITATION FOR CHEMICAL LAB DOCUMENT KIT Price 999 USD 200:2012), ISO/IEC 17025:2017, ANSI/NCSL Z540.1-1994 (R2002) and ANSI/NCSL Z540.3-2006, as well as other terms applied to calibration activities described below. 4 0 obj The new ISO/IEC 17025:2017 4 | Page Clause 6 - Resource requirements . 33. You are capable of supporting and demonstrating the consistent fulfillment of the requirements from clause 4-7 of ISO 17025:2017; You have fulfilled management system documentation and management review requirements (clauses 8.2 and 8.9 of ISO17025:2017). This document was prepared by the ISO Committee on Conformity Assessment (CASCO) and circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This presentation details the clause changes from 2005 to the new ISO 17025:2017 standard. 6.4 ISO/IEC 17025:2017 Clause 5.1 to 5.6 Structural requirements The laboratory’s policies and procedures for making statements of opinions and interpretations need 4.2 of ISO/IEC 17025:2017 expects laboratories to migrate from ISO 17025:2005 impartiality mostly mentioned in notes and conflict interest. Applicable to all organizations performing laboratory activities, regardless of the number of personnel in! P-720 ISO 9001 comply with similar requirements outlined in the light of ISO 9001:2000 17025:2017 expects laboratories to records! 17025:2017 expects laboratories to keep records of non-conforming work and relative actions the laboratory activities and is held by! 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