HOKLAS th Edition HOKLAS 003 Technical Criteria for Laboratory Accreditation 8 th Edition October 2005

HOKLAS th Edition Programme Introduction W W Wong New and revised requirements - cl. 4.1 & 4.2 CC Wong Tea breakAll New and revised requirements – other clauses W W Wong Implementation schedule S S Chan Q&AAll

HOKLAS th Edition Basis of HOKLAS 003 ISO/IEC General requirements for the competence of testing and calibration laboratories

HOKLAS th Edition HOKLAS th edition Sections 2 to 5 are verbatim reproduction of ISO/IEC 17025:2005 Clarifications and updating of HKAS Policies are also made

HOKLAS th Edition

HOKLAS th Edition Implementation Deadline ILAC required all accredited laboratories of signatories to its MRA to comply with ISO/IEC 17025:2005 two years after the publication date of the standard 15 May 2007 Hence, implementation deadline is 15 May 2007

HOKLAS th Edition Amendment of ISO/IEC Purpose – aligned with ISO9001:2000 Initial – issue as AMD (DAM – 2003, FDAM – 2004) Decision made to publish the revision as 2nd edition Published – 15 May 2005 normal revision cycle – once every 5 years Amendments mainly to Section 4 (Management requirements)

HOKLAS th Edition ISO/IEC 17025:2005 Introduction “The first edition referred to ISO9001:1994 and ISO9002:1994. There standards have been superseded by ISO9001:2000, which made an alignment of ISO/IEC17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO9001:2000.

HOKLAS th Edition ISO/IEC 17025:2005 Introduction “Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory’s management system.” “Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.”

HOKLAS th Edition ISO/IEC 17025:2005 Scope “If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001.”

HOKLAS th Edition

HOKLAS th Edition Joint ISO-ILAC-IAF Communique on the Management Systems Requirements of ISO/IEC 17025:2005 ILAC - International Laboratory Accreditation Cooperation ISO - International Organisation for Standardisation IAF - International Accreditation Forum

HOKLAS th Edition Joint ISO-ILAC-IAF Communique on the Management Systems Requirements of ISO/IEC 17025:2005 “A laboratory’s fulfilment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results and calibrations.

HOKLAS th Edition Joint ISO-ILAC-IAF Communique on the Management Systems Requirements of ISO/IEC 17025:2005 The management system requirements in ISO/IEC (Section 4) are written in language relevant to laboratory operations and meet the principles of ISO 9001:2000 Quality Management Systems – Requirements and are aligned with its pertinent requirements.” Dated: 18 June 2005

HOKLAS th Edition Terminology Client(s) Customer(s) Quality SystemManagement system Conformance Conformity Senior/executive management Top management

HOKLAS th Edition Terminology Management system – means the quality, administrative and technical systems that govern the operations of a laboratory Top management – person or group of people who directs and controls an organisaton at the highest level, e.g. CEO, BoD, MD, ED, head of the laboratory, etc. Have the authority to make policies and decisions

HOKLAS th Edition Terminology Customer – organisation or person that receives a product (for laboratories, the product is the calibration or test results). Examples - consumer, client, end-user, retailer, beneficiary and purchaser. Conformity – fulfilment of a requirement.

HOKLAS th Edition HOKLAS th edition Chapter 1 - Introduction Chapter 2 – Normative references Chapter 3 – Terms and definitions

HOKLAS th Edition HOKLAS th edition Chapter 1 - Introduction No major change Update of information

HOKLAS th Edition HOKLAS th edition Chapter 2 – Normative references New for HOKLAS 003 Indispensable for application of ISO/IEC (superseding ISO Guide 2) VIM

HOKLAS th Edition HOKLAS th edition Chapter 3 – Terms and definitions New for HOKLAS and VIM apply