HOKLAS 003 8 th Edition HOKLAS 003 Technical

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

Programme HOKLAS 003 8 th Edition 0930 -0945 Introduction W W Wong 0945 -1015 New and revised requirements - cl. 4. 1 & 4. 2 CC Wong 1015 -1035 Tea break All 1035 -1115 New and revised requirements – other clauses W W Wong 1115 -1130 Implementation schedule 1130 -1200 Q&A S S Chan All

HOKLAS 003 8 th Edition Basis of HOKLAS 003 ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories

HOKLAS 003 8 th edition HOKLAS 003 8 th Edition Sections 2 to 5 are verbatim reproduction of ISO/IEC 17025: 2005 Clarifications and updating of HKAS Policies are also made

HOKLAS 003 8 th Edition

Implementation Deadline HOKLAS 003 8 th Edition 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 Hence, implementation deadline is 15 May 2007

Amendment of ISO/IEC 17025 HOKLAS 003 8 th Edition • Purpose – aligned with ISO 9001: 2000 • Initial – issue as AMD (DAM – 2003, FDAM – 2004) • Decision made to publish the revision as 2 nd edition • Published – 15 May 2005 • normal revision cycle – once every 5 years • Amendments mainly to Section 4 (Management requirements)

HOKLAS 003 8 th Edition ISO/IEC 17025: 2005 Introduction “The first edition referred to ISO 9001: 1994 and ISO 9002: 1994. There standards have been superseded by ISO 9001: 2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001: 2000.

HOKLAS 003 8 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. ”

ISO/IEC 17025: 2005 HOKLAS 003 8 th Edition 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 003 8 th Edition

HOKLAS 003 8 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 003 8 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 003 8 th Edition Joint ISO-ILAC-IAF Communique on the Management Systems Requirements of ISO/IEC 17025: 2005 The management system requirements in ISO/IEC 17025 (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

Terminology HOKLAS 003 8 th Edition Client(s) Quality System Conformance Senior/executive management Customer(s) Management system Conformity Top management

Terminology HOKLAS 003 8 th Edition 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, Bo. D, MD, ED, head of the laboratory, etc. Have the authority to make policies and decisions

Terminology HOKLAS 003 8 th Edition 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 003 8 th edition HOKLAS 003 Chapter 1 - Introduction 8 th Edition Chapter 2 – Normative references Chapter 3 – Terms and definitions

HOKLAS 003 8 th edition HOKLAS 003 8 th Edition Chapter 1 - Introduction • No major change • Update of information

HOKLAS 003 8 th edition HOKLAS 003 8 th Edition Chapter 2 – Normative references • New for HOKLAS 003 • Indispensable for application of 17025 • ISO/IEC 17000 (superseding ISO Guide 2) • VIM

HOKLAS 003 8 th edition HOKLAS 003 8 th Edition Chapter 3 – Terms and definitions • New for HOKLAS 003 • 17000 and VIM apply