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HOKLAS
003
8th
Edition
HOKLAS 003 Technical Criteria for
Laboratory Accreditation
8th EditionOctober 2005
HOKLAS
003
8th
Edition
Programme
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
S S Chan
1130-1200 Q&A All
HOKLAS
003
8th
Edition
Basis of HOKLAS 003ISO/IEC 17025
General requirements for the competence of testing and calibration laboratories
HOKLAS
003
8th
Edition
HOKLAS 003 8th edition
Sections 2 to 5 are verbatim reproduction of ISO/IEC 17025:2005
Clarifications and updating of HKAS Policies are also made
HOKLAS
003
8th
EditionISO 9000 Series
- 1987
ISO Guide 25- 1978
ISO/IEC Guide 25- 1982
ISO/IEC Guide 25- 1990
ISO/IEC 17025- Dec 1999
ISO TC/176established
ISO 9000 Series- 1994
ISO 9001- 2000
ISO 9001- 2000
BackgroundBackground
ISO/IEC 17025 - May 05 2nd ed
ISO/IEC 17025 - May 05 2nd ed
HOKLAS
003
8th
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
Hence, implementation deadline is 15 May 200715 May 2007
HOKLAS
003
8th
Edition
Amendment of ISO/IEC 17025Amendment of ISO/IEC 17025
•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
003
8th
Edition
ISO/IEC 17025:2005Introduction
“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 There standards have been superseded by ISO9001:2000, which made an alignment of ISO/IEC17025 necessary.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
003
8th
Edition
ISO/IEC 17025:2005Introduction
“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
003
8th
Edition
ISO/IEC 17025:2005Scope
“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
8th
Edition
HOKLAS
003
8th
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
8th
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
8th
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
HOKLAS
003
8th
Edition
Terminology
Client(s) Customer(s)
Quality System Management system
Conformance Conformity
Senior/executive management
Top management
HOKLAS
003
8th
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
003
8th
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
003
8th
Edition
HOKLAS 003 8th edition
Chapter 1 - Introduction
Chapter 2 – Normative references
Chapter 3 – Terms and definitions
HOKLAS
003
8th
Edition
HOKLAS 003 8th edition
Chapter 1 - Introduction
• No major change• Update of information
HOKLAS
003
8th
Edition
HOKLAS 003 8th edition
Chapter 2 – Normative references
• New for HOKLAS 003• Indispensable for application of
17025• ISO/IEC 17000 (superseding ISO
Guide 2)• VIM
HOKLAS
003
8th
Edition
HOKLAS 003 8th edition
Chapter 3 – Terms and definitions
• New for HOKLAS 003• 17000 and VIM apply
