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HOKLAS
003
8th
Edition
HOKLAS 003
Technical Criteria for
Laboratory Accreditation
th
8
Edition
October 2005
Programme
HOKLAS
003
8th
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
1115-1130 Implementation
schedule
1130-1200 Q&A
W W Wong
S S Chan
All
HOKLAS
003
8th
Edition
Basis of HOKLAS 003
ISO/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
Background
HOKLAS
003
8th
Edition
ISO Guide 25
- 1978
ISO/IEC Guide 25
- 1982
ISO/IEC Guide 25
- 1990
ISO/IEC 17025
- Dec 1999
ISO/IEC
ISO/IEC 17025
17025
nd ed
-- May
May 05
05 22nd
ed
ISO TC/176
established
ISO 9000 Series
- 1987
ISO 9000 Series
- 1994
ISO
ISO 9001
9001
-- 2000
2000
Implementation Deadline
HOKLAS
003
8th
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
8th
Edition
•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 17025:2005
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 There standards have been superseded by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
003
8th
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
8th
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
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
Terminology
HOKLAS
003
8th
Edition
Client(s)
Quality System
Conformance
Senior/executive
management
Customer(s)
Management system
Conformity
Top management
Terminology
HOKLAS
003
8th
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,
BoD, MD, ED, head of the laboratory, etc. Have the
authority to make policies and decisions
Terminology
HOKLAS
003
8th
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 8th edition
HOKLAS
003
Chapter 1 - Introduction
8th
Edition
Chapter 2 – Normative references
Chapter 3 – Terms and definitions
HOKLAS 003 8th edition
HOKLAS
003
Chapter 1 - Introduction
8th
Edition
• No major change
• Update of information
HOKLAS 003 8th edition
HOKLAS
003
Chapter 2 – Normative references
8th
Edition
• New for HOKLAS 003
• Indispensable for application of
17025
• ISO/IEC 17000 (superseding ISO
Guide 2)
• VIM
HOKLAS 003 8th edition
HOKLAS
003
Chapter 3 – Terms and definitions
8th
Edition
• New for HOKLAS 003
• 17000 and VIM apply