Title: Adaptation of a laboratory quality manual based on the European standard EN 50001:1989 to ISO/IEC 17025: 1999

Author(s): Jose Fu Wong
Final project
Year of publication:
Place of publication:
Number of pages:
international standard; European standard; quality manual; guideline;


The adoption of the International Standard ISO/IEC 17025: 1999 “General requirements for the competence of testing and calibration laboratories”, as the new standard for laboratories and its accreditation has had a global impact. This paper contains an analysis of the sections and clauses that are to be included in a laboratory’s quality manual based on the European Standard EN 45001:1989 “General criteria for the operation of testing laboratories” in order to comply with the requirements of the new ISO Standard.
A “diagnosis audit” to this quality manual was performed using the applicable requirements of ISO/IEC 17025. The content of these two standards was compared for supplementing and drafting the missing sections. The main conclusions from the audit point out that seven clauses from ISO/IEC 17025 need to be included in the quality manual. Thereof, three are new and the rest correspond to activities performed by the organization, which are not fully documented. In this report it will be shown how to introduce the new requirements of the standard into an already-established quality system. Furthermore, the inclusion of some guidelines to those chapters that needed little modification was also performed. The implementation of an ISO/IEC 17025-based quality manual for a laboratory has some advantages. An accredited laboratory by this standard can perform tests in certain areas such as the verification of compliance to regulations on handling, production and placing of food products in market.

Documents and links