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THE KAVON RESOURCE CENTER

Detailed Standard Description

Name:

ISO 17025

Revision:
2005
Title:
General Requirements For The Competence Of Testing And Calibration Laboratories
Release Date:
2005-05-15
Status:
ACTIVE
Description:
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.

Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.

Standard FAQ

Question
  Answer

Do you think that organizations, which implement an ISO Quality Management System, do it for the benefits that compliance brings, or is it only for certification?
 

In my experience, I have found that a number of companies & organizations go for ISO certification only because they have to or it is a customer requirement to do business. For medical device manufacturers in the US, FDA GMPs, harmonized with ISO, are mandatory. Top Managements usually look primarily at their bottom lines and see ISO as an expense, not a benefit. They may hire a QA or Engineering Manager to be responsible for ISO enforcement, documentation, and compliance - but primarily to keep the companies out of trouble with customers, government, and regulatory auditors. Only token management support is provided and when they're caught in a non-conformance situation or with a deficient product, they expect the assigned compliance person to get them out of trouble.


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