Title

Organize an external audit to identify the last improvements necessary for accreditation

Why

If, for implementing the quality management system, the phases of this tool were chronologically followed, then the quality management system approaches complete implementation. It must be verified if the quality management system now completely complies with the ISO 15189 standard before accreditation is requested.

What

Verify complete implementation of the quality management system and compliance of the system with ISO 15189. As the Internal Auditors and Quality Officer may have developed blind spots (they are used to the way things are arranged and may not be able to see specific nonconformities in the system) it is better to have the laboratory audited by a "fresh pair of eyes". Therefore, arrange an external audit. External auditors must audit the laboratory as if they have to decide whether the laboratory can be accredited or not. Hire an experienced external auditor/auditors.


This activity provides you with the opportunity to solve as much as possible all the nonconformities before applying for accreditation and will give you more certainty for the final external audit by the accreditation body. Note that organizing a mock audit is cheaper than applying for accreditation without success.

How & who

Laboratory Manager:

  1. Select organizations or persons that could perform an external audit according to ISO 15189. It may be good to have two persons audit the laboratory: one person should have knowledge of the examinations with which the laboratory works and the other person should examine compliance of the quality management system with the ISO 15189 requirements. These should be trained auditors which don’t necessarily have to come from specialized organizations. For example: already accredited laboratories in your country could also be contacted to explore possibilities for hiring their expertise in the form of an auditor/auditors.
  2. Organize the external audit.


Back to Roadmap Activity Overview
This activity belongs to the QSE Assessment
ISO15189:2007: 4.10.1 4.11.1 4.12.1
ISO15189:2012: 4.10 4.11
ISO15190:2003: