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Quality Management (QM) Programme

These activities involve the General European OMCL Network only.

Background

The quality management (QM) programme within the General European OMCL Network started in 1997 with a two-year pilot phase. A common approach for developing and implementing Quality Management systems (QMS) in all OMCLs of the Network had been agreed upon. This was especially important due to the increasing exchange of results and data (e.g. batch release of biologicals, market surveillance of centrally authorised products) among members. Since 1999, work in this area has intensified. It was decided to adopt a specific assistance and maintenance programme for QMS and to harmonise the quality management policies of the OMCLs. It was further agreed to refer to the ISO/IEC 17025 quality standard.

Activities

Mutual Joint Visits (MJVs) are organised by the EDQM. These aim to advise and help OMCLs implement and/or improve their quality management systems.

Mutual Joint Audits (MJAs) of OMCLs are carried out by experts, from the Network, trained in Quality Management. These check that OMCLs quality management systems comply with the requirements laid down in ISO/IEC 17025 and in the General European OMCL Network Quality Management Guidelines. They take place on a routine basis.

Education Activities such as tutorials, training visits, and training courses educate OMCL staff in QM and/or on technical topics related to the implementation and improvement of OMCLs quality management systems.

Quality Management Guidelines have been drafted by experts from the Network. They aim to support laboratories in implementing the ISO/IEC 17025 requirements, while taking into account the specific OMCL environment.

Discussions are also ongoing with representatives of the European co-operation for Accreditation (EA) concerning recognition of the contribution OMCLs are making in setting up quality management systems in their domain. Between 2005 and 2007, the EA approved a number of our quality management guidelines, as recommendation documents to be used in quality management system audits of OMCLs. For a list of these guidelines, click HERE.

Where appropriate, the General European OMCL Network intends to present further guidelines to the EA for approval.

Achievements in 2011

In 2011, 13 MJAs and one MJV were carried out at OMCL sites, corresponding to a more than 50 per cent increase compared to 2010.

In addition, one training visit was organised by EDQM in order to provide technical training on biological laboratory methods.

Since the beginning of the QM Programme in December 1997, 84 MJAs, 49 MJVs, 2 tutorials and 15 training visits have been carried out in the OMCL Network.

In 2011 two training courses for auditors have been held at the EDQM premises in order to train new auditors for ISO/IEC Standard 17025.

The following new or updated OMCL guidelines were adopted at the annual OMCL meeting: 7^th Annex of the OMCL Guideline Qualification of Equipment: “Qualification of Mass Spectrometry (MS) instruments” and the 1^st Annex of the OMCL Guideline Qualification of Equipment: “Qualification of HPLC equipment”. Furthermore, recommendation documents have been elaborated and were distributed during the year 2011, such as “Qualification and re-qualification of analysts” and “General requirements for infrequently performed techniques”.

Other existing guidelines are currently under revision and new guidelines concerning the “Management of Reagents” and “Handling and Use of Reference Standards in OMCLs” are being elaborated.

A new edition of the Quality Management Book containing the latest OMCL guidelines and MJA/MJV/TV instructions/forms was published in 2011.

Guidelines & Procedures

To download all the quality management (QM) guidelines, please go to the Quality Management (QM) Guidelines section.

Events

Training Course "Basic Quality Assurance", 25-26 September 2008, Vienna, Austria

Training Course "Basic Quality Assurance", 27-29 November 2007, Rabat, Morocco, (it was co-organised by WHO for French speaking OMCLs)