Quality Management (QM) Programme
These activities involve the General European OMCL Network only.
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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.
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Activities
- Mutual Joint Visits (MJVs)
They are organised by the EDQM. These aim to advise and help OMCLs implement and/or improve their quality management systems.
- Mutual Joint Audits (MJAs)
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, in the General European OMCL Network Quality Management Guidelines and in the European Pharmacopoeia. They take place on a routine basis.
- Education Activities
Education activities such as 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
They 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 now, 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.
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Achievements in 2012
In 2012, 11 MJAs and one MJV were carried out at OMCL sites. Two of the audits were performed jointly with the corresponding National Accreditation bodies. Following an initial MJA, Ukraine has been accepted as new member of the OMCL Network.
In addition, three training visits were organised by EDQM in order to provide technical training on physico-chemical and biological laboratory methods and to help candidates for the OMCL Network to develop their Quality Management System.
Since the beginning of the QM Programme in December 1997, 95 MJAs, 50 MJVs, 2 tutorials and 18 training visits have been carried out in the OMCL Network.
In 2012 a workshop for technical auditors of the Network was held at the EDQM premises in order to exchange experience and to harmonize requirements during audits.
The following new or updated OMCL guidelines were adopted by correspondence and presented at the annual OMCL meeting: “Management of Reagents” (PA/PH/OMCL (11) 157 5R) and “Handling and Use of Reference Standards in the OMCL Network” (PA/PH/OMCL (11) 204 3R).
Currently, new guidelines on “Qualification of Balances” and “Qualification of Analytical Columns” are under elaboration, other guidelines are being revised. It is also intended to elaborate a new guideline on “Calibration of pH-meters”, which should serve not only as QM-guideline but also for revision of the General Chapter 2.2.3 of the European Pharmacopoeia.
Progress has been made in the re-establishment of contacts with the European co-operation for Accreditation (EA). Following meetings with EA-representatives in Paris in July 2012 and with the EA-Laboratory Committee in Oslo in September 2012, in has been agreed to plan joint audits between EDQM/MJA and National Accreditation bodies with the objective of sharing audit results in future. This shall be beneficial for those OMCLs that prefer to follow both external assessment schemes.
Guidelines & Procedures
To download all the quality management (QM) guidelines, please go to the Quality Management (QM) Guidelines section.
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Past Events
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Training Course "Basic Quality Assurance", 25-26 September 2008, Vienna, Austria
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Training Course "Basic Quality Assurance", 27-29 November 2007, Rabat, Morocco, (it was co-organised by WHO for French speaking OMCLs)
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Related links
EDQM Council of Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
Interesting Links
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