AA

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)
    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. From a legal point of view a guideline is not binding, but deviations from its content require a sound (and, if applicable, scientific based) justification.

  • Recommendation Documents
    They have been drafted by experts from the OMCL Network. Similar to the QM-Guidelines they shall support laboratories in implementing the ISO/IEC 17025 requirements. They provide guidance for OMCLs of the GEON or a specific network without binding character.

    - Qualification of Analytical Columns
      (PA/PH/OMCL (12) 128 5R)

    - Qualification and Requalification of Analysts
      (PA/PH/OMCL (11) 84 R)

    - General Requirements for Infrequently performed techniques
      (PA/PH/OMCL (11) 18 R)

Following meetings with representatives of the European co-operation for accreditation (EA) and presentations given at meetings of the EA Laboratory Committee, the EDQM has been accepted as “Recognised Stakeholder” of the EA in 2013. This recognition will foster future co-operation, exchange of information and mutual acceptance of audit results. The EA now officially supports the performance of joint audits between National Accreditation bodies and EDQM/OMCL experts.

The EA confirmed the use of the EDQM’s quality management guidelines in QMS audits of OMCLs by accreditation bodies

 

For a list of these guidelines, click HERE.

 

Also the members of the OMCL Network officially support the idea of joint audits and express this position in the paper “Complementary Mutual Joint Audits in OMCLs accredited against ISO/IEC 17025”.


Achievements in 2013

In 2013, 13 MJAs were carried out at OMCL sites, two of which were performed as joint audits together with the respective National Accreditation bodies.

 

A part of these MJAs were initials audits which served or will serve the corresponding laboratories to become full or associated members of the OMCL Network. It is an encouraging development that an increasing number of non-European laboratories are willing to join the OMCL Network and ask for audits of their OMCLs.


Since the beginning of the QM Programme in December 1997, 107 MJAs, 50 MJVs, 2 tutorials and 18 training visits have been carried out in the OMCL Network.

 

In 2013 the EDQM organised a workshop for Quality Management System auditors with the objective of harmonising requirements during audits performed within the OMCL Network. 


The new OMCL guideline “Qualification of Balances” was adopted by correspondence in 2013. Furthermore, an OMCL working group elaborated a recommendation document, namely “Qualification of Analytical Columns”, which shall help OMCLs to develop or improve their QMS with regard to the management and qualification of columns. 

 

Other existing guidelines are currently under revision and new guidelines concerning the “Calibration/qualification of pH meters” and “Subcontracting” are being elaborated. The guideline for pH meters will be established in parallel to the revision of the General Chapter 2.2.3 “Potentiometric determination of pH” of the European Pharmacopoeia.

 

Guidelines & Procedures

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

 


Past 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)

 


Related links

Disclaimer - Created by 2exVia with MasterEdit®