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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)
    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 2014

In 2014, 11 MJAs were carried out at OMCL sites, two of which were performed as joint audits together with the respective National Accreditation bodies and one with the WHO.


Since the beginning of the QM Programme in December 1997, 118 MJAs, 50 MJVs, 2 tutorials and 18 training visits have been carried out in the OMCL Network.

In 2014 the EDQM organised two training courses for new auditors. This allowed the EDQM to increase the pool of auditors with expertise and qualifications to perform audits in the OMCL Network.

 

In 2014 a new guideline for “Sub-contracting of tests” was adopted by the OMCL Network. Two guidelines for “Validation of analytical procedures” and “Evaluation and reporting of results” were revised and published. The guideline for “Calibration/qualification of pH meters” is currently under revision and will be established in parallel to the revision of the General Chapter 2.2.3 “Potentiometric determination of pH” of the European Pharmacopoeia. In addition, two recommendation documents for the “Management of documents and records” and “Management of volumetric glassware” are being prepared by experts of the OMCL Network.

Guidelines & Procedures

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

 


Future Events

  • Workshop for Auditors of the MJA/MJV Scheme of the OMCL Network

 

Past Events

  • Training Course "Training Course for Auditors of the MJA/MJV Scheme of the OMCL Network”, 17-18 June 2014, Strasbourg, France

  • Training Course "Training Course for Auditors of the MJA/MJV Scheme of the OMCL Network”, 25-26 September 2014, Strasbourg, France

 


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