Quality Management (QM) Programme
These activities involve the General European OMCL Network only.
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.
- 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.
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.
In 2017 an EA-EDQM joint document has been published on the EA website: EA-INF/15:2017 Joint EA - EDQM Communication regarding cooperation when carrying out (joint) audits/assessments in Official Medicines Control Laboratories.
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 2021
Quality Management Programme
Despite the challenges related to the COVID-19 pandemic, which made it necessary once more to reorganise and redeploy resources in 2021, the EDQM successfully continued to co-ordinate their activities and carry out the work programmes of the General European Network of OMCLs (GEON) including the Quality Management programme of the network.
Harmonising Quality Management Systems (QMSs) among OMCLs and achieving appropriate quality levels that enable mutual recognition of test results between members (for example, official batch release testing of biologicals, market surveillance of authorised medicines and falsified medicines testing) remain the principal goals of this programme.
Mutual Joint Audits/Visits and Training Visits
A system of Mutual Joint Audits and Visits (MJAs/MJVs) is in place within the Network to assess the compliance of OMCLs with the quality requirements laid down in ISO/IEC 17025, the Network’s QM guidelines and the European Pharmacopoeia.
In response to the pandemic, in 2021, the audit programme continued to be carried out remotely by means of videoconferences. The initial system focusing on QMS assessment (surveillance audits) was expanded to the technical part of the ISO/IEC 17025 norm.
In 2021, 14 remote MJAs were carried out. No Training Visits (TVs) or MJVs took place. Since the QM programme for OMCLs was launched in 1997, a total of 207 MJAs, 53 MJVs and 28 TVs/tutorials have been conducted.
OMCL Network Quality Management Documents
During 2021, five Guidelines and one new Recommendation document were adopted:
- Management of Documents and Records
- Externally Provided Products and Services, including Annex 1 - Qualification of testing service provider and Annex 2 - Principles of Contracting and OMCL Model Contract for Outsourcing Testing Services
- Qualification and re-qualification of personnel involved in laboratory activities
- Qualification of Equipment Annex 5 – Qualification of Automatic Titrators
- Recommendations on setting the expiry period for commercial and in-house-prepared reagents used in the laboratories of the OMCL Network
The EDQM’s coordination activities with respect to the QM programme are ISO 9001 certified by AFNOR Certification and audited on a regular basis. The last audit took place in February 2022.
- Workshop for OMCLs “Measurement Uncertainty” (13-15 November 2019, EDQM, Strasbourg, France)
- Workshops “Actions to address Risks & Opportunities” (21-22 and 23-24 May 2019, EDQM, Strasbourg, France)
- Training Course for New Auditors of the MJA/MJV scheme (5-7 February 2019, EDQM, Strasbourg France)
- Workshop for MJA Auditors on ISO 17025:2017 (6-7 February 2019, EDQM, Strasbourg France)
- Workshop on Management of Control Charts to Monitor Laboratory Data and Metrological Topics (26 - 28 June 2018, EDQM, Strasbourg France)
- What’s new, what’s different in ISO 17025:2017 (19-21 September 2018, EDQM, Strasbourg, France).