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Medical Devices
- In-Vitro-Diagnostic (IVD)
- Processing of medical products
- Medical Devices(active/non-active)
- Active Implantable Medical Devices
- QM-System Certification
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- GM Mark

QM-System Certification

Certification of Quality Management Systems

Auditing and certification of a quality management (QM) system in the medical devices sector should be based on the currently harmonized standards of EN ISO 13485:2000*, EN ISO 13488:2000*, EN ISO 13485:2003 or EN 46003:1999. (* These standards have been withdrawn. The transitional period ended on 31 July 2006.)

EN ISO 13485:2003
This international standard specifies the requirements of a QM system that an organization can use "EN ISO 13485:2003" for the design, development, production, installation and servicing of medical devices. A total QM system fulfills the requirements of a quality system in various conformity assessment procedures, such as Annex II of Directive 93/42/EEC, Annex 2 of Directive 90/385/EEC and Annex IV of Directive 98/79/EC.
Well-founded exceptions are possible in design and development. A QM system will then fulfill the requirements of a quality system as per Annex V of Directive 93/42/EEC and Annex VI of Directive 98/79/EC.

EN 46003:1999
This European standard lays down with EN ISO 9003:1994, the requirements of a quality system for final testing of medical devices with the exception of in-vitro diagnostics, active implantable and sterile medical devices. A QM system fulfils the requirements of a quality system as per Annex VI of Directive 93/42/EEC.

Regulated Area

Identified as legal manufacturer of medical devices on the label, they take the fulfillment of the conformity assessment procedure into the consideration. In this statutory regulated area, only a notified body is authorized to assess and certify QM systems. The company´s QM system is assessed as part of a conformity assessment procedure in an audit. The audit is generally carried out by an audit team.

That is why in the regulated area, along with QM system certification, the required approval of the conformity assessment procedure chosen by the legal manufacturer is granted. This approval is required for placing medical devices within the EU market (e.g. Annex II of Directive 93/42/EEC).

The Procedure

During auditing, a Quality Management Representative is appointed by the management with planning, implementing and maintaining the QM system. Workflows or procedures and work instructions for individual areas of the company are written down in the QM manual.

QM documentation of a company consists a valid edition of the QM manual, general information about the company and the products, a list of process descriptions or approved standard operation procedures, checklists and forms. Based on this documentation, the audit team conducts its audit in four phases.

Phase I : Preparation for the Certification Audit:

Documentation is required and the scope for testing and verification (standard, directive, etc.) is defined in an open discussion. A pre-audit can be agreed.

Phase II : Assessment of QM Documentation

The QM system is first checked on the basis of the documentation submitted for testing and the findings are listed in a report.

Phase III : In-Company Certification Audit

The auditors check and evaluate the efficacy of the QM system introduced. They will note any differences and weak points in the system compared with the requirements of the appropriate standard and will discuss possible remedies and improvements. In conclusion of the audit, the company will receive a detailed audit report. If the report includes a positive assessment at this stage, the auditors will recommend a certification. If the assessment is not positive, a re-audit will be arranged for those parts of the QM system that need to be corrected.

Phase IV : Issuing of Certificate, Surveillance Audit, Recertification Audit:

The certification department issues the certificate based on the review of the provided audit documentation and on the auditors recommendation.

The certificate is valid for 3 to 5 years if the annual surveillance audit is positive. Before the certificate´s validity expires, a recertification audit can be conducted to check the efficacy of the entire QM system and reissue the certificate for a further 3 to 5 years.

The Advantages of a QM System

A QM system ensures the high level of national regulations, standards and statutory requirements and may also protects the manufacturer from product liability claims.

A successful and competent managed company has a positive effect on the motivation of its employees, manufacturer and product's image to raise the level of confidency and reliability of customers.