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 harmonised standards EN ISO 13485:2000*, EN ISO 13488:2000*, EN ISO 13485:2003 or EN 46003:1999. (* These standards have been withdrawn. The transitional period ends on 31 July 2006.)

EN ISO 13485:2003
This international standard specifies the requirements of a QM system that an organisation can use for the design and development, production, installation and servicing of medical devices. A total QM system of this kind fulfils the requirements of a quality system laid down 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, e.g. design and development. A QM system of this kind will then also fulfil 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 jointly 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 of this kind fulfils the requirements of a quality system as per Annex VI of Directive 93/42/EEC.

Regulated Area
For manufacturers of medical devices, i.e. identified as legal manufacturer on the label, the fulfilment of the conformity assessment procedure chosen by the manufacturer is also taken into account. In this statutory regulated area only a notified body is authorised 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 in general 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
In the run-up to 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 drawn up and laid down in the QM manual.

A company QM documentation consisting of 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, plus checklists and forms, is the basis on which the audit team conducts its audit, which is undertaken in four phases.

Phase I:
Preparation for the Certification Audit:
Documentation required and the scope for testing and verification (standard, directive, etc.) are defined in a 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 compliance with the relevant scope 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. On 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 certification. If the assessment is not yet 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 provided 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 to a high degree compliance with national regulations, standards and statutory requirements and may also in certain circumstances protect the manufacturer from product liability claims.

A successful and competent managed company has a positive effect on the motivation of its employees, boosts the manufacturer´s image and that of the product and inspires customer confidence.