Quality management
Certification according to EN ISO 9001

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ISO 9001 certification for your quality management: EN ISO 9001 (as the national standard DIN EN ISO 9001) is the most widely used standard in quality management both nationally and internationally.
It represents a comprehensive and generally applicable quality standard that obliges the organisation applying it to continuously improve its own performance and customer satisfaction.

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Range of services for QM certification in accordance with ISO 9001

We also offer ISO 9001 certification for companies that serve other sectors in addition to the medical device sector, as well as for suppliers, subcontractors or organisations in the medical device environment whose activities are not covered by the scope of EN ISO 13485. Here you can benefit from the combined process handling and auditing.

Procedure of a certification process

Here you can see an example of an mdc EN ISO 9001 certification procedure.

Documents

Overview of mdc documents on ISO 9001 that may be of interest

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01

Preparation

  • Offer and application

02

Assessment

Stage 1

  • Review of the QM documentation
  • On-site audit to determine readiness for certification and to verify implementation of the QM system (can be omitted in special cases)

Stage 2

  • Certification audit on site

03

Certification

  • Evaluation of the assessment reports and the process flow
  • Decision on the granting of the certificate
  • Issue of certificate

04

Monitoring

  • Surveillance audits
  • Audit reports
  • Processing of change notifications

05

Re-Certification

  • Preparation
  • Assessment
  • Certification

We offer those interested in certifications the opportunity for an initial exchange of information.

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Additional service that may be of interest

EN ISO 13485?

Here you can find information about the EN ISO 13485 standard

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Advantages of ISO 9001 certification by mdc

An active quality management system forms the basis for continuous development and improvement in your organisation. Structured and transparent processes and the clear definition of responsibilities and procedures help organisations to continuously improve their performance across all areas.
The widespread use of the standard and its high level of recognition also make certification to EN ISO 9001 a quality feature that creates trust.

FAQ

What does ISO 9001 certification cost?

If you would like to know more about the costs and effort involved in certifying your quality management system in accordance with DIN EN ISO 9001, we will be happy to provide you with a customised quote. If you have any questions in advance, you can contact our team of experts at any time, who will also be happy to help you by telephone.

What does the ISO 9001 standard describe?

Over the years, EN ISO 9001 has become an international standard defined by the International Organisation for Standardisation (ISO) and has also been established as a European standard and, in the DIN EN ISO 9001 version, as a German standard. This standard specifies how organisations should introduce and maintain a QM system in order to continuously ensure and improve the quality of their products and services.

In principle, any organisation can set up, maintain and further develop a quality management system in accordance with this standard.

Is ISO 9001 certification mandatory?

Certification to EN ISO 9001 is not initially mandatory. Companies can voluntarily opt for certification if they fulfil the requirements of the standard and wish to prove that quality management processes are being adhered to.

In some areas, market participation is only possible with accredited proof – i.e. certification – for example in the context of tenders or in the form of customer requirements.

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