Objectives of Certification

When a quality management system is evaluated for certification, the certification agency checks whether the company has been complying with the directives of the certification standard (conformity assessment). The procedure follows a standardized protocol which has to be adhered to by all accredited certification agencies.

Who has to be certified?

Only manufacturers who want to place their products on the market according to attachments II, V, or VI of the directive 93/42/EEC are obliged to certify the management system. Typically, this involves an audit according to DIN EN ISO 13485, which states the presumption of conformity for this directive regarding the attachments. For manufacturers of medical devices of class I or for health care service providers (e.g. medical houses, orthopedic technicians, orthopedic shoe technicians) certification is not prescribed by law, however, it is indirectly required through contracts with trading partners or payers.

Who may be certified by Berlin Cert?

Certification is possible for every organization which develops, manufacturers, sells or offers servicing and assembly for medical devices or its components and which falls within the scope of Berlin Cert for the certification of management systems.

What procedure does the certification follow?

The procedure for certification is described in detail in Berlin Cert’s certification regulation. In summary, it consists of the following phases:

  1. Submitting the information necessary for planning the certification process, e.g. through filling in the system certification questionnaire.
  2. Submission and subsequent confirmation of a quote
  3. Application to prepare the certification process
  4. Confirmation of the application and introduction of the audit team
  5. Joint audit planning and coordination
  6. Pre-evaluation of QM documentation
  7. Certification audit at the company
  8. Compiling of a detailed audit report
  9. If needed – implementation of corrective measures
  10. Award of certificate and trademark contract
  11. Monitoring audits
  12. Re-certification audit

Please simply contact our agency team if you have any questions regarding the procedure.

What are the advantages of certification?
  • Impact on business (reduction of defective work and rectifications, reduction of costs for warranty and post-sale services, incoming goods inspection no longer necessary)
  • Process organization (increase of company presence, avoiding of errors, co-worker motivation)
  • Marketing (advertising effect, differentiation from competitors without certificate, product quality is guaranteed)
  • Liability (possible documented proof in liability cases, should the occasion arise, unwarranted and or legal claims might be averted)
Why certify through Berlin Cert?
  • Customer-oriented work and collegial atmosphere
  • Direct contact and quick replies to your inquiries
  • Competent and friendly team in a small certification agency
  • Many years of experience in QM-certification in the health care environment
  • Appropriate price-performance ratio