ISO 13485 Lead Implementer Certification

The ISO 13485 Implementer certifications are professional certifications for professionals needing to implement a Quality Management System (MDQMS) and, in the case of ISO 13485 Lead Implementer Certification, manage an implementation project.

The principal competencies and knowledge skills needed by the market are the ability to support an organization in implementing and managing a Quality Management System as specified in ISO 13485:2016: planning, implementation, surveillance, re-examination and operation of a MDQMS, continual improvement of business processes and quality, management’s commitment, follow-up and review.

Various professions may apply for this certification:

  • Project managers or consultants wanting to prepare and to support an organization in the implementation of a
  • Medical Devices Quality Management System (MDQMS)
  • Quality auditors who wish to fully understand the Medical Devices Quality Management System implementation process
  • Managers responsible for Quality or conformity
  • Members of a Quality team
  • Expert advisors in Quality
  • Technical experts wanting to prepare for a Quality function or for a MDQMS project management function

The requirements for “Implementer” certifications are:

Credential Exam Professional experience MDMS project experience Other requirements
ISO 13485 Provisional Implementer PECB Certified ISO 13483 Lead Implementer exam or equivalent None None Signing the PECB code of ethics
ISO 13485 Implementer PECB Certified ISO 13483 Lead Implementer exam or equivalent Two years: One year of work experience in related field Project activities totaling 200 hours Signing the PECB code of ethics
ISO 13485 Lead Implementer PECB Certified ISO 13483 Lead Implementer exam or equivalent Five years: Two years of work experience in related field Project activities totaling 300 hours Signing the PECB code of ethics

For certification purposes, the following implementation types constitute valid implementation experience: If an applicant doesn’t have all requirements to apply for the credentials of ISO 13485 Lead Implementer, he/she may apply for the credentials of ISO 13485 Implementer or ISO 13485 Provisional Implementer.

  1. Internal implementation
  2. External/consulting implementation
  3. Partial implementation

To be considered valid, these implementation activities should follow best implementation practices and include most of the following activities:

  1. Drafting an MDQMS implementation business case
  2. Managing an MDQMS implementation project
  3. Implementing an MDQMS based on ISO 13485
  4. Implementing corrective and/or preventive actions
  5. Performing internal audit
  6. Performing a management review
  7. Performing evaluation, monitoring and measurement of an MDQMS based on ISO 13485
  8. Managing a quality management team

Informations and registration:

Poza-site-ANAlexandra Niculae, Training Director ENVISO

alexandra.niculae@enviso.org

0723.592.977


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