ISO 13485 Lead Auditor Certifaction

The ISO 13485 Lead Auditor certification is a credential for professionals needing to audit a Medical Devices Quality Management System (MDQMS) and, able to manage a team of auditors.

The principal competencies and knowledge skills needed by the market are the ability to proficiently plan and perform audits compliant with the certification process of the ISO 13485 standard, master the audit techniques, and manage (or be part of) audit teams and audit program.

Various professions may apply for this certification:

  • Auditors wanting to perform and lead a Medical Devices Quality Management System (MDQMS) audit, responsible of an audit team
  • Project managers or consultants wanting to master Medical Devices Quality Management System audit process
  • Persons responsible for the Quality or conformity in an organization
  • Members of the Quality team
  • Expert advisors in Quality
  • Experts wanting to prepare for a Quality audit function

The requirements for ISO 13485 Lead Auditor certification are:

Credential Exam Professional experience MS audit/ assessment experience Other requirements
ISO 13485 Provisional Auditor PECB Certified ISO 13483 Lead Auditor exam or equivalent None None Signing the PECB code of ethics
ISO 13485 Auditor PECB Certified ISO 13483 Lead Auditor exam or equivalent Two years: One year of work experience in related field Audit activities totaling 200 hours Signing the PECB code of ethics
ISO 13485 Lead Auditor PECB Certified ISO 13483 Lead Auditor exam or equivalent Five years: Two years of work experience in related field Audit activities totaling 300 hours Signing the PECB code of ethics

For certification purposes, the following audit types constitute valid audit experience:

If an applicant doesn’t have all requirements to apply for the credentials of ISO 13485 Lead Auditor he/she may apply for the credentials of ISO 13485 Auditor or ISO 13485 Provisional Auditor.

  1. Pre-assessment/pre-audit
  2. Gap analysis
  3. Internal audits
  4. Second party audits
  5. Third/external audits
  6. Opinion audit

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

  1. Audit planning
  2. Audit interview
  3. Managing an audit program
  4. Drafting audit reports
  5. Drafting non-conformity reports
  6. Drafting audit working documents
  7. Documentation review
  8. On-Site Audit
  9. Non-conformity follow-up actions
  10. Leading a team of auditors

 

Informations and registration:

Poza-site-ANAlexandra Niculae, Training Director ENVISO

alexandra.niculae@enviso.org

0723.592.977


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