ISO 13485

Internal Audit Programme

Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.

Fully Customizable Audit Ready Instant Download
Standard
ISO 13485
Document Type
Programme
Format
DOCX
Language
English
Tags
ISO 13485, Medical Devices, Programme

This programme plans the internal audits for the year. ISO 13485:2016 clause 8.2.4 requires internal audits at planned intervals to determine whether the quality management system conforms to planned and documented arrangements, to the requirements of the standard, to your organisation's QMS requirements and to applicable regulatory requirements, and is effectively implemented and maintained.

What's Inside

  • Purpose and Objectives
  • Audit Criteria, Scope and Methods
  • Risk-Based Audit Frequency
  • Auditors and Independence
  • Results of 2027 Programme (Input to This Plan)
  • Programme Monitoring and Review
  • Review and sign-off section

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 8.2.4. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.

Key Benefits

  • Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements