ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medical Device industry. According the International Organization for Standardization, “ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.”
The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device in the European Union and Canada.
ISO 13485:2003 – Requirements
- Establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.
- Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.
- A detailed plan on how remedial processes will be used to assure conformity.
- Planning and performance of regular internal audits.
- Creating a procedure to gather feedback from customers and a feedback system to monitor emerging problems.
To understand the key success factors for risk based verification and validation planning to meet FDA and ISO 13485 requirements, Risk evaluation and development of mitigation strategies
ISO 13485: Auditor Training
Conducting internal audits is a large part of maintaining compliance. Training internal auditors with specialized, on-demand methods tailored to the working environment of the medical device industry is thus essential. The right auditor training for ISO 13485:2003 should focus on:
- How to document audits and auditor interpretations
- How to prepare checklists
- Listening and questioning techniques
- How to prepare Nonconformance reports
- How to write reports
To get more familiar with the requirements of the ISO 9001:2000 quality management system standard; as well as insights useful to internal auditors in companies establishing, maintaining, or implementing and Quality Management System (QMS), Risk evaluation and development of mitigation strategies