Understanding ISO 13485 and Notified Bodies
- ISO 13485:2016: The internationally recognized standard for quality management systems (QMS) specific to medical devices. It outlines requirements for ensuring the design, manufacture, distribution, and servicing of medical devices meet both customer and regulatory expectations.
- IAF (International Accreditation Forum): An international association that oversees the accreditation of bodies providing certification and verification services (such as audits for ISO 13485 certification).
- Notified Body: A private or governmental organization that has been designated by a country’s regulatory authority to conduct conformity assessments of products against specified regulations or standards. In the European Union and certain other regions, a Notified Body assessment is often required before a medical device can be sold.
Key Steps for ISO 13485:2016 Implementation and Certification:
1. Preparation and Planning
- Commitment from Management: Secure top-level support to allocate resources and encourage buy-in throughout the organization.
- Project Leadership: Appoint a qualified project leader or team to manage the implementation process.
- Gap Assessment (Optional): Conduct a gap analysis between your current practices and ISO 13485 requirements. Engage a consultant if needed.
- Implementation Plan: Create a structured implementation roadmap, including timelines, responsibilities, and resource allocation.
2. QMS Development
- Document Your Processes: Develop or refine the following:
- Quality Manual that outlines your QMS at a high level.
- Quality procedures that describe key processes (e.g., design control, document control, corrective action).
- Work instructions providing detailed step-by-step guidance for tasks.
- Risk Management: Integrate risk management activities throughout your quality system and decision-making processes.
- Design Control (If applicable): Implement procedures for design planning, input/output definition, reviews, verification, validation, and transfer to production.
- Supplier Controls: Develop processes for selecting, evaluating, and monitoring suppliers.
- Traceability: Establish systems to track materials, components, and finished devices throughout your supply chain.
3. QMS Implementation
- Training and Awareness: Educate all staff on the new QMS, their roles, and the importance of compliance.
- Roll-Out and Data Collection: Implement the QMS in a phased or comprehensive manner. Begin collecting records and data to demonstrate conformity.
- Internal Audit: Conduct an internal audit to verify if your QMS effectively meets the standard’s requirements and your own procedures.
- Management Review: Have top management formally evaluate the performance of the QMS and identify any areas for improvement.
4. Selection of Notified Body
- Regulatory Needs: Determine if a Notified Body audit is required for the markets where you plan to sell your devices.
- IAF Accreditation: Ensure the Notified Body is accredited by an IAF member Accreditation Body (AB). You can search for ABs and accredited bodies on the IAF website (https://www.iaf.nu/)
- Scope and Expertise: Check if the Notified Body is accredited for the specific types of medical devices you manufacture. Consider their experience and reputation.
5. Certification Audit Process
- Application: Submit an application package to the Notified Body.
- Stage 1 Audit: An initial audit to assess your QMS documentation and overall readiness.
- Stage 2 Audit: A comprehensive on-site audit to verify that your implementation aligns with the standard’s requirements and your own QMS documentation.
- Corrective Actions: Address any non-conformities (observations) raised during the audits.
- Issuance of Certificate: If successful, the Notified Body will issue an ISO 13485:2016 certificate.
6. Surveillance Audits
- Regular Assessment: Notified Bodies conduct ongoing surveillance audits (typically annually) to ensure you maintain conformity with the standard.
- Recertification: After a defined period (usually 3 years), a more extensive recertification audit is needed to renew your certificate.
Tips for Success
- Don’t Just “Check the Boxes”: Focus on creating a QMS that genuinely improves the quality and safety of your medical devices.
- Continuous Improvement: Embrace a mindset of continuous improvement, going beyond minimum compliance.