ISO 13485:2016 Requirements
Here we have broken down the ISO 13485:2016 requirements of the standard to make it easier to understand and put into action. ISO 13485:2016 is the latest version of ISO 13485. The ISO 13485 requirements encompass 8 clauses with supporting subclauses. The requirements to be applied to your quality management system (QMS) are covered in clauses 4-8. To successfully implement ISO 1485:2016 within your organization, you must satisfy the requirements within clauses 4-8, along with meeting customer and applicable statutory and regulatory requirements.
ISO 13485:2016 = ISO 9001:2008 + additional requirements specific to the medical device industry, which is arranged in an 8 clause format (whereas ISO 9001:2015 is based on a 10 clause format). If you are interested in an integrated management system, learn more about how to harmonize the two by comparing ISO 13485:2016 with ISO 9001:2015. Additionally, ISO:13485:2016 has many common requirements to address FDA 21 CFR Part 820. In fact, the United States FDA made a formal announcement that they will be replacing parts of the existing Quality System Regulation (QSR), with the international standard: ISO 13485:2016.
Once you have met the ISO 13485:2016 requirements and are granted certification you can then advertise your certification to ISO 13485:2016.
Overview of the ISO 13485:2016 Requirements
Clause 2: Normative Reference
- References ISO 9000:2015 which should be used along with the standard. It outlines the Quality Management System’s Fundamentals and Vocabulary
Clause 3: Terms and Definitions
Gives definitions used in the standard, many of which are IN ADDITION to ISO 9001:2008:
- Active Implantable Medical Device
- Active Medical Device
- Advisory Notice
- Customer Complaint
- Implantable Medical Device
- Medical Device
- Sterile Medical Device
Clause 4-8 are the ISO 13485:2016 requirements that need to be met within your organization to become certified to ISO 13485.
Clause 5: Management Responsibility Gives requirements for Management’s role in the QMS
- Management Responsibility
- Quality Policy & Objectives
- Customer Focus & Customer Satisfaction
- Management Review
Clause 8: Measurement, Analysis and Improvement Gives requirements on monitoring processes and improving those processes
- Customer Satisfaction
- Internal Audits
- Control of Non-Conforming Product
- Corrective and Preventive Action
NOTE: Several items in section 8 are modified from ISO 9001:2008