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 13485:2016 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.  Learn the details of the requirements with ISO 13485:2016 Requirements Training.

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 1: Scope Talks about the standard and how it applies to organizations and:

• the importance of a process approach
• you need to include regulatory requirements of your products & services
• you need to have processes in place for continual improvement.
• Learn: What is ISO 13485?

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
• Labeling
• 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 4: General Requirements Gives requirements for the overall Quality Management System Documentation Requirements, including:

• Quality Manual with Scope of the QMS
• Required Procedures
• Required Forms & Records
• Control of Documents
• Control of Forms

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 6: Resource Management Gives requirements for resources including:

• Personnel & Training
• Resource Management

Clause 7: Product Realization Gives requirements for:

• The production of the product or service
• Planning
• Customer related processes and Customer Feedback
• Design
• Purchasing
• Process control
• Identification and Traceability
• Customer Property

NOTE: Much of Section 7 is modified from ISO 9001:2008

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

Learn all of the details of the requirements of ISO 13485:2016, and train others in your organization with our requirements training PowerPoint.