ISO 13485 Requirements

 

 

Requirements under ISO 13485:2016

 

ISO 13485:2016 is mentioned in the harmonised European Standards (hENs)'s list. Medical Device Manufacturers and other companies in the same industry can follow this standard to ensure complete compliance with EU MDR and other regulations. Of course, an ISO 13485:2016 certificate doesn't necessarily mean that you sell your product in the market, as there are many more factors around commercialising a Medical product.

 

ISO 13485:2016 is a Quality Management System that enables companies to demonstrate quality compliance in the manufacturing process. In this blog, you will understand the different requirements and clauses involved in implementing ISO 13485:2016. 

 

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 organisation, you must satisfy the requirements within clauses 4-8, along with meeting customer and applicable statutory and regulatory requirements. 

 

Once you have met the ISO 13485:2016 requirements and are granted certification you can then advertise your certification to ISO 13485:2016. [Provided by the EU Notified Bodies]. Additionally, ISO:13485:2016 has many common requirements to address FDA 21 CFR Part 820.

 

• Clause 1: Scope - Talks about the standard and how it applies to organisations and:
  • the importance of a process approach
  • the need to include regulatory requirements of your products & services
  • the need to have processes in place for continual improvement.
• 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 organisation 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 Realisation - 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
• 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

 

Wondering what applies to your Medical Product?

Book a FREE 30 Minute One-2-One call with one of our RAQA Advisers by sending an email to:  mdd@mddltd.com

 

 

Back...