Overview of ISO 13485
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (MDQMS)
Published by International Organization for Standardization (ISO) for the first time in 1996, ISO 13485 contains a comprehensive quality management system for the design and manufacture of medical devices.
ISO 13485 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 applicable regulatory requirements.
Who Should Use ISO 13485?
- Any organization involved in one or more stages of the life cycle of medical devices and related services, including:
- design and development;
- production;
- storage and distribution;
- installation; or
- design and development or provision of services for medical devices and related activities (e.g. technical support); and
- suppliers or external parties that provide products, including quality management system related services to you.
- Any organization that wants to establish, implement, operate, and maintain an MDQMS.
- You may face the risks and lost opportunities involved with not having an ISO 13485:
- where ISO 13485 may be a legal or contractual requirement; and
- you will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to organisations that have ISO 13485.
MLOK’s methodology and approach to making your company ISO 13485 complied for certification
We use the four stages of the most practical and methodological process to help you achieve ISO 13485 certification.
Stage 1: Planning
Conduct Kick-Off Meeting to:
- establish implementation schedule and plan;
- appoint MDQMS Committee;
- establish a documentation framework; and
- have a fundamental understanding of the requirements of ISO 13485.
Stage 2: Documentation
Drafting and writing of ISO 13485 compliant documents:
- MDQMS Manual;
- Job Description;
- MDQMS Core Procedures;
- MDQMS Supporting Process Procedures;
- MDQMS System Procedures; and
- MDQMS Forms, Work Instructions and others.
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