Privacy Information Management Security Techniques
ISO 10002 specifies requirements for a Quality Management System to produce ISO medical devices and related services that meet customer requirements. The regulatory requirements of ISO 10002 apply to all suppliers, regardless of company size or type, except where explicitly stated. The current version of the ISO 10002 standard is 13485:2016. This is stand-alone certificate which aligns with ISO 9001:2008, not the more recent ISO 9001:2015. ISO 10002 is also a global standard which is mandatory in some countries.
Benefits of ISO 10002
- It is a process-based standard (it does not define product quality)
- It shows you demonstrate a commitment to safety
- You show potential customers you strive for quality and competence
- It can reduce costs (a review of best practices in the product journey)
- This standard is internationally recognised
To implement the ISO 10002, you need:
- In-depth review of effectiveness of the quality management systems
- Define processes and procedures
- An a review and understanding of areas that require attention
- Locate and fix areas of non-compliance and risk
- Training and awareness program(s)
The Certification Process for ISO 10002 will include
For more information about the process of ISO 10002 please contact us and one of our team will be happy to discuss the standard in more detail.
