SIGNIFICANCE of ISO 13485/88
BENEFITS of ISO 13485/88
FOR WHOM
SIGNIFICANCE OF ISO 13485/88
ISO 13485 is the most accepted standard world-wide for manufacturers of medical devices (e.g. in the US, Japan, Canada, EU). This standard includes requirements specific to this business sector and defines terms such as medical device, active medical device, active implanted medical device, sterile medical device, and many more. ISO 13485 supports the reduction of unexpected risks for companies who construct, manufacture or use medical products and services, both during fabrication as well as for later use. It aims to increase reputation in the eyes of customers and authorities. The next revision of ISO 13485 is scheduled to be released around the middle of 2003. It will be an independent standard which can be used without consideration of ISO 9001:2000, provided a company works only within the medical industry.
BENEFITS OF ISO 13485/88
- Evidence of adherence to legal and regulatory or contractual requirements
- Minimize and manage risks
- Emphasize competence
- Error prevention instead of error correction
- Improved performance quality
- Customer and employee satisfaction
- Transparency and clarity of internal processes
- Time and cost savings
- Realization of quality policy and company goals
ISO 13485/88 - FOR WHOM
Manufacturers of medical devices and service providers having to fulfill international, European or national legal and regulatory requirements and who want to use these standards to document implementation. Examples for this are Canadian, US or Japanese requirements as well as the European directives for medical devices to include in-vitro diagnostics. This affects, for example, organizations manufacturing medical devices which are ranked within the hazard class 2, 3 or 4 MDR (Medical Device Regulation) to be sold on the Canadian market. Companies which develop, manufacture and distribute medical devices and who want to demonstrate their competitive and performance ability on the international, European and national markets. Suppliers and other service providers within the value-added chain having to ensure compliance to their customers’ requirements.
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