Significance
ISO 13485 is the most accepted standard worldwi¬de for manufacturers of medical devices (e.g. USA, Japan, Canada, EU). This standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition important terms have been defined, 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 with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical de¬vices, but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.
The current revision of ISO 13485 was released middle of 2003. Now it is an independent stan¬dard that can be used without consideration of ISO 9001, provided a company works only within the medical industry. Nevertheless ISO 13485:2003 in¬cludes a lot of requirements coming from ISO 9001:2000 and an assessment easily can cover both re¬quirements, if so desired.
Benefits
- 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
DQS is a Notified Body for medical devices and is accredited according to ISO 13485 by ZLG, ZLS and SCC.
For whom
Manufacturers of medical devices and corresponding service providers who have to fulfill international, European or national legal and regulatory requirements. Examples for this are Canadian, US or Japanese requirements as well as the European directives for medical devices or in-vitro diagnostics. Manufacturers and service providers can use this standard to demonstrate compliance with these regulations or relevant customer requirements. This affects, for example, organizations manufacturing medical devices to be sold on the Canadian market and classified to the hazard classes 2 to 4 of the Canadian Medical Device Regulation (CMDR).
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.
ISO 13485 for Manufacturers - Product information in PDF format (200 KB)
