|Type of Industry||Food|
|Certificate Type||New Certificate,Renewal|
|Document Verification Mode||Door Step/ Office Step|
|Mode of Report||Soft Copy,Hard Copy|
ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.
ISO 13485 is the most commonly chosen path for medical device companies to meet the quality system requirements in Europe, Canada, Japan, Australia and other countries. Although implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada, ISO 13485:2003 is mandatory for Class II, III and IV medical device manufacturers (with additional requirements imposed under Canadian law). Compliance with Japan’s Ministerial Ordinance #169 is quite similar to ISO 13485 with additional requirements imposed under Japan law.
Advantages of ISO 13485 certification:
As we mentioned, ISO 13485 certification is not mandatory in most markets. Here is how your company can benefit from ISO 13485:2003 certification: :
Compliance with European standards offers straightforward access to the Japanese, Australian and New Zealand markets
Other countries around the world also recognize ISO 13485 as a means of meeting their quality requirements
ISO 13485 is a globally recognized standard and having this certification will increase the credibility of your company with potential customers.
Certification can lead to increased efficiency, better product quality, and improved customer service within your company
Demonstrate your consumers and partners a commitment to quality