What is ISO 13485?
There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485:2003. Compliance with ISO 13485:2003 is often seen as the first step in achieving compliance with regulatory requirements.
On the 24th July 2003 BS EN ISO 13485:2003 was published. This superseded the previous incarnations of this standard, such as EN 46001:1997, EN 46002:1997, ISO 13485:1996 and ISO 13488:1996. As before, the 2003 revision of the standard is aligned to ISO 9001:2008, however, it is a stand alone Standard.
A joint ISO 9001:2008 and ISO 13485:2003 certification is an option however, NQA, USA also offers certification to ISO 13485:2003 without an ISO 9001:2008 certification. It is worth noting that there are very few sections of ISO 9001:2008 which are not referenced in ISO 13485:2003.
Increasingly, certification to ISO 13485:2003 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485:2003 is recognized as an aid in supporting compliance with the MDD.
Certification to ISO 13485:2003 is not only used by medical device manufactures as the foundation to their management system, it is also used by non-medical device companies as a first step to gaining new business opportunities within the medical device community.
Download a PDF file of the ISO 13485 Registration Services
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