The manual is divided into eight sections that correlate to the Quality Management System sections of ISO 13485:2016. ISO 13485:2012 can help an organization to express its ability to provide medical devices related services and commitment to quality that continuously meet customer requirements and regulatory requirements applicable to medical devices. This system addresses the design, development, production, installation, and servicing of the company’s products.
ISO 13485:2012 results in increased efficiency, quality and improved customer services for the requirements of a quality management system. Main aim of ISO 13485:2012 is to harmonize the medical device regulatory requirements and to enhance the credibility of an organization with potential customers. To claim compliance with MDD only certain exclusions in clause 7 are possible, see below. Important Notes / Exemptions EN ISO 13485:2016 + AC:2016 allows exclusions in clauses 6, 7 and 8.
ISO 13485:2012 FULL
It can also be used for the development production, installation and servicing of medical devices. 'International Relationships BS EN ISO 13485:2012 Identical, ISO 13485:2003 Identical' It is the NB who issued the certificate which indicates compliance to just 'ISO 13485:2003', so maybe I should be making inquiries with them since I am complying with Annex II of the MDD 93/42/EEC full QMS, based on the (most) current harmonised standard. from the company’s documents should be added to the protocol and numbered as pages. EN ISO 13485:2016 - just released new international and European standard, 3 year transition period. Note the text is identical, but the Z annexes are added. The ISO 13485:2012 is an international standard for Quality Management Systems designed for the manufacturing of medical devices. Versions of 13485 (as at March 2016) ISO 13485:2003 - current international standard EN ISO 13485:2012 - current European standard.
0 kommentar(er)
