Re: Gap Analysis Checklist for ISO 13485:2003 2012
This is what I have done for the Gap Analysis: Hope u can do similar to this
In March 2012, BS EN ISO 13485:2012 was published, following European publication in February. This version will only be applicable within Europe and is expected to be harmonised by the end of summer 2012. For the rest of the world, ISO13485:2003 will remain the applicable standard.
What is the difference between EN ISO 13485:2012 and ISO 13485:2003?
The only changes to the new 2012 standard are within the forward and Annex Zís. There has been no change to the Normative Text, i.e. the requirements of the standard remain unchanged from the 2003 version.
The revision to the (informative) Annex Zís was made to provide greater clarity on the applicability and alignment of clauses of ISO 13485 with the quality systems requirements of each of the three Medical Device Directives (AIMD, MDD and IVD). The new Annex Zs each cover a different Annex (Conformity Assessment Route) within one of the Medical Directives. For example, Annex ZB of BS EN ISO 13485 shows the relationship between the Medical Device Directive 93/42/EEC Annex II, Full Quality Assurance and the clauses of EN ISO 13485.
Quality Management Standards
EN ISO 13485:2012 and ISO13485:2003, are based on the ISO9001:2000 process model approach. These standards provide a good base Quality Management Systems model for compliance with the following:
1. EU CE marking medical device directives
2. Health Canada CMDCAS
3. Taiwan Medical device Regulations
4. Other international regulatory requirements.
As there are no change to the requirements of ISO13485 standard, no amendments are required to QMS.