I assume we need to get a new set of manual done by adding on to the current ISO 9001 manual (Please correct me)
You do not need to get a new or separate set of documentation for this. Your current manual needs just a few minor changes:
- reference to ISO 13485
- scope to include medical devices
- list ALL exclusions and non-applicable clauses; note that 7.5.2 can be excluded but many of the customers will ask for some sort of process validation, so you're better off not to exclude it
- list/reference/include ALL the procedures required by the standard
- include a description of your documentation structure; I did this with a piramid: quality manual at top, procedures on second layer, instructions on third and forms on bottom layer; the auditor was satisfied with the diagram and it is also usefull for the employees
The procedures need to be reviewed and revised to ensure that they address the requirements of the standard. What I did is I opened the standard and highlighted every 'documented' word in there because there was a requirement for either a documented procedure or instruction.
Another thing to remember is to include review of notifications (customer and/or regulatory) in management reviewes. The organization that I got registered did not get any customer notifications to date, so I gat them registered to the FDA web site to be notified of any related recall and notifications. This seems to work well and to address the requirements of the standard. I am not sure what is the equivalent of FDA in your country.
Can we be audited (for ISO 13485) if we do not mold parts that need us to be certified to ISO 13485.
In order to be audited you must be able to demonstrate relevant (related to medical devices) activity and/or records of activity besides the other general activities (management review, internal audits, CAPA, planning, etc). I suggest that, if you are already approved to produce medical devices, you schedule production for some parts during the audit. This will help the auditor conduct a more effective, efficient and value-added audit than just looking at records of past activities. At the same time I also suggest that you postpone any ISO 13485 audits until you are approved to produce medical devices. Most customers will work with you on this if you explain your plans to become registered. You can proceed with the readiness review audit but keep in mind that you have no more than 90 days between this and the registration audit.
Is clean room a must or it depends on the product requirement?
The use of the clean room (if you have one) depends on the product requirement. The auditor should not venture into the clean room if it is outside the scope of the ISO 13485 audit (no medical devices are produced/assembled in there at any time). If he does, you can make his life harder by going in and out of the room a few times and enforcing the gowning (dressing) policy.
I hope this information helps you get through. Good luck!
! Sundar 