My company has two business lines, both of which are currently certified to ISO 9001:2008. In one business line (custom), we manufacture solely custom materials for research applications. In the other (contract), we manufacture components to regulated medical devices / medical device manufacturers. We are in the process of building out a separate facility to separate the custom and contract processes adequately. When doing so, we would like to move the contract business to ISO 13485, with the intention of developing and marketing IVDs in addition to the IVD components we already manufacture.
We want to take the approach of leaving the custom business line certified to ISO 9001, while achieving ISO 13485 certification for the "contract" business line. I have a few questions related to this:
1. Can we maintain a single documentation system that houses both ISO 9001 and ISO 13485 documents? I believe the answer to this question is yes.
2. Can we have documents in common between the two business lines. For example, we would like to share the Quality Manual and high level SOPs between the two systems. Documents, of course, would be shared only where documents are required by both systems. Documents unique to a particular standard would not be shared.
3. If we are able to share high level documents between the two systems, how does one harmonize a Quality Policy to meet the requirements of both ISO 9001 and ISO 13485? I'm having particular difficulty because ISO 9001 requires "continual improvement of..." and ISO 13485 requires "maintaining the effectiveness of..." the Quality Management System.
Your thoughts are appreciated on this topic.
Thanks!
We want to take the approach of leaving the custom business line certified to ISO 9001, while achieving ISO 13485 certification for the "contract" business line. I have a few questions related to this:
1. Can we maintain a single documentation system that houses both ISO 9001 and ISO 13485 documents? I believe the answer to this question is yes.
2. Can we have documents in common between the two business lines. For example, we would like to share the Quality Manual and high level SOPs between the two systems. Documents, of course, would be shared only where documents are required by both systems. Documents unique to a particular standard would not be shared.
3. If we are able to share high level documents between the two systems, how does one harmonize a Quality Policy to meet the requirements of both ISO 9001 and ISO 13485? I'm having particular difficulty because ISO 9001 requires "continual improvement of..." and ISO 13485 requires "maintaining the effectiveness of..." the Quality Management System.
Your thoughts are appreciated on this topic.
Thanks!