Process Interaction Map for ISO 13485

[Markh1248]

Our facility is currently certified to ISO 9001:2000. By the end of 2009 I am planning on having the facility certified to both ISO 9001:2008 and ISO 13485:2003.

Recently, I had a "potential" consultant that I was considering to assist me in this endevor take a look at some of the QMS documentation. He commented that my Process Interaction Diagram would not pass ISO 13485:2003. What?

This is the same diagram I have been using since 2002, and as far as I can tell the ISO 13485:2003 standard has no impact on this area...

I have included the diagram for review. Comments greatly appreciated...

[Doug Tropf]

You diagram looks good to me. As a side bar, I would highly recommend ISO/TR 14969 as a guide for use in achieving certification to 13485.

[Le Chiffre]

I went through the same process a while back. I added the following when considering 13485

• Risk Analysis
• Risk Management
• Problem Reporting
• Recalls & Advisory Notices
• Regulatory Processes

[Markh1248]

Thanks for the feedback I do appreciate it...

[Koivisto - 2009]

Hey Markh 1248, We are ISO/TS and aiming for AS9100 by 9/09. How do you handle risk management? I wrote a procedure showing how we handle risk at each stage. Is that your take?

[jkuil]

To make some improvements:

• Add design transfer (how is the process design related to the manufacturing)
• CAPAs may result in product or process design changes, so you may add change management as a process
• regulatory authorities are also considered customers. Add how you meet regulatory requirements and submit your technical files for marketing approval (Regulatory Affairs process)
• It looks like only internal auditing is feeding into your management review, whereas CAPA, CSM, and QOS also should be considered input to your management review
• Transfer AQP to the management processes
• I would also consider following supporting processes: MRB and control of NCP as management processes. With internal audit, CAPA, CSM and QOS the processes are identified as the measurement, analysis and improvement processes in the ISO standard.

[Markh1248]

Thanks for the feedback, I am investigating many of the recommendations.

As for Risk Management, we are a contract tooling and injection molder of thermoplastic molded products and value-add services to several medical device manufacturers. At the present time we do not manufacture nor supply any finished devices, packaging, labeling, etc.

We conduct risk assessment as part of our pFMEA process. Risk is determined for each Failure Mode using the patient/user severity ranking only.

This is accomplished by entering mfg. and patient/user serverity rankings and RPN into seperate columns to determine the corresponding risk category.

[Roland Cooke]

I'm sure I remember seeing a really neat top-level process interaction map, making very good use of graphics, (it was maybe done in PowerPoint?). I believe it was posted in the last twelve months.

IIRC medical device-specific elements like risk management and post-production feedback were included.

But my search-fu (or perhaps my memory!) is clearly lacking....