Incorporate BCP (Business Continuity Plan) into QMS

[tebusse]

Greetings,

I've recently written the Business Continuity Plan for my company (small medical device that manufactures software) and need to implement it into our QMS, which follow ISO 13485:2003. Is anyone able to provide any guidance on how to complete this task?

Regards, Tonia

[qusys]

In Reply to Parent Post by tebusse

Greetings,

I've recently written the Business Continuity Plan for my company (small medical device that manufactures software) and need to implement it into our QMS, which follow ISO 13485:2003. Is anyone able to provide any guidance on how to complete this task?

Regards, Tonia

Hi ,
my advice is to make a risk assessment in multidisciplinary approach with management of your company to evaluate the most critical potential risk that might mine your business and cause unsatisfaction of the customer.
They are usually in shortage of manpower, stoppage of the utilities (power, communication, information service...) , impossibility of supply for critical materials ( problem from your critical supplier due to shortage of prime material...) , stoppage of critical equipment in your production line ( i.e.eventual bottle-neck in the line).
Make a brainstorming using for example a fishbone diagram, making a breakdown for the main root cause.
For instance shortage of manpower could be cause by strike, illness (flu, virus...) , difficult condition for people to reach the job due some accidents and weather conditions and so on.
Rank the risk using high ,medium, low level ( FMEA approach could be useful as well, but other methods are still valid) of risk and identify plans and procedures to assure business continuity for each identified risk.
Assure to revie the plan and re-modulate risks on a certain time basis with the process owner of yor QMS as well.
Hope this helps