Deviations - Where in ISO 13485 deviations are covered?

duff999

Involved In Discussions
#1
While creating a deviation SOP, I'm trying to find what ISO13485:2016 standard fits best for deviations as a reference.

Thanks
 
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Tagin

Trusted Information Resource
#2
I would think 7.3.9 Control of design and development changes. But of course, depending on the change, impact may occur in additional clauses.
 

shimonv

Trusted Information Resource
#3
From my experience, deviations are more commonly used in production. I would recommend referencing:
7.5.1 Control of production and service provision

In fact, ISO TC 210 mentions deviations in the context of section 7.5.1:
"During manufacture, relevant information should be entered onto the batch record. Such information can include the:
  • quantity of raw materials, components and intermediate product, and their
    batch number, if appropriate,
  • production records including operating parameters,
  • date of start and completion of different stages of production, including
    sterilization records if appropriate,
  • quantity of product manufactured,
  • signed results of all inspections and tests,
  • designation of the product line used,
  • product or process nonconformances including any correction, and
  • deviation from the manufacturing specifications. "

Shimon
 

duff999

Involved In Discussions
#5
Thanks for the replies folks. It seems deviations can touch many aspects of ISO 13485, depending on what the situation is.
 

Jim Wynne

Staff member
Admin
#6
We don't know what "deviation" means in this context. Are we talking about any excursion outside of tolerance limits? Are we talking about what ISO normally refers to as "concession," where a customer is asked to conditionally accept nonconforming product? In the latter case, the word "waiver" is also used sometimes.

More information is needed. What is the proposed procedure intended to address?
 

moritz

Registered
#7
In the companies I have worked for, deviations from planned processes (e.g. departure from an SOP) were always treated like nonconforming product, i.e., chapter 8.3 would describe how to handle them. Each department could see their downstream departments as customers and the output of their processes as their products. If the product does not conform to its specifications (in this case, the planned procedure), it is an NC. I think that does make sense, too, because you might want to correct the deviation anyways and evaluate its impact on your downstream processes. A documented NC event is a great vehicle to document both activities.
 

Jim Wynne

Staff member
Admin
#8
In the companies I have worked for, deviations from planned processes (e.g. departure from an SOP) were always treated like nonconforming product, i.e., chapter 8.3 would describe how to handle them. Each department could see their downstream departments as customers and the output of their processes as their products. If the product does not conform to its specifications (in this case, the planned procedure), it is an NC. I think that does make sense, too, because you might want to correct the deviation anyways and evaluate its impact on your downstream processes. A documented NC event is a great vehicle to document both activities.
If this approach works for you, that's fine, but once again we need to differentiate between deviations and waivers. In most cases, these things apply to products and not processes, necessarily. When you do characterize "deviation" as temporarily changing a process, and your system describes the circumstances and requirements for doing so, you don't have a nonconforming condition (failure to meet a requirement) because the requirements have been changed, albeit temporarily.
 
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