Does ISO 13485 7.3 include the manufacturing process?

Watchcat

Trusted Information Resource
#1
Reacting to a claim that 7.3 "fundamentally and specifically demands that the responsible organization not only design the product, but also the manufacturing process."

There are really several claims here, all of which are news to me:

1. That 7.3 dictates who has to do the design work.
2. That it requires that the same organization that designed the product also design the manufacturing process. (Do you design a manufacturing process?)
3. That it is applicable to the manufacturing process.

All of this is outside my own scope of expertise. Nonetheless, I was very surprised to hear this, and wondered if some of the Covers who are experienced in this area could shed some light.
 
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Tidge

Quite Involved in Discussions
#2
That appears to be a very strong claim about what 7.3 (of ISO 13485:2016) requires. "Manufacturer" is defined in 3.10; this definition allows for the sourcing of both design and/or development by an outside source. My reading of the Design and Development section is (points 1 and 2 above) is that there is a responsible organization, but that as long as there is appropriate planning and control (by the responsible org) there is nothing that forbids sourcing work to a different organization. My opinion is informed by the text of 7.3.2, Design and Development Planning.

It is possible to view manufacturing methods as an output of the development process (7.3.4). For example, if there is a specific design input requirement that requires a certain machined part be free of foreign material, the cleaning steps of the manufacturing process could be a design output intended to satisfy that input requirement. As above, the organization has to assume responsibility for the requirements of this section (and design transfer), even if activities have been out-sourced.
 

William55401

Involved In Discussions
#3
To me, this is the same question (and same result) as the 820.30 Cove thread a day (or so) ago . The standard also has Design Transfer defined. I am not aware of any material differences in US and EU for the contract mfg space.
 
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Watchcat

Trusted Information Resource
#4
To me, this is the same question (and same result) as the 820.30 Cove thread
Yes, same language, one with 7.3 and one with 820.30. Although the language in the standard and regulation are very similar, the mindsets are can be quite different, no doubt in large part due to the fact that regulations have the weight of law, where standards do not, and FDA is essentially a law enforcement agency, where auditing organizations are not. I posted both to see if there might be a difference in perspectives, depending on whether someone worked mostly with the ISO standard/auditors or mostly with the QSR/FDA inspectors.
 

indubioush

Quite Involved in Discussions
#5
1. That 7.3 dictates who has to do the design work.
2. That it requires that the same organization that designed the product also design the manufacturing process. (Do you design a manufacturing process?)
3. That it is applicable to the manufacturing process.
1. ISO 13485 section 7.3 does not dictate who has to do the design work. I agree with Tidge.
2. There is no requirement that the designer also develops the manufacturing process. However, the responsible organization must have oversight over inputs and outputs and have procedures and records for design transfer.
3. Yes, design and development is applicable to the manufacturing process.

From ISO 13485:
  • Design inputs include requirements essential for development of processes (could include manufacture processes)
  • Design outputs shall provide information for production
  • Design outputs are transferred to manufacturing
  • Medical device file must contain specifications or procedures for manufacturing, packaging, storage, handling and distribution
From FDA Guidance for Design Control:
  • "The guidance applies to the design of medical devices as well as the design of the associated manufacturing processes."
 

Biomedical_engeener

Starting to get Involved
#6
Is 7.3. Design and development also applicable to custom-made devices ? If we already manufacture them for a few years, is this chapter still needed to be included ?
 
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Watchcat

Trusted Information Resource
#8
You need to know what regulations apply to you.
Just wanted to add that this might apply if you are pursuing ISO 13485 with one particular regulatory jurisdiction in mind, but maybe not if you are pursuing it to support access to a variety of markets. Also, wouldn't a CB expect you to comply with everything applicable within the standard, even if some regulatory jurisdictions do not?
 

indubioush

Quite Involved in Discussions
#9
Also, wouldn't a CB expect you to comply with everything applicable within the standard, even if some regulatory jurisdictions do not?
If an organization truly can exclude design and development, they will have to document the justification for exclusion in their quality system, typically in the quality manual. If one of the markets they are pursuing requires design control, there is no justification for the exclusion.
 
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