Does the Layout Design of a PCB fall under clause 7.3 in ISO 9001

T

tonyjj

#1
Hello all,

I am curious to know whether or not designing the layout of a printed circuit board is considered part of an overall process or is it deemed to be conceptual design and thus cause 7.3 applies.

If yes does anyone have a design control procedure for same.

Many thanks in advance.:confused:
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
I can't tell you the answer to your question, but I can tell you from experience in the 1980's PCB layout is an art, especially since the advent of SMT components. I have never personally designed PCBs, but I tested many, many of them for failure modes over the years. Many of the failures were board layout issues (as opposed to component failures) such as heavy components in or near the center of the board, resonant frequencies of the board and the enclosure, and things like that.

Just a comment - Hopefully someone here can help with your specific question.
 

somashekar

Staff member
Super Moderator
#3
It very much is a part, whether it is done by the organization or outsourced to a specialist. Apart from what Marc has mentioned there are several other considerations and guidelines that are applied in the process., like the EMI / EMC considerations, electrical safety isolations, grounding, size and shape and connector configurations as desired by the customer, alternate footprint for components in case there are options, test points considerations, physical mounting considerations, add on features considerd to have one PCB for various versions of the product with the BOM listing DNA (Do Not Assemble) parts where not required .... and many more.

Like all other design steps, this is also a very important step to be reviewed, verified and validated, perhaps critical to the performance. Like other skills this is also a specific technical skill mastered over time, and there are several books / litratures on this topic. There is nothing like one best layout design. Check with any good PCB layout expert for more specific design control requirements.
 
T

tonyjj

#4
Thanks the comments guys very informative. would anyone else like to contribute their experience/ comments to the thread.discussion?
 
C

christinelim

#5
Hi Tonyjj,

Currently I had gone through my ISO 9001 2008 stage 1 audit, the auditor asked me must prepare a procedure for PCB layout design. I am facing the same problem as you. Have you solved your problem? Do you mind to share with me?

Thank you
 
J

Jeff Frost

#7
The design of any product falls under clause 7.3 of the standard if your organizations is designing them for manufacture by a board shop or in-house. This does not, however, require jumping through hoops to meet ISO 9001:2008 only the linking of current in-house IPC design practices to the requirements of the Standard and filling in the gap that may be present.
 
W

woody_rod

#8
Hello all,

I am curious to know whether or not designing the layout of a printed circuit board is considered part of an overall process or is it deemed to be conceptual design and thus cause 7.3 applies.

If yes does anyone have a design control procedure for same.

Many thanks in advance.:confused:
Tony,

One thing to keep in mind with design and development, is the purpose this section was included into the standard. Literal translations of the standard often miss the intent - in this case, being that for design of an item that will eventually be part of a system supplied to customer specifications.

Anything that is included into the end product, to fit within any specified requirement, will fall under section 7.3. It must do if you think about it. Consider the process of design - starting with the first line of thought that generates the need for the item in question (such as a meeting of board members to create a product to meet customer demand - the first thing said about what the product needs to look like, size, shape etc is the beginning of design and development). As distant as it seems in later stages, everything leading up to product realisation must be considered under 7.3.

Having said that, there are degrees of criticality with components that will generate the need to have a higher or lower priority within the QMS in order that the more critical processes are more closely monitored. Some examples would be:

1. A bracket holding a computer main board in place that is neither seen by the customer, nor is considered critical for the performance of the product.
2. The main board itself. This is considered critical to the performance of the product to meet specified requirements.

The items above are both required to complete the product, but their criticality is very different. An auditor (and the QMS owner) should both be able to identify that there will be vastly more resources put into the verification and validation of the main board, but not the bracket, and also that there will be much more emphasis on the main board in terms of the need to comply with section 7.3.

Both items need to have a history of design and development either way.
 
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