Implementing ISO 9001 in an Assembly Plant

ME1968 · May 27, 2014

Hi, I have worked in the electronic component industry for over 15 years, and for the first time, I have come into contact with an assembly plant. I was hired to get them ISO certified, but I do not even know where to start. The company has been run without any kind of document control or traceability. It has all been done by tribal knowledge and who knows who. We have product from customers that are so dusty and cannot figure out if they need them back, because there is no part number and no one seems to know exactly which customer it belongs to.
Please help me with the direction of how to start.
Also, does anyone know of good software for the use in assembly plants.

Marc · May 27, 2014

There are lots of discussions here on implementing ISO 9001 in all types of businesses.

You might want to start out reading through this: ISO 9001 QMS Implementation

Also see these discussions about implementing a quality management system: Implementing ISO 9001

AndyN · May 28, 2014

I don't see anything here which doesn't apply to 90% of organizations coming to implement ISO 9001. Have you implemented a QMS before? Software isn't going to be of much use other than to provide a basis for document control (and maybe corrective actions) IMHO. If you have never implemented ISO and you are being paid to do this, you might want to get another person who has to help you!

John Broomfield · May 28, 2014

ME1968,

It may look a mess but the organization is working as a system to satisfy enough customers to remain in business.

Focus on understanding how it does this with the utmost respect. When you say "implement" it suggests out with old and in with your interpretation of ISO.

You may want to start by working with top management to understand how the organization interacts with its customers and suppliers to convert customer needs into cash in the bank.

Do not speak ISO, think system, listen and learn.

John

Marc · May 28, 2014

I will add: Think Systems and their Interactions

kgott · May 29, 2014

Think in terms of how to integrate or apply the requirements of ISO 9001 into the way the company does it thing. Forget about what widget business the company is in.

Go the busienss leadership and help them see whats required by the standard compared to the way things are actually done and what has to be done. 3 columns will do it. Its about gaps and work to be done.

Zetta · May 30, 2014

ME1968 said:
Also, does anyone know of good software for the use in assembly plants.

What kind of software do you mean? Quality management system software?

You mentioned that there is no document control or traceability.
In my opinion you can start with simple files.

PaulJSmith · May 30, 2014

Welcome to The Cove, ME1968.

If you haven't already, buy a copy of the standard. Read it thoroughly. Next, perform a gap analysis to get an idea where the company is with regards to the requirements. I think you'll find, as John indicated above, that they already have many of these things in place, just maybe not well organized or documented.

John Broomfield · Aug 13, 2014

ME1968 said:
Hi, I have worked in the electronic component industry for over 15 years, and for the first time, I have come into contact with an assembly plant. I was hired to get them ISO certified, but I do not even know where to start. The company has been run without any kind of document control or traceability. It has all been done by tribal knowledge and who knows who. We have product from customers that are so dusty and cannot figure out if they need them back, because there is no part number and no one seems to know exactly which customer it belongs to.
Please help me with the direction of how to start.
Also, does anyone know of good software for the use in assembly plants.

ME1968,

How is it going?

Can us Cove members help?

John

DanteCaspian · Oct 20, 2016

ME1968 said:
Hi, I have worked in the electronic component industry for over 15 years, and for the first time, I have come into contact with an assembly plant. I was hired to get them ISO certified, but I do not even know where to start. The company has been run without any kind of document control or traceability. It has all been done by tribal knowledge and who knows who. We have product from customers that are so dusty and cannot figure out if they need them back, because there is no part number and no one seems to know exactly which customer it belongs to.
Please help me with the direction of how to start.
Also, does anyone know of good software for the use in assembly plants.

If you still need some assistance I would be willing to chat with you via telephone.

In the last year we have 1) rewritten our company quality manual, 2) Switched from 9001:2008 to 9001:2015. 3) Dumped some highly expensive software that was terrible. It was supposed to give us traceability and document control, it was junk. We instead have been writing our own software to accommodate our external customer and internal customer needs.

Implementing ISO 9001 in an Assembly Plant

ME1968

Marc

Fully vaccinated are you?

AndyN

Moved On

John Broomfield

Marc

Fully vaccinated are you?

kgott

Zetta

PaulJSmith

John Broomfield

DanteCaspian

Quite Involved in Discussions

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