QMS and ISO - Where to start?

[Ren33]

Hi - I've been tasked with introducing a QMS to our organisation, I attended the ISO9001:2015 course, but right now I have a lot of terms and ideas running around in my head and no idea where to start! Also with no prior experience!

Any suggestions? I am starting with nothing! Yes we have processes in some departments, but not a lot else!

Any tips on where to start would be greatly appreciated!

 

[Marc]

Here are some existing discussions for you:

(broken link removed)

Also, an oldie but goodie: Implementing An ISO 9001 Quality Management System

1. Read the standard, front to back.

2. Do a comprehensive gap analysis.

 

[Ren33]

Thanks Marc!

Maybe I am over complicating it! I have been doing a lot of google searches thinking it would help (this is how I came across this forum) - I have found at least one of those links you've suggested!

Appreciate your prompt and helpful response!

 

[Marc]

It's a relatively simple process, but like anything else, when starting from scratch and no knowledge it takes some time to learn.

I was brief in my response because implementing a QMS has been discussed here many times.

If/when you have more specific questions, don't hesitate to ask.

 

[John Broomfield]

Hi - I've been tasked with introducing a QMS to our organisation, I attended the ISO9001:2015 course, but right now I have a lot of terms and ideas running around in my head and no idea where to start! Also with no prior experience!

Any suggestions? I am starting with nothing! Yes we have processes in some departments, but not a lot else!

Any tips on where to start would be greatly appreciated!

Ren,

Welcome to the Cove!

You may have more than you realize.

Study how your organization works as a system interacting with its customers and suppliers to convert customer needs into cash.

Start by appreciating what your organization already does so your colleagues can see that you respect what they do.

Do not read the standard in isolation and then write your procedures to impose on the organization. Seek to understand the processes from the experts; the people who actually do the work.

Your ISO 9001 training should have taught you the differences between processes and their procedures. Processes are work and procedures are specified ways of doing the work.

Many procedures are undocumented but may benefit from being documented to some extent. Helping your colleagues to understand and agree the extent of documentation that is useful to prevent problems while realizing process objectives is key.

So, what is the purpose of your organization?

John

 

[Golfman25]

Since you have never done it, you may want to find a cheap canned system that you can work off of. I wouldnt just implement it but use it as a reference to work your own system. I think it will help the learning curve.

 

[AndyN]

Hi - I've been tasked with introducing a QMS to our organisation, I attended the ISO9001:2015 course, but right now I have a lot of terms and ideas running around in my head and no idea where to start! Also with no prior experience!

Any suggestions? I am starting with nothing! Yes we have processes in some departments, but not a lot else!

Any tips on where to start would be greatly appreciated!

Find a mentor. Someone who has done this before, not necessarily a consultant, (a QM from a supplier or similar) can be very useful.

 

[AndyN]

Since you have never done it, you may want to find a cheap canned system that you can work off of. I wouldnt just implement it but use it as a reference to work your own system. I think it will help the learning curve.

Based on what I've seen people go through for ISO 9001:2008, using this stuff, I'd avoid them like the plague!

 

[Golfman25]

Based on what I've seen people go through for ISO 9001:2008, using this stuff, I'd avoid them like the plague!

Your mileage may vary. But we used a template system way back in the day. It helped a lot to see how they addressed something. We would make appropriate changes and eventually had our own unique system. It's no different than getting an example procedure from here. As you learn, you put your own spin on things.

 

[Kronos147]

Some important things to consider (IMO):
Read all the stuff before clause 4.

Re-read it. Re-re-read it.

Ok, now read the rest.

Now read the following clauses in order:

[FONT=&quot]Process Approach[/FONT][FONT=&quot]:

0.1 General,
0.2 Quality Management Principles,
0.3.1 Process Approach: General,
4.4.1 QMS and its Processes,
5.1.1 Leadership and Commitment: General,
5.3 Organizational Roles, Responsibilities and Authorities,
6.1.2 Planning: Actions to Address Risks and Opportunities,
7.1.4 Environment for the Operation of Processes,
8.1 Operational Planning and Control,
9.2.2 Internal Audit,
9.3.2 Management Review: Inputs
​

[/FONT][FONT=&quot]Risks and Opportunities[/FONT][FONT=&quot]:

0.3.3 Risk-based Thinking,
0.1 General,
4.4.1 (f) QMS and its Processes,
5.1.2 (b) Customer Focus,
6.1.1, 6.1.2 Planning: Actions to Address Risks and Opportunities,
8.3.3 (e) Design and Development Inputs,
8.3.6 (d) Design and Development Changes,
8.4.2 Type and Extent of Control,
9.3.1 (e) Management Review: General, 10.2.1 Nonconformity and Corrective Action, A.4 Risk-based Thinking
​

[/FONT]
[FONT=&quot][FONT=&quot]Change Management[/FONT][FONT=&quot]:

4.4.1 (g) QMS and its Processes,
5.3 (e) Organizational Roles, Responsibilities and Authorities,
6.3 Planning of Changes,
7.5.3.2 (c) Control of Documented Information,
8.1 Operational Planning and Control,
8.2.4 Changes to the Requirements of Products and Services,
8.3.6 Design and Development Changes,
8.5.6 Control of Changes[/FONT][/FONT]
​

Figure out your scope.

Figure out your context.

Define your processes (keep it simple, receiving inspection may just be a sub process of purchasing).

For each process:

-Owner
-Procedures\work instructions\forms
-Inputs and outputs
-Key performance indicators
-risks and opportunities
​

Now, in sections 4-10, figure out if the clause applies to each process. Review what is done in light of the requirement and find out how it's met (or that it isn't).