Where to Start to Implement ISO 9001

[QualityKey]

Re: Where to Start to Implement ISO9001

You must be aware that ISO 9001:2008 expect only 6 mandatory procedures. Now the choice is left on the organization and their business, how much you need to go down on detail.


As mentioned by tedschmitt, leave Quality Manual for last. I agree.




I’m slightly confused with your clarification to Marc and others that “… system is working for a while…”. Do you mean your organization is complying with all requirements of ISO 9001 and Quality Management System is in place?

Just curious

I come to know this here in the Cove but not sure to what extent!!


Because I think most of the requirements are available so I just wanted to prepare the top level document (QM) which is required by the ISO9001 and also I thought it is a good way to compile the documents and make references! Am I right here?


Well!! we have been for a year and so building the system to meet the ISO9001 requirements and we did put some procedures in place and there were already some operational processes in use so that's what I meant. However, we are moving so slowly and I have just been assigned as (ISO Implementation Project Manager) to expedite the process to make it to certification in the easiest, shortest and effective way. My idea is, once we have the ISO certificate, it would help us as an internal marketing tool so we get the attention and then the full support and participation from employees and top management. Management say they are committed but they are not so convinced!! It is time consuming to re-engineer some of the non-required process and continue on what we are doing. I want to make it fast to the ISO and the next step (after certification) is to go for process improvement projects. Do you agree with my approach?? Please comment??



Thank you Makrap for giving me detail as I do need them.

 

[QualityKey]

Re: Where to Start to Implement ISO9001?

First Step:

Select a Professional Certification Body

Second Step:

Get that Professional Certification Body to perform a full fledged GAP Analysis
the cost compared to what they will spare you with the arguing and the whole team assembly and the mess will be phenomenal, i would say they would charge around 3000-5000 SAR / day (haggle about it, you have leverage because they want to get the certification contract later, especially with you being such a fat cat -20,000 Employees-)

Third Step

Take the GAP Analysis report which is -totally independent- not your opinion but from external bodies, and use it to extort TOP Management so as to get the most support with human resources and such .... don't push it though or else they might call the whole project off

Fourth Step

Fill in the GAPS and Certify, and that part has been covered zillions of times in the forum so just search for it , and that might help...it's a long story


Good Luck
3asak tekoun men 3awada

mirrorcrax

Thank you for your plan. I strongly agree that the cost of 3000/5000 SAR (around US $1000) is by far would save a lot of working hours. I appreciate your advice and I even discussed it with my manager along with the other comments here.


Stay around, I still need more advice.
3sak beseha wa salamah ya habebi!! mashkoor!!

 

[Jen Kirley]

Re: Where to Start to Implement ISO9001?

I am not going to even pretend to be an expert in flow charts. I have seen a lot of different treatments, ranging from very simple to very complex.

And it's true that both regular and swim lanes flow charts can be designed to include enough detail to perform the work. It depends on the process.

I put examples of all three types in this thread's problem solving presentation. (It's an attachment in post #7)

I'm not wild about process maps, I think the inter-department flow chart (has swim lanes) is better. But other people seem to think process maps are worthwhile, so okay. I didn't include any examples in that presentation, sorry.

 

[Peter Fraser]

Re: Where to Start to Implement ISO9001?

Jennifer

I see from your profile that you are a "Deming-ite", so deployment flowcharts (a la Myron Tribus) would be an obvious option, I suspect. I agree that some flowcharts can be very complex (and that doesn't mean that they are very clear for other people to read, although the author may learn a lot about a process when he or she draws it) and I often find that the "simple" ones don't tell the reader very much.

 

[Jen Kirley]

Re: Where to Start to Implement ISO9001?

I agree Peter, which is why I advocate people use the method that suits them and their organizations best. No single approach works for all organizations, or even groups/processes within an organization. I have seen a combination of flow charts and process documents working well together. The flow chart summarizes how the process works, and the process document describes it in funcitonal detail, shows responsibilities, lists absolute requirements and controlled tools like calibrated equipment to be used, and so on.

 

[Jeff Frost]

Re: Where to Start to Implement ISO9001

Process flowcharts are used to show what goes on in a structural manner. There are different kinds of flow charts:

Swim lane flow charts show how different departments can interact in getting the process done. They are good for showing internal customer relationships but give little operational instruction.

Simple flow charts just show what is done - they can also show things like what documents are used, but in themselves give little operational instruction. The documents referenced can be work instructions or process specifications that give appropriate detail.

Scripted flow charts can give details that are needed to perform the tasks. They can serve as combination flow charts and work instructions. They can be of good use when the process is not complex; processes with many steps would take many pages of scripted flow charts to show their detail.

ISO gives no requirement to use flow charts, though I have heard that some organizations use flow charts almost exclusively.

Nor does ISO specify the level of detail your instructions. Instructions for operating a washing machine would be drastically different in nature than instructions for performing a repair on an automobile. ISO expects your organization to define its own needs and build the process to suit.

Jennifer

Sorry about not getting back to you on your question earlier. Flow charts within the organization have their place and should be of sufficient detail to allow you to see the inputs and outputs of the process and who are the customers (internal and external) and process owners.

My reference is more inline with the actual process requirements within the standard. Take for instance the requirements for Management Review Clause 5.6. Most users of the standard understand that 5.6.1, 5.6.2 and 5.6.3 are part of the requirements of Clause 5.6 and then overlook these other process links

8.1 Measurement Analysis and Improvement,
8.2.2 Internal Audit
8.5.1 Continual Improvement
8.5.2 Corrective Actions
8.5.3 Preventive Action

Hope this add some clarity to the subject for you.

Jeff

 

[Jen Kirley]

Re: Where to Start to Implement ISO9001?

I wouldn't dream of arguing with you in context Jeff, but I wouldn't use a flow chart for Management Review - except a scripted flow chart maybe.

Can you show an example of how a flow chart would incorporate those peripheral standard clauses in a manufacturing or service process?

 

[Jeff Frost]

Re: Where to Start to Implement ISO9001?

Jennifer,

You could flow chart this management review process if you care to but I am talking about the interrelated process of the standard it’s self. The very requirements of the management review are a verbal description of the required process. It has input, actions, and output.

Your original question that started the tread was “where to start” and to this end it should be with a well grounded understanding of the requirements of ISO 9001 and how the requirements are linked as I explained in the Management Review Example.

Once you have a clear understanding of the requirements of the standard, your customers’ requirements and regulatory requirements you can move forward creating process flow diagrams, flow charts, performing gap analysis etc.

Please remember you posed a direct question to me and I an only answering it even though the thread has progressed.

 

[Jen Kirley]

Re: Where to Start to Implement ISO9001?

Jennifer,

You could flow chart this management review process if you care to but I am talking about the interrelated process of the standard it’s self. The very requirements of the management review are a verbal description of the required process. It has input, actions, and output.

Your original question that started the tread was “where to start” and to this end it should be with a well grounded understanding of the requirements of ISO 9001 and how the requirements are linked as I explained in the Management Review Example.

Once you have a clear understanding of the requirements of the standard, your customers’ requirements and regulatory requirements you can move forward creating process flow diagrams, flow charts, performing gap analysis etc.

Please remember you posed a direct question to me and I an only answering it even though the thread has progressed.

Okay, sorry if I seemed snide. I did not intend to be.

The examples I put in my presentation didn't include input or output to other processes, which I think would have been helpful.

Honestly, the big reason I make flow charts as an auditor is to help understand and assess a process that is described in an encyclopaedic manner in thick process documents. It's not about gap analysis as much as effectiveness analysis - that is further down the road from the original question.

I hope I am not confusing QualityKey.

 

[JaneB]

Re: Where to Start to Implement ISO9001

Well!! we have been for a year and so building the system to meet the ISO9001 requirements and we did put some procedures in place and there were already some operational processes in use so that's what I meant. However, we are moving so slowly and I have just been assigned as (ISO Implementation Project Manager) to expedite the process to make it to certification in the easiest, shortest and effective way.

My advice is:

• Acquire knowledge - either go to an ISO 9001 training course or read a good book. But get educated asap!!
• Have someone experienced do a formal gap analysis (I would use a good consultant, not a certifier, as I've not found their reports very helpful, but mayhap you have a good one there)
• THEN plan the work required to fill the gaps, when you actually know what they are and what you're aiming to do.