Where to Start to Implement ISO 9001

[John Broomfield]

Re: Where to Start to Implement ISO9001?

JOhn - correct money does count, I can probably link funding to core services, but in the situation of departments like HR, Strategy, Accounts and Payrol, and in some cases IT - they are in essence operational support services whose budgets are created to allow those teams to provide operational support (except in the case where internal SLAs are used ).

I was thinking about this today, from an Accounts perspective, the inputs would be expenditure information from departments, the process would be the checking, formation and production of management accounts, the output would be a corporate report. - from this high level objective, I could then define and create streamlined work packages for core functions within this high level process - please stop me if I am way off target.

I have been challenged this year with the defining of the core principles of ISO9001 so they can be used in 14001 (which I also have to do), 27001 and 18001 (which belong to other sections). In order to get the buy-in I first of all have to prove the business case - I think I will do this by mapping the high level departments, with sections, showing inputs (see accounts) and outputs on a simple flow chart - I could then highlight possible areas of development/improvement through the utilisation of ISO9001 (example business continuity).

Sorry - off track a little - my statement - funding can be mapped to deliverable departments who provide core services to the public - funding is awarded or applications made for funding based upon the perceived or future service needs - the measurement of success is normally thought increased satisfaction or use of the services.
I have grouped the core "services" into the following:
Internal supplier - Internal Customer
Internal supplier - front facing customer (job public)
Internal supplier - external stakeholders (including funding)
External supplier (as above 3)
In addition I have identified "corporate health elements" - these are normally related to sickness days etc. elements which are not owned by single sections or individuals but the who organisation may influence or impact on - still have not got my head around mapping this yet.

So.... Am I on track?

Based on what you have said here, forgive me if I observe, you seem to be thrashing about in response to your thoughts and ideas instead of calmly and methodically analyzing the system that runs your organization.

You should be analyzing the system that runs the organization to determine its key processes (merely identifying them is not determining them).

You can do this from the quality/environmental/health&safety/information security points view at once if you use the SIPOC model and translate every Q/E/H&S/IS nuance into requirements. For this you need to be trained in all the standards and as a lead auditor so you know what you are looking for when you ask your questions of the process owners. Top management owns the core process (that runs from customer needs to satisfied customers if not to cash). BTW, support departments do not have core processes; they are not an end in themselves, they exist solely to serve the core process directly or indirectly.

New key processes (that do not already exist in your organization) come initially from the standards you have listed above - many can be combined such as internal auditing, and problem solving (or removing the root causes of problems). Once you have determined the key processes and named the process owners you can make further progress by analyzing and documenting how each of those processes works.

Meanwhile suspend all thought of functions, departments, elements and work packages. HR for example owns two cross-functional processes that are vital to the system: recruiting and hiring, and training (we often say the expression "departmental procedures" is an oxymoron, HR may call many of their work instructions "procedures or SOPs").

Record the results of your analysis using deployment flowcharts and you will end up with system documents that are clear, concise and easliy updated.

Focus on process. Perhaps start with the SLA as a definition of the product and then analyze the process responsible for that product (it usually involves more than one department).

Everything the support processes do is meant to make the core process better (corporate health is a just a nice sophistication at this stage). Keep it simple and get the depiction of the system that runs your organization issued, used and improved as soon as possible. The sophistications can follow if the system tells you they are needed.

Until you have analyzed the system that runs your organization and shown your organization's system (warts and all) as a simple robust framework (system architecture) so it can be understood you will find it difficult to obtain support for this project. Indeed, I am surprised to read that you have got as far as you have! Perhaps top management is asking you to determine the feasibility of making sure your system conforms to all of these standards, you will also be determining the value. This comes back to the questions you ask during the process analysis sessions - like audits they convey a sense of what is important for the organization's core process(es) to add value and avoid loss.

From this simple architecture you can design your document coding scheme. Please leave a Private Message for me if you want more specific advice.

 

[QualityKey]

Re: Where to Start to Implement ISO9001?

I have got this attached Gap Analysis check list from an old post in the Cove. I would appreciate if someone can take the time and see if it is an ideal list for the newer version (ISO 9001:2008). Or would someone be able to attach something similar, may be easier, that helps me to address the gap before an auditor comes in?

I understand that writing down the key and supporting processes that runs the organzaition is a big part of the gap, as outlined by John earlier. So my other question is about the process map and the flowchart.

q) Is the main purpose of the process map only to make it easy to identify the key processes and then use the flow chart to identify the steps of each process? Is this is to facilitate the processes or is it a requirement by the standard? Or could it be both?

Thanks.

 

[John Broomfield]

Re: Where to Start to Implement ISO9001?

I have got this attached Gap Analysis check list from an old post in the Cove. I would appreciate if someone can take the time and see if it is an ideal list for the newer version (ISO 9001:2008). Or would someone be able to attach something similar, may be easier, that helps me to address the gap before an auditor comes in?

I understand that writing down the key and supporting processes that runs the organzaition is a big part of the gap, as outlined by John earlier. So my other question is about the process map and the flowchart.

q) Is the main purpose of the process map only to make it easy to identify the key processes and then use the flow chart to identify the steps of each process? Is this is to facilitate the processes or is it a requirement by the standard? Or could it be both?

Thanks.

You determine your key processes, and their sequence and interaction, by analyzing your core process(es) with top management. This can result in a high-level deployment flowchart for your system manual.

Then you analyze each of the key processes with their process owners. This can result in flowcharted procedures (usually one page) linked to all of the other documents used in planning, operating and controlling the process.

I am not sure why you want to copy a gap analysis form. As I have said, traditional gap analysis is not necessary; start analyzing the system that runs your organization instead.

 

[QualityKey]

Re: Where to Start to Implement ISO9001?

I am not sure why you want to copy a gap analysis form. As I have said, traditional gap analysis is not necessary; start analyzing the system that runs your organization instead.

I am really not sure why either, but I am just curious and willing to know more in detail. Maybe, at least to have some sense about the traditional Gap Analysis. Never mind, I understand what you have explained is a big part of the task and I am already working on it.

My understanding have changed/improved since my fisrt post here and I am lucky to have such advise.

Thank you very much John and I wish you all the best.

 

[JaneB]

Re: Where to Start to Implement ISO9001?

QualityKey,

That's an outdated version of a GA in any case.

But there's no magic in the one you posted and I don't think it's particularly useful. But it's nothing more than a regurgitated copy of the wording of each clause & subclause of the Standard into an Excel spreadsheet. Then they've just made it a question instead of a statement, & added a couple of columns next to each to allow for notes. Voila!

Get a copy of the 08 Standard. You could do the same thing with it if you really wanted to.

 

[Makrab]

Re: Where to Start to Implement ISO9001?

I have got this attached Gap Analysis check list from an old post in the Cove. I would appreciate if someone can take the time and see if it is an ideal list for the newer version (ISO 9001:2008). Or would someone be able to attach something similar, may be easier, that helps me to address the gap before an auditor comes in?

Dear QualityKey,

I have few observations on your GA.

ISO Exclusions (Page 1):
Along with clause no., ask for justification also. This will help you to analyze and include in Quality Manual.

Some of the clauses you have not included in your GA, e.g. 7.1, 7.2.2, 7.3.1, 7.3.5, 7.4.2, 7.4.3, etc. Have you decided to exclude these clauses???

I’ll suggest you to refer ISO 9004:2000, Annex A, Guidelines for self-assessment. Section A.3 includes 27 typical self assessment questions. You can customize them to suit to your organization.

Hope this will help!

 

[QualityKey]

Re: Where to Start to Implement ISO9001?

QualityKey,

That's an outdated version of a GA in any case.


Get a copy of the 08 Standard. You could do the same thing with it if you really wanted to.

a copy of the 08 Standard is on the way, thanks.

 

[QualityKey]

Re: Where to Start to Implement ISO9001?

Dear QualityKey,

I have few observations on your GA.

ISO Exclusions (Page 1):
Along with clause no., ask for justification also. This will help you to analyze and include in Quality Manual.

Some of the clauses you have not included in your GA, e.g. 7.1, 7.2.2, 7.3.1, 7.3.5, 7.4.2, 7.4.3, etc. Have you decided to exclude these clauses???

I’ll suggest you to refer ISO 9004:2000, Annex A, Guidelines for self-assessment. Section A.3 includes 27 typical self assessment questions. You can customize them to suit to your organization.

Hope this will help!

Thanks Makrap.

I do not have a copy of the ISO 9004:2000 yet, I will try to get it the soonest.

 

[John Broomfield]

Re: Where to Start to Implement ISO9001

I guess you are in right track and you have already taken steps required to consolidate.

I will recommend having a pre-assessment audit. However, before pre-assessment audit you can prepare ground work so that pre-assessment will be used effectively for improvement and not in building QMS.

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 you said all required Work Instructions (or Procedures) are available but in different format. I don’t think there is any need to reformat all WI. However, to begin with your Quality Representatives can perform gap analysis on their relevant procedures to verify if all basic requirements are documented in their procedures.

Basic requirements could be Document Control No., Revision status, Inputs, Outputs, Responsibilities (Owner), Process controls / parameters, Customers, applicable Records and what is documented is still relevant.

WI update or no update will be based on the results of this gap analysis.

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

Just curious,

Every organization has a system whether it is documented or not.

This system largely determines the outcomes of its processes.

To develop a system is to capture the system that runs the business so it can be recognized, understood, used and improved.

The natural system tends to disorder (entropy) so we also add and nurture new processes such as controlling documents, auditing, problem solving and investing in improvement to counter this tendency.

The organization then ends up with a system it can use to add value faster and prevent loss sooner. And, by the way, obtain certification if required for marketing purposes.

I have uploaded a deployment or swimlane flowchart to explain this is a different way.

John

 

[neelu]

Re: Where to Start to Implement ISO9001

I liked what John has written about the general strategy in implementing QMS. I would like to add my little bit to this thread as follows:
My experience shows that the weakest area in an orgn. vis a vis requirements of ISO 9001 is those related to clauses 8.3 and 8.5 whereas maximum benefits through QMS to an orgn. may accrue from implementation of these clauses. So I suggest that while you plan your project, please give equal or priority status to following actions:
1. Advising process owners to identify nonconformities they come across in their processes and record how they correct them (cl 8.3) and how they take corrective action(cl 8.5.2) if they are already doing it. If they are not used to corrective action, you may have to guide them in the corrective action process in their respective areas.
2. You can also devise a nonconformity reporting proforma which could also be used to record correction of nonconformity(disposal of nonconforming product as per cl 8.3);analysis of root cause of nonconformity; and recording of corrective action including verification of effectiveness of corrective action. You can see to it that this proforma is put into use at the first stage of implemenation itself.
3. An action that deserves equal importance is to guide process owners in identifying process performance indicators(cl 8.2.3) in their respective areas and also encourage them to collect data on actual performance in terms of these indicators. This step will faciltate them to analyse data collected, define present level of performance in their respective functional areas and also subsequently arrive at measurable quality objectives(cl 5.4.1) with respect to these areas.