ISO 9001 Quality Manual

ISO documentation practices, requirements

Q: My small company is forcing me in the direction of using flowcharts to specify ISO standards. With their many branch statements, they are convoluted and confusing. I prefer plain, simple English. But my question is: is it ok to use flowcharts to specify ISO 9001 standards?

A: Actually, as long as you do not intend to become registered (also called certified), you can – and probably should – implement the ISO 9001:2008 Quality management systems–Requirements standard any way you want! I happen to like flowcharts, as long as they are limited to one page and fewer than a dozen boxes.

But if you intend to become registered, the registrar you choose will always require you to explain how you are implementing the concepts contained in ISO 9001.  Most firms choose to call this explanation document a quality manual. You do not repeat the words in the ISO 9001, rather you say how you intend to implement the concepts locally. A manual should be site-specific and about 50-60 pages. Some have written them in 20 pages.

Once you have the framework (manual) in place for the system, then you need to write procedures for the processes. Remember, procedures are job performance aids for an already-trained and qualified person. They should be about five to six pages, since the individual already knows how to perform the tasks.

The powers that be in your company want these procedures to be in the form of flowcharts. That’s OK, as long as you have explained this in your manual. The registration company accepts your manual before they ever send an auditor to your site. If they have accepted your description of flowcharts instead of procedures, then the auditor must accept that approach.

The whole point is to provide information to the person doing the job in a way that is useful. Written standard operating procedures (SOPs), or flowcharts, or pictures. It is the implementation that matters.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

Example Quality Manual

Need to write a quality manual that conforms to ISO 9001:2008? Download an example quality manual from the ASQ Knowledge Center and read about how to create one!

ISO 9001 Procedure Vs. Process

Mr. Pareto Head and procedures

Q: I‘m seeking clarity and advice on a recent incident  I was informed about.

An organization I am very familiar with and is fully certified to ISO 9001:2008 Quality management systems–Requirements (with no exemptions) recently had a new external auditor come in to conduct a certification audit.

While continued certification was recommended, a number of small areas of concern were noted.

I understand that most of the recommendations will improve the system, but one recommendation has caused me some concern.

A bit of history of the QMS of this organization:

This company originally gained certification under ISO 9001:2000 and has transitioned to ISO 9001:2008.  They have a very robust quality management system (QMS), have clearly identified their processes, and have mapped their procedures to these various processes.  They have implemented a rigorous internal audit program which has targeted these procedures and their interrelationship with the various processes.

My problem is that the report for this recent certification audit stated that under 8.2.2 of the standard, in order to ‘gain’ full certification to ISO 9001:2008, they have to conduct process audits rather than procedural audits, or their certification could be at risk.  This has caused some angst with senior management, as their previous certification body was happy with their implementation of the standard.

8.2.2 b: Internal audit

“An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited…”

I can see no mandatory requirement in 8.2.2 to support the statement that process audits have precedent over procedural audits as long as the status and importance of the processes are taken into consideration.

My understanding would be that the requirements of 8.2.2 would be met if the organization’s processes are clearly identified and its procedures and their interrelationships are mapped to the processes and it can be clearly identified during the audit that process requirements are being addressed with the procedures.

Obviously if it can be shown that the processes are not adequately covered, then that must be addressed. But I do not believe this is the case here.

Your advice would be greatly appreciated.

A: I hope to answer your questions about process vs. procedure  in ISO 9001:2008. I will offer several different definitions.  This is not to confuse you, but to help you see how different people deliver the same message while using different words.

We will begin by trying to recognize just what a procedure is. You can have any number of procedures within a process.  That means, a process requires one or more procedures. You take actions to get results.  The actions you take are your procedures.

I once read it this way on the internet: procedures / actions / activities / work instructions all describe the lowest level of decomposition, i.e.: the procedure cannot be broken down further.

A process is “something going on.” It is a continuing natural or biological activity or function.

A process is a series of actions or operations conducing to an end. It is a continuous operation or treatment, especially in manufacturing.

A procedure is a particular way of accomplishing something. This is also defined as a series of steps in a regular definite order; a traditional or established way of doing things.

While the two could sound similar, they are clearly not the same thing.  A process refers to a series of actions, but does not place a particular order on those actions.

Procedures however, are focused on steps, order and instruction. As the author Mark McGregor once wrote, “We can see that while a process may contain order, it does not require order to be a process. If we take away the order from procedure, then we don’t have a procedure, but we may still have a process.”

You are not alone in your questioning of this. It is like the ongoing controversy over continual vs. continuous in the quality arena.  However, the distinction between a process and a procedure should be more clear to you after reading above.

Now, let’s consider why. Why is 8.2.2 worded the way it is?  I think the most simple way to put it is this: in the past, it was not uncommon for internal audit teams to concentrate on element auditing. That is, they audited the verbiage of the documented procedures to see if they complied with that of the standard.

Each individual company has their own processes.  It is through those processes, those actions, that you would comply with the intent of the standard.  The value of controlling and improving on those processes is reflected in your audits.

Input -> Process -> Output

So, it does not matter how you word things. The product audit (or service audit) determines if tangible characteristics and attributes of a thing are being met. A process audit determines whether process requirements are being met. During the process audit, the auditor will examine an activity or sequence of activities to verify that inputs, actions, and outputs are in accordance with an established procedure, plan or method.

By now, you have seen a pattern to all the words above.  My intention was not to muddy the waters further, but to help you recognize why so much light has been shined on process activities. To  “do what you say you do” requires having documented procedures and following what they say.  Doing all of this in an efficient and a profitable manner requires process control.

Finally, if you haven’t already done so, I strongly suggest that you acquire a copy of The Process Auditing & Techniques Guide by J.P. Russell.  This is a good guide you can order through ASQ and it can help with setting aside some of your concerns and answer questions.

I hope this has been helpful.

Bud Salsbury
ASQ Senior Member, CQT,CQI

Ask A Librarian

What’s the Difference Between ISO 9001 and ISO 19011?

Reporting, best practices, non-compliance reporting

Q: What is the difference between the ISO 9001:2008 and ISO 19011:2011 literature on your web site? Please provide a detailed explanation and their use.

A: I can see where the confusion might arise, as the numbers are very similar! But the contents are quite different.

ISO 9001 Quality management systems–Requirements is the mother of all quality management systems. It lays out the minimal requirements for an acceptable way of managing your business for quality. In the beginning, it was developed as a requirements document to lay on your suppliers. Then it became the foundation for registration (other countries might call this certification) of your own management approach to quality. About a decade ago, various business sectors – aerospace, automotive, medical devices, laboratories, etc., all used the ISO 9001 document as the base for their specific approaches. They didn’t take anything away, but added additional requirements. By far, the greatest use today is for registration/certification. This is somewhat sad, in that the standard itself is a beautiful way of managing the resources within the enterprise. Registration can get quite bureaucratic and not worth the expense.

ISO 19011:2011 Guidelines for the auditing management systems is the international auditing standard (my specialty). It was first developed as a means to get all the various registration agencies around the world to do their audits in a consistent manner. It also had support from the multinational companies that had factories – and thus registrations – all around the world and often with different cultures. Norms in Canada are not the same as China! Unfortunately, this registration emphasis in the standard made it somewhat hard for internal auditors and supplier auditors to use it. Plus, there is no requirement to use the standard, other than within the registration industry.

For these reasons, the U.S. wrote a supplement for the 2002 version of this standard, giving guidance on how to use the principles for internal audits and small organizations [note: development is underway to offer similar supplements for the ISO 19011:2011 version  — anticipated end of 2012/early 2013.]. ASQ is the only place to get this version, which  includes the supplement, along with the base document. As this auditing standard was revised, it picked up environmental auditing and safety auditing in the scope.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

Is ISO 9004:2009 an Implementation Guide?

ISO documentation practices, requirements

Q: I am looking to purchase the latest ISO 9001:2008 Quality management systems–Requirements. However, in the past, ISO 9004:2000 Managing for the sustained success of an organization — A quality management approach,  included the ‘requirements’ of ISO 9001 in boxes as a reference in ISO 9004 (used for implementation assistance). Is that still the case? I would much rather buy the revision, ISO 9004:2009 if the ISO 9001 requirements were in the standard…it’d be one less standard to have around.

A: We have consistently promoted the concept that ISO 9004 is NOT an implementation guide to ISO 9001. It is designed to provide guidance to organizations that desire to go beyond meeting minimum requirements towards achieving higher levels of performance.

There is much that is required of organizations today to sustain themselves and the next edition did try to focus on addressing issues that were essential to sustainability, perhaps at the expense of revisiting the old ground of content related to 9001 compliance which, by now, have become well understood by many organizations.

So, ISO 9004 is about going beyond ISO 9001. ISO 9004 is still consistent with ISO 9001, but it places more intensity on going beyond and less on hard line-by-line congruence.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

Merging With a Non-ISO 9001 Certified Organization

Reporting, best practices, non-compliance reporting

Q: My federal agency is comprised of many different internal organizations. We have a scenario where a recently certified organization to the ISO 9001:2008 Quality management systems–Requirements is planned to be merged with a non-certified organization that has no type of management system. The certified organization’s certification runs for three years but it will be more closely integrated with the non-certified organizations. Will the merger affect the certified organization’s certification? Do you have any insights on how these types of occurrences typically affect the management system itself when an organization that is certified for 100% of its operations now becomes 50% of a larger organization? It’s quite likely that the certified organization’s name will change at least in part.

A: With regard to your question, if company “A” is already ISO 9001:2008 certified and is now being merged with a non-certified company here’s what should be considered.  First, the current ISO certification is only applicable to company “A” as defined in the scope of the quality manual as well as on the ISO 9001 certification issued by the ISO registrar.

Your ISO registrar needs to be immediately informed of changes effecting the company name, top management and/or processes.  The registrar may very likely require the newly merged companies to be reevaluated for ISO certification and listed under one ISO certification.

Most ISO registrars will not issue ISO certification for just a portion of a company.  All processes that comprise the quality system must be identified and included as a part of the QMS unless specific exclusion is stated in the quality manual as permitted by ISO 9001.  The management representative will need to ensure that top management is aware of how this merge may affect the current QMS so effective actions can be taken to bring company “B” in line with the established QMS procedures and other ISO requirements.  I hope this helps.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

ISO 9001 Management Representative

About ASQ's Ask the Standards Expert program and blog

Q: ISO 9001:2008 Quality management systems — Requirements defines the responsibilities of the management representative (MR). To carry out these responsibilities, the MR needs certain defined authorities. What principle authorities should a MR posses to meet the responsibilities defined? I am a quality manager and I report to the project director, who reports to the CEO. While auditing other directors in the organization, my boss (the project director), requested from me to discuss with him the audit results of other director’s’ audit findings since I am reporting to him. I pointed out that the MR Role is independent and it is not a part of the function of Quality Manager where I report to him.

How can I make it clearer that I need independent authorities to perform the role of the MR?
 
A: Section 5.5.2 Management Representative: defines the appointment and responsibilities of the management representative. He/she is appointed by top management. The implication is that top management can ask for reports on the MR’s responsibilities. A summary of these are:

  • Ensure QMS process are established, implemented and maintained
  • Reporting to top management on performance of QMS and need for improvement
  • Ensure promotion of customer Requirements in the Org.

It is true that management representative responsibilities are not those of the quality manager. But, ISO 9001 does not define responsibilities of the quality manager.

My suggestion is to go to the person who appointed you management representative and ask him if you should provide the information requested.

Sandford Liebesman, Ph.D.
Voting member of the U.S. TAG to ISO/TC 176
ASQ Fellow
Morristown, NJ