I recently overheard a discussion about the position of ISO Management Representative described in Clause 5.5.2 of the ISO 9001:2008 Quality Management System (QMS) Requirements where someone was questioning whether the ISO Management Representative really needed to have the title “manager.”

I think we can take the words of the standard itself – “appoint a member of the organization’s management” – to indicate that it does need to be someone with at least the title of manager.

But we can also use our own common sense and organizational experience to understand the reasoning behind this ISO 9001 requirement, even though it is not explicitly stated.

First of all, the person responsible for managing the ISO QMS needs to have a fairly high level of authority in an organization. They need to be able to make decisions, apply resources, and implement changes in the organization related to the QMS without having to seek permission or feel that they are overstepping their authority. The QMS touches many disparate facets of an organization.Someone in a low position of authority will not be able to effectively implement and manage the QMS.

Secondly, the ISO Management Representative needs to be someone in a secure position in the organization who feels they can tell the truth to top management. That usually means someone at, or near, the top management level. Someone lower in the organization is usually not comfortable telling the truth to top management (for whatever reason, fear, intimidation, feeling out of place).  An ISO QMS that does not have open communication to top management about its functionality and effectiveness will not truly benefit the organization.

Finally, if top management is not willing to use someone with real authority or power in an organization as its ISO Mgt. Rep., what does that say about their commitment to the QMS? In my opinion, the ISO Management Representative needs to be a least a manager, and in larger, multi-tiered organizations it may need to be someone even higher in the organizaiton.

If you read our blog posts and weekly e-newsletters often, you know that Bizmanualz is a strong advocate of having a well-defined and efficient quality management system. To ensure that it’s functioning smoothly, we have internal audits scheduled frequently throughout the year. (ISO 9001 simply requires that an organization conducts IAs at “intervals” and doesn’t specify how many per year.)

Since I was the last person at the office to go through Internal Auditor training, I’ve been getting my feet wet and just finished my second of these audits.

At first, I was completely intimidated. I mean, you have to ask your colleagues—and bosses—how they do their jobs and try to determine what processes are lacking or what actions aren’t being recorded. You have to dissect procedures that you may have no experience with. And then there’s that big, scary QMS “mountain of paperwork” that you’re supposed to pore through looking for inconsistencies.

Well, for those of you who are interested in being IA certified or thinking about conducting internal audits to prepare for ISO certification, here’s how it actually plays out.

First of all, if you’re conducting an internal audit among your peers (not those in the same department, because you’d then be auditing your own work—an ISO “no-no”) the situation will probably be more comfortable than you’d think. People are eager to talk about their work and show pride in their company. And you’re not there to point out errors in an “I gotcha!” moment. You simply ask questions, verify, and document.

Secondly, you don’t need to know the ins and outs of product development or processing orders. You just need to verify that certain procedures are documented, records are kept, and that the system is working.

Finally, if your company has a big, scary QMS “mountain of paperwork,” you’re probably not doing it right. Ours is actually fairly simple, extremely organized, and easy to find what you need. A QMS can even be in electronic form, which for some people, makes it even easier.

If you have any questions about Internal Audits, please feel free to comment and ask. I may not know the answer, but luckily we have some in-house experts. And for a more in-depth look at Internal Auditing, consider our upcoming workshop.

If you are thinking of preparing an ISO 9000 Quality Management System (QMS) then where do you start?  We start with a Gap Analysis to determine the gap between your current management system and an ISO 9000 conforming QMS.  A Gap Analysis is used to assess an organizations scope, readiness, and its resources for building the system.  It also provides us with the data to develop a project plan for ISO implementation.

The first question we need to answer is Scope?  Your QMS scope applies to what product lines, ISO 9000 clauses, and facilities that you are planning on registering to ISO 9001.  You do not have to register every product line.  At Bizmanualz, we are preparing for our own registration audit that will include our manual products, consulting and training services.  That means both our products and services will be included in the registration process. 

To define the scope within the Gap Analysis we look at what processes need to be included and described within the ISO QMS.  The output is a draft process map.  Next we examine each clause of the ISO 9000 standard.  There are 136 “shall” statements that we count to see which ones apply and how an organization may be conforming.  These shall statements include 21 required records, six required procedures, a Quality Manual, and many process requirements that must be fulfilled, but there is a lot of leeway on how you might fulfill those requirements.

For example, collecting customer feedback is a required process or that processes must be measured is a requirement, but how you do this is totally up to you.  You do not have to write a procedure for this or  keep a record of measurements.  As odd as this sounds you have to free your mind of paper solutions and think of visual or electronic methods that could accomplish this.

The output of the ISO Quality “shall” count is a histogram that shows you how your organization stacks up, clause by clause, and a list of possible exclusions of areas within clause seven that may not apply.  Each exclusion claimed will require a proper justification within the Quality manual.  In the Gap Analysis phase we should be able to give you an idea on possible exclusions.

With the Gap Analysis complete, we write up what we saw and deliver to you a draft process map, scope with exclusions, a histogram that lists your conformance by clause and a set of implementation milestones to meet your target date.  An ISO Gap Analysis is basically a full systems audit but instead of audit findings you get consulting advice on how ready your organization is for ISO 9000.  If you are thinking of preparing an ISO 9000 Quality Management System, then an ISO 9000 Gap Analysis will provide the answers to your scope, budget, and implementation questions that management will be asking.

In essence, according to my dictionary, the terms are interchangeable.  I have heard some explanations that continuous implies not interrupted while continual implies prolonged succession.   Merriam-Webster on-line makes that distinction as well, using the example of showers over the weekend.  Continuous showers means the rain will never stop.  Continual showers means that the rain will start and stop regularly over the weekend.

So continual seems to be the term that is most appropriate when it comes to organization’s improving.  Improvement typically happens in spurts or stops and starts;  improvement doesn’t constantly happen without interruption.

More importantly, however, continual is the appropriate term  for organizations employing the ISO  9001 QMS.  The ISO 9001 Standard always uses the term “continual improvement,” so that is the term I have come into the habit of using just to be consistent with the language in the standard.

It is interesting, though, that continual improvement has the more appropriate implication and is used in the ISO 9001 Standard, yet continuous improvement has become the more frequently used term.

Now you know why I prefer continual improvement.  Which do you use?  Should we continue to use them interchangeably, or recognize the subtle differences?

Have you ever wondered how to get rid of old ISO quality procedures originally designed for ISO 9000:1994?  Many of those old legacy procedures are no longer required by ISO 9001:2000 or the current ISO 9001:2008 standard.  In fact, those procedures may be so out of date that many people aren’t following them, anyway.  If your ISO 9001 QMS contains too much documentation and/or much of it is outdated, this workshop is for you. 

Using Lean Thinking, you can reduce your organization’s reliance on procedure documentation.  Using a visual workplace you can perform trending and analysis that generates buy-in for change.  How about a lean Corrective & Preventive Action Kaizen Process that engages your workforce and communicates the latest improvements to your employees? 

Using lean, you’ll understand how to conform to the minimum document and record requirements and reduce the bureaucratic waste commonly (and unfairly) associated with ISO 9001.  Now’s the time to learn how to “lean out” your ISO 9001 Quality Management System.  Attend the ASQ St. Louis Spring Quality Conference at the Crowne Plaza in Clayton on April 2-3, 2009, to learn about lean and other great quality topics.

The long awaited update to ISO 9001:2000 arrived last November.  While ISO 9001:2008 isn’t a huge change from its predecessor, it’s still a great time for us to update our ISO 9001 QMS Policies, Procedures, and Forms manual.

So, I’d like to hear from you.  Whether you purchased our product some time ago, purchased a competitor’s product, designed and implemented a quality management system on your own, or have yet to consider a quality management system for your business, we value your input.

How can we help you?  What are the pitfalls in designing and implementing a quality management system and how can we help you avoid them?  What information do you need?  What features would you like to see?  What would you change in our current product, and what would you keep?  In short, how can we improve our product to serve you better?

We also offer a number of courses dealing with quality and process improvement.  Maybe you’ve taken one of our courses – perhaps you weren’t aware of our offerings.  Either way, take a look at our course listings and let me know what you think.

I look forward to hearing from all of you.