We had a customer ask us this week about obtaining “ASO certification”. Here, in a nutshell, is what we said in reply:

“We’re unfamiliar with ‘ASO’ certification (one of my cohorts “googled” the acronym and didn’t think any of the results fit, so we assumed they meant “ISO” – if we’re wrong, we’ll hear about it). However, if a company wants to obtain ‘ISO’ certification, it has to do the following:

1. Develop a quality management system (QMS);
2. Implement the QMS and collect data;
3. Review the data collected and use it to drive improvement;
4. After several cycles of the QMS, you should have an indication of whether it’s working. When you’re sure it is…
5. Apply for a certification audit.  Your country’s ISO member body should have information on certifying bodies, registrars, etc.;
6. A few weeks after you’ve been through the audit, the certication auditor will tell you if you passed (or if you didn’t, where you were weak and need improvement). If you passed, ring the bell! Have a party! Tell all your friends (Facebook and real), family, and business associates! Your Quality Management System is now ISO certified! And…
7. In the event you didn’t pass, make the necessary changes (at the bare minimum) and reapply for a certification audit.

One thing we didn’t tell the customer initially is, “Don’t have unrealistic expectations.” Developing and utilizing the QMS — as well as the subsequent audit — are going to take time and effort.

If you’re doing it purely for marketing’s sake, if you think you can knock out a QMS and pass a certification audit in a matter of months…you’re in for a load of grief. You’ll never get a solid QMS under you AND you’ll never make deadlines, because they’re unrealistic.

If you build a QMS because you want to provide your customers with the best everything — if customers are the reason for everything you do, including the QMS – you’ll take the time you need to get it right, you won’t set unrealistic goals and deadlines, and you won’t drive yourself crazy trying to figure out why you never meet expectations.

OK, so they’re not really easy steps…but the concept itself isn’t at all complicated. Each of the steps above is broken down into successively smaller pieces (things, activities, people, etc.) but if you start with the “big picture” and keep the big picture handy, you’ll do fine. Refer to it continually as you build. That’s where a lot of companies go wrong — they focus on just one part of the whole story as if that were the whole story, like the blind men and the elephant.

Keep your perspective. Remember — you’re in it for the long haul.  Best of luck in your QMS journey, and let us know if you’d like our help.

Here’s a question we’re asked from time to time: “Are your products ISO 9001 (or other standard/guideline/regulation) compliant?”

The short answer to that is “Not exactly.”  ”Well, why not?!”, you might ask.  Well, the long answer is:

First, the ISO standard does not specify what a document must look like but, instead, specifies what must be contained in the document (as in the “results and action” of a review).  Documents themselves do not comply with ISO 9001, though they can conform to the standard.  Bizmanualz documents do conform in that they include the required procedures, records, etc.; however, compliance comes from how you use your documents.

Quality management systems are what must comply to the standard.  To be certified ISO 9001-compliant, your quality management system, or QMS, has to be audited by an independent external body (certification auditor) who verifies that the QMS conforms to the requirements specified in the standard.

Documents and records are evidence of a system’s conformance to requirements.  Your quality policy, quality manual, and other quality documents and records are all forms of evidence — part of the proof the certifying auditor needs to see in order to verify, or confirm, that your company has a quality management system in place.

Furthermore, it’s not just a matter of whether you have documented processes (procedures) or whether you’re keeping records.  The effectiveness of your quality management system is ultimately determined by how — and whether — your organization uses the information it gathers to continually drive improvement in the system.

Having an effective quality management system means your organization is gathering information from (and about) its processes and is using that information to continually improve:

• The quality of its products and services;
• Business process effectiveness;
• Its quality management system; and
• Its customers’ overall experience.

Second, the content Bizmanualz provides in its policies and procedures (PnP) manuals hasn’t been developed with a specific organization or category in mind.  Our policies and procedures are written in a general tone so that any organization may adapt them to its unique circumstances, issues, and needs, as well as shape them to the requirements that all organizations have in common.

This is exactly what ISO has done — and continues to do — with all of its standards, designing them in a general fashion to assist any organization — not just manufacturers, not just service organizations, not just large or small companies, but all of them.  How much benefit you derive from ISO standards or Bizmanualz PnP products is entirely up to you.

Of course, we want to hear from you on your experiences — good and bad — with our products.  Just like you, we’re always looking for ways to improve our products and services and we need your help.  Like the TV pitchmen say, “Call NOW!”

We’ll be releasing our updated ISO 9001 QMS Policies, Procedures, and Forms manual this week.  The ISO 9001 standard, “Quality Management Systems – Requirements”, was updated for the first time in eight years and released last November.  The changes to our manual go quite a bit further than merely substituting every occurrence of “2000” with “2008”, of course.

We now offer you a leaner manual in more than one sense.  There are fewer pages and fewer procedures in our soon-to-be-released product than in the previous version, reflecting our “lean” philosophy.

The Quality Manual reflects lean thinking most of all.  Rather than borrow the text of the standard verbatim, we stripped the Quality Manual to the bare essentials.  It’s not going to be for everyone – some will, no doubt, still insist that their Quality Manuals parrot the text of the ISO 9001 standard, so that they’re sure their Quality Management System documentation covers every aspect of ISO 9001.  Putting in a lot of verbiage that’s not required by the standard, however, can make your Quality Manual less user-friendly, less useful, and less likely to be improved.

There are fewer procedures in the new and improved ISO 9001 QMS manual.  Procedures retained are ones that many organizations consider important or critical (e.g., Internal Auditing, Corrective Action).  Those procedures are modeled on the Deming Cycle — they have a Plan, Do, Check, and Act phase.  Some procedures that aren’t typically high priority and/or that didn’t amount to much more than simple work instructions (e.g., Serial Number Designation) have been omitted.

Throughout the updated manual, we refer to ISO 9001 requirements.  The six required procedures are highlighted in the Quality Manual; they’re also the first six of the twenty-three procedures we provide.

We’ve done something new with the “Forms and Records” section at the end of each procedure.  We’re still providing sample forms for you to use, but now they’re categorized as “required” or “other” and we tell you which ISO 9001 clause requires the record.  For example, in the Internal Audits procedure, there’s a form for audit reports; the Forms/Records table tells you the report requirement is in clause 8.2.2.

We think this is a much improved product, one that will smooth the bumps in your organization’s road to ISO 9001 compliance and certification.

As always, we eagerly await your comments.

PR: wait… I: wait… L: wait… LD: wait… I: wait… wait… Rank: wait… Traffic: wait… Price: wait… C: wait…

There are occasionally stories in the quality world about ISO 9001 Registrars handing out ISO 9001 certificates, but who are not properly accredited.  Believe it or not, there are unscrupulous people and businesses that are willing to take advantage of those who have not done their homework.

As many of you know, ISO (the International Organization for Standardization) is not actually involved in granting ISO certifications.  ISO creates standards, they are not in the business of enforcing them.  Other organizations actually handle the process of granting ISO certification.

Worldwide, the International Accreditation Forum (IAF) is the organization that handles all the facets associated with granting ISO 9001 Certification.  The IAF works with national or regional bodies, which in turn accredit registration bodies that go out and audit organizations for compliance to the ISO 9001 standard.

Here in the U.S., the American National Standards Institute and the American Society of Quality cooperate to form the ANSI-ASQ National Accreditation Board, known as ANAB.  They accredit registration organizations, attempting to ensure consistency and compliance in ISO 9001 registration auditing.

Make sure you registrar is ANAB accredited

When you hire an ISO auditor for ISO 9001 certification, be sure to verify that they are accredited by ANAB or whatever the equivalent of ANAB is in your country or region (you can find a list of members at the IAF website, http://www.iaf.nu/).  And your registration certificate should have the ANAB and the IAF logos on it.  Without them, you are not truly ISO 9001 certified.

Make sure your ISO 9001 Certificate will have the IAF and ANAB seals

Do your quality personnel speak the language of business?  Do business people speak the language of quality?  I read an interesting blog post a while back that raised this question.

The confusion highlights a core problem with ISO 9000 implementation—communication.  An effective quality implementation is really about effectively communicating with customers, suppliers, employees, and management to indentify, meet, or exceed requirements.  Quality, sales, marketing, design, manufacturing, accounting, and management must all communicate using the same language.

It starts with collecting the customer’s requirements from the customer (i.e., voice of the customer), communicating customer requirements to design/development, and design/development communicating what they think the customer wants back to the customer for confirmation through verification and validation.  Then design/development communicates specifications to purchasing, manufacturing engineering, and quality/testing to ensure it is made as designed.

Quality must communicate to management via internal audits, management reviews, and quality objectives that the system is capable of consistently reproducing the product or process.  The company communicates its consistency to its stakeholders via its quality policy, ISO certification, and management commitment.

Management communicates its quality commitment by allocating budget for continuous improvement using corrective action and preventive action, training, and infrastructure expenditures.  Waste is produced as a result of poor communication between one or more of the groups or departments within an organization.  Total up the cost of all of your nonconformities, defects, and deviations from plan and you get the cost of poor communications.

When we talk about effective communication, we are talking about a real two-way exchange of information.  Both the sender and receiver must be actively engaged and providing feedback for it to be effective.  Implement an effective quality management communication system and the savings will be huge.

Sometimes when I say that phrase, “keeping with the spirit of the ISO 9001 standard,” I get long looks and contradictory comments.  After all, as we all know, with ISO 9001 auditing it’s all about specific criteria and objective evidence.  That does not align very well with the concept of the spirit of the standard, only the letter of the standard.

But consider this.  I have a friend who is an environmental engineer.  He complains that the most difficult aspect of his job is complying with long, tedious, arcane, and sometimes contradictory EPA regulations.  I sympathize with his difficulty; however, his mistake is to blame the extensive regulations on the EPA.  I argue that environmental regulations are so long and complex because every time a business and corporation exploits a loophole or missing detail, the regulation has to be revised to close the gap.  Do this for 50 years and obviously you end up with long, complex, and even contradictory regulations.

So, in my view, he shouldn’t blame the EPA for overly complex regulations; he should blame businesses, corporations, and environmental engineers who, instead of following the spirit of environmental regulations, sought to avoid compliance by exploiting loopholes, unspecific language, and missing details that have lead to this bureaucratic nightmare.

When it comes to the ISO 9001 requirements, the standard is brief and generic.  It is not full of details on what you have to do to comply.  This makes the standard very flexible so any type or size of organization can use it.  I feel this general nature of the standard makes it appropriate to talk about the “spirit” of the standard—the spirit of using a continually improving process approach to improve effectiveness and customer satisfaction.

In order to keep the standard brief and general, then organizations employing it (and auditors as well) have to keep in mind the spirit of improvement behind the standard and adhere to that, not only the literal letter of the standard.  After all, who wants to end up with an ISO Standard as difficult to navigate as EPA regulations?

That’s right we successfully passed our ISO 9001:2008 certification audit today.  We will now be the proud holder of an ISO 9001 registration.  It has been an exciting experience and we have learned a few things along the way.

So, now what do we do with it? 

The ISO organization produces standards and guidelines for a living so of course they have a PDF publication for publicizing, communicating, and promoting your registration called Publicizing your ISO 9001:2000 or ISO 14001:2004 certification. This is a great place to learn about how to market our new registration.  Inside there is an “In brief” section that summarizes what we can do with it.  Surprisingly, it lists more of what you can’t do than what you can.

• You can’t use or modify ISO’s logo… it is ISO’s brand and intellectual property.
• You can’t say ISO 9001 or ISO certified… You must spell it out. We are ISO 9001:2008 certified; we are not certified by ISO or by ISO 9001.
• ISO 9001:2008 cannot be listed on your products or used in literature to imply product certification… It’s not a product certification it’s a company certification.
• You must be careful with your scope description so it properly depicts your certified activities and geographic locations. For Bizmanualz it includes are manual products, training and consulting services from our St. Louis location.

So what can you do?

You can use the fact that your company is ISO 9001:2008 certified in your marketing.  Your management system and its processes have been certified to ISO 9001:2008 so you do want to talk about your successful registration to ISO 9001:2008 just as long as you do not suggest that your products are certified or that you are certified by ISO, which is what ISO certified implies.

Bizmanualz has been certified by Platinum Registration to ISO 9001:2008 and it was a great experience.  Next, we plan to communicate our success to our customers and fans.  We passed with no nonconformances and the auditor did note a number of exemplary practices that our Lean ISO 9000 QMS exhibited.  Yes a lean ISO system is possible and now we have the audit results to prove it.

Information is important.  It helps us do our job.  But in how many places does information need to be kept?  We need to make sure the right information is available to people when they need it, but sometimes we put information in too many places – where it is not really necessary and not really used.  We just do it because it seems like a good idea at the time, or it makes things look official, or because we are just over-doing it.

When information is dynamic, you need to consolidate it as much as possible, because if the information is unnecessarily duplicated in a number of places, then every time it changes you have to locate everywhere the information exists and update it.  This leads to oversights and errors,  which then leads to outdated or incorrect information floating around.

We encountered this recently on some of our document lists that included revision level and revision date.  We use these lists for document control.  For example, we have a list of work instructions in the master work instruction file, so that when a work instruction is updated, we know where “deployed” copies of the work instructions are kept so they can be replaced with the latest revision.

And we like to have living documents, meaning we update them frequently.  But every time, say, a work instruction is updated, the list had to be updated too.   Sometimes it wasn’t.  So now the list had wrong information.

But the point is that it was unnecessary to have revision information on the list.  We do not use the list to track revisions, we use it to track location (which rarely changed).  Why have revision information there?   It is an unnecessary duplication of information.

We took the revision information off, and made updating work instructions (and other documents) easier because there is less overhead activity associated with it.  And less wrong information floating around.

Quality has always been at the forefront of our operations here at Bizmanualz. Fundamental quality principles have always guided how we do things, whether it’s getting new products out or strategically measuring our performance metrics.

This week, however, Quality has taken center stage at Bizmanualz. First, as Dan Davison writes in his blog post, we are going though an ISO 9001 certification audit. The whole week, we’ve been discussing the audit, and have eagerly awaited the arrival of the Auditor. The audit should conclude tomorrow, but the quality journey at Bizmanualz continues. Quality audits and certification are just a couple of milestones in the journey, the system has to sustain. And, most importantly, the ultimate goal is to make our customers happy.

Our actual system may only have “officially” been in place for a few months, but the concept is familiar to all of us. Almost all of us have gone through the Internal Auditor Training course, and four of us are ASQ Certified Quality Auditors. Customer satisfaction is always a big factor in influencing how we approach our tasks.

Talking about ASQ, the annual Spring Conference of the ASQ St. Louis Section starts tomorrow and runs through Friday. Bizmanualz is participating as a vendor and will have a booth. Additionally a few of us are attending the conference either as helpers or as participants. On Friday, Chris Anderson, our Managing Director is conducting a breakout session on Lean Quality and Innovation.

And on goes the quality journey. Next week may be business as usual, but quality will continue to be an integral part of the way we conduct our business. Whether it is discussing our metrics during our daily morning meeting, reviewing corrective and preventive actions, or completing our Kaizens, quality will continue to be at the forefront here at Bizmanualz.

We’ve been talking a lot about implementing an ISO 9001 Quality Management System over the past month or so. It’s something that Bizmanualz holds to be very important-not just for the certification status-but because a strong QMS means a more organized and efficient workplace.

That got me thinking back to my Internal Auditing training and what are the common deficiencies of most organizations. Typically, the No. 1 weakness of companies tends to be training records, but the problem can be one of a number of issues.

Do you document cross training? Are written job descriptions filed and easily accessible? Can your employee point to a filed certificate or form to prove certain training?

We keep fairly detailed training records. Never before had I been asked for copies of my diplomas or certificates of past training. But after reviewing the ISO 9001 Standard, it was clear why I had to dig them all up. Clause 6.2.1 states:

“Personnel performing work affecting product [or service*] quality shall be competent on the basis of appropriate education, training, skills, and experience.”

*added by our Quality Manager

In our records, that means each person has a folder containing his or her job description, diplomas or other education certificates, training certificates or on-the-job training records, and resumes stating skills and experience.

To supplement those records and keep them updated, our staff members have gotten into the habit of using on-the-job and group training forms every time a new skill is picked up or cross training occurs. Another way to record training is to have your manager vouch for you, signing a memo that records training took place. It doesn’t have to be formal; it just has to be there.

These are easy ways to comply with the standard. Any other suggestions for compliance? I’d like to hear your thoughts.