Lean ISO 9001? To many of you this will seem like a contradiction in terms. The term Lean and ISO 9001 are not generally used together, but why not? Does a Quality Management System (QMS) have to be complicated and cumbersome? Do you know how to simplify the quality manual?
I’m reminded of speaking to an adult evening management class at the local junior college in 1995. At the start I asked the class of about 20 students, “How many of you have heard of ISO 9001;please raise your hands?? Then I asked, “How many of those with your hands up have heard or believe that ISO 9001 is a documentation nightmare?” Not a single student lowered their hand. I went on to explain how ISO 9001 was only a documentation nightmare if a company chooses to make it so. The documentation myth of ISO 9001 persists to this day.
I recently had a telephone conversation with a manufacturing Quality Manager requesting some advice. His dilemma is that as his company nears the completion of their QMS conversion from ISO 9001 to TS 16949, he has a couple of key suppliers who refuse to pursue a formal registration to a Quality Standard. Their rationale is that they cannot justify spending a lot of money for a piece of paper or a plaque.
Simplify the QMS
My response to the Quality Manager was, “All they need is a simple Quality Manual and six procedures to document an ISO 9001 Quality System. To show they are at least moving toward a formal system, all they really need right now is a Quality Manual.” I further added, “It does not cost a lot of money, unless a company chooses to develop a complicated Quality System. In fact, a formal Quality Management System should help a company to become more efficient, and therefore more profitable! But, whatever they do, they should keep it simple!?
After further discussion with the Quality Manager it was clear that his understanding of the requirements is that a lot of procedures and documents are needed. So the myth of ISO 9001 being a documentation nightmare is still a common misconception at many levels. This manager is definitely in the old school of Quality Systems as a documentation nightmare. He was amazed when I explained to him different methods of fulfilling the Quality Manual and procedure requirements, along with the concept of lean and ISO together.
So what is a Lean ISO 9001:2008 QMS? Well, a good place to start this discussion is with the required Quality Manual. Clause 4.2.2 of ISO 9001:2008 states the following: The organization shall establish and maintain a quality manual that includes;
- the scope of the quality management system, including details of and justification for any exclusions (see 1.2)
- the documented procedures established for the quality management system, or reference to them, and
- a description of the interaction between the processes of the quality management system.
There is nothing in this requirement that says a Quality Manual needs to be 50, or even 20 pages long. It does not state that each “shall” statement in the ISO 9001 standard needs to be addressed. It does not require pictures, the organization’s legal structure, or any additional details. However, most Quality Manuals seem to follow the pattern of addressing each and every ISO 9001 “shall” statement by essentially repeating the standard’s requirements. What an incredible waste!
The Registrar and the Registrar’s Auditor(s) know the content of ISO 9001:2008;there is no need to repeat it back to them. What about our customer’s you may ask? Usually a customer is not going to read a 30 page Quality Manual. If they do require a copy, they will merely file it and check off that you have one;so why not send them a simple Quality Manual?
Design a Quality Manual to Meet the Standard
Let’s look at the specific requirements for the Quality Manual. Compliance to 4.2.2a can be accomplished in 2 or 3 paragraphs. A brief description of the scope of the organization’s Quality System, followed by a list or paragraph noting and explaining any exclusions to ISO 9001 clauses. So we are up to 1/2 to 2/3 of a page and we comply with 4.2.2a;agreed?
Section 4.2.2b calls for a list of documented procedures. It will help to simplify this requirement. Start with the six required procedures. If your company needs a few more;that is okay. Additional procedures are at the discretion and needs of the organization. One additional procedure that I always recommend to organizations is to address clause 6.2.2; Competence, Awareness, and Training. I found this to be a weak area in the average QMS, and addressing it in a procedure can help to strengthen this activity.
While it is still at the discretion of an organization to include additional procedures, the following example may help with this determination. Perhaps an organization has a small staff and sub-contracts much of their activity. Clause 4.1 requires an organization to ensure control over any outsourced processes and to identify any outsourced processes. This can lead to a short paragraph or a few additional sentences in the scope portion of the Quality Manual. However, I would recommend that this organization write a procedure identifying their activity related to clause 7.4, Purchasing. This is where the control and identification of the sub-contracted activity should be identified.
With this example, the organization would now have eight documented procedures; the six required procedures, a procedure for clause 6.2.2 and one for 7.4 (based upon their business needs). Most organizations should identify six to ten documented QMS procedures.
With the document list, our Quality Manual has increased by about a page. Now let’s consider ISO 9001 section 4.2.2c; the interaction of processes. This is often the most difficult task in developing the Quality Manual. Unfortunately, many organizations do not understand how their business works. My recommendation is to just do a simple overview of how the company functions and how processes interact. A good way to do this is in a flow chart or process flow diagram. A short 1 or 2 paragraph description can also be added, depending on the complexity of the organization.
Add the Finishing Touches
Now we have about a 2 to 2 1/2 page Quality Manual. Stop! You are done! You have met the requirements of an ISO 9001:2008 Quality Manual. I know you want to do more. Most organizations will want an attractive cover page with the organization’s logo and/or a picture of the facility. Most organizations will typically want to have their approval signatures included in the manual and a revision history. This can be included in the manual or kept separate;it is the organization’s choice. So with a cover page, the approval signatures and brief revision history we have added two pages.
After adding these we now have a 4 to 4 1/2 page Quality Manual. Are we finished? Yes! Stop! There is no need to add more. It is hard to break the paradigm of a lengthy Quality Manual, so there will be the pressure to add to it. A good Lean Quality Manual, however, should be two to five pages long. There is absolutely no reason to have an ISO 9001:2008 Quality Manual that is more than eight pages in length.
Now we have a lean and functional Quality Manual. It is easy to maintain and distribute, whether electronic copy or hardcopy, which eliminates waste. People are more inclined to actually review it due to the small size, so we have added value. It can be bound in a variety of formats for presentation to customers or sent to customers electronically. Why not go all the way and have an all electronic copy documentation system.