I just read Lean ISO 9001: Adding Spark to your ISO 9001 QMS and Sustainability to your Lean Efforts, and this excellent book opened my eyes on many things.

I thought ISO 9001 was too rigid for a true lean culture (control documents can’t be written on, need to be approved by a certain authority, etc.). But it can actually help sustain the gains of a lean implementation. And vice versa, lean does help ISO 9001 to be truly a part of the organization’s management system.

The notes I took are below.

The common critics of ISO 9001 are actually about its registration process

• The registration & certification processes are often a joke — by the way, China counts more ISO 9001-certified companies than any other country, by far!
• Many companies pursuing the certification purchase a set of documents, adapt them a little to their activity, and then hide nonconformities a few days days before the registrar’s audit.
• A registration audit is a cat-and-mouse game, and usually the cat (the registrar) purposefully avoids looking too hard because he is chosen and paid by the mouse.

Lean practices improve the quality system and are compatible with ISO 9001

• The spirit behind ISO 9001, as explained in ISO 9004, is very close to that of a lean enterprise.
• Management reviews can take place very often, even daily, in the form of a “daily accountability meeting” (in lean terms).
• Internal audits can be parts of the regular “gemba walks” (another lean term).
• Over time, the documents (quality manual, procedures, work instructions, forms…) tend to increase in number and size. It means they are read by no one, and they contain many redundancies and inconsistencies. But, for example, the quality manual (often 50-100 pages) can take 2 pages only and be compliant with the standard. With a bit of 5S, a lot of useless content is deleted.
• Procedures should be written in process flow: first do this, second do that, and so on. Batching the elements of a process in categories (inputs, outputs, resources…) is bad communication.
• The ISO 9001 standard requires much less than most people think. For example, documents don’t need to have a number in their name (the best is to give them a clear description as a name). And the revision history doesn’t need to contain more than the 1 last revision.

ISO 9001 can help sustain kaizen activities

• When defects are observed, a corrective action plan is to be prepared.
• When process waste (apart from defects) is observed, a preventive action plan can be prepared. The reason is simple: these types of waste (transportation, inventory, unnecessary motion, waiting, over-processing, over-production) generally make operations less likely to satisfy the customer. More about this topic in this video.
• Example: if materials are transported more than strictly necessary (process waste), there is a risk they they get damaged or lost (quality problems).
• ISO 9001 repeats 86 times that the goal is “effective and efficient” processes. It is not incompatible at all with the search for waste.
• Contrary to what most people believe, registrars are supposed to audit a quality system for compliance to the ISO 9001 standard, but also for effectiveness (unfortunately, they never do this).
• Adding some 5S assessment forms, kanbans, and other lean documents in the quality management system is perfectly fine. ISO 9001 should be seen as guidance for a good “business management system” — it is not just about quality.
• Similarly, adding some typically lean metrics (such as inventory turns or adherence to kanban quantities) to performance boards is perfectly fine.

Has any reader got similar or dissimilar experiences?