Got No Time For ISO 9001 Quality Systems? Maybe You Need a Time Machine!

“Ticking away the moments that make up a dull day…” go the lyrics of Pink Floyd’s song “Time,” taken from the seminal album The Dark Side of the Moon. This iconic work of progressive rock music reflects on the negative effects of performing mundane or routine actions and how time can control one’s life.

The meaning behind the song’s lyrics, while strongly applicable to everyday life, also is an apt description for the way certain clauses of ISO 9001:2015 are implemented. Often, requirements including Management Reviews, Internal Audits and Calibration of Measuring Equipment are planned according to a misperception that they must be conducted at certain intervals, generally throughout a calendar year. 

However, an examination of the relevant clauses reveals there is zero mention of when to implement the requirements, as seen below. 

7.1.6 Monitoring and measuring resources
“…calibrated…at specified intervals…”
9.2 Internal audit
“…conduct internal audits at planned intervals…”
“…an audit program(s) including the frequency…”
9.3 Management review
“…at planned intervals…”

Of course, there may be external influences that impact when these parts of the Quality Management System (QMS) are implemented. Your contract with a Certification Body, for example, might set additional guidelines requiring you to audit the whole QMS in one year. However, in my experience, when organizations choose to adopt a simple time-based approach to implementing these requirements, significant opportunities are lost and costs incurred which may have otherwise been avoided.

In one situation, a company bought the best (and most expensive) torque wrenches they could find, sending them to an ISO/IEC 17025 accredited lab for calibration every year thereafter. A quick review of calibration results obtained over the next five years revealed no appreciable change in the “as found” condition compared to the previous “as received” condition. So, why bother sending them out at all? Aside from an arbitrary schedule telling them a calibration was due, there was no reason or need to continue having them calibrated in this way. 

Consider another instance where, due to the frequency of use, a thread plug gauge was becoming worn out of specification in a matter of a few months. But, because the organization only checked equipment on an annual basis, the worn out gauge was in use for eight or nine months longer than it should have been, with potentially damaging results in that period.

A further example is when an organization chose to internally audit their management system according to a 12-month calendar. In July, most assembly workers left for vacation and were back-filled with seasonal workers for the first two weeks of the month. The impact on product quality was predictable – resulting in increased rejections, rework and delays. Did the internal auditors ever audit the training process to see if it was actually used during this time? No! Because the schedule arbitrarily directed them to only audit Product Identification (which had never been an issue) in that month. Clearly, despite the audits being completed according to plan, they were almost a waste in determining the cause of the problems in July.

Management Review is a key function of the QMS and, as such, should be employed as a means to examine business operations, identifying the status of plans, related performance and actions needed to keep the organization on track. This is particularly important when encountering situations that are, by their very nature, not what was planned to occur. Since these perturbations in business performance are rarely experienced at a predictable point, management’s review shouldn’t be done to simply satisfy a calendar. 

If any organization implementing an ISO 9001:2015 compliant QMS finds themselves doing mundane things simply “because ISO says so,” there’s a good chance management should revisit their understanding of these ISO 9001 requirements. Otherwise, they are at risk of becoming just like the rest of the song:

“Fritter and waste the hours in an offhand way. 
Kicking around on a piece of ground in your home town, 
Waiting for someone or something to show you the way…”

A Rose By Any Other Name

Previously, we discussed the fact that ISO 9001:2008 requires documentation of the organization's Quality Management System, including a Quality Manual, some procedures, and probably other types of documents of an indeterminate type. The need for any form of documentation is actually defined in the standard, under 4.2.1, in the phrase "documents...determined by the organization to be necessary to ensure effective planning, operation and control of its processes. This gives people quite a lot of freedom to create whatever quantity, content and format of documents it chooses, especially if they choose NOT to be constrained by the hierarchical "pyramid" we discussed previously.


We've established, in a previous blog entry, that the need for and content of many documents is going to be, in good part, dependent upon the competency of the people who use them. In general terms, the higher the competency of the person using documents, the less detailed the description in the document needs to be. A key consideration is that someone will probably figure out pretty quickly what the document is about, if they are competent.


Try this simple example; write down the preparation and cooking of scrambled eggs - for yourself! How detailed would such a task need to be for someone with experience in a kitchen? These are fairly simple concepts and practices, so why do people make the creation of "ISO" documentation so complex?


Form Over Function?


Where people start going off the rails in the design (format) of their Quality Manual (see 4.2.1.b). If we take a look at the ISO 9001 section which defines what should be included in a Quality Manual (4.2.2) it says:


"The organizations shall .... a quality manual that includes:-


a) the scope of the quality management system (and some stuff we won't concern ourselves with here)


b) the documented procedures - or reference to them, and


c) a description of the sequence and interaction of the QMS processes"


Pretty simple, really. If we add a couple of other requirements of ISO 9001 which would seem appropriate to include in such a manual:

• and organization chart or some way to show who 'top management' are (5.1, 5.5.1)
• the Quality Policy (5.3)
• Quality Objectives (5.4.1)
• Who the "Management Representative" is (5.5.2)

Then, maybe assign a page to each of these (which might be considered overkill), adding a nice cover page, we have a total document of some 7 pages. Going beyond what ISO-says, perhaps including some really useful information, like a description of the history/background to the company, details of markets served, products, office/factory locations, contact details, including a web address etc. we might expand it to 10 pages.


One example of an ISO 9001-compliant Quality Manual I saw was actually a tri-fold, made from an 81/2 x 11 sheet. It was prepared in the same way as a company marketing brochure might be, from the front outer cover showing a photograph of the building, the 4 "inside" pages containing the "ISO stuff" and the back page being a map, address, phone numbers etc. What a good looking, useful and very readable document! Imagine being given that on your first day at work, or as a potential customer...

It's interesting, then, to note that in spite of these (minimal) requirements, many people create (or even buy) a document which closely resembles the layout of the ISO 9001 standard itself. Since the Quality Management System is supposed to describe the key or core processes of the organization, which are responsible for determining customers' requirements, through to delivering product/service to those customers, and also the process which support and enable the key/core processes, why use ISO 9001 as a template? It clearly isn't laid out in this manner! 

If we take a look at other types of documents the standard mentions (or people think are necessary), it's common to employ the following format for procedures and work instructions, which often  includes:

• Purpose
• Scope
• Applicability
• Definitions
• ISO 9000 reference(s)
• Responsibilities
• Flow chart (possibly)
• Procedure
• Records
• Change History

In one (extreme case), even the office stationery needed to complete the work was listed!


Good grief! Look at how much "stuff" has to be waded through before any mention of a procedure is made! Plus, with all this content, how many pages are the result? No wonder people have heard that "ISO" is a paperwork nightmare!


Good Design - You Know It When You See It!


Rigorous adherence to a format is NOT what is required. Well communicated requirements and controls are! The documented management system is a product first and foremost. And good product design considers, first and foremost, the needs of the user. In fact, good product design is elegant! If you look up “elegant” in a dictionary, one of the definitions is:

"gracefully concise and simple; admirably succinct"

Notice it doesn’t just say “concise” or “simple” or “succinct”, but “gracefully concise” and “admirably succinct”. And, for many of us, we know it when we see it. Consider Apple products, if you want a really good example. People actually get "carried away" with their ownership of Apple iPhones, Macs etc. OK, so maybe that's a little extreme as a comparison for QMS documentation, but why shouldn't an organization strive to make its documentation at least "friendly" to users? Why does everything have to be forced to fit this structure?

The answer is, of course, that it doesn't. Now, we all use documentation in our everyday lives - outside of any ISO based QMS - without the need for an similar format. Take, for example a humble bank note, or a bus or train ticket. Often they contain a lot of information. Some of it is for us, some used by the issuing agency. Do they need the structure above, to enable them to be used by a huge population of users with all levels of education etc?


Frankly, I see no real reason to force such a set of descriptors on what should be simple documents. What are we attempting to use QMS documents for? Convey the requirements for effective process "planning, operation and control", elegantly...