The Hidden Requirements of ISO9001:2015 – An Introduction

The origins of this series were long in the making – An in-depth report on what it is and how to deal with it. It started back in 2010 while researching trends in Standard development. I noticed a correlation between updates in ISO 9004 which later found their way into ISO 9001. Granted the current revision of ISO 9004 was released in 2009 so I was a little slow on the uptake. But in my defense, I was managing a consulting business at the time, traveling and serving many clients along the way.

What I noticed was the progression of topics of current interest in the UK, finding their way into BS (British Standards) documents and migrating into ISO Standards or vice versa. Sometimes with the same identifier (number) sometimes different. But sometimes with only a ‘hat tip’ to the original, inserted into ISO 9004 only to be incorporated into the next revision of ISO 9001..

The tracking of these Hidden Requirements, as I like to call them, has become a game for me and identifying and implementing the ‘next best thing’ is what has kept me ahead of the competition for quite a while. When I say ‘competition’ I’m really referring to CB auditors. I know something today that they don’t and I’ve ‘beaten them to the punch.’

Take Risk, for instance, and call it what you like – I began implementing Enterprise Risk Management Frameworks (ERM) for clients back in 2011. For some, a four-year history of both formal and informal risk assessments is more than enough ‘objective evidence’ to convince any CB auditor that the requirements of ‘Risk Based Thinking’ are being met.

The relationship between BSI and ISO is common knowledge (as bed-fellows usually are) and so it makes sense that ISO would want to ‘cash in’ on the spoils, making the ideas contained therein an International Standard instead of just a National Standard. ISO 45001 is a good example – replacing the National Standard BS / OHSAS 18001: 2007 with an International version and of course usurping the copy rights.

But I digress… So, here’s the hype

Annex SL: Origins

Annex SL grew out of what was previously known as ISO Guide 83. ISO claimed that Most organizations have more than one management system, and many expressed frustrations at the extra time and resources that it took to implement and certify their various management systems with differing structures, definitions, and requirements. ISO Guide 83, which was adopted in 2011, was the first formal effort to create consistency in structure and terminology across ISO management systems standards.

Annex SL: A common structure

Annex SL is a high-level structure created by ISO to provide a universal high-level structure, identical core text, and common terms and definitions for all management system standards. It was designed to make it easier for organizations that have to comply with more than one management system standard.

What I’m seeing today in ISO 9004 pertaining to implementation of multiple management systems, specifically, ISO 14001, ISO 45001 and ISO 27001, which I suspect, at least some aspects may become mandatory requirements in some later revision of ISO 9001 and made possible by this new HLS. In 2027 I don’t want to hear any whining that I didn’t tell you so!

So on to Hidden Requirements. One thing you will note is by the time these make it into ISO 9001, a Technical Committee (TC) is, or soon will be, formed along with sub-committees whose responsibilities it is (will be) to develop standards which in turn will generate revenue.

First on the list is Human Factors (TC-159,) if you read my last post “What a Good Question,” you may have noticed I mentioned that, “It begins with environment: ergonomics, light, temperature, noise level (safety guy stuff) as conducive to productivity (things like the ‘Hawthorn Effect’) and moves to stressors and eventually the cause for nonconformance (and its opposite: Poka-Yoke.) ISO 9001 is presently only interested in the former, AS 9100 the latter. As I see it, eventually, both AS & ISO will be interested in both and you’ll need to be ready for it!”

ISO/TC 159 Ergonomics
Creation date: 1974

ISO/TC 159/SC 1 General ergonomics principles
ISO/TC 159/SC 3 Anthropometry and biomechanics
ISO/TC 159/SC 4 Ergonomics of human-system interaction
ISO/TC 159/SC 5 Ergonomics of the physical environment
________________________________________

Scope:
Standardization in the field of ergonomics, in particular, general ergonomics principles, anthropometry and biomechanics, ergonomics of human system interaction and ergonomics of the physical environment, addressing human characteristics and performance, and methods for specifying, designing and evaluating products, systems, services, environments and facilities

ISO/TC 159/SC 1 General ergonomics principles
ISO/TC 159/SC 3 Anthropometry and biomechanics
ISO/TC 159/SC 4 Ergonomics of human-system interaction
ISO/TC 159/SC 5 Ergonomics of the physical environment

Total number of published ISO standards related to the TC and its SCs (number includes updates) 128
________________________________________

Really! 128 Standards already? Yep – Get ready to open the pocketbook! Now on to what it is and what we need to do about it.

What’s New and Why Is It in MY Standard? Part 3

Is your HF Program effective?

In our last post we learned a little something about Human Factors. Now we’ll learn how tell the auditor, “Go to ‘H’ ‘E’ double hockey sticks!” and have them look forward to the journey.

Originally conceived as an Occupational Health and Safety practice, focusing on controls to minimize safety hazards and conditions leading to personal injury, Human Factors was later adapted by the US military for people working with “complex systems” and adopted by organizations within suitably complex industries such as FAA aircraft repair stations, space vehicle design and nuclear power. It’s a complicated group of disciplines and comprised of multiple components such as ergonomics, psychology, safety, environmental management, training, human resources and corrective action.

It doesn’t stop there. The application of HF is equally complicated, affecting multiple aspects of an organization, including:

  • Work planning
  • Facility and equipment design and planning
  • Maintenance, repair and inspection of product
  • Product design
  • General management
  • Training
  • Work rules

oopsWhen planning work, for example, factors such as the physical and mental fatigue of workers must be considered, while product design must consider the ergonomics aimed at the end-user of the product. The inclusion of HF in ISO 9001 could potentially force companies to consider alternate methods of information transfer in order to reduce mental fatigue; this usually pushes companies to move to methods other than documentation, towards signs, illustrations, verbal instruction. How do you control verbal instruction?

Full implementation of HF under ISO 9001 would be extremely difficult. HF professionals are one third OH&S expert, one third psychology major, one third EMS guru and one third professional trainer. Yes, that’s four thirds; it’s that complex!

Next we have the fact that auditors, who will receive no training whatsoever on Human Factors, won’t know how to audit it. Like the process approach from ISO 9001:2000, the first year or two they will just ignore it. Then, as confidence grows (or ANAB writes CBs up) they’ll come into their own. Bogus nonconformities will be written, costing end user organizations more money as they scramble to fix nebulous, amorphous findings not really grounded in any firm requirement.

homerSo, now what?

Hey look folks, it ain’t rocket science – Illegitimi non carborundum! (Don’t let the bastards grind you down.)

The first thing you do is to adopt the World Health Organization’s definition. The Standard says you must consider (implying this is a requirement) with no documented information needed and it doesn’t mandate“Who’s” definition you must adopt. So (with tongue in cheek) you adopt WHO’s definition. And, it’s perfectly legal.

“Human factors refer to environmental,organizational and job factors, and human and individual characteristics which influence behavior at work in a way which can affect health and safety. A simple way to view human factors is to think about three aspects: the job, the individual and the organization and how they impact people’s health and safety-related behavior.”

Nowhere in the above is there any inference to human error and should there be any question as to how you have considered your human factors, you can smile and remind them that, “It’s the law!” (29CFR 1910 – Table of Contents)

And, there are record requirements required by OSHA – But you don’t have to show them because the information contained therein is of a personal nature.

And… If mention of 10.1(b) comes up, you tell them that you are continually looking for opportunities: correcting, preventing and reducing, all day, every day… no documented information required.

Are you still holding that thought (from Parts 1 & 2)?

ISO 9001:2015 element 10.1 does contain a scary note.

NOTE: Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.

The references to breakthrough change and innovation may someday become the fodder for another post. And, re-organization (Organizational Development) is a discipline unto itself – Let’s see the auditors assess that one!

So, although we have zoomed in on how to deal with one complex topic like Human Factors, I hope you see it’s a simple fix. The requirements might be very involved; the fix doesn’t have to be. The Standard tells us we have to consider all the new requirements but leaves the details up to us. Make sure you consider them before your auditor tries to impose his or her belief system on you.

I hope this helps. Thanks for visiting…

Now for those of you who happen to be Aerospace inclined (or Masochists) the next post will detail everything you need to know about Human Factors in a marathon of useless trivia. Eventually, we’ll discuss all the new additions in detail… Lots of luck!

Note: Once again, The Kilpatrick Group would like to express thanks to Oxebridge Quality Resources International and their Senior V.P. Christopher Paris for his contribution to this series.