9001:2015 Overview – ‘Big picture’

Well I’ve had some terrific feedback from people wanting to learn about the new ISO 9001:2015 standard. It’s coming up very quickly, with the next draft due out at the end of this month. We anticipate that this next draft will be very close to final. Remember if you want to stop receiving these emails, please scroll down and unsubscribe at the bottom.

As mentioned last week, the first thing you’ll notice when you see the next draft will be the number of ‘Clauses’. Where ISO 9001:2008 had 8 clauses, the 2015 version has 10.

2008 2015
Clause 1: ScopeClause 2: Normative ReferencesClause 3: Terms and Definitions

Clause 4: Quality Management System

Clause 5: Management Responsibility

Clause 6: Resource Management

Clause 7: Product Realization

Clause 8: Measurement, Analysis, and Improvement

Clause 1: ScopeClause 2: Normative ReferencesClause 3: Terms and Definitions

Clause 4: Context of the Organization

Clause 5: Leadership

Clause 6: Planning

Clause 7: Support

Clause 8: Operation

Clause 9: Performance Evaluation

Clause 10: Improvement


In addition to expanding to 10 clauses, you’ll note that clauses 4-10 have new titles. We’ll go through these structural changes systematically, each week.

Let’s start with the big picture…

First, there’s a less explicit requirement for documented procedures. There’s no requirement for a quality manual or any specific documented procedures. As in ISO 14001 and OHSAS 18001 (clause 4.4.6 d) you only need to document procedures ‘where their absence could lead to a deviation from policies and/or objectives. We still need documented “information” – data that is required to be controlled and maintained to demonstrate fulfillment of requirements.

This means documents and records (now called ‘documented information) still must be ‘controlled’. We have to take care of the results determined by our measurements and monitoring of our quality processes. We have to retain appropriate documented information as evidence of the results This information has to be stored, be retrievable, be preserved, retained, access controlled and maintained.  We imagine most organizations will still document most of their processes, but at least we now might be inclined to replace some documentation with training like we do with activities like CPR. A binder never saved a life!

This does not mean documented processes are no longer necessary – they are still necessary for the success of a good QMS, but your ISO certification will not be evaluated on them as much as they have been in the past. I think this will also encourage us to explore newer, more ‘visual’ ways to show how we do things. You’ll see what we mean if you take a tour of our ‘One Page Quality Manual’.

Other major shifts in philosophy include a higher level of involvement from senior management, the measuring and assessment of risk and a focus on ‘change management’. These will all help us create stronger, more useful quality management systems that are an asset, not a liability.

A formal ‘risk management program’ is not required (as of CD1) but our Risk Management Tool will give you the ability to identify risks and opportunities, and develop a systematic approach to address them. With ‘Preventive Action’ gone, proactive processes become even more vital to system improvement and a good return on your Management System investment.

The shift is to make ISO more relevant to business. For example “preventive action” is terminology specific to or at least common to QMS folks, while “risk management” is a more commonly used business/organizational term, especially among senior executives who may not be directly involved in quality control, but whose decisions directly impact it.

Simply reading through the titles of the new clauses gives you further insight into the “bigger picture” view of 2015. “Management Responsibility” is now “Leadership”, implying an evolution from ISO requirements restricted to tactical operations and into a strategic perspective.

“Quality Management System” is now based on the “Context of the Organization”. This implies an evolved perspective that quality is a strategic organizational issue, not a specific ‘activity’.  There’s even a requirement to consider our ‘purpose’ and ‘strategic direction’ when designing our systems. More on this in other posts.

As I mentioned briefly last week, the new standard is not a ‘make work’ project, but is a significant step in evolving your QMS to become an organizational asset. The new standard will present a core set of requirements for the next decade. It will remain generic and relevant to organizations of all sizes and types within any sector. It will maintain the current focus on effective process management to produce a desired set of outcomes.

Business is evolving rapidly – fuelled by access to greater data and analysis capability. The greater visibility we have into processes, the greater control we can exert. Also the business environment we find ourselves in has grown more complex, demanding and requiring continual response to stay competitive.