Issue 10 – Element 10.0: Improvement
Element 10.0 – Improvement
What’s new in Element 10.0?… We covered “performance evaluation” of the Quality Management System (QMS) in my last Newsletter (ISO 9001:2015 Newsletter Issue 9), and now Element 10.0 (Improvement) focuses on “raising the bar” on the effectiveness of your QMS. There really is not much new that has been added into this Element but one term has been eliminated, that being “preventive action”. They explain in Annex A.4 that “risk-based thinking” replaces the concept of “preventive action” and therefore that Clause from 2008 was no longer needed. I see it a little differently, I think they simply took the old “Preventive Action” section from 2008 and sprinkled it throughout this revised Standard and came up with a new term called “risk-based thinking”. Here in Clause 10.1 item b) you see a good example of what I am referring to, where they use this phrase “These shall include… correcting, preventing or reducing undesired effects“. If you do a word search of the word “potential”, (as in potential nonconformity or potential problem or potential risk) you’ll find it occurs seven (7) times as part of a “shall” requirement in ISO 9001:2015. The bottom line is that “Preventive Action” as a process or activity is still very much a requirement within this new Standard.
The new Clause numbering…
Section 4 – Context of the organization
Section 5 – Leadership
Section 6 – Planning
Section 7 – Support
Section 8 – Operation
Section 9 – Performance evaluation
Section 10 – Improvement
Element 10.0 Improvement consists of three (3) Clauses as listed below:
10.2 Nonconformity and corrective action
10.3 Continual Improvement
Clause 10.1 General – Although this Clause contains no sub-clauses it is more prescriptive then its predecessor in 2008. It also includes some interesting and somewhat-new requirements, as seen within Clause 10.1 item a) with this phrase “These shall include…improving products and services to meet requirements as well as to address future needs and expectations“. Along with Clause 10.1 item b) which states “These shall include…correcting, preventing or reducing undesired effects“. Those last two words are quite broad and subjective in nature so once again it will be up to you to put some scope around the term “undesired effects”.
Clause 10.2 Nonconformity and corrective action: This Clause contains two (2) sub-clauses, Sub-Clause 10.2.1 and Sub-Clause 10.2.2, neither of which have titles on them. Both of these are essentially a repeat from 2008, with a bit more detail added, including a new requirement found in 10.2.1 item e) which states “…the organization shall…update risks and opportunities determined during planning…“.
Clause 10.3 Continual Improvement – This Clause contains no sub-clauses and includes nothing substantially different from what was found in the previous 2008 version.
Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
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ISO 9001:2015 Essentials + Gap Audit
This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed. PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event. This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.
Q: How can I get my QMS Internal Auditors up to speed on this new ISO 9001:2015 Standard?
A: Well, to get them educated on the new ISO 9001:2015 you can send them to offsite training courses or have them sign-up for online training. The other option is that you can conduct a customized training session at your facility that is more hands-on and focused on just your business, with yourself as an instructor, or by using an outside resource (click HERE to see what training we offer). Alternatively you can do some internet research and pull together webpages/links that they can use to self-educate themselves on this new Standard, as well as viewing the multitude of free online webinars on this topic. Based on Reader feedback, our past Newsletters (we’ve been publishing them since 1999) have proven to be helpful not only in providing a “big picture” view of the ISO 9001 Standard but by also delivering specific guidance on how Internal Auditors should audit each section, which we will do in our upcoming Newsletters. This is where we will cover the individual Clauses within all of the Elements, which will contain a “Q&A” section that will include typical audit questions that should be asked. This was particularly popular in the past and I expect it will be again this time.
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!