Category Archives: ISO 9001

9001:2015, Annex SL, ISO, ISO 14001, ISO 27001, ISO 9001

Annex SL’s Impact

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What does Annex SL have to do with an interesting table leg?
Some supports are interesting

While it might have been the intent that Annex SL would be the template for all new standards and revisions to standards – this isn’t exactly the reality.

Annex SL was described in the last post – you may review that HERE if you like.

As a quick summary, “Annex SL” is an ISO document that defines a framework – the basic structure with common terms and requirements – for a generic management system. A standard would be this structure PLUS any additional sector specific requirements.

Understanding this is the key to new ISO releases, such as DIS ISO 9001:2015.

ISO 9001:2015 will not be the first ISO management standard to employ Annex SL – nor will it be the last.

Already released and compliant with Annex SL:

  • ISO/IEC 27001, Information technology: Security techniques, Information security management systems
  • ISO 30301:2011, Information and documentation: Management systems for records
  • ISO 22301:2012, Societal security: Business continuity management systems
  • ISO 21101:2014, Adventure Tourism
  • ISO 20121:2012, Event sustainability management systems
  • ISO 39001, Road-traffic safety (RTS) management systems
  • ISO 55001, Asset management – Currently on CD ballot with publication scheduled for 2014.

What this means is, for one thing, organizations that have one management system in place will have the basic structure needed to adopt another one – or several.

En route via Annex SL:

  • ISO 9001:2015 (General Quality Management) – I’m guessing you knew that one
  • ISO 14001:2015  (Environmental management) – Also expected in 2015.  I have been following the development of this standard and you’ll find related articles on the site
  • ISO 13485 (Medical devices. Quality management systems. Requirements for regulatory purposes) – Released as a Draft International Standard (DIS) on 20 Feb 2014.  The voting period for that closes on 20 July of this year.

Probable Defections to Annex SL:

These standards, for various political and structural issues I can’t pretend to understand, probably will not utilize Annex SL as their template in the coming updates:

  • ISO/TS 16949 – International Automotive Task Force standard. Cars – the big automotive companies dictate what takes place in this rarefied playing field
  • AS9100/10/20 – International Aerospace Quality Group (IAQG) standards  –  Essentially these folks are the Vegans of the management system world . If you don’t know what I mean by that then I am sorry. Actually, I am also sorry either way
  • ISO 45001 (formerly OHAS 18001) – Occupational Health and Safety. A bit of a controversial one to end on because the ultimate format isn’t set in stone. There are those who believe complying with the Annex SL structure will add too much “bloat” to the document.  Apparently bloat is a bad thing.

That’s approximately the current Annex SL situation, with a few less notable omissions.

Personally, I’m hoping the structure holds firm and far as it should serve to make it easier for clients to adopt – and for auditors and certification bodies to consistently understand.

Can it be better? Probably – but it’s a start, and more importantly – a basis for common ground.

Thanks for checking in – and for calibrating yourself.

And now a word from our sponsor:

9001:2015, ISO, ISO 9001

DIS New ISO 9001:2015

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The “Draft International Standard” (DIS) of ISO 9001:2015 was released a couple of weeks ago. The previous version of ISO 9001:2015, the “Committee Draft” (CD), was out about a year ago – this latest version brings it into more focus.  I’ll review the differences between the current version (2008) of ISO 9001 and this latest draft of ISO 9001:2015.

The game plan for the full 2015 version goes something like this:

updated sequence
You’ve likely noticed “FDIS Skip Possible” – what this means is that due to the later release of the DIS, there may not be enough time for a complete review so, in accordance to the rules, there is an allowance for the FDIS to be skipped. It could happen…

I’ve summarized most of the new sections of ISO 9001:2015 in previous posts, based on the CD. I’ll be continuing the summaries and re-releasing the existing ones with any needed updates as directed by the recent DIS.

Here’s a very brief overall summary of the whole 9001:2015 shebang (hey, it’s a word).

  • It is restructured based on the requirements of Annex SL (previously known as ISO Guide 83). I will put a summary of what Annex SL is HERE. For now let’s say “it defines a framework for a generic management system with a reasonable analysis of risks and successful responses to them and uses metrics that are meaningful to support improvement”. Many new and updated standards will conform to Annex SL.
  • So, risk is integrated into the standard at a very basic level. It challenges the organization to analyze risks in order to improve.
  • Introduces the concept of “Context” – the business environment; the combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested parties.
  • Eliminates “Preventive Action” as a standalone item. Preventive action is now folded into Risk.
  • Documents and Records are combined into “Documented Information”.
  • Stronger emphasis on leadership and commitment from top management to take accountability for the effectiveness of the quality management system.
  • A stronger focus on objectives as drivers for improvements, and related planning needed to achieve the goals.
  • More detailed attention to the control of externally provided processes, products and services.
  • Greater emphasis on planning and control of changes, including required changes in processes and needed changes to the management system.

I purchased a copy (they may be still available) so I’ll be posting more detail on the content of this latest draft of ISO 9001:2015 in the coming weeks.

Go forth, and calibrate thyself – and thank you for visiting.

Sal

9001:2015, ISO 27001, ISO 9001, Quality Tools

Sunday Summary – 27 Oct., ’13

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Phew, that was a busy week – four audits. FOUR. One day each, and one day in an airplane. Travel time: 22 hours – would have been much more painful without listening to a book along the way. Thank you,  Audible audiobooks (wait for it… Special Offer – Get Your First 3 Months at Audible.com for $7.49/month!).

Three were ISO 9001 audits, and one for ISO 27001 (Information System Security), and all concerned did quite well – though a few minor nonconformances were handed out (fresh out of Halloween candy, sorry).

Here’s a recap of the posts from this week:

I’d call that a busy week. Next week should be a bit leaner – just a two-day audit on the west coast (call it four days since it takes a day to get there and another to get back).

Hoping to get a few nice photographs of the San Francisco area, if the audit days allow enough time for it.

Enjoy your day of self-calibrating-free rest – and thanks for joining me this week.

Sal