Using your ISO 9001:2008 - Compliant QMS to Plan for the 2015 Changes
Ch-ch-changes…
The 1974 David Bowie song suggests the singer has to “turn and face the strange”, and certainly from what we’ve seen in the current “DIS 9001” document (the draft international standard) some of those new requirements do look strange. There’s the addition of “risk”, the deleted requirement for documented procedures, no quality manual or management representative.
And, what about the new-look format? The so-called “Annex SL” structure expands the requirements, numbering from 4 through 8 to 4 through 10? Definitely strange for some! How will you cope?
Relax! If you use your current ISO 9001 Quality Management System, you have all the tools at your fingertips to plan and implement the revisions, whatever they finally are when release later this year – you can turn and face the change without being “Under Pressure”…
Firstly, the powers that be have provided organizations seeking to upgrade and recertify their Quality Management System (from meeting the 2008 requirements to 2015) with a 3 year transition period. If the “Plan, Do, Check, Act” approach is adopted, then we should have time to accomplish the required changes – if we have a robust plan. Planning is a key part of identifying what changes are needed and who will implement them. Such a plan will become an imperative, as we shall see.
History Repeating?
Since the dawn of modern quality assurance system documents, (NATO AQAP, BS 5750, MIL-Q-9858A et al) which predate even ISO 9000, the requirements have looked very similar to each other. With the release of ISO 9001:2000, significant changes arrived and, because Certification of an organization to these requirements was a common practice, a change-over period was permitted for organizations to align with the new requirements.
In 1999, no-one thought to formally plan for this major event. Today, that’s changed too! The IAF Accreditation Bodies are requiring Certification Bodies to have plans for handling their certification audits, in light of the 2015 changes, which are also considered fairly significant in nature. A plan is going to be a good thing to have…
“If you don't know where you are going, you'll end up someplace else.”
There are a number of requirements in the current version of ISO 9001 which give strong clues to how to use the QMS to prepare and plan for changes:
Quality management system planning – 5.4.2
“Top management shall ensure that
The planning of the quality management system is carried out in order to meet the requirements given in 4.1…and,”
“the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented”
Management Representative – 5.5.2
“a) ensuring that processes needed for the quality management system are established, implemented and maintained…”
Management review – 5.6.1 General
“This review shall include assessing…the need for changes to the quality management system…”
Review input 5.6.2
“The input to management review shall include information on
f) changes that could affect the quality management system”
There is, however, a challenge for implementation in that organizations simply doesn’t go home on Friday, after switching off their 2008 QMS, and arrive the following Monday to a new, 2015-based way of managing Quality. ISO 9001 also indicates what has to be considered in the transition:
Quality management system – 4
“The organization shall establish, document, implement and maintain a quality management system…in accordance with the requirements of this International Standard”
“These processes shall be managed by the organization in accordance with the requirements of this International Standard”
A key part of planning is going to be the use of the organization’s “Management Review”. If the organization adopts “P, D, C, A” as its methodology, the review becomes a platform for management of change, instead of just being something “ISO” requires.
WARNING: An organization which carries out their “Management Review” once per year, may wish to consider that, when set against the 3 year transition window and the P, D, C, A cycle, more frequent reviews will be needed to maintain control and assure a successful recertification!
At the time of writing this piece, we know only what the final draft requirements are. We do know, however, that these are unlikely to be significantly revised in the actual released standard – ISO 9001:2015.
If we take, as an example, one of these draft requirements which could impact a 2008 based QMS – the dropping of the requirement for a Quality Manual - and put it as an input to Management Review, management would need to:
- Consider the effect of (no longer) having a Quality Manual
- On the organization
- On customers’ needs and expectations
- On regulatory compliance
- Consider the value of a Quality Manual to the organization
- As a means of communicating quality policy, quality objectives, the scope of the management system, exclusions and any justifications etc.
- Describing the sequence(s) and interaction(s) of the processes of the quality management system.
Having reviewed this, the ISO 9001:2008 requirements then go on to indicate what should happen:
Review output 5.6.3
“The output from the management review shall include any decisions and actions relating to:
a) Improvement of the effectiveness of the quality management system and its processes…
c) Resource needs”
It may well be that management decides to keep the quality manual as “documented information” (another requirement which has changed terminology) in light of perceived customer needs and expectations. A further decision may be to improve the format of the existing quality manual so it doesn’t simply follow the ISO 9001 layout, since no-one internally really reads/understands it!
Of course, in deciding to do that, someone will be assigned to the tasks associated with those decisions.
Golden Years
The 3 year transition period given to organizations to revise and recertify their Quality Management Systems to the ISO 9001:2015 requirements, presents a significant opportunity, not to simply implement a new set of clauses, rejig the Quality Manual and renumber procedures, but to do away with much of the ineffectiveness and paradigms currently associated with implementing the 2008 requirements.
By engaging the various tools of the current Quality Management System and asking how they can assist in planning and controlling what has to be changed or improved, they will in themselves be improved. If your organization still thinks doing ISO 9001 means “Say what you do, do what you say” - or something similar - the next 3 years may prove a golden opportunity to make much needed improvement. You could be heroes…