ISO 9001 - The Revision Process

In these last few months I have had a hectic teaching schedule where I worked on teaching ISO 9001 and ISO 14001. It was only natural that students would have questions on the changes / revisions coming up for ISO 9001 as the ISO 9001:2015 version is being considered. Many of the students wanted to know if there was a process followed to update standards or was it just ad-hoc when some one felt the need and so on. 

At Huntington, WV with the CO and students

CG students in the 5 day RABQSA certified training, in Huntington and Duluth had questions and wanted me to explain the procedure. I also received an e-mail from a student of ISO 28000 from Qatar asking a similar question. This prompted me to write a few lines on the subject. In brief here is the process for updating the standard.

    The ISO 9001 as many good thoughts has its roots in the USA. It was first published as MIL-Q-9858 in by the Department of Defense in 1959. In 1969 NATO adopted it, subsequently the UK published it as BS5750 in 1979. As ISO 9000 it was first published in 1987. The first real revision came in 1994 and this was followed by a revision in 2000. The present standard came out as ISO 9001: 2008 in 2008. The 2008 version did not have many changes. It did stress on the outsourced processes and a few changes.

  

   This new version, expected in September of 2015, however has major changes. The fundamentals remain unchanged but more standardization has been introduced to enable ease of integration of standards. More on this in a separate article.

     The main stages of a standard development are:

1. PWI: This is the Preliminary Work Item where the preliminary work is done.
2. NP or NWIP: New Work Item Proposal. The proposal is put together at this stage. 
3. WD: Working Draft. This is the preparatory stage. 
4. CD: Committee Draft. 
5. DIS: Draft International Standard. This really is the inquiry stage. 
6.  FDIS: Final Draft International Standard 
7.  IS: International Standard. This is the stage when the finally approved standard is published.

In the development of the ISO 9001:20015, the standard reached the CD stage of voting in June 2013 and the voting closed in August 2013. This is a stage where the CD is distributed to the members of the committee. It is these committee members who can at this stage distribute the CD to public. We at QMII  re-reviewed a copy at this stage. (I shall be writing on some of the expected changes shortly.)

The DIS is expected sometime in August 2014. Traditionally the DIS is available to members of the public. It is expected that the FDIS ballot will close in August 2015 and the revised ISO 9001 will be published in September 2015.

QMII conducted the RABQSA certified EMS LA (Environmental Management System Lead Auditor) training for the USCG at Yorktown. The ISO 14001:2004, together with ISO 9001 and ISO 27001 will have a revised addition in 2015. All standards in future will incorporate the HLS (High Level Structure).

ISO 9001:2015 - Expected changes from ISO 9001:2008

I did make an introductory mention to the ISO 9001:2015 standard expected to be released in September 2015. The principled changes are mentioned there. Some QMII students and alumni have asked me to write a few introductory comments on the expected structure. I have already written on the HLS (High Level Structure). In this second blog entry on 9001:2015, I want to introduce our readers and followers of my blog to the expected changes to ISO 9001:2008 when it is revised and available as ISO 9001: 2015.

In the terms and definitions itself, some changes are expected. Stakeholder remains a term but the  preferred term “interested party” has been introduced.  Audit, conformity, continual improvement, correction, corrective action, documented information, effectiveness, management system, measurement, monitoring, non-conformity, objective, organization, performance, policy, process, requirement, risk, competence, and  top management , have now been defined. 

ISO 9001:2008 has stood the test of time, and there are statistics to clearly show that there is satisfaction with the current version. However, with the change in environment and to ensure the standard will continue to deliver in the future, changes are required. The standard must meet not only customer expectations but must consistently provide goods and services that meet the statutory and regulatory requirements. In the revised standard, the term “product” is being replaced by “goods and services.” Some of the standards had different definitions and or implications for the same term. Now these terms have been standardized for all the standards. The terms “outsourced” and “purchasing” have been removed and replaced with "external provision of goods and services". Another major conceptual change is that “design and development” has been replaced by “development.”

In ISO 9001:2008, clauses under 7.3 took us from design and development planning (7.3.1) to inputs (7.3.2) to outputs (7.3.3) to review (7.3.4) to verification and validation to control of design and development changes (7.3.4 thru 7.3.7). However, the standard allowed exclusions under 7.3 since not all organizations go through each of these stages. This has now been done away with. 

The principles in clauses grouped under 4 have not changed in concept, except that clause 4.3 has left the determination of the scope of the organization to the organization. The clauses under 5 are for leadership and these in principle have not changed. Clauses grouped under 6 provide the requirements for planning. Clause 6.3 is a change in that it requires an organization to plan the changes. It replaces the concept of integrity of the system covered under clause 5.4.2 of ISO 9001:2008.

As we study what to expect under clauses 7, we see overall the concept is the same. Except in 7.1 resources, there are changes. Presently in ISO 9001: 2008, clause 6.3 & 6.4 provide the requirements for infrastructure and work environment. This has been elaborated and process environment defined together with infrastructure, monitoring and measuring and in 7.1.5 Knowledge. This new requirement on how organizations manage knowledge, understand it and deal with it is a new concept. It is still not clear if this concept will remain and be approved by the committee. Clause 7.5.3 control of documented information replaces the ISO 9001:2008 clauses 4.2.3 and 4.2.4.

Training: A Luxury or Strategic Necessity?

Well-developed management systems are developed and implemented to drive efficiency in organizations.  These systems when implemented ensure that  the organization does not become vulnerable or lose its integrity when key personnel change as also during any mergers and splits in organizations. Just as technology is constantly upgraded, so must human potential. In any organization, large or small, training which needs the least investment can play a very important role given the critical contribution by human resources in ensuring efficiency. The necessity of training in building human potential and productivity to ensure optimization of human resources can hardly be emphasized.  

Top Management often go in for implementation of management systems without answering the employee’s question of “what is in it for me?” Training and exposing 10 to 15% of the manpower to management system related standards for efficiency (ISO 9001), risk management (ISO 33000), the environment management (ISO 14001) and security of the global supply chain (ISO 28000) quite prepares them for the system implementation. Some  organizations might choose to implement an integrated management system encompassing all or a combination of two or more of the above standards.

Organizations view training as a luxury and often not as a strategic necessity. A well trained manpower is a great asset in getting the “job done” . When budgets are cut training is often given a low priority. In difficult financial situations when all else costs the organizations so much more, a little investment in well trained manpower results in rich dividends and ensures human capital continues operating at their peak efficiency as a motivated work force even through bleak periods thus ensuring a continually efficient system. As a system is developed and put into place a trained workforce helps to better implement the system and results in a ‘buy in’ of the entire team. A team that appreciates the important role that a well implemented system plays in increasing the efficiency of a system while reducing non-conformities (NC).

As NCs are embraced to drive continual improvement the number of problems affecting the system reduce and the work force has its answer to "what is in it for me". This gives the organization strength in depth and provides more time to innovate and thus continually strive for new heights of excellence.

The benefits of training are intangible but below are listed a few: 

• Better output

• Higher Retention 

• Team Spirit 

• Improved corporate Image 

• Higher morale 

• Improved Profitability 

• Fewer Accidents

A small investment in training will ensure an oriented manpower, familiarized and ready to implement and meet the management’s system objectives and align them with the organizations aim of doing much more with much less.

ISO 9001:2015 ... What can we expect?

In this fast moving global environment the flexibility permitted by the international standards, whereby interpretation of the standard, correctly makes it applicable to "all organizations, regardless of the type, size and product provided" - Clause 1.2 of ISO 9001. Never the less to keep the standards aligned it is essential that they are updated on a regular basis. TC-176 works on ISO 9001 and considers and evaluates the inputs from users and SMEs (Subject Matter Experts) in the intervening period. The ISO standards are generally revised every 5 years. ISO 9001:2008 is now due for a revision.

In 2015 we will have the revised standard which should come out as ISO 9001:2015. QMII keeps track of the changes and ensures our alumni and students are always updated.  The process involves submitting  our comments via bodies affiliated with BSI in the UK and ANSI in the USA.  The CD is available and there is a lot to sort out before it becomes the DIS. However I do see that lot of training providers have already put out the draft standard for review! In fact some are offering courses to learn it!!

We should really be waiting for the DIS. Once that happens we too will update our course material to prepare our students for the changes in 2015. There are no worries there for the current users of the Standard. As always every organization is given a period of two years to comply with the new standard. Thus ISO 9001:2008 should tentatively go out of date sometime in 2017.

You can review the scrubbed version here. Please remember it is for "Review Only" as an advance copy. I would encourage you, our readers, to challenge yourself by reviewing the scrubbed version and recognizing the changes compared to the ISO 9001:2008. You may comment on the differences here, on the scrubbed version link or by sending me an email at iarora@qmii.com.

Please watch this blog. I shall soon put my comments to keep you updated and advised.