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Wednesday, March 13, 2013

TIMELINE ISO 9001:2015 - ROLE OF MANAGEMENT REPRESENTATIVE


GENEVA, SWITZERLAND, 6 MARCH 2013 - As part of its ongoing revision and development process, the International Organisation for Standardisation (ISO) has been preparing for the next major revision to ISO 9001 (the last, minor amendment to the Standard was made in 2008). The ISO Working Group (TC176-SC2-WG24) is currently forecasting final publication in the last quarter of 2015.  Before then, however, there are a number of preparatory stages which have to be carried out.

ISO 9001 REVISION TIMETABLE

The current ISO timeline anticipates that a draft version of the revised Standard (DIS) will be available in Q2 of 2014. Subject to comment and voting on its content, a final draft version (FDIS) could be available during the final quarter of 2014 with publication of the revised version of the Standard approximately a year later. Clearly this timeline may be subject to delay and date slippage.

REVISED CONTENT

At this stage in the revision process, it is uncertain what the precise requirements of the final revised version of ISO 9001 will be. However, it is already known that certain structural changes will be made. 

Following the adoption by ISO of ‘Annex SL’ in 2012, all technical committees developing management system standards have to use the same structure, terms and definitions. Management system standards have already been published using this harmon­ised structure (e.g. ISO 20121:2012, Event Sustainability Management Systems) and ISO 9001 will follow this new format during its revision process.

For this reason, we know that the revised version of ISO 9001 will have ten sections:

1.       Scope
2.       Normative references: Both of these sections will have wording that is specific to the Standard (including its intended outcome)
3.       Terms and definitions: This will reference the common terms and core definitions outlined in Annex SL as well as any which are specific solely to QMS
4.       Context of the organisation: This section will include requirements relating to understanding the organisation implementing the Standard, the needs and expectations of interested parties, the scope of its QMS and the QMS itself.
5.       Leadership: Top management leadership and commitment, the QMS policy, as well as organisational roles, responsibilities and authorities.
6.       Planning: Actions to address risks and opportunities, QMS objectives and plans to achieve them.
7.       Support: Resources needed for the QMS, personnel competence and awareness, communication and documented information.
8.       Operation: Operational planning and control.
9.       Performance evaluation: Monitoring, measurement, analysis and evaluation, internal audit and management review.
10.   Improvement: Non-conformity, corrective action and continual improvement.

Aside from some general wording changes (using the term ‘documented information’ to replace references to ‘documentation’ and ‘records’, for example), the text that Annex SL requires to be used contains no specific requirements for ‘preventive action’. Although it is made clear that this is because one of the principal purposes of any management system as a whole is to act as a tool for preventing non-conformity in the first place, ‘preventive action’ may still yet be included in the final revised version of ISO 9001.

Annex SL includes a specific requirement that organisations determine the risks that need to be addressed to ensure that their management system can achieve its intended outcomes, prevent or reduce undesired effects and achieve continual improvement. Each management system standard can define risk in terms that are relevant to their specific discipline; so the revised version of ISO 9001 may do so in relation to product or service conformity and customer satisfaction.

Clearly at this stage in the revision process  no organisation can be sure of the additional QMS specific content that will be included in the final revised version of ISO 9001. Until the final draft is issued towards the end of 2014, no organisation can realistically make any definite forecast about requirements, detailed plans for internal process or procedural revisions, or for ISO 9001 certificate transition arrangements.

We have seen through several years transformations in ISO 9001 which substantiates the important role of Management Representatives (MRs)  from Managing Procedures to Managing Processes to Managing Results .  ISO 9001 has gone past the 25 years since its inception last 1987 and is here to stay. The concepts of customer, process, management review and continual improvement among others have been stable through many organisations and so is the application of the ISO 9001 standard. Everyone can associate with the requirements that guided organisations in managing the assurance for quality products and services all towards increasing assurance for customer satisfaction and the drive for continual improvement. 

With its silver years of existence and 4 revisions, it has seen through the transformation of the role of management representatives in various organisations and is yet to see some further developments to address the emerging issues that we have today. Through the years, with the observed  revisions of related management system standards and the emerging revision for ISO 9001:2015, we are about to see further challenges for the post of being the management representative, be it a QMR : Quality Management Representative or the increasing role of being the IMR: Integrated Management Representative. A growing question then arises in every practitioner for Management System.


(Q) What do we anticipate for ISO 9001:2015? What is in store for the new QMR?
The technical experts behind the ISO 9000 series of standards have been chartering the change and soliciting data from user communities and reviewing the feedback from the market. With the results of such studies are two key directions: 

The first being intention is that ISO 9001:2008 would be revised with only minor changes, and this had  already been witnessed approximately 5 years ago where the revision was only on terminologies, linkage with relevant standard and provisions for managing competence particularly for auditors as has been supported with the ISO 19001 version 2011. 

Second, ISO 9001:2015 which is its target date of release would result in a more extensive revision, addressing global and technological changes in the marketplace.  There are areas of consideration that will go into the next revision, and they are those that relates to (1) sector - specific standards and to improvements and changes in technology, supply chain management, and globalisation.

(1)    Sector-specifics and related management system standards
Over the years, there’s been a proliferation of sector-specific standards based on ISO 9001. In the last two years, standards have been added relating to food safety - ISO 22000,   road safety management – ISO 39001, and the petroleum industry - ISO 29001. They join the now-mature standards in such areas as medical device - ISO 13485, automotive - ISO/TS 16949, telecommunications - TL 9000, and aerospace - AS9100. These sector-specific standards are mostly founded on ISO 9001 and their sector-specific nature revolves around the addition of requirements that are unique to a particular industry. For example, automotive suppliers, registered to ISO/TS 16949, deal with customer specific requirements and application of core tools. 

The standards field has been further augmented by standards relating to environmental issues - ISO 14001, health and safety - OHSAS 18001, energy management – ISO 50001, sustainable events management – ISO 20121 and competence in laboratory testing and calibration - ISO 17025.  The above related standards are now growing to be not just an effort for environmental integrity and societal accountability but are becoming to be a customer contractual requirement. 

It can be challenging for an organisation complying with such commitments with customers and to develop a QMS that incorporates the requirements of multiple sector-specific standards effectively and efficiently.  Though reality prevails that meeting customer requirement entails that you manage the business risks and related risks that will lead to its disruption. And such is where the auditors’ competence and the integrative function of the management representative are headed in the future of ISO 9001:2015- the ability of your present management system to integrate or link with related management system standards and the accompanying objectives.

Some of the future concepts being addressed are the integration of risk-based thinking. The objective of other management system standards i.e.  ISO 14001 and OHSAS 18001 differ significantly from this quality management system standard but the model being espoused in the ISO 14001 and the OHSAS 18001 as has been summarised in PAS 99 is being looked at as the integrative model for effective reconciliation of management plans, processes and performance results. This is expected to be another significant input in the next major revision of ISO 9001 to formally adopt the wider perspective of planning which incorporates risk-based thinking.

With such, the QMR: Quality Management Representative or the IMR: Integrated Management representative has to consider the completeness of his knowledge regarding the risks prevalent to the business that will affect customer requirements and their satisfaction. Likewise, this necessitates the challenge on the currency and completeness of the Quality Management Principle to manage uncertainties on its objectives and not only its process and system interfaces. An auditor and a management representative thus not only must possess process and systemic approach of thinking but a risk-based approach for the decisions he must make.

(2)    Improvements and changes in technology, environmental factors, information management, supply chain management, and globalisation.

The developments we see in the technology will likewise give rise to enhancements in processes that deals with Knowledge   Management, Technology and changes in Infrastructure and Communications technology, Lifecycle Management including Outsourcing and Offshoring.

Outsourcing has been addressed in the 2008 version as such that refers to those processes needed by the organisation that are performed by an external entity. It is recognised that outsourcing is a growing aspect of many organisations in focusing on its core competencies and managing cost-effectiveness in managing its processes. The outsourcing strategies also lead the way for globalisation and the growing dependence in supply chain management. Challenges in the management of supply chain abound such as managing least-cost and least-distance including the medium and frequency of shipments that challenges the paradigm towards an efficient and optimal way of doing things.

The growing pace of information growth creates a challenge for application systems to manage documentation and the convenience gives rise to certain risks on information security. 

The future of ISO 9001 depends on its ability to retain the generic and universal concepts that make it work among organisations to be workable in managing its most important stakeholder- its customers and its ability to give a framework for managing emerging needs to ensure its continued applicability in our ever-changing world. The thrust for the PDCA cycle might bring further enhancements on the way we improve things utilising principles beyond improvement and on to innovation taking the premise to manage  Performance Effectiveness through Product Conformity and Process Efficiency and the incorporation of Quality Tools and Best Practices.

It is still an anticipated revision but the manner in which such will be addressed will have a long-range effect on the continued viability of ISO 9001 and its value-add to the business. Being an MR then may mean that you manage the emerging concerns abound the industry that your business is in and focus not only on the customer satisfaction but its linkage with the emergence of developments on the global market-place, and such entails managing risks in the business setting. The risks may not be exactly on higher perspectives such as environmental integrity and social accountability just yet but there are risks that go beyond quality that matters to your customers and the top management that you represent.

So as ISO 9001: Quality Management System is here to stay , so does the Management Representative in their role for managing the system along with the risks that goes with it. Way to go FORWARD for all MRs will be to learn Risk-Based Process Management and Auditing and towards Business Risk Management. Risks comes in the picture as creating uncertainties in achieving our objectives, and so we journey from Managing Results and on to the future of Managing Risks and Value Chain in the continuing developments in ISO 9001.


Original Source: ISO.org, SGS & Neville Clark