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Management Systems Are Changing in 2015 and Beyond!

by R. Dan Reid

The International Organization for Standardization (ISO) requires that their standards be reviewed every five years to determine if they need to be revised. When the review for ISO 9001:2008 (Quality Management System Requirements) came due in 2012, ISO conducted a global user survey which indicated that 27% of survey respondents thought that ISO 9001:2008 was "fine as it is." Another 64% said it was "OK, but with enhancement." More than 70% of respondents favored including the following concepts in ISO 9001:

  • Resource management
  • Voice of the customer
  • Measurements (performance, satisfaction and return on investment)
  • Knowledge management
  • Risk management
  • Systematic problem solving and learning

However, only 7,918 respondents generated these findings from a field of more than 1.1 million ISO 9001-certified organizations globally. The survey respondents represent a small sample size for such a large population. The results do not suggest a mandate for significant change, but the decision was nevertheless taken by ISO to revise the standard. Why?

The ISO Technical Committee (TC) 176 responsible for quality management system documents has indicated that ISO 9001 is being revised to:

  • Account for changes in quality management systems (QMS) practices and technology since the last major revision to ISO 9001 in 2000
  • Provide a stable core set of requirements for the next 10 years or more
  • Ensure requirements in the standard reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Ensure requirements are stated to facilitate effective implementation by organizations and effective conformity assessment by first, second and third parties, as applicable
  • Ensure the standard is adequate to provide confidence in those organizations meeting the standard’s requirements
  • Decrease the emphasis on documented procedures
  • Increase the emphasis on achieving value for the organization
  • Increase emphasis on risk management

Based on the drafts to date of the revised standard, the revision will likely cause some problems. The standard is now being written more generically to increase its appeal to non-manufacturing sectors. There is less emphasis on documentation, and no longer a requirement for a quality manual. The likely result is that there will be more variability in audit results than with the current version. The revision will require auditors to perform more interviews and audit a larger sample size to determine conformity where there are fewer records or other documentation to provide the evidence. Some prefer this option, but it will surely drive up the cost of audits as well as allow more variation in the audit results.

Also, the removal of previously agreed-upon verbiage used in today’s standards will be objectionable to manufacturing sectors where ISO 9001 has thrived.

Annex SL is developed

Prior to drafting the text of a revised ISO standard, a design specification is developed. The design specification for the next revision to ISO 9001 includes a requirement that "the revised standard will apply Annex SL to the ISO/IEC Directives, Procedures specific to ISO, third edition, 2012, to ISO 9001 to enhance its compatibility and alignment with other ISO management system standards." So, what is Annex SL?

ISO has long had an interest in driving the use of integrated management standards. A report of the ISO Technical Management Board Ad-Hoc Group on MSSs advocated such standards in February 2006. Annex SL is just the latest in these attempts.

ISO/IEC Directives Part 1, Consolidated ISO supplement, 2013, Annex SL, Appendix 26 "sets out the high-level structure, identical core text, and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001, developed by the Joint Technical Coordination Group. The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed" (based on ISO/Technical Management Board resolution 18/2012).

Notice the use of the qualifying phrases on two occasions from this directive: "when possible" and "in principle." It was not intended that there would strictly be no deviations from this guidance. In reality, though, the drafters of the ISO 9001 revision have taken this more literally and are not considering amendments or deletions from the high-level structure or common text. They are allowing only additional text.

The Annex SL high-level structure for all new or revised management system standards going forward will consist of 10 Clauses:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the Organization
  5. Leadership
  6. Planning
  7. Support
  8. Operational Planning and Control
  9. Performance Evaluation
  10. Improvement

This mandated structure also has common text that must be used with some of these elements. New elements, such as context of the organization, and new terms, such as "documented information," "innovation," “risk-based thinking,” “context of the organization,” “organizational knowledge,” “contingency actions” will likely drive the need for additional processes and training for many currently-certified organizations. Other requirements already common across the key MSSs have been deleted, such as a management representative, an MSS manual, preventive action and “exclusions”.

The current ISO standards development process takes as long as it does—five years or more—to reach consensus to ensure the standards can be accurately translated into local languages and applied to all types and sizes of organizations. This process has been bypassed by the committee that developed Annex SL. The U.S. delegation and others have objected to this but the global consensus is to proceed.

Annex SL has already met significant resistance from manufacturing sectors—automotive, aerospace and medical devices. It has been viewed as a return to a "clause-based approach" even though there is now a requirement in the draft standard mandating the use of the process approach, which was introduced in ISO 9001:2000.

The automotive sector has already petitioned ISO and was granted a waiver to continue to use the current edition of ISO 9001. For organizations that have automotive and other customers, this could mean compliance with two versions of ISO 9001.

The ISO drive for integrated management systems would not be so objectionable if it used existing text from one or more of the currently issued MSSs for the mandated common text. There is already a high degree of alignment of MSSs, such as ISO 14001, OHSAS 18001 and others issued recently. This would forego the need for new training on the terms while avoiding potential translation problems in the national versions of the new standard. It would respect the intent of the ISO consensus process for standards development.

The biggest impact of implementing Annex SL, however, is not on ISO 9001.

ISO 14001 – Environmental Management System (EMS) Requirements

ISO 14001 was also reviewed and is being revised at this time. It is also targeted for release next July. The number of clauses in the new ISO 14001:2015 will increase from four to the 10 mandated by Annex SL. The length will also increase considerably from the 2004 edition, for example, Committee Draft (CD) 2 increased from 23 to 44 pages.

There currently is not an element in ISO 14001 for top management, but there will be in the new revision. The revision also will include a requirement for value chain control—whether goods are procured from an outside supplier or affiliated location. The context of the organization is new for all current management system standards including ISO 14001. There are also implications for ISO 14001-related standards, such as OHSAS 18001/ANSI Z10, Responsible Care 14001.9

It remains to be seen how much appetite there is in the global community for changes to ISO 14001, especially based on Annex SL. The trend for third-party EMS certification is already on the decline with a couple of exceptions.

OHSAS 18001 / ISO 45001 – Occupational Health & Safety Management System Requirements

In March of 2013, the British Standards Institution (BSI) submitted a proposal for a new international standard that would specify requirements for an occupational health and safety (OH&S) management system. According to the proposal, the standard would define requirements for an OH&S system, with the goal of providing organizations with increased control over OH&S risks and providing for improved performance in this area. The standard would not establish specific performance criteria for OH&S and would not provide detailed specifications for the design of an OH&S management system. It is expected that the standard would be applicable to any organization seeking to establish, maintain, or improve an OH&S management system. It would not address product safety, environmental impacts, or other health and safety-related subjects.

ISO/Project Committee (PC) number 283 was established in June 2013 by the ISO Technical Management Board to develop this standard. ISO advised that the future standard will be ISO 45001 as the number 18001 has already been assigned to a different standard. Some of the key issues the PC has to resolve within the standard concern: the application of “risk”; “people” under the control of the management system; the understanding of what constitutes the “workplace”; and participation in the setting of policies and objectives. The target date for publication of ISO 45001 is October 2016.

What Should You Do Now?

This column is not suggesting that all of the planned MSS changes are bad. However, the process and approach used to develop and mandate Annex SL is flawed and will likely have lasting ramifications if it is implemented as planned.

Do not, therefore, begin implementing any of the drafts’ new requirements just yet. There will be additional drafts of the standards now being revised, and more changes are likely. Also, don’t assume your current MSS documentation—your quality manual—procedures are obsolete. If they are still applicable, they can be used with the new standard to efficiently prove to auditors that processes are working and are effective. So what should you do now?

  1. Develop an organization position on the proposed ISO 9001 changes and communicate your position to your customers. There likely will be auditability concerns and additional auditing costs.
  2. Provide comments on the drafts to your national standards body. It is not too late to get revisions to the current plan. The deadline for submission of comments to the US body, ASQ, is July 15, 2014.
  3. Know what is going on and be ready to implement any new requirements. A transition period will be designated for implementing any new standard. In the past, this has been up to three years.
  4. Have processes that accommodate any new clauses. This can be facilitated by implementing an integrated management system for your organization, but one that is based on an approach that makes sense for your organization. Eventually, clause cross-references can be implemented or updated to show how your system maps to any of the customer-required ISO standards. There is a lot of redundancy among current ISO management system standard content, e.g. internal audit, management review, or competency that can be effectively leaned out, even now. Omnex helps companies effectively integrate various standards into one lean management system. See omnex.com for more information on our training and consulting expertise.

R. Dan Reid is director of consulting at Omnex Engineering and Management in Ann Arbor, MI. He is the first delegation leader of the International Automotive Task Force, an author of ISO Technical Specification 16949, QS-9000/QSA, ISO 9001:2000, the first ISO International Workshop Agreement, and its replacement, Automotive Industry Action Group’s Business Operating Systems for Healthcare Organizations (HF-2). Reid is an ASQ fellow and certified quality engineer.

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