2019

STANDARDS OUTLOOK

Circling the Wagons

by R. Dan Reid

The U.S. technical advisory group to International Organization for Standardization technical committee 176 (ISO/TC 176) recently released a document called Quality Management Systems—Advice From ISO/TC 176 for Sector Specific Applications.1 This is the latest of several TC 176’s sector related initiatives over the years.

In this document, ISO/TC 176 restates its mission:

  • Identify and understand the quality management needs of society and of standards users.
  • Develop, support and improve generic quality management system (QMS) standards that respond to identified needs.
  • Safeguard the integrity of the use of its standards, including conformity assessment.
  • Minimize the proliferation of QMS standards.
  • Contribute to the compatibility of management system standards (MSSs).

Let’s look at each of these mission statements more closely and see whether they are being followed.

First, ISO 9000 mentions it is applicable to organizations and users of products, among others.2 This separation is deliberate. In a past QP column I noted Hitoshi Kume also contrasted purchaser and supplier views of quality control.3

Kume said, “Quality control based on existing standards and purchasers’ requirements is quality control from the purchaser’s standpoint. On the supplier’s side, quality control can be made into a management tool by building a system for performing quality improvement methodically, systematically and continuously.”4 The latter is true in that “it can be,” but it also can be an exercise in finding a minimum set of requirements to get by with.

Organizations are like students in school: Some are content to do enough to slide by with a minimal amount of effort and barely passing grades, while others work harder to achieve higher grades.

In my experience, standards development in TC 176 has migrated toward the needs of users—those that have to implement the requirements. For example, standards writers pay more relative attention to how a potential requirement may impact those who have to implement it in an organization than they do to how compliance with a requirement by the organization might benefit its customers or improve customer satisfaction.

In the sector specific document vision statement, TC 176 aspires to “continue to offer QMS standards suitable for improving the performance of an organization and enhancing satisfaction of interested parties.”5

The term “interested party” is defined as a “person or group having an interest in the performance or success of an organization.”6 It includes customers. Yet, in my experience with TC 176, the customer needs seem to be considered less than the needs of implementing organizations.

The second statement in the TC 176 mission purposefully emphasizes generic QMS standards intended to apply to all sizes and types of organizations. QMS documents that fall into this category continue to be the strong focus of the committee. A particular challenge facing TC 176 has been that some countries make ISO 9001 compliance a regulatory requirement, which makes noncompliance more costly. Hence there is a bias to include fewer, more lenient requirements.

The Integrity Issue

Regarding safeguarding the integrity of the use of its standards, including conformity assessment, ISO/IEC Guide 2: 1996 defines conformity assessment as “any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.”7

Conformity assessment procedures provide a way to ensure the products, services or systems produced or operated have the required characteristics and these characteristics are consistent from product to product, service to service or system to system. The procedures include:

  • Sampling and testing.
  • Inspection.
  • Certification.
  • Quality and environmental system assessment and registration.
  • Accreditation of the competence of those activities by a third party.
  • Recognition (usually by a government agency) of an accreditation program’s capability.

Protecting standards integrity ap-pears to be a tall order for TC 176. Standards writers are supposed to be independent of conformity assessment people, at least for third-party certification. But there are a number of certification body representatives on TC 176 subcommittees and work groups.

At the opening of a meeting of the ISO committee on conformity assessment in Geneva in 2001, Larry Eicher, the late ISO secretary-general, called for the conformity assessment community to do a better job weeding out malpractice and dishonest operators. Effective solutions have not been found yet, so variation in the delivered quality performance of certified organizations continues.

One result is too much poor quality product is shipped to customers. This causes concern about the integrity of the standard, the conformity assessment process or both.

For a long time, TC 176 has tried to minimize the proliferation of sector specific standards. The committee recognizes some sectors may have unique terminology or specific requirements beyond ISO 9001 but emphasizes sector specific standards should be developed only “if it’s absolutely necessary.”8

ISO 9001 can be thought of as the minimum QMS requirements. Some sectors continue to want more from a standard that they use to control quality from a purchaser’s view.

Reg Shaughnessy, then chair of TC 176, approached the automotive industry in 1996 to see whether the sector could use ISO 9001 instead of a sector specific requirements document—first QS-9000 and later ISO Technical Specification (TS) 16949. The sector wanted to maintain automotive requirements beyond ISO 9001 requirements at that time.

This and subsequent discussions did result in a TC 176 liaison relationship for the international automotive sector and eventually led to publication of TS 16949, the first sector specific ISO technical specification based on ISO 9001 but with additional requirements. Finding an alternative document outside the ISO 9001 standard to address the additional sector requirements was key to TC 176.

Fundamental to the TC 176 strategy to limit the standards proliferation is its requirement for compliance with ISO Guide 72,9 which is applicable to all types of MSSs, including sector documents that use a generic MSS.

MSSs can apply to quality and to a broad range of sectors or interests, including information security, financial management, environmental management and corporate social responsibility. Such standards also can involve various technical requirements and regulatory issues.

TC 176 adoption of Guide 72 as a process requirement mandates an independent justification study prove the need of any TC 176 new work item prior to its approval for development and publication. This task can be onerous and expensive. For this and other reasons, it is reasonable to expect some organizations or sectors will publish their own standards outside ISO in the future.

What ISO Should Do

If they want to effect any meaningful future change, ISO and its technical committees should find creative ways to more effectively comprehend the needs of organizations’ customers and interested parties. This could include making participation in standards writing more attractive.

But ISO’s desire to contribute to the compatibility of MSSs is appropriate. ISO technical committees should cooperate and coordinate their efforts to ensure consistency and compatibility across ISO’s generic MSSs to benefit organizations and their stakeholders. So far, the primary thrust of this initiative has been on compatibility between ISO 9000 and ISO 14000.

IATF Did It on a Smaller Scale

Interestingly, the International Automotive Task Force (IATF) has actually made great progress in addressing these TC 176 mission statements within the international automotive sector. It did this through the following actions:

  • Using ISO 9001 as the base requirements improved compatibility with ISO 14000 and addressed the fundamental needs of organizations. The specific needs of purchasers then were added as sector specific requirements.
  • Publishing several editions of its guidance and rules for TS 16949 certification (even though they weren’t generic) responded to the sector and included customer needs.
  • Establishing regional oversight bodies reduced certification body variation and included customer presence in the certification process.
  • Replacing several regional requirements standards with one inter-national automotive standard simplified certification.

What the Sectors Want

The auto sector wanted to keep several sector specific requirements, some of which were in place prior to the development of ISO 9000 (see “What the Auto Industry Wants To Keep” in the online version of this article at www.asq.org/pub/qualityprogress/
past/0506/index2.html).

Other sectors likely have their own unique lists of purchaser requirements that would need to be included in any standard mandated for suppliers.

There are still some large sectors, including healthcare, for ISO 9001 to conquer. But ISO TC 176 has gradually made the option of doing a new ISO QMS sector document more difficult.

Perhaps a better approach for long-term sustainability of ISO QMS standards is for TC 176 to find ways to embrace sector initiatives that want to use ISO 9001 as the foundation, thus promoting rather than discouraging its use.


REFERENCES

  1. Quality Management Systems—Advice From ISO/TC 176 for Sector Specific Applications, International Organization for Standardization (ISO), 2006.
  2. ANSI/ISO/ASQ Q9000-2000, ASQ Quality Press, 2000, clause 1.
  3. R. Dan Reid, “Purchaser and Supplier Quality: Going Beyond ISO 9001, QS-9000 and TS 16949,” Quality Progress, August 2002, p. 81.
  4. Hitoshi Kume, Management by Quality, 3A Corp., 1995, p. 5.
  5. Quality Management Systems—Advice From ISO/TC 176 for Sector Specific Applications, see reference 1.
  6. ANSI/ISO/ASQ Q9000-2000, see reference 2, clause 3.3.7.
  7. Maureen A. Breitenberg, ABCs of the U.S. Conformity Assessment System, National Institute of Standards and Technology, 1997, http://ts.nist.gov/ts/htdocs/210/ncsci/primer.htm.
  8. Quality Management Systems—Advice From ISO/TC 176 for Sector Specific Applications, see reference 1.
  9. ISO Guide 72, ISO, www.tc176.org/PDF/News_Articles/2002/2002_7.pdf.

R. DAN REID, an ASQ Fellow and certified quality engineer, is a purchasing manager at General Motors (GM) Powertrain. He is co-author of the three editions of QS-9000 and ISO/TS 16949 and the Chrysler, Ford and GM manuals Advanced Product Quality Planning With Control Plan, Production Part Approval Process and Potential Failure Modes and Effects Analysis. Reid also co-authored ISO 9001:2000 and ISO IWA 1 and was the first delegation leader of the International Automotive Task Force.


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