A standard defines a set of requirements or an acceptable level of attainment; or it can be a specification that assures compatibility between interfacing systems. The extent of recognition of a standard varies from International, adopted across the world, to independent norms that are subscribed to by members of an association or particular industry.
Standards are strategic tools that help an organisation assure it is doing right, in meeting pre-defined, recognised levels of performance and safety. Working to standards can thereby reduce mistake-costs and other consequences from non-conformity – sometimes including legal liability. This, it is argued, will support an organisation’s sustainability.
Standards are fundamentally designed for voluntary use. Some can however become obligatory by regulatory ‘harmonisation’ – e.g. a standard becomes referenced in a legal instrument, as a means for demonstrating legal conformity across a sector or geographical region. Harmonisation simplifies the development and verification processes, which in turn reduces an industry sector’s overall compliance costs.
All-in-all, the arguments for adopting standards are strong. So what is there not to like about them?
Firstly, standards are slow
Standards are developed and evolved in a consensus-based process that involves all the members of the issuing organisation or industry association. This wide consensus-seeking results in new standards often being many years in the making, where the initial versions tend to be either too openly compromising or too narrowly scoped for their practical application.
Established standards continue to be periodically reviewed and revised, as necessary to keep up with changing expectations and applications. For example, the ISO 9001 quality management standard – including its forerunners – took some 50 years of evolution, before it could be said to have reached a point where it was reasonably compatible with all types of organisations. Standards are therefore often lagging behind an industry or society’s needed rate of change. It is not uncommon that standards are years behind today’s evolved needs and capabilities.
Secondly, standards can obstruct progress
The image at the top of this page represents a well-reported design weakness in the now mothballed Space Shuttle. Its 2 booster rockets have a form factor that is too narrow/elongated for an optimal performance. The reason for this is the limiting dimensions of railway bridges on the travel route between the place of their manufacture and their use. The dimensions for railway bridges relate by ratio to the standardised railway track width, which in the United States can be traced back, through Britain, to standards that the Romans originally determined for horse-drawn carts before the birth of Christ.
Noriaki Kano developed a model for classifying customer needs into three categories, each of which influencing customer satisfaction in a different way. Importantly, the Kano model tells that the prevention of wrong-doing is not the same as doing right. A strategy based solely on preventing and removing dissatisfaction can over time never result in satisfaction. The model thereby highlights a dilemma with a performance assurance approach that seeks to control everything to pre-defined standards. This is because yesterday’s standards will always lack behind today’s evolved needs. Sustained success depends on continually exceeding and evolving the standards and expectations. There must of course be sound controls in place, to prevent doing the wrong things; but such controls must not get in the way of simultaneously enable doing the right things – even if this means occasionally deviating from yesterday’s standard.
Any system practically always has 30% improvement to be found. Learning through the theory-of-variation tells that we must allow for a degree of divergence from standards, to enable new better ways to be discovered – even if this sometimes risks unintended ‘accidents’. Just make sure to have responsiveness and resilience in place to acceptably mitigate what could happen. I would advocate that we continually think beyond and consider deliberate divergences from the standards, while smartly managing the associated risks. I know this is more easily said than done, in particular where a standard offers litigation protection.
Keep the standards in mind, but don’t use aspects of them if the prevailing evidence tells they merely represent an obstructive lower common denominator.
Thirdly, standards can introduce commercial bias
From personal experience of taking part in national phase meetings, at the UK NPL, I can categorically say that some of the organisations coming forward to influence a new ‘consensus-based’ standards will have self-serving agendas. I have in the past represented one of them. Standards affect business, so it is only natural that a business prefers for the contents of a new standard to favour its own particular situation, or to disadvantage a competitor. Although the consensus-based development and revisions of standards involve a large and disparate group of organisations, a degree of bias does regularly slip into standards. The shear multiplicity of standards under development at any one time, makes it impossible keep an eye on the rationale for every detail of that goes into them. Commercial bias can take form of:
- Creation of standards for purpose of favouring the technology and/or methods of a limited number of market players, thereby restricting competition for unsuspecting customers.
- Inclusion or over-emphasis of lesser important requirements, adding an unwarranted overhead burden on smaller new market entrants; but which the larger established organisations can more easily absorb.
- Omission of requirements that are important to the end-customers, but inconvenient to the suppliers.
The standards institutes are themself revenue-driven organisations, whose business results can be augmented by the creations of new standards and revisions. The release of a new standard or a revision can mean that hundreds of thousands of subscribers must each spend $100 buying a 25-page document (which often cost less than $1 each to print or serve electronically).
In terms of examples, I personally cannot see the needs for IEC 60601-2-66 and ISO 21388 in the hearing care sector. The first of these is for a product that has no ‘particular performance’ requirements in context of mains power connected medical devices. IEC 60601 series simply adds another layer of overheads, above the pre-existing and perfectly adequate IEC 60118 series. The second, ISO 21388, can obstruct the development of more customer-convenient and cost-effective distribution models. The two standards have conspicuously come about at a time when technological advances promise a revolution in hearing care. To me, they have a feel of being driven by an established industry seeking to embed the old ways, to protect itself against competition from new market models and entrants.
A further example is the ISO 16355-1 guidance standard on QFD, which over-emphasises a poorly evidenced “Modern” approach. The specified method happens to be trademarked by the Convener (Chair-person) of the working group that developed the standard. The ISO 16355 standard further states that QFD project “leaders or moderators should be trained in the tools and methods”. Holding the commercial rights to both the promoted method and its training/qualification program, the standard has enabled the Convener’s commercial organisation to claim that ISO 16355 “obsoletes the classical approach” and that their organisation is now the “official” and “world’s only” source for QFD resources and training [recorded from website 20/11/2016]. In my view, a cynical person can easily perceive ISO 16355 as creating a commercial monopoly. Unfortunately, the International Standards Organisation has supported this by adopting the standard. Fortunately, 95% of real QFD practitioners know better and will ignore this ISO standard.
I contacted the International Standards Organisation, to raise my concerns over ISO 16355. Their reply was that the development, phased reviews and adoption of the standard has followed the correct due process. To me, this merely evidences that the standard for introducing standards is not immune to commercial bias. We have to suspect that many standards are biased.
Although I have taken a critical view, I do not advocate the abolishment of standards. However, I would encourage anyone to think carefully about the voluntary use of standards that are:
- Specifying requirements that are unnecessarily prescriptive and cannot easily be reversed once the standard is published.
- Created so that they effect a restriction in market competition, whether intentionally or not.