Horses for courses: the differences between accreditation and certification of laboratories

Recently, some manufacturers of Australian wine have been criticised for deliberately and deceptively catering to the 'medal' mentality of many consumers. Knowing that a sector of the wine-buying public selects wines that have medals and/or awards on the label, some winemakers have added their own 'medals' to their products. These little gold and silver circles on the label look impressive at arm's length, yet closer inspection reveals they say things such as 'Award winning screw top design', 'Best buy', even 'Contents 750 mL'.

The buying public can hardly be blamed for believing (logically) that the more 'medals' found on a bottle of wine, the better it is, and the wine producers who exploit this marketing trick are not the first to do so. Medals and badges are a visible and well understood display of some kind of independent recognition or achievement. Most producers and manufacturers know that third party endorsements of their product or service are one of the most powerful marketing tools available, and that discerning purchasers do look for something other than a supplier's own attestations that their goods are worth the money. In recognition of this, many organisations go to the trouble and expense of gaining third party recognition for their products and services. This is done not only for marketing reasons but, in many cases, to improve their operations by working towards the goal of recognition, or conformance to a recognised standard.

There is no end of 'recognitions' now available, for the product, the service, the system, the standard, or even for industry-specific programs. The challenge for the producer or supplier is to select the one most relevant both to their needs, and those of their customers. A recognition or achievement worth its salt will not be a 'push-over' to achieve, as it is usually there to help distinguish a solidly run business, or a quality product, or the best client service, from the 'also-rans'.

There is little doubt that the introduction of the ISO 9000 quality management standards in the 1990s had a major impact on the face of industry and business in Australia. In the last two decades, thousands (probably tens of thousands) of pages have been written in various journals and other professional publications extolling the virtues of ISO 9000 as a tool for improving the quality of a company's output, be it a product or a service. Testimonials by many organisations that have undergone certification to the ISO 9000 standards attest to its positive effects on their attitudes to quality and to customers, their staff's performance and productivity, the enhancement of their products, improvement in work practices and their ability to deal with problems related to product performance and customer satisfaction. The various state and federal governments have, to varying degrees, given support and credence to Australian companies introducing ISO 9000 standards into their organisations.

However, the rapid introduction of these quality management standards throughout Australia came at a price. Probably the major problem associated with the spread of ISO 9000 related to both the company's reasons for seeking it and the customer's understanding and attitude towards it.

What customers want may not be what they need

Many companies seeking ISO 9000 certification in the 1990s were not doing so primarily to improve their company's quality practices. They were seeking ISO 9000 as a quality credential to satisfy their customers' demands. This was not necessarily undesirable, as many companies who would not have sought quality certification for the former reason, nevertheless gained certification to satisfy supplier/purchaser contracts, and in the process improved their performance, products and services. In other words, the reasons for seeking ISO 9000 certification did not necessarily determine the effectiveness of the process and the value of the outcome.

In the 1990s, it became increasingly evident that customers (both in the private and government sectors) were asking for ISO 9000 certification as a blanket requirement for their suppliers if they wish to do business with them. In many cases, ISO 9000 certification was the appropriate quality credential for customers to ask for. But in many other cases, it was not.

Laboratories were a notable example of where the requirement of ISO 9000 implementation and certification caused considerable dilemma, both for the laboratories themselves, the users of laboratory services (eg, manufacturers and service providers) and those who purchased products or used laboratory data further downstream (ie, those who use products based on the specifications or attributes derived from laboratory data).

The problem, which still persists today, centres on laboratory customers asking for (or expecting) testing and calibration facilities to have ISO 9001 certification, when what they should really be asking for is technical accreditation of the laboratory. Unfortunately, ISO 9001 certification was, and still is, interpreted by many purchasers as THE quality credential regardless of the circumstances. In fact, many customers still do not even really understand what ISO 9001 is, and what it is designed to do. As mentioned earlier, the sheer momentum of the ISO 9000-based quality phenomenon in this country in the last decade simply overran many of those who were making purchasing decisions and writing purchasing policies based around securing the most reliable and quality-conscious suppliers.

Compounding the problem was that the alternatives to ISO 9000 certification, such as laboratory accreditation, did not (for better or worse) receive the hype and adulation of ISO 9000. There are many laboratory customers today who do understand the benefits of using an accredited laboratory. They may even realise that ISO/IEC 17025-based laboratory accreditation is a more effective demonstration of a laboratory's technical competence than ISO 9000 certification. But at least as many laboratory customers today still do not appreciate the differences between the two, or worse, are not even aware of laboratory accreditation. This problem is not unique to Australia. Other developed countries, including those where laboratory accreditation is a relative newcomer to the scene, have recognised the difficulties in educating customers about what form of reassurance and what standard of competence they should be seeking from their suppliers.

A matter of education

The problem really is about education. And the responsibility for this education in the area of laboratory customers rests with the laboratories themselves, and with laboratory accreditation bodies around the world, including the National Association of Testing Authorities (NATA). Laboratories and their clients need to acquaint themselves with the issues at hand, notably the differences between ISO 9001-based certification and ISO/ IEC 17025-based laboratory accreditation.

Over the past decade, NATA has published articles in certain professional journals on the differences between the two types of third-party assurance. Other laboratory accreditation bodies such as the United Kingdom Accreditation Service (UKAS) and the American Association for Laboratory Accreditation (A2LA) have also published similar papers. These papers describe the main differences between ISO 9000 and ISO/IEC 17025, which can be summarised in terms of:

1. The requirements of the standards;
2. The process of certification versus accreditation;
3. The forms of approval or recognition provided by both processes.

It is clear, though, from the confusion and misunderstanding still evident in the marketplace, that the distinction between the two processes is still well understood.

The requirements of the two standards

Both ISO/IEC 17025 and ISO 9001 have similar quality requirements. However, ISO/IEC 17025 goes beyond ISO 9001 in extending its criteria to cover aspects affecting the technical competency of a laboratory. These more laboratory-specific criteria include:

• The technical qualifications, experience and competence of the staff;
• The suitability, calibration and maintenance of testing equipment;
• The adequacy of quality control procedures;
• The validity, appropriateness, and adherence to sampling, testing and calibration procedures;
• Recording, reporting and review of test data;
• The suitability of the laboratory environment;
• The participation in available proficiency testing programs.

The process of certification versus accreditation

The auditing by certification bodies of a company's quality system to ISO 9001 involves the use of professionals trained in auditing techniques and with a thorough working knowledge of the ISO 9000 standards. While these auditors often hold academic qualifications, they are not required to have expertise in the specific technology or processes used by the company under examination. By contrast, laboratory assessors evaluating a facility against ISO/IEC 17025 are expected to be not only familiar with, but have a solid understanding of, the testing and sampling procedures being utilised by the laboratory. This is in addition to the ability of the assessment team to evaluate the ISO 9001-related components of the laboratory's quality assurance system. This is the concept of 'peer review', used as the basis for laboratory accreditation.

Besides assessing the standard of documentation, a typical laboratory assessment will involve the witnessing of tests, the evaluation of staff, the checking of equipment, a review of calibration records and procedures, and an examination of any recent participation in proficiency programs. Participation in proficiency testing programs, whereby a laboratory's performance of a particular test or calibration is compared to that of similar laboratories, is a particularly powerful tool in demonstrating technical competence. This is why NATA maintains such an active involvement in operating a wide range of proficiency programs.

To adequately evaluate laboratories, the requirements of ISO/IEC 17025 require additional interpretation for the particular technologies and testing procedures being employed. This is where NATA applies the field-specific criteria detailed in its supplementary requirements for accreditation, covering each field of testing and calibration. Hence, the specificity of criteria utilised for laboratory accreditation extend well beyond the generic requirements of ISO 9001.

The forms of approval or recognition provided

In general, organisations certified to ISO 9001 have their certification defined in fairly general terms related to the products/services they provide. This is appropriate because quality systems certification is meant to convey as simply as possibly to customers the scope of an organisation's certification. It does not generally need to go into detail on the specific technical capability of a company, as that is not the purpose of the certification.

By contrast, laboratories are accredited in terms of very specific testing or calibration activities. The level of detail included can extend to listing particular sampling and testing methods, ranges of determinations and associated uncertainties. Under NATA's system, individual staff in the laboratory may also be identified as competent to evaluate and authorise the release of test results. The level of detail in a laboratory's recognition has to be very specific because of the complex nature, limitations and demands of many testing and sampling procedures.

Where to from here?

NATA, as an association of testing laboratories, has both an interest and an obligation to ensure laboratories and their clients understand issues pertaining to the production, quality and interpretation of test and calibration data. To this end, NATA needs to communicate with both the producers and the users of test data. The former is relatively easy as NATA has several avenues of direct contact with its accredited laboratories. However, direct communication with laboratory customers is not as straightforward for NATA and requires the collaboration and cooperation of accredited laboratories, and professional and industry journals, to carry the message.

To help educate the users of laboratory data on the differences of laboratory accreditation and quality systems certification, testing and calibration services need to familiarise themselves with the issues and then speak to their customers, particularly with regard to how their requirements can be met by the different types of assurance.

Ultimately this will benefit both parties by ensuring clarity in specifications and contracts, and a more considered approach from clients in selecting suitable suppliers for their testing and calibration needs.