What do we mean when we talk about “quality”? It’s a seemingly simple question, and yet it’s not so easy to answer. It may come as no surprise that quality can be defined in many different ways: value for money, fitness for use or purpose, to do a right thing at a right time, features that meet consumer needs, freedom from defects, conformance to standards, etc.
All these definitions clearly indicates that quality is hard to define in a way that is appropriate for all situations. What is certain is that companies have to continuously deliver high-quality products and/or services if they want to be successful in the marketplace over the long term.
In testing laboratories, quality can be defined as compliance with specifications. Therefore, quality means that the laboratory results meet the customer’s expectations and are as accurate and reliable as possible. Of course, the laboratory is a complex system involving many steps of activity and many people. For this reason, in order to achieve the highest level of accuracy and reliability, it is necessary to perform all processes and procedures properly. Therefore, the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance.
The laboratory quality management system works on the organizational level to implement an overall quality policy. It includes management of equipment, supplies and inventories, management of capital, finances and budgeting, and providing training and continuous support of staff and customer service. One critical part of the quality system is assessment, which means performance is measured against a standard. In February 1947 the International Organisation for Standardization (ISO) officially began operating in Geneva, Switzerland. Since then, industry began to work on standards.
In terms of laboratory quality systems, the relevant ISO standards are ISO 9000, which addresses quality management issues, and ISO 17025, which specifies the general requirements that testing and/or calibration laboratories have to meet in order to demonstrate that they are technically competent and able to produce precise and accurate results.
The general goal of the ISO standards is, as the name of the organization connotes, “ISOS” – which is etymologically from the Greek word meaning equality or consistency. The goal of the conceptual framework is to create equal work product coming out from an organization and across organizations.
The main difference between ISO 9000 and ISO 17025 is that the first one is a generic standard for quality management systems applicable to all organisations irrespective of type, size or product or service provided. It can, therefore, be applicable to laboratories but in this case the emphasis is on establishing a laboratory’s compliance with requirements for a quality management system. Unlike ISO 17025, it does not contain technical requirements for laboratory personnel and operations. On the other hand, accreditation against ISO 17025 demonstrates – as said before – the technical competence of a laboratory to produce valid data and results.
To that end, the ISO 17025 standard does not define exactly how the processes should be carried out, but rather a set of general requirements and controlled outcomes that specific procedures should ensure.
We can consider the ISO 17025 standard to consist of two sections:
- Management requirements – which relate to the operation and effectiveness of the quality management system within the laboratory.
- Technical requirements – which address the competence of staff, testing methodology; equipment and quality; and reporting of test and calibration results.
The question now arising is: why shall a testing and/or calibration laboratory decide to be accredited according to ISO 17025?
Implementing ISO 17025 as part of laboratory quality initiatives provides both laboratory and business benefits such as:
- Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help to get more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations.
- Increase of the laboratory’s prestige on a national and international level.
- Continually improving data quality and laboratory effectiveness.
- Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.
Of course, it has been observed that a laboratory that is not accredited to ISO 17025 might be equally competent with an accredited laboratory. But without the ISO 17025 accreditation it is quite difficult to prove it!
