Quality Assurance of Energy Measurements

Caroline Stewart PhD, ORLAU

Increasingly clinical staff, including doctors and physiotherapists, are being required to defend their gait laboratories to the outside world. Within the field concern over correct procedures has formed part of European initiatives including CAMARC, ABCMALE and ESMAC’s peer review process. No mandatory accreditation process has yet been applied across Europe. ISO 9001 is a general standard for managing quality. It is not designed for clinical movement analysis laboratories, or even for measurement services. Its scope is broad so it can be applied to almost any organization. As a result it has been adopted very widely and accreditation to ISO 9001 is understood to provide a badge of good practice by professionals in many different sectors. ISO 9001 has a track record of use in the health services and industries. The Medical Devices Agency (MDA) in the UK strongly recommends the adoption of ISO 9001 and EN 46001 by manufacturers of Class 1 orthotic devices to ensure compliance with the European Medical Devices Directive. ORLAU’s experience as an orthotic manufacturer revealed the appropriateness of the standard for application in movement analysis. The final decision to extend the system was made in 2001.

To reflect the process approach introduced with the new edition of the standard, the whole movement analysis service, from the receipt of a referral letter to the delivery of the report and data archiving, was broken down into a series of flow charts. Each step clearly identified the input and outputs, the staff responsible, the resources needed and any records which should result. Operating procedures were referenced where necessary, typically defining more complex activities within the gait laboratory. Across the whole system paperwork and forms were standardized forming, along with computer files, records of activity. Around these core processes a series of supporting procedures was defined. These covered, for example, the calibration of lab equipment and the training of staff. Also included were 6 procedures compulsory under ISO 9001:2000, Nonconformance, Corrective Action, Preventive Action, Internal Audit, Quality Records and Document Control. The new system was introduced in stages over a period of approximately 12 months, with full implementation by July 2002. All the elements were documented in a manual, as required, mostly in the form of computer files with hard copies available where needed. Once in place the system continued to evolve under the requirements for auditing and continuous improvement.

BSI accreditation to ISO 9001:2000 was obtained in September 2002. Benefits to the clinical service have included:

Increased awareness of practice and confidence for clinicians in the results of data collection.

Improved efficiency in the use of resources and the availability of patient information.

Tighter control over procedures, of benefit in clinical practice and essential if the data are to be used in research.

Better mechanisms for monitoring the service and making improvements.

There is likely to be increasing pressure on clinical movement analysis services to implement standards and establish accreditation mechanisms. Whatever route is chosen labs will be required to make a considerable investment in time and money. Difficult decisions need to be made. Should an existing standard be adopted or an entirely new one designed? ISO 9001 has the advantage of its breadth of scope. It extends quality issues well beyond laboratory calibration and testing protocols, covering the whole management process. Being general in its requirements it does not address specific, detailed areas of concern within the field. This has the benefit of avoiding the heated controversy that arises with any attempt to agree common practice. There is, however, some potential for incorporating bad practice unchallenged within the implementation of the standard. This risk is minimized by the requirement for external assessment and the transparency required of the manual, making the whole movement analysis process open to inspection. ISO 9001 is understood by those outside the field of movement analysis, including those responsible for purchasing services. This is perhaps its greatest benefit.

ISO 9001 is an appropriate standard for application in clinical movement analysis laboratories. As such it provides a potential candidate for use in a future accreditation process.

Application of Quality Assurance to Energy Measurement

The general principles of ISO 9000 are applicable to the process of energy measurement as with any other process. The quality assurance document produced in ORLAU for the Cosmed K4 system highlights the individual aspects of the process.

Reference

BS EN ISO 9001:2000 Quality management systems – Requirements. Published in English in the UK by BSI, London.