– what is quality?

1]. Approaches to quality have seen a shifting emphasis and have evolved through the following stages:

1. inspection and remedial action

2. identifying improvements and taking steps to prevent mistakes occurring

3. doing things differently, i.e. modernization.

This is reflected in the history of quality in radiotherapy [2], such that the interpretation of quality has widened and can now be applied to every aspect of the service, incorporating many local, professional and national standards. It is not possible to cover every aspect of quality in detail in a single chapter. This chapter aims to provide an overview of quality and quality management and their significance to radiotherapy, outline the requirements of the international quality standard BS EN ISO 9001, signpost readers to further information on a number of quality initiatives and promote an integrated approach to quality management in UK Oncology Centres.

There are many different definitions and perceptions of quality and several terms associated with quality that are important to describe from the outset. Quality may be defined as fitness for purpose or conformance to requirements, but it is more than this.

Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs [3].

In other words, it is the degree to which a product or service satisfies the requirements of the user. Some definitions do not take costs into account. However, quality is about meeting customer requirements, stated or implied, while also keeping costs to a minimum.

Another often used term is quality control (QC): ‘the part of quality management focused on fulfilling quality requirements, [4].

In radiotherapy, quality control does not only apply to controlling the performance of the equipment, but also to controlling the performance of radiotherapy processes.

Quality assurance (QA) refers to ‘the part of quality management focused on providing confidence that quality requirements will be fulfilled’ [4] or: ‘a systematic process of verifying that a product or service is meeting specified requirements’ [5].

Quality assurance incorporates risk assessment, determining what might go wrong, or what is critical to get right, then planning the process and putting procedures in place to ensure that a reliable service is provided. Aspects to be included should be operational, including legislative and educational requirements; physical and technical checks to verify correct functioning of equipment; and clinical aspects, including patient care and management. This can be achieved through activities such as documentation, training and ongoing review of existing processes.

Quality management (QM) is ‘the coordinated activities to direct and control an organization with regard to quality’ [4]. The underpinning philosophy, to get the process and the service right first time, applies to all parts of the organization, involving managing all functions and activities to achieve quality.

A quality system (QS) is the organizational structure, responsibilities, procedures, processes and resources which must be in place to implement quality management.

A quality management system (QMS) is a management system to direct and control an organization with regard to quality [4].

There are a number of documented approaches to quality, including total quality management (TQM), continuous quality improvement (CQI) and business process re-engineering. From these different approaches, it is possible to identify a number of recurring key themes:

• management commitment

• staff involvement

• identification of clear requirements or standards

• identification of clear processes, broken down into identifiable steps

• a focus on the prevention of problems

• recognition that quality is a continual process.

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