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.

The steps to achieving any quality initiative must include the following stages:

• analysis of current service

• identification of recommendations for change

• implementation of change

• evaluation of the impact of change.

The main aim of quality in radiotherapy is safe and effective treatment. In addition to ensuring that all treatments are optimized, a quality system should ensure that all possible measures are taken to prevent inappropriate exposures from occurring [6].

History of quality in radiotherapy

There are a number of well-documented radiotherapy incidents [7–12], which have occurred both in the UK and internationally (Table 14.1). These have led to hundreds of patients receiving incorrect doses of radiation which, in turn, may have led to the possibility of the treatment intent being compromised or causing unnecessary and distressing acute and late side effects of treatment. Subsequent outcomes in the UK have included key reports which have contributed to the development of quality management systems in radiotherapy.

Table 14.1 Chronology of quality development in radiotherapy in the UK

Year	Event	Reference
1988	Exeter. Overdose, 207 patients affected
1988	Thwaites Report: detailed root cause of Exeter incident.	[13]
	DoH working party, chaired by Professor Bleehen, to investigate the application of quality assurance to radiotherapy to reduce the probability of incidents occurring in other centres.
1982–1991	Stoke. Underdose, 1045 patients affected
1991	Bleehen Report: Quality assurance in radiotherapy (QART). Took the form of a quality standard and provided a formal system for managing quality in radiotherapy. It was based on the Quality Standard BS 5750, Part 2, 1987 (the predecessor of ISO 9001), a quality standard which was generic to a range of industries and services and thus, open to a degree of interpretation and translation.	[14]
	DoH funded two pilot sites, Bristol and Manchester: • To implement a quality system to see if it was feasible. • To prepare manuals that would serve as examples to other radiotherapy departments	[14]
1994	Stoke: report from investigation.	[15]
1994	Sample documents from two pilot sites published and DoH recommendation for all departments to develop their own quality management system (QMS)	[16]
1994	BS EN ISO 9001:1994 replaced BS5750
2000	BS EN ISO 9001:2000 replaced BS EN ISO 9001:1994	[17]
2006	Incident at Beatson Oncology Centre	[18]
2006	Report into overexposure at Beatson	[19]
2008	Redacted Independent review of the circumstances surrounding a serious adverse incident	[12]

It is notable that, throughout numerous reported incidents, a number of recurring themes can be identified as contributing factors. These include:

• lack of communication, especially at staff group interfaces

• training, competency and supervision issues

• lack of up-to-date procedures, protocols and documentation

• no independent check/calibration

• inadequate identification of clear responsibilities.

It is of the utmost importance that the radiotherapy community shares information and learns from past mistakes [6,20]. Departments should also search for, correct, monitor and learn from their own incidents. Departments open themselves up to risk if there are workload or time pressures or if there is an insufficiency in:

• attention to detail, alertness or awareness

• procedures or checks

• resources, e.g. qualified and well-trained staff

• coordination, communication and clear responsibilities [6].

All of these factors are encompassed by ISO 9001 and should be incorporated into a department’s quality management system. They are areas that should be kept under regular review with a view to continual improvement.

Quality management systems

A quality management system (QMS) is a set of interrelated or interacting processes which provide a framework for an organization to manage its activities in order to achieve its quality policy and quality objectives. Management system standards, such as ISO 9000 (see below), provide a model to follow in setting up and operating a quality management system. The ISO 9001 requirements are based on eight quality management principles (QMP), the key elements of which are illustrated in Figure 14.1.

Figure 14.1 Key quality management principles underpinning ISO 9001:2008.

QMP 1 Customer focus

A service should understand and strive to meet the needs and expectations of its customers. In radiotherapy, this would include not only external customers, such as patients and carers, the Commissioning Health Authority and the Primary Care Trust, whose respective requirements and expectations may well be different from each other, but also internal customers, such as sections within oncology, e.g. mould room, radiotherapy physics and treatment machines.

QMP 2 Leadership

Management is responsible for creating an environment in which quality can flourish. The department’s management team must establish a clear quality policy with related objectives which are achievable, realistic, incorporate other initiatives and are communicated to all staff.

A clear understanding of the organization’s aims and all the interrelated processes involved in achieving objectives will maximize efficiency. Processes should be integrated to ensure improved efficiency, especially where there are interfaces between different key areas or staff groups, such as the planning department and pretreatment.

ISO 9000

ISO 9000 is a family of documents that provides an international standard code of practice for quality management systems. It is designed to be generic so that it is independent of any specific industry and therefore applicable to both manufacturing and service industries, including healthcare. It consists of:

• ISO 9000 Quality management systems – Fundamentals and vocabulary (last published 2005 [21])

• ISO 9001 Quality management systems – Requirements (last published 2008 [22])

• ISO 9004 Quality management systems – Guidelines for performance improvements (last published 2000 [23], due for republication 2009 [24] with a new focus on ‘sustained success’).

The standards themselves are subject to a review programme to ensure that they remain relevant. There were major changes when ISO 9001:2000 was introduced, whereas the publication of ISO 9001:2008 included only minor amendments.

The scope of a department’s QMS defines the activities included within the QMS and is determined by the organization. There are variations between oncology departments: some include just radiotherapy whereas others include planning and dosimetry, medical physics, chemotherapy, clinical trials and clerical areas. ISO 9001 is the standard against which an organization is assessed. It specifies the requirements a QMS must meet but not how the organization should meet them.

The ISO 9001:2008 [22] standard comprises nine clauses, listed in Box 14.1.

Box 14.1 The clauses of ISO 9001:2008

0 Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Quality management system

5 Management responsibility

6 Resource management

7 Product realization

8 Measurement, analysis and improvement

Clause 0, Introduction, describes a ‘process approach’ and compatibility with other management systems. Clause 1, Scope, specifies the type of organization that the standard is applicable to. Clause 2, Normative references, gives reference to the document ISO 9000:2005 [21], which is necessary for the application of the ISO standard. Clause 3, Terms and definitions, defines what particular terms, e.g. product, mean within the concept of ISO 9000. The remaining clauses, 4–8, contain the requirements against which departments are assessed.

These requirements are based on the eight quality management principles outlined above. Table 14.2 illustrates the quality management principles which underpin the clauses of ISO 9001. The ISO 9001:2008 requirements are very much based on the Plan – Do – Check – Act cycle [22], as illustrated in Figure 14.2. Clauses 4–8 and their requirements are described further below, with the relevant quality management principles (QMP) indicated in brackets.

Table 14.2 Quality management principles underpinning ISO 9001 clauses