Publishing and copyright information

The BSI copyright notice displayed in this document indicates when the document was last issued.

The following BSI references relate to the work on this document:
Committee reference CH/100
Draft for comment 15/30323396 DC

Publication history

First published January 2017

Foreword

Publishing information

This British Standard is published by BSI Standards Limited, under licence from The British Standards Institution, and came into effect on 31 January 2017. It was prepared by Technical Committee CH/100, Healthcare and Medical Equipment. A list of organizations represented on this committee can be obtained on request to its secretary.

Relationship with other publications

This accreditation standard references a range of certification standards where these are considered essential elements in the delivery of particular healthcare science services and products. It is expected that conformity to these standards can be demonstrated for such services and associated products as appropriate. Fundamental to accreditation to BS 70000 is the implementation of a formal quality management system equivalent to BS EN ISO 9001.

Presentational conventions

The provisions of this standard are presented in roman (i.e. upright) type. Its requirements are expressed in sentences in which the principal auxiliary verb is “shall”.

Commentary, explanation and general informative material is presented in smaller italic type, and does not constitute a normative element.

Contractual and legal considerations

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

In particular attention is drawn to the following specific directives and regulations:

European Directive 90/385/EEC on active implantable medical devices (AIMDD) (1990) [1];
European Directive 93/42/EEC on medical devices (MDD) (1993) [2];
European Directive 98/79/EC on in vitro diagnostic medical devices (IVDMD) (1998) [3];
The Medical Devices Regulations 2002 [4].

0 Introduction

The application of science and technology in healthcare is fundamental to the delivery of high-quality care and improved patient outcomes in many clinical areas. Services based on science and technology can be described as healthcare science services and are often sub-divided into laboratory and non laboratory-based services. Laboratory-based services are principally involved with the analysis and interpretation of measurements from samples, such as tissue and blood taken from the patient. Non laboratory activities provide services, including associated products aimed at delivering or supporting the direct or indirect diagnosis and treatment of disease, including equipment management, design and manufacture of medical devices and patient aids, and might or might not involve direct patient contact.

Such activities are not without risk to the patient due to technical and human factors. The need for independent and peer review of these services is widely recognized in order to minimize risk and maximize quality and safety. BS EN ISO 15189 is an international accreditation standard applied to laboratory-based services. Whilst it can be applied to non laboratory-based services it requires significant interpretation. BS 70000 provides an interpretation of BS EN ISO 15189, giving a consistent framework for the accreditation of non laboratory-based services and products irrespective of service configuration and scope. Conformity to BS 70000 satisfies the requirements of BS EN ISO 15189.

BS 70000 specifies requirements for quality, safety and competence for medical physics, clinical engineering and associated science services in healthcare. Its language and requirements are generic and widely applicable, focusing on the scientific aspects of service delivery as well as technical, managerial, leadership and patient experience.

This accreditation standard references a range of certification standards where these are considered essential elements in the delivery of particular healthcare science services and products. It is expected that services and products would demonstrate conformity to the requirements of these standards as appropriate. Fundamental to accreditation to BS 70000 is the implementation of a formal quality management system equivalent to BS EN ISO 9001.

BS 70000 has been informed by professional standards and is not intended to replace such standards, but to evolve to reflect best practice as these develop.

A service conforming to this accreditation standard satisfies both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results and advice. The management system requirements in Clause 4 meet the principles of BS EN ISO 9001 and are aligned with its pertinent requirements.

1 Scope

This British Standard specifies requirements for quality, safety and competence in medical physics, clinical engineering and associated science services, including the development and manufacture of associated products, in healthcare, which include:

the optimization and delivery of diagnostic and therapeutic procedures;
provision of expert professional advice;
project management;
provision of scientific and technical support for the procurement, governance and life cycle management of medical devices;
the repair, maintenance, testing, metrological confirmation and quality assurance of equipment and facilities within a healthcare environment;
design and manufacture of devices and patient aids;
NOTE See “Further reading” in the Bibliography for standards covering the design and manufacture of devices.
radiopharmaceutical production;
healthcare science education and training; and
innovation, research and development.

It specifies a framework for good practice in service delivery, training and innovation research and development, including the roles, responsibilities, activities, facilities and equipment that are required for the delivery of such healthcare science services and associated products for the benefit of patients.

This British Standard can be used:

by service providers in developing their quality management systems and assessing the performance of their service and the competence of their staff; and
for confirming or recognizing the competence of these professional services by service users (including patients), regulating authorities and accreditation bodies.

Services for the maintenance of buildings and environmental conditions of healthcare facilities are not covered by this British Standard, although its main principles can be used to improve the provision of such services.

2 Normative references

3 Terms and definitions

4 Management requirements

4.1 Organization

4.2 Quality management system

4.3 Governance and risk management

4.4 Planning to achieve management objectives

4.5 Service delivery

4.6 Management of change

4.7 Outsourcing

4.8 Management of suppliers

4.9 Document control

4.10 Control of nonconforming work

4.11 Control of unexpected findings

4.12 Service improvement

4.13 Quality indicators

4.14 Staff engagement

4.15 Corrective action

4.16 Preventive action

4.17 Control of information assets

4.18 Internal audits

4.19 Management reviews

4.20 Assuring quality in research and development activities

4.21 Assuring quality in education and training activities

5 Technical requirements

5.1 General

5.2 Personnel

5.3 Facilities and environmental conditions

5.4 Operation methods/procedures and validation

5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

5.8 Handling of production, investigation, therapy, repair, test and metrological confirmation items

5.9 Controlling the quality of healthcare scientific service outputs

5.10 Service processes

5.11 Service output management

5.12 Surveillance

5.13 Reporting the results

Bibliography

BS 70000:2017

Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence

Current

Published:

31 Jan 2017