|
|
|
ISO 9000 - Do We Need It? From Spectrum September 1995 |
ISO 9000 - Do We Need It?Frank Kelly is Area Service Manager for Fannin ireland Limited. This is a welcome viewpoint from the private sector Most organisations - industrial, commercial or governmental - produce a product or service intended to satisfy a user’s needs or requirements. Such requirements are often incorporated in specifications. However, technical specifications may not in themselves guarantee that a customer’s requirements still be consistently met... Industrial Standards Organisation (ISO) 9000, Quality Management and Quality Assurance Standards. In today’s consumer orientated society the trend is towards higher customer expectations with regard to quality. The area of biomedical engineering is a prime example of where quality of service is required. In hospital departments such as operating theatres, diagnostic imaging departments, intensive therapy units and others, the needs of the medical user must be met to the highest standards. Implementation of ISO 9000 by Biomedical Engineering Departments would ensure that this quality of service is achieved. ISO 9000 consists of quality system standards and guidelines that are designed to complement the relevant product or service requirements given in the technical specifications. With the rapid development of health technology there is a greater need for an overall conformity to standards in the area of biomedical engineering. The purpose of international standards is to: (a) Clarify the distinctions and inter-relationships among the principal quality concepts, and (b) Provide guidelines for the selection and use of a series of international standards or quality systems that can be used for internal quality management purposes(ISO 9004) and for external quality assurance purposes (ISO 9001. 9002, 9003). To achieve a quality assurance system that complies with ISO and European Standards, the following elements are required: 1. A quality policy, quality management 2. A documented quality system 3. Maintenance of quality records/information systems 4. A quality manual. The programme for the implementation of the above elements would be as follows> (a) Initial requirements report to survey existing systems (b) Quality Manual, procedures and work instructions (c) Document review by assessment body and implementation of any recommendations (d) Implementation of documented quality management system (c) Audit prior to assessment (I) Review by assessment body (g) Corrective action (h) Final assessment audit Improvements in the quality system of any organisation usually help to achieve and sustain good economic performance, and to satisfy user requirements. The diverse objectives, products and services of organisations influence the particular type of quality system they require. Knowledge and understanding and strict compliance with the appropriate standards allows the Biomedical Engineering Department to fulfil its role as a link in the chair of provision of safe patient care in our hospitals. References:
|