Quality Management Systems - ISO 9001

ISO 9001:2000 Quality Management Systems is used around the world in all types of organizations, including the healthcare sector. ISO 9001:2000 is a generic standard that provides your organization with a model and framework for your management system.

Healthcare service providers - large and small, delivering clinical, clinical support and administrative services - all use ISO 9001:2000. For organizations that deliver a diverse range of services, ISO 9001:2000 is particularly well suited to meeting their management system needs. Using ISO 9001:2000 as their management system framework, they fit in the various health and disability sector standards and specifications, as required by regulations and contracts with funders. Because of its generic nature, ISO 9001:2000 is designed to accommodate and complement not only service standards but also your guidelines and codes of practice.

Within ISO 9001:2000 there are five main parts (they are numbered 4 - 8) and each of these parts has clauses:

4 Quality management system
    4.1 General requirements
    4.2 Documentation requirements
5 Management responsibility
    5.1 Management commitment
    5.2 Customer focus
    5.3 Quality policy
    5.4 Planning
    5.5 Responsibility, authority and communication
    5.6 Management review
6 Resource management
    6.1 Provision of resources
    6.2 Human resources
    6.3 Infrastructure
    6.4 Work environment
7 Product realization
    7.1 Planning of product realization
    7.2 Customer-related processes
    7.3 Design and development
    7.4 Purchasing
    7.5 Production and service provision
    7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
    8.1 General
    8.2 Monitoring and measurement
    8.3 Control of nonconforming product
    8.4 Analysis of data
    8.5 Improvement

In combination the clauses cover the requirements of a quality management system in any organization.

ISO 9001:2000 is published by Standards New Zealand and widely recognized both internationally and by regulators and funders in New Zealand. Audit and certification by the DAA Group gives your organization external recognition of its compliance with ISO 9001:2000. Healthcare providers often choose a DAA Group certification programme that includes the generic ISO 9001:2000 standard in combination with other applicable standards and specifications, as stipulated within regulations and their contracts with funders. A DAA Group certification programme is designed to minimize compliance costs, both in terms of implementation and of audit.

The DAA Group has a history of ISO 9001 certification programmes delivered to clients within the healthcare sector going back to 1993. Our agency offices have auditors with in-depth experience in management systems implementation and auditing. We have widely recognized skills in designing a certification programme to accommodate the particular needs of each client organization.