This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
2. Normative reference
The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical Specification.
3. Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
4. Quality management system
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
4.1 General requirements
4.2 Documentation requirements: the organization shall establish and maintain a quality manual
5. Management responsibility
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
5.5 Responsibility, authority and communication
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
5.6 Management review
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
6. Resource management
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
6.1 Provision of resources
6.2 Human resources
6.4 Work environment
7. Product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
8. Measurement, analysis and improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data