1 Scope
1.1 General
This 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 statutory and regulatory requirements;
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 statutory and regulatory requirements.
Note 1: In this Standard, the term “product” only applies to:
a) product intended for, or required by, a customer;
b) any intended output resulting from the product realization processes.
Note 2: Statutory and regulatory requirements can be expressed as legal requirements.
1.2 Application
All requirements of this 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 Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 19000-2008 Quality management systems — Fundamentals and vocabulary (ISO 9000:2005, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 19000 apply.
Throughout the text of this Standard, wherever the term “product” occurs, it can also mean “service”.
4 Quality Management System
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this Standard.
The organization shall:
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2);
b) determine the sequence and interaction of these processes;
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
e) monitor, measure where applicable, and analyse these processes;
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
Note 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.
Note 2: An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
Note 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as:
a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements;
b) the degree to which the control for the process is shared;
c) the capability of achieving the necessary control through the application of 7.4.
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
