1.1 General
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of GB/T 19001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to GB/T 19001 unless their quality management systems conform to all the requirements of ISO 9001 (see Appendix B).
1.2 Application
All requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with this standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3].
If any requirement(s) in Chapter 7 of this standard is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system [see 4.2.2 a)].
The processes required by this standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)].
In this standard the terms “if appropriate” and “where appropriate” are used several times. Where a requirement is qualified by either of these phrases, it is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for
- the product to meet specified requirements, and/or
- the organization to carry out corrective action.
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 (excluding amending errors in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of the normative document is applicable. For undated references, the latest edition of the normative document applies.
GB/T 19000-2000 Quality Management Systems - Fundamentals and Vocabulary (idt ISO 9000:2000)
3 Terms and Definitions
For the purposes of this standard, the terms and definitions given in GB/T 19000-2000 apply, together with the following.
The following terms, used in this standard to describe the supply chain, have been changed to reflect the vocabulary currently used:
suplier→orgnization→customer
The term “organization” replaces the term “supplier” used in YY/T 0287-1996, and refers to the unit to which this standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this standard, wherever the term “product” occurs, it can also mean “service”.
Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization.
The following definitions should be regarded as generic, as definitions provided in national regulations can differ slightly and take precedence.
