YY/T 0287-2003Medical devices - Quality management systems - Requirements for regulatory purposes (English PDF)

YY/T 0287-2003 is the English-translated version of 医疗器械 质量管理体系 用于法规的要求.

YY/T 0287-2003 is the Chinese standard "Medical devices - Quality management systems - Requirements for regulatory purposes".

Its scope clause reads: 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).

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. Its clauses include terms and definitions.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 36 pages — is available in the English PDF.

GB/T 42061-2022|YY/T 0468-2003|YY/T 0595-2020|YY/T 0468-2015|YY/T 1172-2010|YY/T 0595-2006

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