1.1 General
This standard provides guidance for the application of the requirements for quality management systems contained in YY/T 0287. It does not add to, or otherwise change, the requirements of YY/T 0287. This standard does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
Note: The terms “should”, “can” and “might” within this standard are used as follows. “Should” is used to indicate that, amongst several possibilities to meet a requirement in YY/T 0287, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. “Can” and “might” are used to indicate possibilities or options. These terms do not indicate requirements. This guidance can be used to better understand the requirements of YY/T 0287 and to illustrate some of the variety of methods and approaches available for meeting the requirements of YY/T 0287.
1.2 Application
YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
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 Clause 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. When 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.
1.2.1 General
Certain product realization requirements of YY/T 0287 can legitimately be omitted in one of two ways: they can be “excluded”, or they might be “not applicable”. It is important to note, however, that any exclusion or non-applicability should be detailed and justified in the organization’s quality manual.
1.2.2 Exclusions
Some regulatory requirements permit organizations to place some medical devices on the market without having to demonstrate conformance with design and development controls (see YY/T 0287-2003, 7.3).
