MEDICAL EQUIPMENT, MEDICAL DEVICES, QUALITY ASSURANCE, QUALITY ASSURANCESYSTEMS, PRODUCTION, INSTALLATION, AFTER-SALE SERVICES, SPECIFICATIONS, DETAILSPECIFICATIONS, IMPLEMENTATION, QUALITY AUDIT
被代替标准
2001-01-01
适用范围
This National Standard of Canada is equivalent to International Standard ISO
13488:1996. 1 Scope This International Standard specifies, in conjunction with IS0 9002, the
quality system requirements for the production and, when relevant, installation
and servicing of medical devices. This International Standard, in conjunction with ISO 9002, is applicable when
there is a need to assess a medical device supplier's quality system. As part of an assessment by a third party for the purpose of regulatory
requirements, the supplier may be required to provide access to confidential
data in order to demonstrate compliance with this International Standard. The
supplier may be required to exhibit these data but is not obliged to provide
copies for retention. NOTE - In this International Standard the term "if appropriate" is used
several times. When a requirement is qualified by this phrase, it is deemed to
be "appropriate" unless the supplier can document a justification otherwise. a
requirement is considered "appropriate" if its non-implementation could result
in - the product not meeting its specified requirements, and/or
- the supplier being unable to carry out corrective action.