MEDICAL EQUIPMENT, MEDICAL DEVICES, QUALITY ASSURANCE, QUALITY ASSURANCESYSTEMS, DESIGN, DEVELOPMENT (WORK), PRODUCTION, INSTALLATION, AFTER-SALESERVICES, SPECIFICATIONS, DETAIL SPECIFICATIONS, IMPLEMENTATION
被代替标准
CAN/CSA-ISO 13485:03
适用范围
This National Standard of Canada is equivalent to International Standard ISO 13485:1996. 1 Scope This International Standard specifies, in conjunction with ISO 9001, the
quality system requirements for the design/development, production and, when
relevant, installation and servicing of medical devices. This International Standard, in conjunction with ISO 9001, 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.