AAMI TIR14969 pdf free download

AAMI TIR14969 pdf free download.Medical devices- -Quality management systems- Guidance on the application of ISO 13485:2003.
1.2.1 General
Certain product realization requirements of ISO 13485 may 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 ISO 13485:2003, 7.3). Organizations should determine the exclusion of 7.3 on a product by product, market by market basis.
Even if the organization is permitted by regulations to exclude the requirements of 7.3, it still has obligations to meet product realization requirements of ISO 13485:2003, 7.2, 7.4, and 7.5 and 7.6.
1.2.3 Non-applicability
ISO 13485 provides for the organization to omit from its quality management system those product realization requirements that are not applicable due to the nature of the medical device.
For example, an organization providing single-use, stenle medical devices does not need to include within its quality management system elements related to installation and servicing. Similarly, an organization providing non-sterile medical devices does not need to include the elements related to sterilization.
It is important for the organization to review carefully all the requirements of ISO 13485:2003, clause 7, in order to identify those requirements that do apply to functions performed by the organization. Once those requirements are identified, the organization is obliged to comply with ISO 13485:2003, 7.1 and to perform the planning associated with identified product realization requirements.
EXAMPLE—An organization intends
— to place its own label on a medical device designed and developed, produced, and serviced by suppliers outside its quality management system, and to market this medical device,
— to communicate with customers who have purchased the medical device, and
— to have systems in place for receiving customer complaints.
Even though the organization does not perform design and development activities itself, it cannot consider 7.3 to be non-applicable. It still has obligations to meet the requirements of 7.3, unless relevant regulations permit an exclusion. Once the organization identifies those requirements, it is obliged under 7.1 to plan for the quality management system processes needed to meet those requirements.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2000, Quality management systems—Fundamentals and vocabulary
ISO 13485:2003, Medical Devices—Quality management systems—Requirements for regulatory purposes
3 Terms and definitions
For the purposes of this docment, the terms and definitions given in ISO 9000 and ISO 13485 apply. NOTE—The terms provided in Annex A should be regarded as generic, as definitions provided in national regulatory requirements can differ.
4.2.4.5 If an error is made or detected on a record, it should be corrected in such a manner that the original entry is not lost and the correction is initialed and dated. If appropriate, the reason for the correction should be recorded. Where electronic records systems are used in place of paper based ones, these systems should, wherever possible, incorporate time- stamped, immutable, system generated audit trails, for tracking changes. Such audit trails may include the identity of the authorized user, creations, deletions, modifications/corrections, time and date, links, and embedded comments. 4.2.4.6 The organizations may have alternative provisions for critical data entry of electronic records, for example: a second authorized person with logged name and ientification, with time and date, can verity data entry via the keyboard, or systems with direct data capture can have the second check as a part of validated system functionality.AAMI TIR14969 pdf download.