Documentation requirements of ISO 13485
Documentation requirements of ISO 13485
Clause 4.2
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,
e) records required by this International Standard (see 4.2.4), and
f) any other documentation specified by national or regional regulations.
Where this International Standard specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall, in addition, be implemented and maintained.
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
NOTE 1 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 2 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
The quality manual shall outline the structure of the documentation used in the quality management system.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to review and approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions.
The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements.
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements.
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on Sunday, November 22nd, 2009 at 10:04 am and is filed under ISO 13485 standard.
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