4.1 General Requirements

4.1.4  The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes shall be:

a) evaluated for their impact on the quality management system;

b) evaluated for their impact on the medical devices produced under this quality management system;

c) controlled  in  accordance  with  the  requirements  of  this  International  Standard  and  applicable regulatory requirements.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation (see 4.2.4) shall include:

a) documented statements of a quality policy and quality objectives;

b) a quality manual;

c) documented procedures and records required by this International  Standard;

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes;

e) other documentation specified by applicable regulatory requirements.

4.2.2 Quality manual

The organization shall document a quality manual that includes:

a) the scope of the quality management system, including details of and justification for any exclusion or non-application;

b) the documented procedures for the quality management system, or reference to them;

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 Medical device file

For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.

The content of the file(s) shall include, but is not limited to:

a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use;

b) specifications for product;

c) specifications or procedures for manufacturing, packaging, storage, handling and  distribution;

d) procedures for measuring and monitoring;

e) as appropriate, requirements for installation;

f) as appropriate, procedures for servicing.

4.2.4 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 4.2.5.

A documented procedure shall define the controls needed to:

a) review and approve documents for adequacy prior to issue;

b) review, update as necessary and re-approve documents;

c) ensure that the current revision status of and changes to documents are  identified;

d) ensure that relevant versions of applicable documents are available at points of use;

e) ensure that documents remain legible and readily identifiable;

f) ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled;

g) prevent deterioration or loss of documents;

h) prevent the unintended use of obsolete documents and apply suitable identification to them.

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function that 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 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 4.2.5), or as specified by applicable regulatory requirements.

4.2.5 Control of records

Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of  records.

The organization shall define and implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements.

Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable.

The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.