4 Quality Management System Flashcards
- 1 General requirements:
4. 1.1 The organization shall document:
4.1.1 The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.
The organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements.
The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements.
NOTE Roles undertaken by the organization can include manufacturer, authorized representative, importer or distributor.
4.1.2 The organization shall:
- 1.2 The organization shall:
a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization;
b) apply a risk based approach to the control of the appropriate processes needed for the quality management system;
c) determine the sequence and interaction of these processes.
4.1.3 For each quality management system process, the organization shall:
- 1.3 For each quality management system process, the organization shall:
a) determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
b) ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
c) implement actions necessary to achieve planned results and maintain the effectiveness of these processes;
d) monitor, measure as appropriate, and analyse these processes;
e) establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see 4.2.5).
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:
- 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.
4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall:
4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes.
The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes.
The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4.
The controls shall include written quality agreements.
4.1.6 The organization shall document procedures for:
4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system.
Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.
Records of such activities shall be maintained (see 4.2.5).
- 2 Documentation requirements
- 2.1 General
The quality management system documentation (see 4.2.4) shall include:
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:
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:
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:
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:
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.
