Summary of clause 4 QMS

Requirements

Document a quality management system (QMS)

Maintain the effectiveness of your QMS

Establish any requirement, procedure, activity or arrangement

Implement any requirement, procedure, activity or arrangement

Maintain any requirement, procedure, activity or arrangement

Document the roles undertaken by the organization under the applicable regulatory requirements

Determine the processes needed for the QMS and the application of these processes

Apply a risk based approach to control the processes needed for the QMS

Determine the sequence and interaction of these processes

Determine criteria and methods to ensure process effectiveness and control

Ensure the availability of resources and information needed to support process operation and monitoring

Implement actions to achieve planned results and process effectiveness

Monitor, measure and analyze these processes

Establish and retain records needed to demonstrate conformity with ISO 13485 standard and with applicable regulatory requirements

Manage QMS processes

Evaluate the impact of changes on the QMS

Evaluate the impact of changes on the medical devices produced under this QMS

Control the process changes

Monitor and control outsourced processes

Retain responsibility of conformity

Keep controls proportionate to the risks involved

Include in the controls written quality arrangements

Document procedures for the validation of software used in the QMS

Validate software applications prior to initial use and after any change

Keep validation and revalidation activities proportionate to the risk associated with the use of the software

Retain records of these activities

Document a quality manual and quality objectives

Include the quality manual in documented form

Include documented procedures and records required by the standard ISO 13485

Include documents and records, determined by the organization as necessary to ensure the effective planning, operation and control of its processes

Include other documentation related to applicable regulatory requirements

Prepare a quality manual including the scope of the QMS

Document a quality manual with documented procedures

Document a quality manual with interaction between processes of the QMS

Outline the structure of the documentation of the QMS

Establish and maintain a file containing documents to demonstrate conformity to the requirements of the standard ISO 13485 and applicable regulatory requirements

Include in this file a description of the medical device, intended use and labelling

Include in this file product specifications

Include in this file manufacturing, packaging, storage, handling and distribution specifications

Include in this file measuring and monitoring procedures

Include in this file installation requirements

Include in this file servicing procedures

Control required QMS documents

Control records

Review and approve documents

Review and re-approve documents

Ensure identification of changes and current revision status

Ensure availability at points of use of relevant versions of applicable documents

Ensure legible and readily identifiable documents

Ensure that documents of external origin are identified and their distribution controlled

Prevent deterioration or loss of documents

Prevent the unintended use of obsolete documents

Ensure that changes to documents are reviewed and approved by authorized persons

Define the period for which obsolete documents will be retained

Ensure a period for which documents will be retained at least equal to the lifetime of the medical device, but no less than the retention period as specified by applicable regulatory requirements

Retain records as evidence of meeting requirements

Provide evidence of the effectiveness of the QMS

Document the procedure for control of records

Define and apply methods for protecting confidential health information

Keep records legible, readily identifiable and retrievable

Keep changes to records identifiable

Retain records at least at least equal to the lifetime of the medical device

Top of the page