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4 Quality Management System (ISO 13485:2016) (4.1 General Requirements (4…
4 Quality Management System
(ISO 13485:2016)
4.1 General Requirements
4.1.2
Apply a risk based approach
Determine the sequence and interaction of processes
4.1.3
For each QMS process, to include items (a-e)
4.1.1
Document the role(s)
Establish, implement and maintain any requirement and procedure
4.1.4
Manage QMS processes to meet this Standard and regulatory requirements
Changes to processes to be done according to items (a-c)
4.1.6
Specific approach and activities associated with software validation & revalidation to be proportionate to risk associated with use
Document procedures for validation of application of computer software used in QMS
Applications to be validated before initial use & as appropriate, after changes to software or application
Maintain records of such activities
4.1.5
Conform to this Standard, customer & regulatory requirements for outsourced processes
Controls to be proportionate to the risk involved & ability of the external party to meet requirements in accordance with 7.4
Monitor and ensure control over processes
4.2 Documentation Requirements
4.2.3 Medical device file
File to include, but not limited to, items (a-f)
For each medical device type/family:
Establish and maintain 1 or more files containing/referencing documents generated to meet this Standard and regulatory requirements
4.2.4 Control of documents
Documented procedure need to include items (a-h)
Documents are available for at least the lifetime of the medical device
4.2.2 Quality manual
QM to include items (a-c)
Outline structure of documentation used in QMS
4.2.5 Control of records
Document procedures to define controls needed for identification, storage, security and integrity, retrieval, retention time & disposition of records
Retain records for at least the lifetime of the medical device
4.2.1 General
QMS to include items (a-e)