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8.2 Monitoring & Measurement (ISO 13485:2016) (8.2.4 Internal Audit…
8.2 Monitoring & Measurement
(ISO 13485:2016)
8.2.1 Feedback
Document methods for obtaining and using this information
Document procedures for feedback process
Gather and monitor information about whether customer requirements are met
Information gathered to serve as potential input into risk management for monitoring & maintaining product requirements & product realization/improvement processes
One measurement of QMS effectiveness
If regulatory requirements require organization to gain specific experience from post-production activities, review of this experience to form part of feedback process
8.2.3 Reporting to Regulatory Authorities
Document procedures for providing notification to regulatory authorities IF regulatory requirements require
Maintain records of reporting to regulatory authorities
8.2.6 Monitoring & Measurement of Product
Records shall identify the test equipment used to perform measurement activities
Maintain evidence of conformity to acceptance criteria
Carried out at applicable stages of product realization process in accordance with planned and documented arrangements & procedures
Record identity of the person authorizing release of product
Monitor and measure product characteristics to verify that product requirements have been met
Product release and service delivery shall not proceed until satisfactory completion of planned & documented arrangements
Record identity of personnel performing any inspection or testing for implantable medical devices
8.2.4 Internal Audit
Define and record audit criteria, scope, interval & methods
Selection of auditors and conduct of audits ensure objectivity & impartiality of audit process
Plan an audit program
Maintain records of audits & their results
Document procedure to describe responsibilities and requirements for planning and conducting audits & recording and reporting audit results
Management responsible for area being audited to ensure necessary corrective actions are taken without undue delay
Conduct at planned intervals to determine whether the QMS:
Conforms to planned & documented arrangements, requirements of this Standard, QMS requirements & regulatory requirements
Is effectively implemented and maintained
Follow-up activities include verification of actions taken & reporting of verification results
8.2.5 Monitoring & Measurement of Processes
Methods to demonstrate the ability of the processes to achieve planned results
Correction & corrective action to be taken when planned results are not achieved (as appropriate)
Apply suitable methods for monitoring & as appropriate, measurement of QMS processes
8.2.2 Complaint Handling
Document resulting corrective action
Relevant information shall be exchanged between organization and external party involved if an investigation determines activities outside organization contributed to the complaint
Document justification if any complaint is not investigated
Maintain complaint handling records
Document procedures for timely complaint handling in accordance with regulatory requirements
Procedures to include at a minimum requirements and responsibilities for items (a-f)