Evaluate need and identify action to prevent reoccurrence?.A description or illustration of the interrelation of the processes of the QMS? Does the Quality Manual outline the structure for the documentation used in the QMS? Additional Questions 4.2.3 Medical Device File Is a medical device file maintained for each medical device type or medical device family? ©2016 5.The documented procedures (6) established for the QMS, or reference to them?.The scope of your QMS including the details of and justification for any exclusion and/or non-application in clauses 6, 7 or 8?.Other documentation required by national or regional regulations? ©2016 4 When the standard specifies that a requirement, a procedure, an activity or arrangement be “documented”, is it implemented and maintained? Additional Questions 4.2.2 Quality Manual Review the Quality Manual (if available).Availability of the required documents?.A list or other means of identifying the documentation required by your QMS?.Documents required to ensure the effective planning, operation and control of your processes?. Documented procedures (6) required by the standard?.
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