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MDSAP exercises meticulous control over the duration of audits, taking into account various factors. Th ese include the
complexity of the manufacturer’s operations, the scope of the audit, and the size of the organization. Th e key considerations in
duration determination include:
•
Size and Complexity of the Manufacturer:
Larger or intricately structured organizations may require extended audit durations to thoroughly assess all pertinent areas
of their quality management system (QMS) and regulatory compliance.
•
Scope of the Audit:
Th e audit’s scope defi nes the extent of the manufacturer’s operations under evaluation. A broader scope encompassing
multiple sites or an extensive range of products may necessitate a more prolonged audit duration.
•
Number of Sites and Locations:
Manufacturers with multiple sites or facilities may require additional time for on-site inspections and the assessment of
quality management systems at each location.
•
Range of Products and Processes:
Manufacturers producing a diverse array of medical devices or involved in complex manufacturing processes may necessitate
more time for a comprehensive evaluation.
•
Regulatory Requirements of Participating Countries:
Specifi c regulatory requirements of participating countries may infl uence the depth and breadth of the audit, potentially
aff ecting its duration.
•
Risk-Based Approach:
Th e risk assessment performed by the audit team may guide the allocation of time to higher-risk areas, potentially aff ecting
the overall audit duration.
•
Cooperation and Accessibility of the Manufacturer:
Th e readiness and cooperation of the manufacturer during the audit process can signifi cantly contribute to the effi ciency of
the assessment.
Ultimately, the audit team determines the audit duration based on a judicious consideration of these factors. Eff ective
communication and collaborative eff orts between auditors and manufacturers are crucial to ensure the audit is comprehensive
and conducted effi ciently.
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Distinct from other audits, MDSAP rigorously controls the grading of nonconformities. All fi ndings are assessed on a scale
of 1 to 5. Nonconformities graded as 4 or 5 are deemed critical fi ndings and are promptly reported to the relevant regulatory
authorities. Four factors infl uence the grading of nonconformities.
•
Impact on Quality Management System (QMS):
Nonconformities are stratifi ed based on their impact, categorized as either indirect or direct QMS impact.
a. Indirect QMS Impact:
Pertains to clauses considered “enablers” for the QMS, indirectly infl uencing medical device safety and performance. (ISO
13485:2016 clauses 4.1 through 6.3 (except 4.2.3))
b. Direct QMS Impact:
Relates to clauses with a direct infl uence on design and manufacturing controls, directly aff ecting medical device safety and
performance. (ISO 13485:2016 clauses 6.4 through 8.5 (except 8.2.4))