Podcast
Questions and Answers
What type of audits may occur at any time within the audit cycle in case of noncompliance?
What type of audits may occur at any time within the audit cycle in case of noncompliance?
- Internal audits and external audits
- Regular audits and scheduled audits
- Process audits and compliance audits
- Special audits and unannounced audits (correct)
What is the purpose of the audit sequence in medical device manufacturers' audits?
What is the purpose of the audit sequence in medical device manufacturers' audits?
- To create a standardized audit template
- To allow for logical, focused, and efficient audit conduct (correct)
- To minimize the number of audits conducted
- To support pre-market and post-market compliance
What process do MDSAP audits follow?
What process do MDSAP audits follow?
- Regulatory audits focusing on marketing authorization and facility registration
- Outcome-based audits focusing on post-market compliance
- Random audits conducted without any predefined process
- Process based audits following 7 specific processes (correct)
What do Auditing Organizations do with the audit outcomes?
What do Auditing Organizations do with the audit outcomes?
When are special audits and unannounced audits typically conducted?
When are special audits and unannounced audits typically conducted?
What is the purpose of the list of Registrars Recognized by Health Canada?
What is the purpose of the list of Registrars Recognized by Health Canada?
What is the IMDRF MDSAP WG N4 focused on?
What is the IMDRF MDSAP WG N4 focused on?
In the Auditing Organization Assessment Cycle, what occurs during Year 0?
In the Auditing Organization Assessment Cycle, what occurs during Year 0?
What is the outcome of a Grade 1 nonconformity in Auditing Organization Assessment?
What is the outcome of a Grade 1 nonconformity in Auditing Organization Assessment?
What is the purpose of On-Site Assessment of Critical Locations for Auditing Organizations?
What is the purpose of On-Site Assessment of Critical Locations for Auditing Organizations?
What is the scale used to grade nonconformities identified during an audit?
What is the scale used to grade nonconformities identified during an audit?
What triggers the performance of an unannounced audit in some cases?
What triggers the performance of an unannounced audit in some cases?
Which organizations will be allowed to apply to the MDSAP program for recognition?
Which organizations will be allowed to apply to the MDSAP program for recognition?
What documents do Auditing Organizations issue upon successful certification or recertification audits?
What documents do Auditing Organizations issue upon successful certification or recertification audits?
What must the manufacturer provide and the Auditing Organization review after high grade nonconformities are identified?
What must the manufacturer provide and the Auditing Organization review after high grade nonconformities are identified?
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