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Health Canada Registrars and MDSAP Auditing Organizations Quiz

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Health Canada Registrars and MDSAP Auditing Organizations Quiz

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Questions and Answers

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?

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?

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?

Share the outcomes with participating Regulatory Authorities Signup and view all the answers

When are special audits and unannounced audits typically conducted?

In case of noncompliance within the audit cycle Signup and view all the answers

What is the purpose of the list of Registrars Recognized by Health Canada?

To identify the registrars recognized by Health Canada for medical device auditing Signup and view all the answers

What is the IMDRF MDSAP WG N4 focused on?

Competency and Training Requirements for Auditing Organizations Signup and view all the answers

In the Auditing Organization Assessment Cycle, what occurs during Year 0?

Initial Assessment Signup and view all the answers

What is the outcome of a Grade 1 nonconformity in Auditing Organization Assessment?

Unlikely to have a direct impact on the organization's operations Signup and view all the answers

What is the purpose of On-Site Assessment of Critical Locations for Auditing Organizations?

To ensure compliance with regulatory requirements at critical locations Signup and view all the answers

What is the scale used to grade nonconformities identified during an audit?

1 to 5 Signup and view all the answers

What triggers the performance of an unannounced audit in some cases?

High grade nonconformities Signup and view all the answers

Which organizations will be allowed to apply to the MDSAP program for recognition?

Accredited organizations/registrars utilized in the Health Canada CMDCAS Program Signup and view all the answers

What documents do Auditing Organizations issue upon successful certification or recertification audits?

MDSAP specific certification documents Signup and view all the answers

What must the manufacturer provide and the Auditing Organization review after high grade nonconformities are identified?

Remediation plans and evidence of implementation of these plans according to a specified timeline Signup and view all the answers