ISO 13485 and Internal Audit
ISO 13485 Internal Audit Quiz
Test your knowledge on ISO 13485 and internal audit practices with our comprehensive quiz! This quiz is designed to help you understand the key aspects of quality management systems and ensure that you are well-prepared for internal audits.
- Multiple choice questions
- Checkbox selections for deeper insights
- Check your understanding of essential quality management principles
Which documents come under level I in our QMS
Quality Manual and Quality Policy
Quality Procedures
Quality objectives
Formats and records
Management review meeting should be conducted twice in a year?
True
False
What is the frequency to conduct internal audits
Once in a year
Twice in a year
A non-conformity should be issued within how many days by an internal auditor
6
7
8
5
All records, including obsolete documents shall be retained for at least how man years?
Two years or as per applicable regulatory requirements.
Two years
Five years
Ten years
Select the correct sequence of action for CAPA process
Approval of action plan, root cause identification, verification of effectiveness
Root cause identification, approval of action plan, verification of effectiveness
Root cause identification, verification of effectiveness, approval of action plan
Every non-conformity should be followed by a corrective action
True
False
Who is responsible to maintain the effectiveness of QMS?
MR
All employees
Top Management
All of the above
Which are the documents necessary in the quality management system as per the clause 4
Quality manual
Medical device file
Procedures and formats
Quality policy and objectives
All of the above
Which clauses are applicable for purchasing
7.5
7.4
7.3
Cluase 7.5.3 and 7.5.4 are applicable to our organization
True
False
Rework is applicable to us
True
False
Clause 7.5.2 is not applicable to us
True
False
All the customer complaints shall be converted to CAPA
True
False
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