ISO 13485 Exam Questions with Actual Solutions
Internal audits
For building, maintaining, and improving QMS
What are the types of internal audits?
First party audit, second party audit, third party audit
First party audit
internal audit
Second party audit
carried out by a customer or customer's representative, usually to ensure that supplier can meet
client obligations.
Third party audit
carried out by a regsitrar to certify that a QMS is compliant to ISO.
Purpose of audits
make sure everyone is following QMS instructions, make sure that QMS instructions are the best
way to do things, and isolate any opportunities for upgrades.
What process does ISO standard follow?
Plan, Do, Check, Act
PLAN ISO Standards
establish the objectives and processes needed to deliver the QMS results.
, DO ISO standards
Implement the planned QMS process.
CHECK ISO Standards
Audit the QMS processes to make sure that meets regulations, objectives, policies, and reporting
requirements.
ACT ISO Standards
Take actions to improve the QMS
Who can perform an Internal Audit?
Anyone within the organization can perform the internal audit.
What part of ISO 13485 regulates who can perform Internal Audits
ISO 13485 Part 8.2.4 states that auditors cannot audit their own work.
Why are Internal Audits required before the registration audit
To help employees know and implement the QMS, to ensure that the QMS is effective, and to
demonstrate implementation of QMS.
How are annual internal audit schedule set?
Top management in organizations usually prepares an annual internal audit schedule during
management review.
What provides the authority for the audit team to perform internal audits?
The audit schedule created by top management provides the authority.
Internal audits
For building, maintaining, and improving QMS
What are the types of internal audits?
First party audit, second party audit, third party audit
First party audit
internal audit
Second party audit
carried out by a customer or customer's representative, usually to ensure that supplier can meet
client obligations.
Third party audit
carried out by a regsitrar to certify that a QMS is compliant to ISO.
Purpose of audits
make sure everyone is following QMS instructions, make sure that QMS instructions are the best
way to do things, and isolate any opportunities for upgrades.
What process does ISO standard follow?
Plan, Do, Check, Act
PLAN ISO Standards
establish the objectives and processes needed to deliver the QMS results.
, DO ISO standards
Implement the planned QMS process.
CHECK ISO Standards
Audit the QMS processes to make sure that meets regulations, objectives, policies, and reporting
requirements.
ACT ISO Standards
Take actions to improve the QMS
Who can perform an Internal Audit?
Anyone within the organization can perform the internal audit.
What part of ISO 13485 regulates who can perform Internal Audits
ISO 13485 Part 8.2.4 states that auditors cannot audit their own work.
Why are Internal Audits required before the registration audit
To help employees know and implement the QMS, to ensure that the QMS is effective, and to
demonstrate implementation of QMS.
How are annual internal audit schedule set?
Top management in organizations usually prepares an annual internal audit schedule during
management review.
What provides the authority for the audit team to perform internal audits?
The audit schedule created by top management provides the authority.
