ISO 13485 Knowledge
ISO 13485 Knowledge Quiz
Test your understanding of ISO 13485 with our comprehensive quiz designed for professionals in the medical device industry. This quiz features 10 multiple-choice questions that cover key sections of the ISO standard and its requirements.
- Evaluate your knowledge of quality management systems.
- Prepare for certification and compliance.
- Enhance your expertise in ISO standards.
What sections could be excluded from the ISO scope?
Section 4, 5, 6, 7 and 8
Section 5, 6, 7 and 8
Section 6, 7 and 8
Section 7 and 8
What word indicate a requirement?
Shall
Should
May
Can
What is not required to include in the quality manual?
Scope
Records
Documented procedures
Interaction between the processes
Records shall....
Remain legible, readily identifiable and retrievable
Readily identifiable and retrievable
Remain legible and readily identifiable
None of them
The management representative has responsibility and authority that includes...
Ensuring that processes needed for the QMS are documented
Reporting to top management on the effectiveness of the QMS and any need for improvement
Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organisation
All of them
None of them
What shall be documented during design and development planning?
A less as possible
Design & development stages
Review(s) needed at each design and development stage
Resources needed
Responsibilities and authorities for design and development
Method of traceability
What shall be done with changes before implementation?
Reviewed and verified
Validated and approved
Reviewed and approved
Reviewed, verified, validated and approved
What data should be analysed?
Feedback, Audits and Suppliers
Service Reports and Conformity to product requirements
Eedback, Audits, Suppliers and Service Reports
Feedback, conformity to product requirements, characteristics and trends of processes and product, suppliers, audits and service reports
How should an orgasation dealth with a non-conforming product (detected before delivery)?
Taking action to authorise its use or release
Taking Action to eliminate the detected nonconformity
Taking action to preclude its original intended use or application
Authorizing its use, release or acceptance under concession
What purchasing information shall be described or referenced?
Product specifications and QMS requirements
Product specifications
Product specifications, requirements for qualification of supplier personnel and QMS requirements
Product specifications, requirements for qualification of supplier personnel, requirements for product acceptance, procedures, processes and equipment and QMS requirements
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