Regulatory Compliance & Quality Assurance Flashcards

Which ISO standard specifies requirements for a quality management system?

Answer: ISO 9001

ISO 9001 is the QMS standard; 14001 is environmental, 27001 information security, 45001 occupational health and safety.

What is the purpose of a risk-based approach to quality assurance?

Answer: Focus resources on areas with the greatest potential impact on quality or compliance

Risk-based thinking prioritizes controls where failure would matter most.

During a regulatory inspection, the most appropriate way to respond to a request for records is to:

Answer: Provide accurate, complete records promptly through a designated contact

Cooperation with accurate, unaltered records via a designated point of contact is the compliant approach.

A control chart is used in quality assurance to:

Answer: Monitor process stability over time and detect unusual variation

Control charts distinguish normal variation from special-cause variation in a process.

Which best describes 'validation' of a process?

Answer: Documented evidence that a process consistently produces results meeting predetermined requirements

Validation provides documented, high-assurance evidence of consistent performance.

Employee compliance training records are important primarily because they:

Answer: Demonstrate that staff were trained on required policies and regulations

Training records provide evidence of competence and awareness for audits and inspections.

If an audit identifies an observation or 'opportunity for improvement,' it generally means:

Answer: No requirement was violated, but a potential weakness or improvement was noted

Observations flag potential issues that are not yet formal nonconformities.