Quality 2 (Apprenticeship)

This module is designed to provide students with an understanding of the purpose of quality management systems, and of the relationship between the different ISO quality standards. Learners will appreciate the impact that Risk Assessment has on the decision-making process for manufacturing firms. The module also introduces Process Validation, and Corrective and Preventive Action.

1. Describe the purpose of a quality management system and explain the 8 principles of quality management.

2. Explain the purpose, content and interrelationship of quality management standards ISO9000, ISO13485, auditing and assessment standards ISO9004, ISO19011 and sustainability standards ISO14000, ISO15001 and ISO2600. 

3. Explain Risk Management, how to identify and quantify risks, decide on the acceptability of those risks and re-evaluate risks following corrective actions. Explain the impact that ISO14971 Risk Management has on the decision-making process in the medical device industry. 

4. Apply various risk assessment methodologies such as FMECA, Fault Tree Analysis and HAZOP. 

5. Explain the context of Process Validation within the quality management system and describe the steps needed to conduct a Process Validation.

6. Identify and distinguish between a correction, corrective action and preventive action and identify a process to implement corrective/preventive actions.