3.1 The following key terms and phrases are defined to ensure a standard interpretation and understanding of the QMS and internal QA procedures.
A concern is a derived conclusion, supported by objective evidence that may become a Finding. A concern may generate a Preventive Action.
Controls are management and operational techniques, activities, and procedures that monitor the satisfactory performance of the organisation’s operating processes and procedures.
Evidence is a documented statement of fact that is based on observations, measurements, or tests that can be verified in a physical way, e.g. copies of documents or parts of documents, images showing the issue, signed file note or statement of circumstances, etc.
A finding is a conclusion, supported by objective evidence that demonstrates noncompliance with a specific procedure, requirement or standard. A finding will generate a Corrective or Preventive Action.
An inspection is the act of observing, measuring, testing, or gauging one or more characteristics of a particular event or action. This is to ensure that correct procedures and requirements are followed during the accomplishment of that event, or action.
3.1.6 Quality control (QC)
QC are procedures to ensure a manufactured product or service complies to a defined set of quality criteria, or meets the requirements of the client or end-user.
3.1.7 Quality Assurance (QA)
QA ensures a number of products or services meet consistently the specified requirements.
3.1.8 Quality Management System (QMS)
The quality management system is the glue that bonds all the following together:
- The organizational structure
- The procedures
- The processes
- The resources
All needed to implement a successful quality management system.
3.1.9 Root cause
The root cause is the underlying organisational or technical system cause, or causes, of any finding or concern.