Downloads - Quality Management System Requirements
The requirements of international standards (e.g. ISO) include provisions for certain requirements to be in place and documented in the organisations quality managements system. In addition to having processes that ensure operations and support functions are effectively coordinated and implemented to provide the services to clients' requirements, the organisation's requirements and legal requirements, the following need to be developed and managed:
- Quality Manual: : Uses the various ISO standards requirements as framework and references the company's various internal systems to illustrate compliance with the ISO standards requirements.
- Human Resources Requirements: The positions/people who have received training in their QMS roles including Management Representative, Document Controller and Internal Quality Auditors./li>
- Internal Quality Audit (IQA): The IQA Schedule and department/operational IQA Checklists complete with Audit Reports assess the extent of compliance with the QMS and recommend corrective action where required.
- Management Review Meetings: : ISO standards require, and provide the agenda for, the senior management to hold periodic meetings to discuss the status of the QMS and opportunities for improvement.
- System Requirements Include: Document & Data Control, Control of Quality Records, Preventive Action, Corrective Action, Client Facilities, Product Identification & Traceability and Non-Conforming Product.