Quality Management System - Scope
1.2 Quality Management System Documented information
1.2.2 Has each site implemented the MDSAP QMS P0002 in the following aspects:
1.2.3 Has the established MDSAP Quality Manual been implemented, including:
1.2.5 Has each site implemented the MDSAP QMS P0007 in the following aspects:
2.1 –Leadership and Commitment - MDSAP Quality Manual – Section 5.1 Leadership and Commitment
2.1.1 Has the RAC demonstrated commitment to the QMS development and improvement by:
2.2 Leadership - Customer Focus
MDSAP Quality Manual – Leadership - Section 5.1.2 Customer Focus
2.3 Leadership - Policy
MDSAP Quality Manual – Leadership- Section 5.2 Policy
MDSAP QMS F0001.1 QMS Policy and Objectives
2.4 Leadership - Responsibility and Authority
MDSAP Quality Manual – Leadership - Section 5.3 Organizational roles, responsibilities and authorities
3.1 Planning - Strategic and Quality Planning
MDSAP Quality Manual – Section 6. Planning
MDSAP QMS F0001.1 QMS Policy and Objectives
4.1 Support – Resources, Competence and Awareness
PROCEDURE MDSAP QMS P0014 – Training
MDSAP Quality Manual – Support – Section 7.1 Resources, Section 7.2 Competence and Section 7.3 Awareness
4.2 Support – Internal Communication
MDSAP Quality Manual – Support - Section7.4 Communication
5.1 Operation – Operational planning and control
5.2 Operation – Release of Product and Services
MDSAP Quality Manual – Operation, Section 8.6 Release of products and services
MDSAP Audit Procedures and Forms
MDSAP Assessment Procedures and Forms
MDSAP products and services: Assessment documentation, audit reports and manufacturer certificates
5.3 Operation – Control of Non-conforming outputs
5.3.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
6.1 Performance Evaluation and Improvement – General
6.2 Performance Evaluation and Improvement – Monitoring, measurement, analysis and evaluation - Customer Satisfaction - Complaints & Feedback
6.2.3 Has each MDSAP site implemented the MDSAP QMS P0011 in the following aspects:
6.3 Performance Evaluation and Improvement – Analysis and Evaluation
6.4 Performance Evaluation and Improvement - Monitoring, measurement, analysis and evaluation - Internal Assessment/Audit and Continual Improvement
6.4.2 Has each MDSAP site implemented the MDSAP QMS P0008 in the following aspects:
6.5 Performance Evaluation and Improvement - Management Review
6.5.2 Do management reviews include at a minimum:
6.5.4 Are management reviews recorded to include:
6.6 Performance Evaluation and Improvement - Improvement – Nonconformity and Corrective Action
6.6.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
6.7 Performance Evaluation and Improvement - Improvement - Continual Improvement
6.7.3 How are data analyzed to provide information and identify opportunities for improvement on:
6.7.6 How is continual improvement of the quality management system facilitated through use of: