Quality Management System | Observation/Comments | Results |
General Requirements | | |
Has your organization established a management system (QMS) giving consideration to: - Identifying the processes
- needed and the application of the processes throughout the organization:
- Determining the sequence and interaction of the processes?
- Determining the criteria and methods for operation and control of the processes?
- Ensuring the availability of resources and information to support the processes?
- Monitoring, measuring, and analyzing these processes?
- Implementing actions to achieve planned results and continual improvement?
If your organization outsources any processes that affect product conformity, are the outsourced processes controlled and identified? | | |
Documentation Requirements | | |
Quality Manual | | |
Does your organization have a quality manual? Does it include the following: - The scope of your QMS and justifications and details of any exclusions
- The documented procedures for the QMS or reference them?
- A description of interactions between the processes of the QMS?
| | |
Control of Documents | | |
Does your organization have a formal procedure regarding the control of documents for your organization: Does this procedure address the following items: - Are documents approved before the issue?
- Are documents reviewed and updated as necessary and then re-approved?
- Are changes and the current revision status of documents identified?
- Are relevant versions of applicable documents available at points of use?
- Are documents legible and readily identifiable?
- Are documents of external origin identified and their distribution controlled?
- Is a mechanism in place to prevent unintended use of obsolete documents: Are old documents identified if retained?
| | |
Control of Quality Records | | |
Does your organization have a formal procedure for the control of quality records? Are quality records legible, readily identifiable, and retrievable? Does the procedure describe the identification, storage, protection, retrieval, retention time, and disposition of records? | | |
Management Responsibility | | |
Management Commitment | | |
Has top management demonstrated commitment to both the development and implementation of the QMS and to continual QMS improvement by: - Communication the importance of meeting customer requirements and statutory/regulatory requirements:
- Establishing a written quality policy?
- Identifying quality objectives
- Conducting management reviews?
- Ensuring resources are available?
| | |
Customer Focus | | |
Does your organization have a process in place to identify your customer requirements? Are your customer needs and requirements identified continually? Is your organization aimed at achieving customer satisfaction? | | |
Quality Policy | | |
Has top management established a quality policy that: - Is appropriate to the purpose of your organization?
- Includes a statement of commitment to meet requirements and continually improve?
- Provides a framework for establishing and reviewing quality objectives?
| | |
