Professional Documents
Culture Documents
Context
4.1 Understand your organization and its unique context
• Clarify boundaries and think about what your QMS should apply to.
• Establish documents and records that define the scope of your QMS.
5. Leadership
5.1 Provide leadership by focusing on quality and customers
6.1.1 Consider risks and opportunities when you plan your QMS
7. Support
7.1 Support your QMS by providing the necessary resources
7.1.2 Provide suitable people for your QMS and your processes
• Identify the people that you need in order to operate your QMS processes.
• Identify the people that you need in order to control your QMS processes.
• Provide the people that you need in order to operate your QMS processes.
• Provide the people that you need in order to control your QMS processes.
• Identify those under your control who do work that affects quality.
• Select all the documents and records that your QMS needs.
8. Operations
8.1 Develop, implement, and control your operational processes
• Verify that you are capable of meeting product and service requirements.
• Clarify all differences between your original proposal and final order.
• Confirm that you can meet specified product and service requirements.
• Ensure that outputs facilitate and support product and service management.
8.4.1 Evaluate and select external providers of processes, products, and services
• Identify risks related to the external provision of processes, products, and services.
• Define data and criteria to manage external process, product, and service providers.
• Establish controls for all externally provided processes, products, and services.
• Assign responsibility and authority for deciding if external providers are used.
• Define the actions to take when external providers fail to meet requirements.
8.4.2 Establish external provider controls and carry out external verifications
• Establish a process to evaluate the accuracy of test data and test reports.
8.4.3 Discuss requirements with external process, product, and service providers
• Retain the documents and records that are needed to facilitate traceability.
• Preserve outputs by setting up shelf life controls and by rotating your stock.
• Identify the activities that must be carried out after product delivery.
• Identify the activities that must be carried out after service delivery.
• Identify the people who may authorize the release of products to customers.
• Identify the people who may authorize the release of services to customers.
8.7.2 Document your nonconforming outputs and the actions that are taken
9. Evaluation
9.1 Monitor, measure, analyze, and evaluate QMS performance
9.1.1 Plan how you're going to monitor, measure, analyze, and evaluate
• Plan how you're going to monitor, measure, analyze, and evaluate your QMS.
10. Improvement
10.1 Determine improvement opportunities and make improvements
10.2.2 Document your nonconformities and the actions that are taken