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5.5 Responsibility, Authority, and Communication
Verify responsibilities and authority are defined and communicated.
Are responsibilities and authority clearly defined and communicated?
Organizational Charts, Job Descriptions
Check the appointment and responsibilities of the Quality Assurance Director.
Is the Quality Assurance Director appointed and their responsibilities defined?
5.5.1 Executive Management Representative
Confirm Functional Managers understand and implement Quality Policies.
Do Functional Managers understand and implement Quality Policies?
5.5.2 Functional Management
Verify internal communication processes are effective.
Are internal communication processes effective?
5.5.3 Internal Communication
Ensure management reviews are conducted, documented, and include necessary inputs and outputs.
Are management reviews conducted and documented, including all necessary inputs and outputs?
Management Review Records, Review Agendas
5.6 Management Review
Confirm resource provision for implementing and maintaining the QMS.
Are adequate resources provided for implementing and maintaining the QMS?
Resource Allocation Records, Budget Reports
6. Resource Management
6.1 Provision of Resources
6.2.1 Competency, Awareness, and Training
Verify training and competency requirements are defined and met.
Are training and competency requirements defined and met?
6.2 Human Resources
Check if position descriptions are controlled and reviewed.
Are position descriptions controlled and regularly reviewed?
6.2.2 Position Descriptions
6.2.3 Personnel Reviews and Appraisals
Ensure periodic reviews and appraisals are conducted.
Are periodic personnel reviews and appraisals conducted?
Verify infrastructure requirements, including facilities and equipment, are met.
Are infrastructure requirements for facilities and equipment met?
Infrastructure Maintenance Records, Facility Audit Reports
6.3 Infrastructure
Confirm work environment requirements are defined and maintained.
Are work environment requirements defined and maintained?
Work Environment Policies, Environmental Monitoring Records
6.4 Work Environment
Ensure planning includes quality objectives, resource needs, and validation activities.
Does planning include quality objectives, resource needs, and validation activities?
Product Realization Plans, Quality Objectives
7. Product Realization
7.1 Planning of Product Realization
Verify contract review processes and customer requirement determinations.
Are contract review processes and customer requirement determinations verified?
7.2.1 Determination and Review of Requirements
7.2 Customer-Related Processes
Confirm effective communication with customers.
Is there effective communication with customers?
7.2.2 Customer Communication
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