ISO 13485 audit checklist about Resource management
ISO 13485 audit checklist about Resource management
Clause 6.0
6.1 Provision of resources
• What resources has Organization provided to implement and maintain the QMS and continually improve its effectiveness?
• What resources has Organization provided to ensure that customer and regulatory requirements are met?(See 6.2, 6.3, 6.4)
6.2 Human resources
6.2.1 General
• What are the education, training, skills and experience required by this job/task?
• How does this person meet those qualifications?
6.2.2 Competence, awareness and training
• How do you determine the necessary education, training, skills and experience for people performing work affecting product quality?
• What training or other actions do you provide to satisfy the needs of personnel?
• When you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records)(Sample throughout organization)
• How do your activities contribute to the achievement of quality objectives?
• Where do you maintain records of education, training, skills and experience?
• NOTE National or regional regulations might require the organization to establish documented procedures for identifying training needs.
6.3 Infrastructure
• Are the buildings, workspace, and utilities appropriate to meet product requirements? How are they maintained?
• What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained?
• What supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained?
• Documented requirements?
• Records?
6.4 Work environment
• What kind of work environment is required to achieve conformity to product requirements? How is this environment managed and maintained?
• Documented requirements and work instructions
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