ISO 9001 Audit Checklist
How To Create and Use ISO 9001 Audit Checklists
ISO 9001 places heavy emphasis on using a process based approach to implementing your quality management system. To understand what this means, read Process Approach
ISO 9001 Audit Checklists
Internal audits are a necessary tool to monitor and maintain the health of management systems. Audits are used to determine the extent management systems conform to requirements and whether they have been effectively implemented and maintained. Requirements may be:
- Stated by your customers,
- Defined by your policies and procedures,
- Stipulated in government regulations,
- Established as industry standards, or
- Specified in the applicable management system standards.
Sample Process Audit Checklist
Control Requirements:
Process
- Identify QMS process
- Identify Process owner
Process Inputs/Outputs
- From customer (physical or information)
- From supplier (physical or information)
- From regulatory body (information)
- From internal (physical or information)
- To customer (physical or information)
- To regulatory body (information)
- To next process (physical or information)
- To supplier or sub-contractor (physical or information)
Controls for Input/Output/Conversion
- Identify Applicable Risk
- Identification/traceability/ownership
- Handling/packaging/transportation mode
- Quality Status –pass/fail indicator
- Protection/preservation
- Environment/safety/health
- Communication/interaction
- Capability/Capacity/availability
- Storage space
- Inventory control
- Availability & use
- Documentation
- Records
- Competence
- Maintenance/
- Calibration
Input/Output/Conversion - Quality
- Measuring & monitoring equipment
- Measurement/test/check/monitoring method
- Measurement frequency/scope/criteria
- N/C Handling/disposition
- Sample size
- Monitoring method
- Performance objective/indicator
- Quality records
Conversion (value-adding) Activity
Nature of activity:
- Manual
- Automated
- Steps/flow
- Technology
- Set up
Resources
- Machinery & equipment
- Tools, Molds & fixtures
- Facility
- Transportation Equipment
- Information Systems
- Measuring & monitoring equipment
- Material Handling equipment
- Labor
How To Use This Process Audit Checlist
For each line item on the above checklist, you must ask questions as appropriate to gather objective evidence about the process in terms of the above headings. The most effective form of questions you should ask should be along the lines of -Who, What, When, Where, Why, How, Show Me. To learn more about auditing, go to ISO 9001 Auditor Training Course.
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