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 subcontractor (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
|
|
- Labour
|
How To Use This Process Audit CheclistFor 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 about
auditing, go to ISO 9001 Auditor Training Course
 Call us today at 905-593-8867 or email
us at artjlewis@rogers.com
for a no obligation review of your specific
needs
| 
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