ISO 9001 Consulting-Framework for a Process Audit Checklist

By | June 24, 2017

ISO 9001 Consulting
How To Create and Use ISO 9001 Process 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”.

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 Framework for a Process Audit Checklist 

Process
– Identify the QMS process
– Identify the Process owner/responsibilities

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 process risks
– Responsibility & Authority
– Quality Status –pass/fail indicator
– Identification/traceability/ownership
– Handling/packaging/transportation mode
– 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 Framework for a Process Audit Checklist
For each line item on the above checklist, you must ask questions as appropriate to gather objective evidence for controls for each of the items listed under each heading. The most effective form of questions you should ask should be along the lines of -Who, What, When, Where, Why, How, Show Me.

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