ISO 9001 audit in manufacturing

In a manufacturing setting you can ask questions related with clauses:

• 7.1.3; 7.1.4; 7.1.5
• 8.5; 8.6; 8.7

You can check if preventive maintenance is done, if critical environmental conditions are satisfied, if monitoring and measuring resources are calibrated or verified.

Look into clause 8.5.1 that details several relevant topics.

• Products and Services to be produced defined and characterized with results to be obtained
• Availability of adequate monitoring and measurement resources
• Process and Products and Services control defined and implemented
• Adequate and available infrastructure and environment
• Competent and available people
• Special processes periodically validated and revalidated
• Prevention of human error
• Release, delivery and post-delivery activities 

You can check if traceability is a requirement and if that is so if it works.

You can check if the control state is clear

You can check if process control activities are done and recorded if required.

You can check if quality control activities are done and recorded

You can check if nonconformities are treated

You can check if mandatory records are kept. You can check if documents and records, decided by the organization as relevant, according to clause 4.4.2 are kept or maintained.

You can find more information below:

• List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
• ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance - https://advisera.com/9001academy/blog/2015/11/03/iso-90012015-clause-8-5-product-realization-practical-examples-for-compliance/
• Record of Traceability [ISO 9001:2015] - https://advisera.com/9001academy/documentation/record-traceability/
• Free online training ISO 9001:2015 ISO 9001:2015 Internal Auditor Course - https://advisera.com/training/iso-14001-internal-auditor-course/ nal-auditor-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/