ISO 9001:2015 Audit Checklist - By Dept

Information

ISO 9001:2015 Audit Agrana Fruit Australia. Note: This template has been reviewed & screened to audit each department against specific ISO 9001:2015 criteria as opposed to the entire standard / checklist

Conducted on
Audit Completed By:
Department being Audited
- Commercial
- Procurement
- Finance
- Human Resources
- NPD
- Business Management (GM)
This internal audit is completed inline with the ISO 9001:2015 Standard. Refer following file path to access a copy: Z:\Common\Food Safety & Quality Systems\4 Reference Material\ISO 9001-2015
To minimise risk of auditing bias. It is recommended that the internal auditor does not audit their own department.
Upon completion of this audit, the auditor will consult with the auditee and key stakeholders for agreement. As necessary the QA Compliance Manager can adjudicate (if needed).
The QA Compliance Manager will register any non-conformance(s) within the internal audit NC Register (AFQA-REG-0015) and issue a Corrective Action Report (CAR) to the respective department Manager & key stakeholders to action accordingly.
The Department Manager must apply corrective action and return completed CAR to the QA Compliance Manager within the specified time. The Compliance Manager shall review all CAR's to ensure they are managed in a timely manner

ISO audit checklist

This internal audit will evaluate the compliance of the department Management System in compliance with ISO 9001:2015 requirements. Remember to attach evidence to items where required, and to sign off and complete this assessment in the final section.
During the course of the audit, some documentation may be considered Confidential and thus photographic evidence may not be permitted. In this instance, record in the "Notes" section, "Document confidentiality, sighted SOP, Contract etc..." and record the document name and reference number reviewed.

Has there been any significant changes in the past 12 months? (If YES, please elaborate and record brief summary). Note: A significant change may be considered as a change that has had a detrimental impact on the department &/or normal operational process.
undefined

Does the department have company procedures (i.e. Work Instruction; Standard Operating Procedures; Forms etc) in place?
Are the company procedures (SOP, Work Instructions, Forms etc.) document controlled . Record evidence of such documents.
Verify how knowledge is maintained and made available for staff to fulfill their role. i.e. Training Docs, Procedures, Literature, Specification, WI's etc, (especially with new staff)
Has training been applied to existing and new staff to fulfill their role? How has this been documented (i.e. competency assessment, toolbox etc)

Verify how the department continually improves. Does the department conduct Management / Performance reviews & evaluates KPI's; Risks & Opportunities that shall be addressed as part of continual improvement?
Verify what methods are used to monitor, measure and evaluate processes (KPI's?) to achieve intended results.
Are Risks & Opportunities identified with an action plan developed to address?
At what frequency are these Management / Performance reviews undertaken?
Verify status of actions from previous management reviews
Does the department conduct performance reviews (KPI's; Risks; Opportunities) for their staff?
Briefly describe how this is managed
Are job descriptions available for all staff within the department? (New and long term employees)

Verify how internal & external non-conformance are considered & identified. What corrective actions are taken to address them. How is this managed?
How are NC's communicated
Is an NC register in place?
Are non-conformance's addressed and closed out in a timely manner (where applicable)

How are department staff aware of the business, department & personal objectives.
Do periodic meetings occur within the department
How are these meetings documented
Are actions assigned as part of these meetings? If so, are corrective action monitored for effectiveness?
Verify how departmental changes are communicated / managed. (example: New product / raw material introduction, New customer / Supplier, Service provider change, Product changes etc)
Verify how other means of communication may occur within the department

Verify how the department ensures that the resources provided are suitable for the specific type of role / activities being undertaken (i.e training, competency assessment, feedback review mechanisms)
Are new employees being trained correctly? How is this managed & documented

Verify appropriate documentation is in place for Customers; Supplier(s); Service Provider(s); Vendors &/or Employees. Choose an example and follow process / documentation through
Verify how the department reviews contracts, order requirements (for delivery and post-delivery), Supplier, Vendor and Employee performance.
Does the department monitor & report KPI performance (eg. customer, supplier, vendor, employee). How is this completed and what is the frequency?

Does a New Product Development Process exist.
Is this process communicated to all NPD personnel
Verify New Product Development process by choosing an example and following the process / documentation through from concept through to Commercialisation.
Does NPD lab & Magic Lab have equipment that requires calibration
List equipment or Document Reference (Name / Number)
Is equipment verified internally? Are results recorded (i.e Register) and compliant. If non compliance is evident, are corrective actions in place?
Is equipment calibrated externally by third party. Provide evidence of last test to ensure currency

Sign Off

I, the undersigned, have completed this audit in an accurate manner. I have attached evidence as required and declare this assessment complete.
Full name and signature of auditor
I, the auditee, accept all findings including any non-conformances raised and issued as part of this internal audit
Full name and signature of auditee