ISO 9001 Full Audit Section 7

• Audit Title checklist 7

• Client / Site

• Conducted on

  Date
• Location
  Address

• Prepared by

Section 7. Product Realisation (Planning of product realisation

• 7.1A. What quality objectives & requirements are recorded for provision of service

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. What processes are put in place prior to service delivery

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• C. What verification/ Validation monitoring and inspection activities are required for each project

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• D. What records are generated which provide evidence that the realisation process meets requirements

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 2/7

• Previous Audit Reviewed

• Department

• Auditor

• Select date

  Date

Reference 7.2.1. How does the Organisation Determine

• A. Requirement specified by the customer including delivery and post- delivery activities such as maintenance

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. Requirements not stated by the customer but necessary for the projects completion

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• C. Statutory and regularly requirements related to the project

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• D. Any additional requirements determined by the organisation

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 3/7

• Previous Audit Reviewed

• Department

• Auditor

• Select date

  Date

Reference 7.2.2 Can you show me evidence of review of the project requirements prior to commitment to supply - this will include

• A. Product requirements are defined

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. Order requirements differing from those previously expressed are resolved

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• C. The organisation has an ability to meet defined requirements

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• General. When the customer provides no documented statement, the requirements shall be confirmed by the organisation before acceptance ( Can you Evidence )

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 4/7

• Previous Audit Reviewed

• Department

• Auditor

• Select date

  Date

Reference 7.2.3. How does the company determine and implement effective arrangements for communicating with customer in relation to -

• A. Product Information

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. Enquires, Contracts or order handling including project amendment s

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• C. Customer Feedback including Compliants

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 5/7

• Previous Audit Reviewed

• Yes

  No

  N/A

• Department

• Auditor

• Select date

  Date

Reference 7.4. Purchasing -

• 7.4.1. How to evaluate and select supplies. What is the selection and valuation critera

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

7.4.2. Does purchase information describe:

• A. Requirements for approving product, procedures, processes and equipment

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. Requirements for Qualifications

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.4.3 Verification of purchased product

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5. Production and service provision

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5.1A. What information is available to describe the characteristics of the product

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 6/7

• Previous Audit Reviewed

• Department

• Auditor

• Select date

  Date

• 7.5.1B. What work instructions are available to staff

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• C. How do you ensure equipment is suitable

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• D. How do you ensure monitoring and measuring equipment is suitable

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• E. How do you determine what measure and monitoring is required

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• F. What arrangements are in place for product release, Delivery & Post delivery activities

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5.2. Validation/ Verification

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5.3. Identification and Traceability

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5.4. How are customer supplied goods identified, Verified and protected

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• 7.5.5. Can you demonstrate how products are managed during projects

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Audit Checklist Number 7/7

• Previous Audit Reviewed

• Department

• Auditor

• Select date

  Date

Reference 7.6. Control of Monitoring and Measuring Equipment

• A. How is the measuring monitoring equipment managed

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• B. Can you show me that equipment can not be adjusted or re- ajusted

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

7.6C. Can you show me that the calibration status can be determined

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• D. That the equipment has been safeguarded from adjustments

  Yes

  No

  N/A

• Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

• E. That the equipment has been protected from damage and deterioration during handling maintained and storage. If equipment is found to be out with calibration what action is taken

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance / improvement opportunity

Action Taken

• By Whom

• Category

• Add signature

  Sign

Action Taken

• By Whom

• Category

• Add signature

  Sign