ISO 9001 Full Audit Section 4

• Audit Title checklist 4

• Client / Site

• Select date

  Date
• Location
  Address

• Prepared by

Audit Checklist Number - 1/4

• Previous audit reviewed:

• Department

• Author

• Select date

  Date

Reference

• 4.1A - Can you show me where the company have identified needs for the quality system

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• 4.1B - How have you determined the sequence and interaction of these process

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• 4.1C- How does the company determine the methods for operation and control

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• 4.1D- How do you ensure availability of resources and information necessary to support the operation

  Yes

  No

  N/A

• Evidence Viewed

• Auditee

• Compliance improvement opportunity

• 4.1E,F - How do you monitor measure and analyse these processes and how do you ensure continual improvement

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

Audit checklist number 2/4

• Previous audit reviewed.

• Department:

• Author

• Select date

  Date

Reference

• 4.2A - Can you show me the quality policy and quality objectives

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

• 4.2B - Can you show me the quality Integrated manual

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

• 4.2C - Can you show me the documented procedures as required by this standard

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

• 4.2D - Can you show me the documents, records etc that are required to ensure the operations

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

• 4.2E - Can you show me the list of controlled documents retained as per the requirements of the company

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

• 4.2.2 - Can you show me that the Intergrated manual includes

  Yes

  No

  N/A

• Actions

• Evidence Viewed

• Compliance improvement opportunity

Audit checklist number - 3/4

• Previous audit reviewed

• Department

• Author

• Select date

  Date

Reference

• 4.2.2A - Scope of registration and justification of exclusions

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• B - A list of the management procedures

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• C - An indication as to how the key management procedures interact

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• 4.2.3 - Can you show me the document control procedure

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• A - Does it cover hoe documents are approved for their adequacy prior to use and how they are withdrawn

  Yes

  No

  N/A

• Auditee

• Yes

  No

  N/A

• Evidence Viewed

• Compliance improvement opportunity

• B - Does it cover review and updates as necessary and re- approval of documents

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

• C - How many changes identified on new or revised documents

  Yes

  No

  N/A

• Auditee

• Evidence Viewed

• Compliance improvement opportunity

Audit Checklist Number 4/4

• Previous audit reviewed

• Department

• Author

• Select date

  Date

Reference

• 4.2.3E - Where is it described that documents remain legible and readily, identified

  Yes

  No

  N/A

• Auditee

• Evidence viewed

• Compliance improvement opportunity

• F - How are documents of external origins identified, distributed and controlled

  Yes

  No

  N/A

• Auditee

• Evidence viewed

• Compliance improvement opportunity

• G - How is unintended use of obsolete documents prevented and if requested to be retained how are they marked

  Yes

  No

  N/A

• Auditee

• Evidence viewed

• Compliance improvement opportunity