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The following checklist can be used as a template for ISO9001:2000 internal audits. Cut and paste this document into an spreadsheet and add your company specific header. The audit check sheet starts with section 4 so that the numbering of all header is synchronized with the ISO 9001:2000 version of the standard. List documentation numbers of procedures and QM sections that demonstrate compliance for each area.

Section 4 is great place to start an internal audit because it address the "big picture" items. If there are any non-conformances from a section 4 audit, fix the problems before auditing sections 5 through 8. This will save a lot of effort documenting the same problem over and over.

Question Reference Documents Notes
4.1 General Quality System Requirements
Has the organization established, documented, implemented and maintained a quality management system in accordance with the ISO 9001 Requirements
Is the Quality Management System (QMS) continually improving?
Does the organization:
1) Identified the process needed for the QMS throughout ISO9001:2000 the organization?
2) Determined the proper interaction between the process ISO9001:2000 Is there a flow chart that shows the process flow for the entire organization?
3) Determined and document criteria and methods to ensure ISO9001:2000 that the operations and process control are effective?
4) Have resources and information necessary to support ISO9001:2000 the operation and maintenance of their process.
5)Measure, monitor and analyze their processes? .
6) Implement corrective and preventive actions needed to achieve the planned results as documented in the quality plans?
7) Have documentation to show continuous improvement of their process?
Does the organization have documentation (Quality Manual, ISO9001:2000 Procedures, Records) to demonstrate that they manage their processes ISO9001:2000 in accordance with the requirements of the ISO 9001 Standard
How does the company control quality processes that are performed outside of the ISO approved facility?
4.2 Documentation Requirements
4.2.1 General
Does the QMS documentation system include:
1) Quality Manual?
2) Documented company quality policy and quality objectives?
3) Documented level 1 and level 2 procedures as required by ISO 9001?
4) Document how the company can effectively plan, operate and control its processes?
5) Creation and management of Records that demonstrate compliance the ISO standard?
4.2.2 Quality Manual
Has a quality manual been created and maintained the includes:
1) The scope of the quality management system and any justification for exclusion to the standard (such as obsolete product lines)?
2) Description of the interaction between the process of the quality management system (usually in the form of a flow chart showing product flow from design and order to delivery and service)?
3) The procedures required by the ISO standard or references to the required procedure control numbers (usually the general statements are in the quality manual and the detailed procedures are separate documents)?
4.2.3 Control of Documentation
Are all QMS documents (manuals, procedures, data sheets, work instructions, records, and procedures) controlled (including revision control, controlled access to originals, control of distributed copies)?
Does the company have a document control procedures that including:
1) Notification (and pre-approval) of the ISO approval body prior to implementation of any change to a agency controlled document?
2) Approval, update and distribution processes for changes to all quality documents (May be part of the ECO procedure)?
3) Ensure that the current revision documents (with no confusion about the current revision) are available at the point of use?
4) Ensure that the documents remain legible and easily identifiable?
5) A process for controlling documents of external origin
6) Control of obsolete documents to assure they are not used in current production.
4.2.4 Control of Records
Does the company create and maintain records to provide evidence of conformity to the requirements (examples include test and production records, customer order files )?
Does the company have records to provide evidence that the QMS is effective (examples include management review records, corrective and preventive actions logs, customer survey or feedback records)?
Has a documented procedure been written to define the following record control mechanisms:
Identification and retrieval?
Storage and protection (to prevent loss or miss-use of the records, passwords and keys)?
Retention time and Disposition (each type of record should have a defined period for retention)?

Go To ISO 9001:2000 Audit Checklist Section 5