Procedure Template for ISO 9001

Document Title: [Procedure for _________] Document Number: [Unique Identifier] Revision Number:
[Revision Number] Effective Date: [Date] Reviewed By: [Reviewer’s Name] Approved By: [Approver’s
Name]

1. Purpose

Describe the purpose of the procedure, focusing on the process or activity it addresses and its importance in
terms of quality.

Example: "The purpose of this procedure is to ensure consistent and high-quality [process/activity] that meets
customer requirements and organizational objectives."

2. Scope

Define the scope of the procedure, specifying what it includes and, if necessary, what it does not include.

Example: "This procedure applies to [specific activities, departments, products, or services]. It does not cover
[any exclusions]."

3. Responsibilities

List who is responsible for different aspects of the process. Define roles and responsibilities clearly.

Example:

 "Project Manager: Responsible for overseeing the [specific process]."

 "Quality Control Team: Responsible for monitoring and ensuring compliance."

4. Definitions

Include any specific terms or acronyms used in the procedure, providing clear definitions.

Example: "Non-conformance (NC): Failure to meet specified requirements."

5. Procedure

Break down the process into clear, numbered steps. Include input and output for each step if applicable.

5.1 [Step Title]

 Detail the actions required for this step.

 Include who performs the action and any necessary equipment or documents.

5.2 [Next Step Title]

 Continue with sequential steps.

6. Records
Specify the records that need to be maintained for this procedure. Mention where and how they should be
stored.

Example: "All inspection reports must be recorded and stored in the Quality Management System (QMS)
database."

7. Monitoring and Measurement

Explain how the process will be monitored and measured for effectiveness.

Example: "Performance of [process/activity] will be monitored through [specific metrics or KPIs]."

8. Non-Conformities and Corrective Actions

Describe the process for handling non-conformities, including corrective actions and preventive measures.

Example: "In case of non-conformity, the following corrective action process will be initiated..."

9. Review and Improvement

State how and when the procedure will be reviewed for effectiveness and continuous improvement.

Example: "This procedure will be reviewed annually or upon significant process changes."

10. Appendices and References

Include any relevant appendices or reference documents that support the procedure.

Example: "Appendix A: Inspection Checklist"

11. Revision History

Document the history of revisions to the procedure.

Example:

 "Rev 01 - [Date] - [Changes made]"

 "Rev 02 - [Date] - [Changes made]"

Completion Notes:

 Make sure to adapt the template to fit the specific process you are documenting.

 Engage relevant stakeholders in drafting the procedure to ensure accuracy and completeness.

 Ensure the language is clear, concise, and free of jargon.

 Keep the procedure up-to-date with any changes in processes, regulations, or organizational objectives.

Remember, the goal of the procedure is to ensure consistency, meet quality standards, and comply with ISO
9001 requirements.