ISO 9001 Procedure

Prepared by: [Your Name]

1. Objective

The objective of this procedure is to establish and maintain an effective quality management system (QMS) to ensure compliance with the ISO 9001 standard. This procedure outlines the steps required to implement, monitor, and continuously improve the QMS within [Your Company Name].

2. Scope

This procedure applies to all departments and personnel involved in the quality management process within the organization.

3. Responsibilities

• Quality Manager: Oversee the implementation and maintenance of the QMS.

• Department Heads: Ensure departmental adherence to QMS procedures.

• All Employees: Follow the established procedures and contribute to continual improvement.

4. Procedure

4.1. Document Control

1. Identify the documents needed for the QMS.

2. Develop and approve documents ensuring they are complete, accurate, and appropriately detailed.

3. Maintain a master list of documents including distribution and revision status.

4. Ensure that current documents are available at points of use.

4.2. Record Control

1. Identify records required to provide evidence of conformity to requirements.

2. Establish a system for record identification, storage, protection, retrieval, retention, and disposition.

3. Ensure that records remain legible, identifiable, and traceable.

4.3. Internal Audits

1. Plan an internal audit schedule based on the importance of the processes and areas to be audited.

2. Select and train internal auditors ensuring they are impartial and objective.

3. Conduct internal audits to verify that the QMS conforms to planned arrangements.

4. Document and report the audit findings and ensure corrective actions are taken.

4.4. Corrective and Preventive Actions

1. Identify nonconformities and potential nonconformities within the QMS.

2. Determine the root cause of nonconformities and take action to prevent recurrence.

3. Establish preventive actions to eliminate the causes of potential nonconformities.

4. Review the effectiveness of corrective and preventive actions taken.

5. Monitoring and Measurement

Activity	Frequency	Responsible	Records
Internal Audits	Semi-Annually	Internal Audit Team	Audit Reports
Management Review	Annually	Quality Manager	Management Review Minutes
Customer Feedback	Ongoing	Customer Service	Feedback Forms

6. Continual Improvement

Continual improvement of the QMS is achieved through the use of quality policies, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.

7. References

• ISO 9001:2015 Quality Management Systems – Requirements

• Company Quality Manual

• Operational Procedures and Work Instructions

Procedure Templates @ Template.net