ISO 9001 6 mandatory procedures [2024]

ISO 9001 6 mandatory procedures

1. Document Control

The document control procedure ensures that all relevant documents are controlled and maintained throughout their lifecycle. This includes documents such as quality policies, procedures, work instructions, and records. The procedure should define the following:

• The types of documents that are subject to control
• The responsibilities for creating, approving, and distributing documents
• The process for reviewing and updating documents
• The process for controlling obsolete documents

2. Record Control

The record control procedure ensures that all relevant records are created, maintained, and retained throughout their lifecycle. This includes records such as inspection reports, test results, and customer complaints. The procedure should define the following:

• The types of records that are subject to control
• The responsibilities for creating, approving, and storing records
• The process for reviewing and updating records
• The process for disposing of obsolete records

3. Internal Audit

The internal audit procedure ensures that the organization's quality management system (QMS) is effective and meets the requirements of ISO 9001. The procedure should define the following:

• The scope of the audits
• The frequency of audits
• The responsibilities for conducting audits
• The process for reporting audit findings

4. Nonconformity Control

The nonconformity control procedure ensures that any nonconformities are identified, investigated, and resolved promptly. The procedure should define the following:

• The responsibilities for identifying and investigating nonconformities
• The process for determining the root cause of nonconformities
• The process for taking corrective and preventive actions

5. Corrective and Preventive Action

The corrective and preventive action procedure ensures that any nonconformities are prevented from recurring. The procedure should define the following:

• The responsibilities for identifying and implementing corrective and preventive actions
• The process for evaluating the effectiveness of corrective and preventive actions

The 6 mandatory procedures listed above are essential for the successful implementation of ISO 9001. By following these procedures, organizations can ensure that their QMS is effective and meets the requirements of the standard.

6. Frequently asked questions

Question 1: What are the 6 mandatory procedures in ISO 9001?

Answer: The 6 mandatory procedures in ISO 9001 are Control of Documents, Control of Records, Internal Audit, Control of Nonconforming Product, Corrective Action, and Preventive Action.

Question 2: Why is the Control of Documents procedure essential in ISO 9001?

Answer: The Control of Documents procedure ensures that documented information is managed effectively, preventing the use of outdated documents and maintaining the integrity of the quality management system.

Question 3: How does the Control of Records procedure contribute to ISO 9001 compliance?

Answer: The Control of Records procedure ensures that records are identified, stored, and maintained to demonstrate conformity with requirements and provide evidence of effective QMS implementation.

Question 4: What is the significance of the Internal Audit procedure in ISO 9001?

Answer: The Internal Audit procedure evaluates the effectiveness of the QMS, identifies areas for improvement, and ensures compliance with ISO 9001 standards through systematic and independent assessments.

Question 5: How does the Control of Nonconforming Product procedure address quality issues in ISO 9001?

Answer: The Control of Nonconforming Product procedure establishes processes for identifying, segregating, and taking appropriate actions on nonconforming products, preventing their unintended use or delivery.

Question 6: Explain the role of Corrective Action and Preventive Action procedures in ISO 9001.

Answer: Corrective Action addresses existing nonconformities, while Preventive Action proactively identifies and eliminates potential issues, both contributing to continual improvement and the effectiveness of the QMS.