ISO 9001:3015 Clause 4.4.2 – Documented Information

Clause 4.4.2 – Documented Information

ISO 9001:2015

1. Purpose

To ensure that documented information required for the Quality Management System (QMS) is maintained and retained to support effective process operation and provide evidence of conformity.

2. Scope

This procedure applies to all documents and records generated as part of the organization's QMS.

3. Maintained Documented Information (QMS Documents)

The following documents shall be maintained, reviewed, approved, and controlled:

Level 1 – Quality Documents

• Quality Manual (if maintained)
• Quality Policy
• Quality Objectives

Level 2 – Procedures / SOPs

• Document Control
• Change Control
• Deviation Management
• CAPA
• Risk Management
• Internal Audit
• Supplier Qualification
• Complaint Handling
• Training
• Management Review

Level 3 – Operational Documents

• Work Instructions
• Specifications
• Standard Test Procedures
• Validation Protocols
• Cleaning Procedures
• Calibration Procedures

Level 4 – Controlled Formats

• Forms
• Checklists
• Logbooks
• Templates

4. Retained Documented Information (QMS Records)

The following records shall be retained as evidence of conformity and effective QMS implementation:

• Batch Manufacturing Records (BMR)
• Batch Packaging Records (where applicable)
• Analytical Test Reports
• Certificates of Analysis (CoA)
• Training Records
• Equipment Logbooks
• Calibration Records
• Preventive Maintenance Records
• Validation Reports
• Qualification Reports
• Deviation Records
• CAPA Records
• Change Control Records
• Internal Audit Reports
• Management Review Minutes
• Supplier Evaluation Records
• Customer Complaint Records
• Risk Assessment Reports

5. Control of Documented Information

All documented information shall:

• Be reviewed and approved before issue.
• Have a unique document number and revision status.
• Be available at the point of use.
• Be protected from unauthorized access or modification.
• Be periodically reviewed and updated.
• Be archived and retained according to the document retention policy.
• Be disposed of securely after the retention period, where applicable.

6. Responsibilities

Quality Assurance

• Maintain document control.
• Issue, revise, archive, and withdraw controlled documents.
• Ensure records are complete and retrievable.

Department Heads

• Ensure current documents are used.
• Ensure records are completed accurately and on time.

Employees

• Follow approved documents.
• Complete records legibly, accurately, and contemporaneously.

7. References

• ISO 9001:2015 – Clause 4.4.2
• Document Control Procedure
• Record Retention Schedule
• Applicable GMP Guidelines