Mandatory Documents for ISO 9001: What You Must Have

ISO 9001:2015, the international standard for quality management systems (QMS), does not prescribe specific mandatory documents that must be included in an organization's QMS. Instead, ISO 9001:2015 follows a risk-based approach, allowing organizations to determine which documents and records are necessary to demonstrate compliance with the standard and achieve their quality objectives. However, there are some key documents and records commonly associated with ISO 9001 certification. These may include:

1. Quality Policy (Mandatory):

• An organization's quality policy is a mandatory document. It outlines the organization's commitment to quality and its overall quality objectives.

2. Quality Manual (Optional):

• ISO 9001:2015 no longer requires a quality manual, but some organizations still choose to create one. It provides an overview of the QMS structure and processes.

3. Process and Procedure Documents (As Needed):

• Organizations should document their processes and procedures as needed to ensure effective control and consistency. These documents describe how processes are carried out, including steps, responsibilities, and interactions.

4. Work Instructions (As Needed):

• Work instructions provide detailed guidance on how specific tasks or activities should be performed. They are often used in manufacturing and service environments.

5. Records (Mandatory):

• ISO 9001 requires the creation and maintenance of certain records to demonstrate conformity and effectiveness. These may include records of corrective actions, preventive actions, non-conformities, customer feedback, and more.

6. Risk Assessment and Management Documents (As Needed):

• ISO 9001:2015 emphasizes risk-based thinking. Organizations may document their risk assessment and management processes, including risk registers, assessments, and mitigation plans.

7. Monitoring and Measurement Records (As Needed):

• Records related to the monitoring and measurement of processes, products, and customer satisfaction may be necessary to demonstrate compliance and track performance.

8. Supplier and Contractor Evaluation (As Needed):

• Documents related to supplier and contractor evaluation, such as criteria, assessments, and performance records, may be required if relevant to the organization.

9. Internal Audit Records (Mandatory):

• Records of internal audits, including audit plans, findings, corrective actions, and follow-up, are essential for assessing QMS effectiveness.

10. Management Review Records (Mandatory):- Records of management reviews, including meeting minutes, actions, and decisions, are required to evaluate the QMS's continued suitability and effectiveness.

11. Customer-related Documents (As Needed):- Customer contracts, orders, and other customer-related documents may be necessary to ensure that customer requirements are met.

It's important to emphasize that the specific documents and records required will vary depending on the organization's size, complexity, industry, and unique circumstances. ISO 9001 allows for flexibility in documentation to avoid unnecessary bureaucracy while ensuring that the QMS effectively meets the organization's quality objectives and customer requirements.

Organizations seeking ISO 9001 certification should work with their chosen certification body or auditor to determine the appropriate documentation and records required to demonstrate compliance with the standard.