ISO 9001:2015 is a globally recognized standard for quality management systems (QMS), helping organizations consistently meet customer requirements and improve quality. To achieve and maintain ISO 9001 certification, specific mandatory documents must be in place. These documents ensure that the QMS is effectively implemented, controlled, and maintained according to the standard.

Here, we’ll explore four critical mandatory documents required by ISO 9001:2015, including their purpose and the specific clauses they relate to.

1. Scope of the QMS (Clause 4.3)

Defining the scope of the QMS is one of the foundational documents required by ISO 9001:2015. This document establishes the boundaries and applicability of your QMS, identifying which areas of your business are covered by the quality management system.

What to Include:

• The products and services provided by your organization

• The relevant processes that impact quality

• Any exclusions from the standard, with justifications

• Information about external and internal factors that influence the QMS

The scope document provides clarity on what parts of the business are involved in quality management, helping ensure that all relevant areas are properly monitored and controlled.

2. Quality Policy (Clause 5.2)

The quality policy is a mandatory document that outlines your organization’s overall intentions and direction with regard to quality. It reflects the organization’s commitment to consistently meeting customer requirements and continually improving the QMS.

Key Elements of the Quality Policy:

• A commitment to fulfilling applicable requirements, including legal and regulatory standards

• A focus on continuous improvement of the QMS

• Alignment with the organization’s strategic goals

• Communication of the policy throughout the organization to ensure employee understanding

A well-documented quality policy serves as the foundation for your QMS, guiding decisions and actions related to quality management across the organization.

3. Quality Objectives (Clause 6.2)

Setting clear and measurable quality objectives is essential for maintaining the effectiveness of your QMS. These objectives provide direction for improving processes, products, and services, and must align with your organization’s overall goals and quality policy.

How to Define Quality Objectives:

• Ensure they are Specific, Measurable, Achievable, Relevant, and Time-bound (SMART)

• Link the objectives to key performance indicators (KPIs) for tracking progress

• Focus on areas such as reducing defects, improving customer satisfaction, or enhancing process efficiency

• Regularly monitor and review the objectives to ensure continual improvement

Documenting quality objectives demonstrates a commitment to quality improvement and provides a structured approach for achieving measurable outcomes.

4. Criteria for Evaluation and Selection of Suppliers (Clause 8.4.1)

ISO 9001:2015 requires organizations to control the performance of external suppliers that affect product or service quality. The criteria for evaluation and selection of suppliers document outlines the methods for assessing and monitoring suppliers to ensure they meet your quality standards.

Key Criteria to Include:

• Supplier performance metrics, such as delivery times, product quality, and reliability

• Evaluation methods, such as audits, performance reviews, and supplier scorecards

• Risk assessment of suppliers based on their criticality to your operations

• Ongoing monitoring and re-evaluation processes to ensure consistent quality

By defining and documenting these criteria, organizations can effectively manage supplier relationships, ensuring that suppliers contribute positively to the overall quality of products and services.

Conclusion

ISO 9001:2015 requires several mandatory documents to establish, maintain, and control a Quality Management System. Key documents include the scope of the QMS, quality policy, quality objectives, and criteria for supplier evaluation. Each of these documents plays a vital role in ensuring that the QMS is effective, compliant, and focused on continual improvement.

To streamline your ISO 9001:2015 certification journey, ensure that these mandatory documents are clearly defined, properly maintained, and regularly reviewed to meet the standard’s requirements and support your organization’s commitment to quality.