A comprehensive guide to the requirements of ISO 9001:2015. Understand what your organization needs to implement for successful Quality Management System certification.

Understanding ISO 9001:2015 Structure

ISO 9001:2015 follows the High-Level Structure (HLS) common to all modern ISO management system standards. The standard contains 10 clauses, with clauses 1-3 providing introduction and definitions, and clauses 4-10 containing the requirements for certification.

Clause 4: Context of the Organization

This clause requires you to understand your organization's context and stakeholder needs:

4.1 Understanding the Organization and Its Context

Identify external issues (market, regulatory, economic, technological)
Identify internal issues (organizational culture, capabilities, resources)
Monitor and review information about these issues

4.2 Understanding Needs and Expectations of Interested Parties

Identify relevant interested parties (customers, suppliers, regulators, employees)
Determine their relevant requirements
Monitor and review this information

4.3 Determining the Scope of the QMS

Define boundaries and applicability of the QMS
Consider external and internal issues, requirements of interested parties
Include all products and services within scope
Document and make available

4.4 Quality Management System and Its Processes

Establish, implement, maintain, and continually improve the QMS
Determine processes needed and their interactions
Determine inputs, outputs, sequence, criteria, resources, and responsibilities

Clause 5: Leadership

Leadership requirements ensure top management commitment and accountability:

5.1 Leadership and Commitment

Take accountability for QMS effectiveness
Ensure policy and objectives are established
Ensure integration of QMS requirements into business processes
Promote process approach and risk-based thinking
Ensure resources are available
Promote continual improvement

5.2 Quality Policy

Appropriate to purpose and context of organization
Provides framework for setting quality objectives
Includes commitment to satisfy applicable requirements
Includes commitment to continual improvement
Documented, communicated, and available

5.3 Organizational Roles, Responsibilities and Authorities

Assign and communicate responsibilities and authorities
Ensure QMS conforms to standard requirements
Ensure processes deliver intended outputs
Report on QMS performance to top management

Clause 6: Planning

Planning requirements address risks, opportunities, and objectives:

6.1 Actions to Address Risks and Opportunities

Consider context and interested party requirements
Determine risks and opportunities to address
Plan actions to address them
Integrate actions into QMS processes
Evaluate effectiveness of actions

6.2 Quality Objectives and Planning to Achieve Them

Establish objectives at relevant functions and levels
Objectives must be consistent with policy, measurable, monitored, communicated, and updated
Plan what will be done, resources required, responsibility, timeline, and evaluation method

Clause 7: Support

Support requirements ensure adequate resources and documentation:

7.1-7.4 Resources, Competence, Awareness, Communication

Determine and provide necessary resources (people, infrastructure, environment, monitoring resources, knowledge)
Ensure competence of persons affecting quality performance
Ensure awareness of policy, objectives, contributions, and implications
Determine internal and external communications

7.5 Documented Information

Include documented information required by the standard
Include documented information needed for QMS effectiveness
Control creation, updating, and control of documents

Clause 8: Operation

This is the largest clause, covering operational planning and product/service realization:

8.1-8.7 Operational Requirements

8.1: Operational planning and control
8.2: Requirements for products and services (customer communication, determining and reviewing requirements)
8.3: Design and development of products and services
8.4: Control of externally provided processes, products and services
8.5: Production and service provision (control, identification, property, preservation, post-delivery, change control)
8.6: Release of products and services
8.7: Control of nonconforming outputs

Clause 9: Performance Evaluation

9.1-9.3 Evaluation Requirements

9.1: Monitoring, measurement, analysis and evaluation (including customer satisfaction)
9.2: Internal audit at planned intervals
9.3: Management review of the QMS

Clause 10: Improvement

10.1-10.3 Improvement Requirements

Determine and select opportunities for improvement
React to nonconformities, take corrective action
Continually improve QMS suitability, adequacy, and effectiveness

Required Documented Information

ISO 9001:2015 requires the following documented information:

Scope of the QMS (4.3)
Quality policy (5.2)
Quality objectives (6.2)
Evidence of competence (7.2)
Operational planning and control (8.1)
Product/service requirements (8.2.3)
Design and development outputs (8.3.5)
Control of external providers (8.4)
Production and service provision (8.5.1)
Traceability (8.5.2)
Customer/external provider property (8.5.3)
Change control (8.5.6)
Release of products and services (8.6)
Nonconforming outputs (8.7)
Monitoring and measurement results (9.1.1)
Internal audit program and results (9.2)
Management review outputs (9.3)
Nonconformity and corrective action (10.2)

ISO 9001 Requirements