ISO 9001:2015 Quality management systems – Requirements

DIN EN ISO 9001:2015 is the most widely accepted standard for quality management worldwide. The “mother of all QM standards” defines the requirements for ensuring the quality standards in the company. It defines the minimum requirements for a quality management system that organizations must meet in order to meet the expectations of internal and external (interested) parties.

Chapter 1 – Scope of Application
Chapter 2 – Normative references
Chapter 3 – Terms and Definitions
Chapter 4 – Context of the Organization
Chapter 5 – Leadership
Chapter 6 – Planning
Chapter 7 – Support
Chapter 8 – Operation
Chapter 9 – Performance Evaluation
Chapter 10 – Improvement

Depending on the industry to which they belong, there are industry-specific characteristics or variations. These include, for example, IATF 16949, ISO 13485 or EN 9100.

DHC VISION Compliance Matrix for ISO 9001

Request AreaDescription Solutions and Products
Chapter 4 – Context of the Organization· Organization and context
· Requirements and expectations of interested parties
· Scope of application of the QM System
· QM System and ist processes
· Process and Quality Management
· SOP Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Chapter 5 – Leadership· Leadership and commitment
· Quality policy
· Roles, responsibilities and powers
· Process and Quality Management
· SOP Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Chapter 6 – Planning· Measures to deal with risks and opportunities
· Quality goals
· Planning changes
· Process and Quality Management
· SOP Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Chapter 7 – Support· Resources
· Competence
· Awareness
· Communication
· Documented Information
· Process and Quality Management
· SOP Management
· Training und Learning Success Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Chapter 8 – Operation· Operational planning and control
· Determination of requirements
· Development of products and DL
· Control of externally provided products and DL
· Production and DL delivery
· Release of products and DL
· Control of non-compliant results
· Process and Quality Management
· SOP Management
· Training und Learning Success Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Chapter 9 – Performance Evaluation· Monitoring, measurements, analysis and evaluation
· Internal audit
· Management review
· Process and Quality Management
· SOP Management
· Training und Learning Success Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management
Kapitel 10 – Improvement· Non-conformities and corrective actions
· Continuous improvement
· Process and Quality Management
· SOP Management
· Training und Learning Success Management
· Auditmanagement
· Deviation Management
· Complaint Management
· Change Management
· CAPA-Management