Of the 28 main sections of ISO 9001:2015, the IATF 16949 Standard adds requirements under 22 of them.
The table shows where there are additional requirements and a short description of the topic or header from IATF.
Section | Section Title | ISO 9001:2015 Requirement | IATF 16949 Additions | Topic of Additional Requriements | ||||||
4 | Context of the organization | |||||||||
4,1 | Understanding the organization and its context | x | ||||||||
4,2 | Understanding the needs and expectations of interested parties | x | ||||||||
4,3 | Determining the scope of the qualiity management system | x | x | Determining the scope – Supplemental, Customer specific requirements | ||||||
4,4 | Quality management system and its processes | x | x | Conformance of products and processes, Product safety | ||||||
5 | Leadership | |||||||||
5,1 | Leadership commitment | x | x | Corporate responsibility, Process effectiveness and efficiency, Process owners, Customer focus | ||||||
5,2 | Policy | x | ||||||||
5,3 | Organizational roles, responsibilites and authorities | x | x | Organizational roles – Supplemental, Responsibility and authority for product requirements and corrective action | ||||||
6 | Planning | |||||||||
6,1 | Actions to address risks and opportunities | x | x | Risk analysis, Preventative action, Contingency plans | ||||||
6,2 | Quality objectives and planning to achieve them | x | x | Quality objectives – Supplemental | ||||||
6,3 | Planning of changes | x | ||||||||
7 | Support | |||||||||
7,1 | Resources | x | x | Plant, facility, and equipment planning, Environment for the operation of processes, Environment for the operation of processes, Measurement systems analysis, Measurement traceability, Calibration/verification records, Laboratory requirements | ||||||
7,2 | Competence | x | x | Compentence – Supplemental, On-the job training, Internal auditor competency, Second-party auditor compency | ||||||
7,3 | Awareness | x | x | Awareness – Supplemental, Employee motivation and empowerment | ||||||
7,4 | Communnication | x | ||||||||
7,5 | Documented Information | x | x | Quality management system documentation, Record retention, Engineering specifications | ||||||
8 | Operation | |||||||||
8,1 | Operational planning and control | x | x | Operational planning – Supplemental, Confidentiality | ||||||
8,2 | Requirements for products and services | x | x | Customer communication – Supplemental, Determining the requirements -Supplemental, Customer – designated special charateristics, Organization manufacturing feasibility | ||||||
8,3 | Design and development of products and services | x | x | Design and development – Supplemental, Design planning – Supplemental, Product design skills, Development of products with embedded software, Product design input, Manufacturing process design input, Special characteristics, Monitoring, Design and development validation, Prototype program, Product approval process, Design and development outputs, Manufacturing process design output, Design and development changes – Supplemental | ||||||
8,4 | Control of externally provided processes, products and services | x | x | General – Supplemental, Supplier selection process, Customer-directed sources, Control – Supplemental, Statutory and regulatory requirements, Supplier quality management system development, Automotive product- related software, Supplier monitoring, Second-party audits, Supplier development, External providers – Supplemental | ||||||
8,5 | Production and service provision | x | x | Control plan, Standardized work, Verification of job set-up, Verification after shutdown, Total productive maintenance, Management of production tooling, Production scheduling, Identification and traceability – Supplemental, Preservation – Supplemental, Feedback from service, Service agreement with customer, Control of changes – Supplemental, Temporary change of process controls | ||||||
8,6 | Release of products and services | x | x | Release – Supplemental, Layout inspection and functional testing, Appearance items, Verification of conformity of externally provided products and services, Statutory and regulatory conformity, Acceptance criteria | ||||||
8,7 | Control of nonconforming outputs | x | x | Customer authorization for concession, Customer specified process, Control of suspect product, Control of reworked product, Control of repaired product, Customer notification, Nonconforming product disposition | ||||||
9 | Performance evaluation | |||||||||
9,1 | Monitoring, measurement, analysis and evaluation | x | x | Monitoring and measurement of manufacturing processes, Identification of statistical tools, Application of statistical concepts, Customer satisfaction – Supplemental, Prioritization | ||||||
9,2 | Internal audit | x | x | Internal audit program, Quality management system audit, Manufacturing process audit, Product audit | ||||||
9,3 | Management review | x | x | Management review – Supplemental, Managemennt review inputs – Suppliemental, Management review outputs – Supplemental | ||||||
10 | Improvement | |||||||||
10,1 | General | x | ||||||||
10,2 | Nonconformity and corrective action | x | x | Problem solving, Error-proofing, Warranty management systems, Customer complaints and field failure test analysis | ||||||
10,3 | Continual improvement | x | x | Continual improvement – Supplemental |