The IATF 16949:2016 standard clearly defines several mandatory documented processes that automotive organizations must establish, implement, maintain, and continually improve.
Unlike ISO 9001, IATF 16949 goes deeper into product safety, supplier control, risk management, competence, and defect prevention.
During certification or customer audits, these documented processes are frequently verified clause by clause.
This article explains the complete list of mandatory documented processes as per IATF 16949:2016, strictly aligned with standard clauses.
What Are “Mandatory Documented Processes”? #
Mandatory documented processes are those where IATF 16949 explicitly uses phrases such as:
- “The organization shall have a documented process…”
- “A documented procedure shall be established…”
Failure to show these processes typically results in:
- Major nonconformities
- CSR escalation
- Certification risk
List of Mandatory Documented Processes – IATF 16949:2016 #
1. Product Safety Management Process #
Clause: 4.4.1.2
A documented process shall be established for:
- Product safety responsibilities
- Escalation of safety concerns
- Control of safety-related characteristics
- Communication across the supply chain
📌 Audit focus: Named product safety officers, escalation flow, linkage to FMEA and Control Plan.
2. Calibration and Verification Records Management #
Clause: 7.1.5.2.1
A documented process shall define:
- Calibration and verification activities
- Record retention and traceability
- Reaction to out-of-tolerance equipment
📌 Audit focus: Gauge history, impact analysis, recall of affected products.
3. Identification of Training Needs and Awareness #
Clause: 7.2.1
The organization shall have a documented process to:
- Identify training needs
- Ensure employee awareness of quality objectives, risks, and consequences
📌 Audit focus: Skill matrix, training effectiveness, awareness interviews.
4. Competence Verification of Internal Auditors #
Clause: 7.2.3
A documented process shall ensure:
- Internal auditors are competent
- Qualification, training, and experience are verified
📌 Audit focus: Auditor qualification records, training, witnessed audits.
5. Employee Motivation Process #
Clause: 7.3.2
A documented process shall define methods to:
- Motivate employees
- Promote quality awareness
- Encourage continuous improvement
📌 Audit focus: Suggestion schemes, Kaizen programs, recognition systems.
6. Customer Engineering Standards & Specification Management #
Clause: 7.5.3.2.2
A documented process shall exist for:
- Review
- Distribution
- Implementation of customer engineering standards and specifications
📌 Audit focus: Latest drawing availability, CSR updates, controlled access.
7. Design and Development Procedure #
Clause: 8.3.1.1
A documented procedure shall define:
- Design planning
- Inputs and outputs
- Reviews, verification, and validation
📌 Audit focus: Design plan, DFMEA, design review records.
8. Identification of Special Characteristics #
Clause: 8.3.3.3
A documented process shall be established to:
- Identify special characteristics
- Flow them into PFMEA, Control Plan, and work instructions
📌 Audit focus: SC/CC symbols consistency across documents.
9. Manufacturing Process Design Output #
Clause: 8.3.5.2
Documented outputs shall include:
- Process flow diagrams
- PFMEA
- Control Plan
- Work instructions
📌 Audit focus: APQP linkage and alignment across documents.
10. Supplier Selection Process #
Clause: 8.4.1.2
A documented process shall define:
- Supplier selection criteria
- Risk-based supplier approval
📌 Audit focus: Supplier approval logic and risk classification.
11. Control of Externally Provided Processes, Products, and Services #
Clause: 8.4.2.1
A documented process shall define:
- Control methods
- Verification activities
- Supplier responsibilities
📌 Audit focus: Purchased product controls and outsourcing management.
12. Statutory and Regulatory Compliance – Purchased Products #
Clause: 8.4.2.2
A documented process shall ensure:
- Compliance with legal and regulatory requirements
- Flow-down to suppliers
📌 Audit focus: Regulatory declarations and supplier compliance evidence.
13. Supplier Evaluation Process and Criteria #
Clause: 8.4.2.4
A documented process shall include:
- Evaluation criteria
- Performance monitoring
- Re-evaluation frequency
📌 Audit focus: Supplier scorecards and corrective actions.
14. Control of Changes in Product Realization #
Clause: 8.5.6.1
A documented process shall ensure:
- Risk analysis for changes
- Customer approval where required
- Validation after implementation
📌 Audit focus: Change logs, updated FMEA and Control Plans.
15. Management of Alternate Control Methods #
Clause: 8.5.6.1.1
A documented process shall define:
- Conditions for alternate controls
- Approval and monitoring
📌 Audit focus: Temporary deviation controls.
16. Rework Confirmation Process #
Clause: 8.7.1.4
A documented process shall ensure:
- Rework instructions
- Re-verification after rework
📌 Audit focus: Rework validation and traceability.
17. Repair Confirmation Process #
Clause: 8.7.1.5
A documented process shall define:
- Repair authorization
- Customer approval (if required)
📌 Audit focus: Repair records and customer acceptance.
18. Disposition of Nonconforming Product #
Clause: 8.7.1.7
A documented process shall define:
- Scrap
- Rework
- Repair
- Concessions
📌 Audit focus: Decision authority and traceability.
19. Internal Audit Process #
Clause: 9.2.2.1
A documented process shall cover:
- QMS audits
- Manufacturing process audits
- Product audits
📌 Audit focus: Audit program and closure effectiveness.
20. Problem Solving Process #
Clause: 10.2.3
A documented process shall define:
- Root cause analysis
- Corrective action methodology
📌 Audit focus: Use of 8D, effectiveness verification.
21. Error-Proofing Methodology Determination #
Clause: 10.2.4
A documented process shall define:
- When and how error-proofing is applied
📌 Audit focus: Poka-Yoke implementation evidence.
22. Continual Improvement Process #
Clause: 10.3.1
A documented process shall ensure:
- Use of quality objectives
- Performance trends
- Lessons learned
📌 Audit focus: Improvement projects and measurable results.
Key Takeaway for Audits #
If any one of these documented processes is missing, weak, or not implemented, auditors typically raise:
- Major nonconformity
- Systemic failure observation
These processes together form the core backbone of IATF 16949 compliance.
Conclusion #
The mandatory documented processes of IATF 16949:2016 are not just documentation requirements—they represent the minimum maturity level expected from an automotive organization.
Strong implementation ensures:
- Audit readiness
- Customer confidence
- Reduced defects
- Robust risk management
