Quality Management System Document structure | IATF

Curious to know entire series of quality management system document structure.

Every Engineer is struggling to learn QMS documentation or the documentation part of the job.

But why?

The reason is career growth and opportunity to work on quality system. Also the documentation is the part where management, customer and auditor are doing evaluation all the time.

Also you will be the documentation expert.

quality management system document structure

Why we do IATF documentation?

The QMS documentaion ensure that our company is compliance to quality assurance, regulatory and customer requirements.

It is a documented structure and framework of organizational processes align together to achieved objectives and goal of an organization.

By following these documentation structure companies are able to do

  • Consistency and standardization
  • Improvement in quality processes
  • Comply with regulation and automotive requirements.
  • Achieve customer satisfaction

What are those documents? | level of documents in QMS

Quality Management System Document structure has 5 level of documents.

quality management system document structure
quality policy icon

Quality Policy

It is a commitment of an organization. The policy provide the purpose and direction to the organization.

Quality manual part of quality management system document structure

Quality Manual

This document provides an overview of the QMS. It covers quality policy, objectives, and documentation structure.

quality procedure part of quality management system document structure


Detailed, step-by-step instructions on how to perform specific processes

work instruction icon

Work Instruction

Documents provide precise directions on performing tasks within a procedure.

records a& formats part of quality management system document structure

Records & Forms

Templates and records used to capture and maintain data of activities.

Quality Management System Procedures

Mandatory procedures

  1. Product safety procedure (
  2. Managing calibration /verification records procedure (
  3. Training, awareness and competency procedure (7.2.1)
  4. Procedure to verify competence of internal auditors (7.2.3)
  5. Employee motivation procedure (7.3.2)
  6. Procedure of maintaining customer engg. standards/specifications (
  7. Procedure for Design and Development (
  8. Procedure to identify special characteristics (
  9. Supplier selection process (
  10. Identify and control externally provided processes, products and services (
  11. Ensure compliance with statutory and regulatory requirements of purchased processes, products and services (
  1. Evaluation of supplier performance procedure (
  2. Process to control and react to changes in product realization (
  3. Process for management of the use of alternate control methods (
  4. Rework procedure (
  5. Repair procedure (
  6. Nonconforming product handling procedure (
  7. Internal audit procedure (
  8. Procedure of problem solving (10.2.3)
  9. Use of error-proofing methodologies procedure (10.2.4)
  10. Procedure of continual improvement (10.3.1)

Other Required Procedures

  1. Procedure for Document and Record Control (7.5)
  2. Procedure to determining the context of the organization and Interested Parties (4.1 & 4.2)
  3. Procedure for Addressing Risks and Opportunities (6.1)
  4. Production Part Approval Process Procedure (
  5. Workplace Organization (5S) Procedure (7.1.4)
  6. Laboratory management procedure (
  7. Procedure for second-party audits (
  8. Process for Equipment Maintenance (
  9. Tooling Management procedure (
  10. Verification and acceptance of conformity of externally provided products and services (8.6.4)
  11. Customer satisfaction monitoring procedure (9.1.2)
  12. Procedure for Management Review (9.3)
  13. Warranty management process (10.2.5)

Work Instructions

  • Process work instruction
  • Incoming inspection work instruction
  • Machine work instruction

Documents & Records/Forms

This list covers the IATF requirement and respective documents or record or work instructions along with respective department. You can find the quality management system document structure in below table.

IATF ClauseType of DocProcedure / Document / Record / WI
4.0 Context Of The Organization
4.1 Understanding The Organization And Its Context
4.2 Understanding The Needs And Expectations Of Interested PartiesProcedureDetermining Context of the Organization and Interested Parties
RecordConformance Evaluation
4.3 Determining The Scope Of The QMSDocumentScope of the Quality Management System
4.3.2 Customer-specific requirementsDocumentList of Interested Parties and Customer Specific Requirements
4.4 QMS and Its Processes Conformance of products and processes Product safetyMandatory ProcedureProduct Safety Procedure
5 Leadership
5.1 Leadership And Commitment Corporate responsibilityDocumentCorporate Responsibility Policy Process effectiveness and efficiency Process owners
5.1.2 Customer Focus
5.2 PolicyDocumentQuality policy
5.2.1 Establishing The Quality Policy
5.2.2 Communicating The Quality Policy
5.3 Organizational Roles, Responsibilities And AuthoritiesDocumentRoles & responsibilities
5.3.2 Responsibility and authority for product requirements and corrective actions
6 Planning
6.1 Actions To Address Risks And OpportunitiesProcedureAddressing Risks and Opportunities
Registry of Key Risks and Opportunities Risk analysisRisk analysis
ProcedureProcedure for FMEA Risk Assessment
RecordDesign & Process FMEA Form Preventive actionRecordPreventive action
RecordPreventive Action Record Contingency plansDocumentContingency plan
6.2 Quality Objectives And Planning To Achieve ThemDocument/RecordQuality Objectives and planning
6.3 Planning Of Changes
7 Support
7.1 Resources
7.1.2 People
7.1.3 Infrastructure Plant, facility, and equipment planningDocument/RecordPlant and Lines Layout
Document/RecordValidation Plan
Document/RecordManufacturing feasibility assessments (Capacity Planning)
7.1.4 Environment For The Operation Of ProcessesProcedureWorkplace Organization (5S)
Document/RecordWorkplace Organization (5S) Audit Form
7.1.5 Monitoring And Measuring ResourcesDocument/RecordPlan for Preventive Maintenance of Equipment
7.1.5,1.1 Measurement systems analysisProcedureControl of Gauges
Document/RecordMSA Study
Document/RecordMeasurement System Analysis Plan
Document/RecordMeasurement System Analysis Form Measurement TraceabilityProcedureEquipment Maintenance and Measuring Equipment
Document/RecordCalibration Certificate of Master Equipment
Document/RecordMaintenance and Calibration Record Calibration/verification recordsMandatory procedureCalibration
Document/RecordCalibration / verification records of gauges and equipments
Document/RecordList of Equipment Laboratory requirementsProcedureLaboratory management
Document/RecordTest Schedule Form Internal laboratoryDocument/RecordTest reports, laboratory personnel competence
Document/RecordInternal Laboratory Scope External laboratoryDocument/RecordLaboratory scope
Document/RecordExternal Laboratory Acceptance Checklist
7.1.6 Organizational KnowledgeDocument/RecordOrganization knowledge (library, standards, trainings, LMS)
Document/RecordLesson Learned Template
7.2 CompetenceDocument/RecordTraining records, education, experience record
Document/RecordTraining Record
Document/RecordTraining Program
Mandatory ProcedureProcedure for Competence, Training and Awareness
7.2.2 Competence — on-the-job trainingDocument/RecordOperators Job Rotation Matrix
Document/RecordOn-the-job training records
7.2.3 Internal auditor competencyMandatory ProcedureInternal Auditor Competency
Document/RecordList of Qualified Internal Auditors
Document/RecordInternal trainer competency records
7.2.4 Second-party auditor competency
7.3 AwarenessDocument/RecordRecord of Attendance
Document/RecordAwareness Training Report
Document/RecordEmployee awareness (control plan, FMEA, work instruction)
7.3.2 Employee motivation and empowermentMandatory ProcedureEmployee Motivation
7.4 Communication
7.5 Documented InformationMandatory ProcedureDocument and Record Control
Document/RecordMaster list of documents and records
Document/RecordList of absolute and archive documents and records
7.5.1,1 Quality management system documentationDocument/RecordQuality Manual
7.5.2 Creating And Updating
7.5.3 Control Of Documented Information Record retentionDocument/RecordRecord retention policy
Document/RecordSample inspection reports, test records Engineering specificationsMandatory ProcedureEngineering Specification
Document/RecordEngineering change records
8 Operation
8.1 Operational Planning And ControlDocument/RecordPatrol inspection records, pre-dispatch inspection record
8.1.2 Confidentiality
8.2 Requirements For Products And Services
8.2.1 Customer CommunicationProcedureSales Procedure
Document/RecordCustomer complaints register
8.2.2 Determining The Requirements For Products And ServicesDocument/RecordCustomer Requirement Review Checklist
8.2.3 Review Of The Requirements For Products And Services Review of the requirements for products and servicesDocument/RecordFeasibility Study Report
Document/RecordCustomer deviation Customer-designated special characteristicsDocument/RecordCustomer designated special characteristics Organization manufacturing feasibilityDocument/RecordContract review
8.2.4 Changes To Requirements For Products And ServicesDocument/RecordProcess / engineering change records
8.3 Design And Development Of Products And ServicesMandatory ProcedureProcedure for Design and Development
8.3.2 Design And Development PlanningDocument/RecordDesign review records
Document/RecordProject Plan and Review Product design skills Development of products with embedded softwareDocument/Recordsoftware development capability self-assessment record
8.3.3 Design And Development InputsDocument/RecordDesign review records Product design inputDocument/RecordDesign review records Manufacturing process design inputDocument/RecordManufacturing process input review Special characteristicsMandatory ProcedureSpecial characteristics
Document/RecordList of special characteristics
8.3.4 Design And Development ControlsDocument/RecordDesign review, verification & validation records Monitoring Design and development validation Prototype program Product approval processProcedureProduction Part Approval Process Procedure
Document/RecordPart submission warrant / product approval record
Document/RecordPPAP Record
8.3.5 Design And Development OutputsDocument/RecordDesign Review Minutes
Document/RecordDesign review records Manufacturing process design outputDocument/RecordManufacturing process output review
8.3.6 Design And Development ChangesDocument/RecordChange Review Record
Document/RecordEngineering change records
Document/RecordCustomer deviation, revision level of hardware / software in change records (for embedded software only)
8.4 Control Of Externally Provided Processes, Products And ServicesProcedurePurchasing and Evaluation of Suppliers
Document/RecordSupplier complaint register
Document/RecordSupplier audit / evaluation report
8.4.1 GeneralDocument/RecordList of Approved Suppliers
Document/RecordRequest and Order for Purchasing Supplier selection processMandatory ProcedureSupplier Selection
Document/RecordChecklist for Evaluation of Suppliers Customer-directed sourcesDocument/Record
8.4.2 Type And Extent Of ControlDocument/RecordIncoming Inspection Control Plan and Log
Mandatory ProcedureOutsource Process Control procedure Statutory and regulatory requirementsMandatory ProcedureStatutory and Regulatory Requirement of purchased product Supplier quality management system developmentDocument/RecordSoftware development capability self-assessment record Automotive product-related software or automotive products with embedded software Supplier monitoringMandatory ProcedureSupplier Monitoring
Proceduresecond-party audits,1 Second-party auditsDocument/RecordSecond Party Audit Checklist
Document/RecordSecond-party audit report Supplier development
8.4.3 Information For External Providers
8.5 Production And Service ProvisionProcedureProduction and Service Provision
Document/RecordQuality Plan
8.5.1 Control Of Production And Service Provision Control planDocument/RecordControl plan Standardized workDocument/RecordWork Instructions Verification of job set-upsDocument/RecordFirst Part Approval Form
Last Part inspection Report
Document/RecordJob setup records Verification after shutdown Total productive maintenanceProcedureEquipment Maintenance
Document/RecordMaintenance objectives
Document/RecordTQM documents and records
Document/RecordMTBF and MTTR Downtime
Document/RecordMachine Poka yoke list List
Document/RecordMaintenance Work Instruction Management of production tooling and manufacturing, test, inspection tooling and equipmentProcedureTooling Management Production schedulingDocument/RecordProduction Scheduling and planning
8.5.2 Identification And Traceabil1tyDocument/RecordTraceability records (Invoice, Pre-dispatch inspection records, production and quality records)
Document/RecordTraceability and identification system
.5.3 Property Belonging To Customers Or External ProvidersDocument/RecordNotification to a Customer about Changes on their Property
Document/RecordCustomer property record and status
8.5.4 PreservationDocument/RecordInventory management
ProcedureWarehousing Procedure
Document/RecordRecord of Warehousing Parameters Control
8.5.5 Post-Delivery Activities Feedback of information from service Service agreement with customer
8.5.6 Control Of ChangesMandatory ProcedureControl of Changes
Document/RecordProcess / engineering change records Temporary change of process controlsDocument/RecordList of Alternate Controls
Mandatory ProcedureTemporary Change of Process Control
Document/Recordlist of alternate process control / method
8.6 Release Of Products And ServicesDocument/RecordRecords of conformity of product and services with acceptance criteria
Document/RecordProduction Change Review Record Form
8.6.2 Layout inspection and functional testingDocument/RecordLayout inspection and functional testing records
8.6.3 Appearance itemsDocument/RecordList of Appearance Items
8.6.4 Verification and acceptance of conformity of externally provided products and services.Procedureverification and acceptance of conformity of externally provided products and services
Document/RecordSecond party auditor report
Document/RecordThird party audit report
8.6.5 Statutory and regulatory conformity
8.6.6 Acceptance criteria
8.7 Control Of Nonconforming OutputsDocument/RecordNonconformity Record Customer authorization for concessionDocument/RecordDeviation Request and Approval Form
Document/RecordCustomer deviation
Document/RecordInternal Failures Report Control of nonconforming product — customer-specified process Control of suspect product Control of reworked productMandatory ProcedureControl of Rework
Document/RecordRework Instruction
Document/RecordControl plan / drawings, work instruction
Document/RecordRework record Control of repaired productMandatory ProcedureControl of Repair
Document/RecordControl Plan, work instruction
Document/RecordCustomer deviation
Document/RecordRepair record
Document/RecordRepair Instruction Customer notificationDocument/RecordCustomer notification Nonconforming product dispositionMandatory ProcedureNon-Conforming Product Handling
8.7.2Document/RecordNonconformity records with action plan
9 Performance Evaluation
9.1 Monitoring, Measurement, Analysis And Evaluation Monitoring and measurement of manufacturing processesDocument/RecordSPC study, process change records Identification of statistical tools Application of statistical concepts
9.1.2 Customer SatisfactionProcedurecustomer satisfaction monitoring
Document/RecordCustomer Satisfaction Dashboard
Document/RecordCustomer Satisfaction Questionnaire
Document/RecordReport of Customer Satisfaction
Document/RecordMonitoring of Customer Satisfaction
9.1.3 Analysis and evaluationDocument/RecordKey Performance Indicators Matrix
Document/RecordData Analysis Report
9.1.3,1 Prioritization
9.2 Internal AuditDocument/RecordInternal audit scope and criteria
Document/RecordPlan Vs Actual
Document/RecordInternal Audit Report for QMS Audits internal audit programProcedureInternal Audit
Document/RecordInternal QMS Audit Checklist Quality management system auditDocument/RecordInternal Audit Program Manufacturing process auditDocument/RecordManufacturing Process Audit Checklist Product auditDocument/RecordProduct Audit Checklist/report
Dock Audit Checklist/report
9.3 Management reviewProcedureManagement review
9.3.2 Management Review Inputs
9.3.3 Management Review OutputsDocument/RecordManagement review minutes of meeting
Document/RecordAction plan when customer performance targets not met
10 Improvement
10.2 Nonconformity And Corrective ActionDocument/RecordNonconformity records with action plan
Document/RecordRegistry and Status of Nonconformities and Corrective Actions
10.2.3 Problem solvingMandatory ProcedureCorrective Action/ Problem-Solving
Document/RecordProblem Solving 8D Report
Document/RecordControl Plan, FMEA
10.2.4 Error-proofingMandatory ProcedurePoka Yoke/ Error Proofing
10.2.5 Warranty management systemsDocument/RecordReport of Warranty Failures
Document/RecordWarranty Incidents Analysis Report
Document/RecordProduct User Instruction Template
Procedurewarranty management process
10.2.6 Customer complaints and field failure test analysis
10.3 Continual ImprovementMandatory ProcedureContinual Improvement
Quality Management System Document Structure

Hope this complete list of QMS documentation will give you the idea of how every organization has the documents and what is the requirement behind it.

This quality management system document structure is followed worldwide by every organization who want to eligible for IATF certification.

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