IATF 16949:2016
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ISO/TS 16949:2009
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0.1 General
0.2 Quality Management Principles
0.3 Process Approach
0.4 Relationship With Other Management System Standards
1 Scope
1.1. Scope – automotive supplemental to ISO 9001:2015
2 Normative references
2.1 Normative and informative references
3 Terms and definitions
3.1 Terms and definitions for the automotive industry
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.3.1 Determining the scope of the quality management system - supplemental
4.3.2 Customer specific requirements
4.4 Quality management system and its processes
4.4.1 (clause does not have a title)
4.4.1.1 Conformance of products and processes
4.4.1.2 Product Safety
4.4.2 (clause does not have a title)
5.1 Leadership and commitment
5.1.1 General
5.1.1.1 Corporate responsibility
5.1.1.2 Process effectiveness and efficiency
5.1.1.3 Process owners
5.1.2 Customer Focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities, and authorities
5.3.1 Organizational roles, responsibilities, and authorities – supplemental
5.3.2 Responsibility and authority for product requirements and corrective actions
6.1 Actions to address risks and opportunities
6.1.1 (clause does not have a title)
6.1.2 (clause does not have a title)
6.1.2.1 Risk analysis
6.1.2.2 Preventive action
6.1.2.3 Contingency plans
6.2 Quality objectives and planning to achieve them
6.2.1 (clause does not have a title)
6.2.2 (clause does not have a title)
6.2.2.1 Quality objectives and planning to achieve them – supplemental
6.3 Planning of Changes
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.3.1 Plant, facility, and equipment planning
7.1.4 Environment for the operation of processes
7.1.4.1 Environment for the operation of processes – supplemental
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.1.1 Measurement system analysis
7.1.5.2 Measurement traceability
7.1.5.2.1 Calibration/verification records
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory
7.1.5.3.2 External laboratory
7.1.6 Organizational knowledge
7.2 Competence
7.2.1 Competence – supplemental
7.2.2 Competence – on the job training
7.2.3 Internal auditor competency
7.2.4 Second-party auditor competency
7.3 Awareness
7.3.1 Awareness – supplemental
7.3.2 Employee motivation and empowerment
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.1.1 Quality Management System Documentation
7.5.2 Creating and updating
7.5.3 Control of documented information
7.5.3.1 (clause does not have a title)
7.5.3.2 (clause does not have a title)
7.5.3.2.1 Record retention
7.5.3.2.2 Engineering specification
8.1 Operational planning and control
8.1.1 Operational planning and control – supplemental
8.1.2 Confidentiality
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.1.1 Customer communication – supplemental
8.2.2 Determining the requirements for products and services
8.2.2.1 Determining the requirements for products and services – supplemental
8.2.3 Review of the requirements for products and services
8.2.3.1 (clause does not have a title)
8.2.3.1.1 Review of the requirements for products and services – supplemental
8.2.3.1.2 Customer designated special characteristics
8.2.3.1.3 Organization manufacturing feasibility
8.2.3.2 (clause does not have a title)
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.1.1 Design and development of products and services – supplemental
8.3.2 Design and development planning
8.3.2.1 Design and development planning – supplemental
8.3.2.2 Product design skills
8.3.2.3 Development of products with embedded software
8.3.3 Design and development inputs
8.3.3.1 Product design input
8.3.3.2 Manufacturing process design input
8.3.3.3 Special characteristics
8.3.4 Design and development controls
8.3.4.1 Monitoring
8.3.4.2 Design and development validation
8.3.4.3 Prototype programme
8.3.4.4 Product approval process
8.3.5 Design and development outputs
8.3.5.1 Design and development outputs – supplemental
8.3.5.2 Manufacturing process design output
8.3.6 Design and development changes
8.3.6.1 Design and development changes – supplemental
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.1.1 General – supplemental
8.4.1.2 Supplier selection process
8.4.1.3 Customer-directed sources (also known as “Direct-Buy”)
8.4.2 Type and extent of control
8.4.2.1 Type and extent of control – supplemental
8.4.2.2 Statutory and regulatory requirements
8.4.2.3 Supplier quality management system development
8.4.2.3.1 Automotive product-related software or automotive products with embedded software
8.4.2.4 Supplier monitoring
8.4.2.4.1 Second-party audits
8.4.2.5 Supplier development
8.4.3 Information for external providers
8.4.3.1 Information for external providers – supplemental
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.1.1 Control plan
8.5.1.2 Standardized work – operator instructions and visual standards
8.5.1.3 Verification of job set-ups
8.5.1.4 Verification after shutdown
8.5.1.5 Total productive maintenance
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment
8.5.1.7 Production scheduling
8.5.2 Identification and traceability
8.5.2.1 Identification and traceability – supplemental
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.4.1 Preservation – supplemental
8.5.5 Post-delivery activities
8.5.5.1 Feedback of information from service
8.5.5.2 Service agreement with customer
8.5.6 Control of changes
8.5.6.1 Control of changes – supplemental
8.5.6.1.1 Temporary change of process controls
8.6 Release of products and services
8.6.1 Release of products and services – supplemental
8.6.2 Layout inspection and functional testing
8.6.3 Appearance items
8.6.4 Verification and acceptance of conformity of externally provided products and services
8.6.5 Statutory and regulatory conformity
8.6.6 Acceptance criteria
8.7 Control of nonconforming outputs
8.7.1 (clause does not have a title)
8.7.1.1 Customer authorization for concession
8.7.1.2 Control of nonconforming product – customer-specified process
8.7.1.3 Control of suspect product
8.7.1.4 Control of reworked product
8.7.1.5 Control of repaired product
8.7.1.6 Customer notification
8.7.1.7 Nonconforming product disposition
8.7.2 (clause does not have a title)
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1.1 Monitoring and measurement of manufacturing processes
9.1.1.2 Identification of statistical controls
9.1.1.3 Application of statistical concepts
9.1.2 Customer satisfaction
9.1.2.1 Customer satisfaction – supplemental
9.1.3 Analysis and evaluation
9.1.3.1 Prioritization
9.2 Internal audit
9.2.1 (clause does not have a title)
9.2.2 (clause does not have a title)
9.2.2.1 Internal audit programme
9.2.2.2 Quality management system audit
9.2.2.3 Manufacturing process audit
9.2.2.4 Product audit
9.3 Management review
9.3.1 General
9.3.1.1 Management review – supplemental
9.3.2 Management review inputs
9.3.2.1 Management review inputs – supplemental
9.3.3. Management review outputs
9.3.3.1 Management review outputs – supplemental
10.1 General
10.2 Nonconformity and corrective action
10.2.1 (clause does not have a title)
10.2.2 (clause does not have a title)
10.2.3 Problem solving
10.2.4 Error-proofing
10.2.5 Warranty management system
10.2.6 Customer complaints and field failure test analysis
10.3 Continual improvement
10.3.1 Continual improvement – supplemental
Annex A: Control Plan
Annex B: Bibliography – supplemental automotive
Corresponding clause in ISO/TS 16949:2009 - 0.1 General
These clauses are almost the same; the new version explains the context of the organization and its influence on the structure of the Quality Management System (QMS), while pointing out that the standard does not imply a need for uniformity in the structure of the QMS. Additionally, enhancing customer satisfaction is pointed out in this clause.
Corresponding clause in ISO/TS 16949:2009 - Not included
The 2009 revision of the standard only mentions that the quality management principles are taken into consideration; the 2016 revision lists the quality management principles, pointing out that detailed descriptions of the principles are given in ISO 9000.
Corresponding clause in ISO/TS 16949:2009 - 0.2 Process Approach
The clause name is the same, but the 2016 revision has three sections that explain the process approach, PDCA cycle, and risk-based thinking. For more information, read
Plan-Do-Check-Act in the ISO 9001 standard
.
Corresponding clause in ISO/TS 16949:2009 - 0.4 Compatibility with other management systems
This clause of the new version of the standard refers to ISO 9000, ISO 9004, and Annex B of the standard, which provide more details about other standards on quality management.
Corresponding clause in ISO/TS 16949:2009 - 1 Scope
This clause is almost the same for both versions of the standard.
Corresponding clause in ISO/TS 16949:2009 - Not included
This clause provides clarification on the applicability of IATF 16949:2016 on various processes and sites of the organization where manufacturing of automotive parts occur.
Corresponding clause in ISO/TS 16949:2009 - 2 Normative references
These clauses are almost the same for both versions of the standard.
Corresponding clause in ISO/TS 16949:2009 - 3 Terms and definitions
The new version refers to ISO 9000:2015.
Corresponding clause in ISO/TS 16949:2009 - Not included
The new version provides definitions for automotive industry-specific terms.
Corresponding clause in ISO/TS 16949:2009 - Not included
This is a completely new requirement; the organization will need to determine the external and internal contexts that affect the organization.
Corresponding clause in ISO/TS 16949:2009 - Not included
Interested parties are introduced in the new version of the standard. The previous version was only focused on the customer.
Corresponding clause in ISO/TS 16949:2009 - 4.2.2 Quality manual
This requirement was related to the Quality Manual in the previous version. Now, there is only a requirement to document the scope.
Corresponding clause in ISO/TS 16949:2009 - 1.1 General
These requirements were originally included in ISO/TS 16949:2009 Sections 1.1 and 1.2. The first requirement was slightly revised to not only address the need to include supporting functions in the audit, but also to ensure that the supporting functions are also included in the scope of the QMS.
Corresponding clause in ISO/TS 16949:2009 - 1.2 Application
These requirements were originally included in ISO/TS 16949:2009 Sections 1.1 and 1.2. The first requirement was slightly revised to not only address the need to include supporting functions in the audit, but also to ensure that the supporting functions are also included in the scope of the QMS.
Corresponding clause in ISO/TS 16949:2009 - All clauses of the standard.
Although the need to fulfill and satisfy customer-specific requirements was already mentioned throughout the whole ISO/TS 16949 document, this requirement specifically addresses the need to evaluate the customer-specific requirements and include them where applicable in the organization's Quality Management System.
Corresponding clause in ISO/TS 16949:2009 - 4.1 General requirements
The requirements from the previous version remain; the new requirements are related to determining the risks and opportunities, inputs and outputs of the processes, as well as assigning responsibilities and authorities for the processes.
Corresponding clause in ISO/TS 16949:2009 - Not included
The requirements from the previous version remain; the new requirements are related to determining the risks and opportunities, inputs and outputs of the processes, as well as assigning responsibilities and authorities for the processes.
Corresponding clause in ISO/TS 16949:2009 - All clauses of the standard.
This requirement was adopted based on survey feedback. It ensures two things: that the organization is responsible for the conformity of outsourced processes, and that all products and processes meet the requirements and expectations of all interested parties.
Corresponding clause in ISO/TS 16949:2009 - 6.4.1 Personnel safety to achieve conformity to product requirements
This is a new section with new and enhanced requirements that address current and emerging issues that the automotive industry is facing related to product and process safety. The list of items a) through n) requires that the organization addresses them in a documented and dedicated process for the management of product safety-related products and manufacturing processes.
Corresponding clause in ISO/TS 16949:2009 - 5.1 Management commitment
The clauses are very similar; the emphasis in the new version is on promoting awareness and support of other persons who contribute to the effectiveness of the QMS. The main difference between the clauses is that the new version requires the top management to take accountability for the effectiveness of the QMS.
Corresponding clause in ISO/TS 16949:2009 - 5.4.2 Quality management system planning
The clauses are very similar; the emphasis in the new version is on promoting awareness and support of other persons who contribute to the effectiveness of the QMS. The main difference between the clauses is that the new version requires the top management to take accountability for the effectiveness of the QMS.
Corresponding clause in ISO/TS 16949:2009 - Not included
Corporate responsibility was not included in ISO/TS 16949.
Corresponding clause in ISO/TS 16949:2009 - 5.1.1 Process efficiency
The requirement to review the processes to ensure effectiveness and efficiency was covered in ISO/TS 16949, Section 5.1.1. Based on the IATF survey feedback, the IATF strengthened the requirement to ensure that the results of the review are now to be included in the management review.
Corresponding clause in ISO/TS 16949:2009 - Not included
ISO/TS 16949:2009 addressed management responsibility and authority, but it did not explicitly mention that management must ensure that process owners understand their roles and are competent. The IATF adopted this requirement to ensure that management understands this expectation.
Corresponding clause in ISO/TS 16949:2009 - 5.2 Customer focus
The old requirements remain the same. Determination of the risks and opportunities regarding conformity of products and services is a new requirement, as well as the consideration of the statutory and regulatory requirements.
Corresponding clause in ISO/TS 16949:2009 - 5.3 Quality Policy
The requirements remain the same. An additional requirement is to be available to interested parties, as appropriate.
Corresponding clause in ISO/TS 16949:2009 - 5.5.1 Responsibility and authority
The main difference is that the new standard does not require appointing a management representative; however, the new clause describes in more detail the roles, responsibilities, and authorities within the QMS, implying that they can be allocated to different persons.
Corresponding clause in ISO/TS 16949:2009 - 5.5.2.1 Customer representative
This requirement was already part of ISO/TS 16949:2009. However, the IATF adopted some modifications to the requirement to address the need to document assigned personnel responsibilities and authorities. Additionally, it clarifies that the goal is not just to address customer requirements, but also to meet customer requirements fully.
Corresponding clause in ISO/TS 16949:2009 - 5.5.1.1 Responsibility for quality
The IATF adopted some enhancements to the requirement originally included in ISO/TS 16949 to address the need to explicitly make top management responsible for ensuring conformity to product requirements and to corrective actions taken.
Corresponding clause in ISO/TS 16949:2009 - Not included
This is a completely new requirement. When planning the QMS, the organization will need to determine the risks and opportunities affecting the organization.
Corresponding clause in ISO/TS 16949:2009 - 7.2.2.2 Organization manufacturing feasibility
The need to identify, analyze, and consider actual and potential risks was already covered in various areas of ISO/TS 16949. The IATF adopted the additional requirements for risk analysis recognizing the continual need to analyze and respond to risk and to have organizations consider specific risks associated with the automotive industry.
Corresponding clause in ISO/TS 16949:2009 - 8.5.3 Preventive action
The IATF enhanced the requirement found in ISO/TS 16949 by providing more detail regarding what is considered to be best practice in the automotive industry.
Corresponding clause in ISO/TS 16949:2009 - 6.3.2 Contingency plans
The IATF enhanced the requirement found in ISO/TS 16949 by providing more detail regarding what is considered to be best practice in the automotive industry. The expanded requirement ensures that the organization defines and prepares contingency plans, along with a notification process to the customer or other interested parties.
Corresponding clause in ISO/TS 16949:2009 - 5.4.1 Quality objectives
The requirements remain the same, but are further elaborated in the new version.
Corresponding clause in ISO/TS 16949:2009 - 5.4.1.1 Quality objectives — Supplemental
ISO/TS 16949 included the importance of addressing customer expectations in the NOTE to Section 5.4.1.1. The IATF decided to enhance the requirement by including the NOTE in Section 6.2.2.1 and to require that it be done at all levels throughout the organization.
Corresponding clause in ISO/TS 16949:2009 - 5.4.2 Quality management system planning
The new version of the standard defines how the changes in the QMS should be managed by considering the purpose of the change, the potential consequences, availability of resources, and allocation of responsibilities.
Corresponding clause in ISO/TS 16949:2009 - 6.1 Provision of resources
The old requirements remain, but the new version emphasizes consideration of capabilities and constraints of the organization, as well as resources obtained from external providers.
Corresponding clause in ISO/TS 16949:2009 - 6.2.1 General
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 6.3 Infrastructure
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 6.3.1 Plant, facility and equipment planning
The new version puts increased focus on risk identification and risk mitigation, evaluating manufacturing feasibility, re-evaluation of changes in processes, and inclusion of on-site supplier activities.
Corresponding clause in ISO/TS 16949:2009 - 6.4 Working environment
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 6.4.2 Cleanliness of premises
The requirement was maintained from ISO/TS 16949 to IATF 16949, only moved to Section 7.1.4.1.
Corresponding clause in ISO/TS 16949:2009 - 7.6 Control of monitoring and measuring equipment
The new version of the standard emphasizes the provision of resources for monitoring and measurement. The organization must retain the documented information as evidence of fitness for purpose of monitoring and measurement resources. The old standard only focuses on the measuring equipment.
Corresponding clause in ISO/TS 16949:2009 - 7.6.1 Measurement system analysis
Records are now required for customer acceptance of alternative methods. See Annex B, which contains IATF-recommended tools for implementation.
Corresponding clause in ISO/TS 16949:2009 - 7.6.2 Calibration/verification records
Ensuring that customer requirements are met, and enhanced calibration / verification record retention requirements, including software installed on employee-owned or customer-owned equipment.
Corresponding clause in ISO/TS 16949:2009 - 7.6.3 Laboratory requirements
Corresponding clause in ISO/TS 16949:2009 - 7.6.3.1 Internal laboratory
Added requirement to have the organization (client) define a methodology to verify measurement system capability if no national or international standard(s) exist.
Corresponding clause in ISO/TS 16949:2009 - 7.6.3.2 External laboratory
Allows the organization to conduct second-party assessments of laboratory facilities; however, requires customer approval of assessment method. Added government regulatory confirmation, if required.
Corresponding clause in ISO/TS 16949:2009 - Not included
This is a completely new requirement, which acknowledges the organizational knowledge as an important resource. The organization will need to determine the knowledge necessary to run its processes and achieve conformity of products and services.
Corresponding clause in ISO/TS 16949:2009 - 6.2.2 Competence, training and awareness
Competence and awareness are split into different clauses to emphasize their importance and provide more detailed requirements.
Corresponding clause in ISO/TS 16949:2009 - Not included
The standard strengthens requirements for identification of training needs and achieving competence.
Corresponding clause in ISO/TS 16949:2009 - 6.2.2.3 Training on the job
Enhanced emphasis of on-the-job training and its importance in meeting customer requirements, including other interested parties.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2.5 Internal auditor qualification
Enhanced requirements for the organization's internal auditor competency requirements to ensure a more robust internal audit process.
Corresponding clause in ISO/TS 16949:2009 - Not included
New requirements for second-party auditors to meet in order to be properly qualified to conduct those types of audits, with customer-specific requirements being a main focus.
Corresponding clause in ISO/TS 16949:2009 -
6.2.2 Competence, training and awareness
Competence and awareness are split into different clauses to emphasize their importance and provide more detailed requirements.
Corresponding clause in ISO/TS 16949:2009 - 6.2.2.4 Employee motivation and empowerment
Additional requirements to ensure all employees are aware of their impact on the organization’s (client’s) product quality output, customer-specific requirements, and risks involved for the customer with non-conforming product.
Corresponding clause in ISO/TS 16949:2009 - 6.2.2.4 Employee motivation and empowerment
Not a major change, just now requiring maintenance of a "documented process" for employee motivation and empowerment.
Corresponding clause in ISO/TS 16949:2009 - 5.5.3 Internal communication
The new clause includes both external and internal communication and requires definition of responsibility and methods of communication.
Corresponding clause in ISO/TS 16949:2009 - 4.2.3 Control of documents
Documents and records now belong to the same category – documented information. The requirements of both versions are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 4.2.4 Control of records
Documents and records now belong to the same category – documented information. The requirements of both versions are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 4.2.4.1 Records retention
Requiring a record retention process that is defined and documented and that includes the organization’s record retention requirements.
Corresponding clause in ISO/TS 16949:2009 - 4.2.3.1 Engineering specifications
Added a requirement that the process is documented and agreed with the customer. Also, clarified product design changes and product realization process changes.
Corresponding clause in ISO/TS 16949:2009 - 7.1 Planning product realization
The requirements of both clauses are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 7.1.1 Planning of product realization — Supplemental
Enhanced detail to ensure key processes are included and considered when planning for product realization.
Corresponding clause in ISO/TS 16949:2009 - 7.1.3 Confidentiality
Minor editing, no major change in the intent of this section.
Corresponding clause in ISO/TS 16949:2009 - 7.2 Customer-related processes
The requirements are almost the same, but the new version emphasizes communication about treatment of customer property.
Corresponding clause in ISO/TS 16949:2009 - 7.2.3 Customer communication
The requirements are almost the same, but the new version emphasizes communication about treatment of customer property.
Corresponding clause in ISO/TS 16949:2009 - 7.2.3.1 Customer communication — Supplemental
Added a requirement for a communication method (written or verbal) to be agreed with the customer.
Corresponding clause in ISO/TS 16949:2009 - 7.2.1 Determination of requirements related to the product
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.2.1 Determination of requirements related to the product (Notes 2 and 3)
Strengthened the standard by elevating Notes into requirements.
Corresponding clause in ISO/TS 16949:2009 - 7.2.2 Review of requirements related to the product
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.2.2.1 Review of requirements related to the product — Supplemental
Strengthens the requirement, stating that the organization is required to retain a documented customer authorization waiver.
Corresponding clause in ISO/TS 16949:2009 - 7.2.1.1 Customer-designated special characteristics
Minor editing, no major change in the intent of this section.
Corresponding clause in ISO/TS 16949:2009 - 7.2.2.2 Organization manufacturing feasibility
Enhanced requirements for manufacturing feasibility analysis.
Corresponding clause in ISO/TS 16949:2009 - Not included
This new clause defines requirements related to changes to requirements related to products and services.
Corresponding clause in ISO/TS 16949:2009 - 7.3 Design and development
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - Not included
This clause defines when the design and development process is necessary.
Corresponding clause in ISO/TS 16949:2009 - 7.3 Design and development (Note)
Strengthened the standard by elevating the NOTE to a requirement, added a requirement for documentation of the design and development process.
Corresponding clause in ISO/TS 16949:2009 - 7.3.1 Design and development planning
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.3.1.1 Multidisciplinary approach
Clarification of when the multi-disciplinary approach is to be used and who should be involved.
Corresponding clause in ISO/TS 16949:2009 - 6.2.2.1 Product design skills
NOTE added as an example of a product design skillset.
Corresponding clause in ISO/TS 16949:2009 - Not included
Added requirements for organization-responsible embedded software development and software development capability self-assessments.
Corresponding clause in ISO/TS 16949:2009 - 7.3.2 Design and development inputs
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.3.2.1 Product design input
Expanded the minimum set of product design input requirements, emphasizing regulatory and software requirements.
Corresponding clause in ISO/TS 16949:2009 - 7.3.2.2 Manufacturing process design input
Expanded the list of manufacturing process design inputs; further strengthened the requirement by putting the NOTE into a requirement.
Corresponding clause in ISO/TS 16949:2009 - 7.3.2.3 Special characteristics
Identify source of special characteristics; include risk analysis to be performed by the customer or the organization.
Corresponding clause in ISO/TS 16949:2009 - 7.3.4 Design and development review
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities.
Corresponding clause in ISO/TS 16949:2009 - 7.3.5 Design and development verification
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities.
Corresponding clause in ISO/TS 16949:2009 - 7.3.6 Design and development validation
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities.
Corresponding clause in ISO/TS 16949:2009 - 7.3.4.1 Monitoring
Aligned the IATF 16949 standard with IATF OEM advanced quality activities; reduced the customer-specific requirements and further clarified the NOTE.
Corresponding clause in ISO/TS 16949:2009 - 7.3.6.1 Design and development validation — Supplemental
Strengthening of requirements for design and development validation; also, added embedded software.
Corresponding clause in ISO/TS 16949:2009 - 7.3.6.2 Prototype programme
Strengthened the standard by focusing the organization on the Quality Management System for managing outsourced products and services.
Corresponding clause in ISO/TS 16949:2009 - 7.3.6.3 Product approval process
Clarified approval requirements with emphasis on outsourced products and/or services and record retention required.
Corresponding clause in ISO/TS 16949:2009 - 7.3.3 Design and development outputs
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.3.3.1 Product design outputs — Supplemental
Recognition of the use of 3D models; inclusion of service parts and packaging.
Corresponding clause in ISO/TS 16949:2009 - 7.3.3.2 Manufacturing process design output
Strengthened verification requirements, process input variables, capacity analysis, maintenance plans, and correction of process nonconformities.
Corresponding clause in ISO/TS 16949:2009 - 7.3.7 Control of design and development changes
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.3.7 Control of design and development changes (Note)
Strengthened requirement for change validation and approval prior to implementation and added embedded software.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1 Purchasing process
Although the name of the clause has changed, the requirements are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1 Purchasing process (Note 1)
Strengthened the IATF 16949 standard by elevating the NOTE to a requirement.
Corresponding clause in ISO/TS 16949:2009 - Not included
Strengthened the standard by specifically calling out supplier selection process criteria.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1.3 Customer-approved sources
Clarification of organization’s responsibilities for customer-directed sources, even for Direct-Buy.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3 Verification of purchased product
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3.1 Incoming product conformity to requirements
Further strengthened the requirement for control of outsourced processes, including the assessment of risk.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1.1 Statutory and regulatory conformity
Further strengthened requirements; clarified applicability of statutory and regulatory requirements.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1.2 Supplier quality management system development
Provides a method to strengthen ISO 9001 certification; alignment of customer-specific requirements; clarification of acceptable third-party certification bodies (recognized by the IATF).
Corresponding clause in ISO/TS 16949:2009 - Not included
Added requirements for software development assessment methodology.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3.2 Supplier monitoring
Strengthened requirements for supplier monitoring.
Corresponding clause in ISO/TS 16949:2009 - Not included
Alignment of customer-specific requirements into the IATF 16949 standard.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3.1 Incoming product conformity to requirements
Emphasis on performance-based supplier development actions.
Corresponding clause in ISO/TS 16949:2009 - 7.4.2 Purchasing information
The requirements of both clauses are pretty much the same. The new version emphasizes the monitoring and control of external providers’ performance.
Corresponding clause in ISO/TS 16949:2009 - Not included
Requires the organization to provide key information to their supply chain.
Corresponding clause in ISO/TS 16949:2009 - 7.5 Production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1 Control of production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities.
Corresponding clause in ISO/TS 16949:2009 - 7.5.2 Validation of processes for production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.1 Control plan
Strengthened control plan requirements and aligned IATF OEM customer-specific requirements into the IATF 16949 standard. Elevated NOTE to a requirement; strengthened control plan review and update criteria and linked to PFMEA update.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.2 Work instructions
Strengthened requirements for standardized work, including the requirement to address specific language needs.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.3 Verification of job set-ups
Elevated NOTE to a requirement; clarified record retention.
Corresponding clause in ISO/TS 16949:2009 - Not included
Defined the requirement for verification after shutdown; improved integration of industry lessons learned / best practices.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.4 Preventive and predictive maintenance
Strengthened the requirement for equipment maintenance and overall proactive management of the total productive maintenance.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.5 Management of production tooling
Strengthened tooling and equipment marking and tracking requirements.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.6 Production scheduling
Emphasized the importance of planning information; integrated IATF OEM customer lessons learned.
Corresponding clause in ISO/TS 16949:2009 - 7.5.3 Identification and traceability
The requirements of both clauses are pretty much the same.
Corresponding clause in ISO/TS 16949:2009 - 7.5.3.1 Identification and traceability — Supplemental
Strengthened requirements for traceability to support industry lessons learned related to field issues.
Corresponding clause in ISO/TS 16949:2009 - 7.5.4 Customer property
The requirements of both clauses are the same, but in the new standard the requirements are extended to property belonging to external providers as well.
Corresponding clause in ISO/TS 16949:2009 - 7.5.5 Preservation of product
The requirements of both clauses are the same.
Corresponding clause in ISO/TS 16949:2009 - 7.5.5.1 Storage and inventory
Added specificity to preservation controls and included application to internal and/or external providers.
Corresponding clause in ISO/TS 16949:2009 - Not included
The post-delivery activities are mentioned in several places in the old version, but in the new standard they are set apart as a separate sub clause.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.7 Feedback of information from service
Expanded scope to include material handling and logistics.
Corresponding clause in ISO/TS 16949:2009 - 7.5.1.8 Service agreement with customer
Clarification of service agreement requirements.
Corresponding clause in ISO/TS 16949:2009 - Not included
The control of changes is mentioned in several places in the old version; however, the importance of controlling changes is stressed in the new standard by defining a separate sub clause.
Corresponding clause in ISO/TS 16949:2009 - 7.1.4 Change control
Strengthened the standard to align with existing IATF OEM requirements.
Corresponding clause in ISO/TS 16949:2009 - Not included
Added a requirement to address issues experienced by the IATF OEM customers.
Corresponding clause in ISO/TS 16949:2009 - Not included
This is a new requirement, dealing with verification of product and ensuring that product or service meets requirements.
Corresponding clause in ISO/TS 16949:2009 - Not included
Strengthened the standard to ensure that process controls align with the control plan.
Corresponding clause in ISO/TS 16949:2009 - 8.2.4.1 Layout inspection and functional testing
Clarified that the frequency of layout inspections is determined by the customer.
Corresponding clause in ISO/TS 16949:2009 - 8.2.4.2 Appearance items
Inclusion of haptic technology, as appropriate, for appearance items.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3.1 Incoming product conformity to requirements
Alignment with ISO 9001:2015 terminology; clarification of source of statistical data.
Corresponding clause in ISO/TS 16949:2009 - 7.4.1.1 Statutory and regulatory conformity
Strengthened standard for statutory and regulatory conformity to require evidence of compliance.
Corresponding clause in ISO/TS 16949:2009 - 7.1.2 Acceptance criteria
Minor editing, no major change in the intent of this section.
Corresponding clause in ISO/TS 16949:2009 - 8.3 Control of nonconforming product
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 8.3.4 Customer waiver
Alignment of terminology; clarification of concessions applied to rework of nonconforming product and sub-component reuse.
Corresponding clause in ISO/TS 16949:2009 - 8.3.1 Control of nonconforming product — Supplemental
Ensures customer-controlled shipping requirements are followed.
Corresponding clause in ISO/TS 16949:2009 - 8.3.1 Control of nonconforming product — Supplemental
Strengthened requirements by ensuring that containment training is implemented.
Corresponding clause in ISO/TS 16949:2009 - 8.3.2 Control of reworked product
Expanded scope to include: customer approval, risk assessment, rework confirmation, traceability, and retention of documented information.
Corresponding clause in ISO/TS 16949:2009 - 8.3.3 Customer information
Clarified the requirement and the need for follow up with detailed information for reworked product.
Corresponding clause in ISO/TS 16949:2009 - 7.4.3.2 Supplier monitoring
New automotive requirement to address modifications in ISO 9001 requirements and address customer issues for IATF OEM concerns.
Corresponding clause in ISO/TS 16949:2009 - 8.2.1.1 Customer satisfaction — Supplemental
New automotive requirement to address modifications in ISO 9001 requirements and address customer issues for IATF OEM concerns.
Corresponding clause in ISO/TS 16949:2009 - 8.3.1 Control of nonconforming product — Supplemental
Strengthened the requirement of disposition of nonconforming product.
Corresponding clause in ISO/TS 16949:2009 - 8.2.3 Monitoring and measurement of processes
The new clause sublimates all requirements for processes and products / services monitoring and measurement.
Corresponding clause in ISO/TS 16949:2009 - 8.2.4 Monitoring and measurement of product
The new clause sublimates all requirements for processes and products / services monitoring and measurement.
Corresponding clause in ISO/TS 16949:2009 - 8.2.3.1 Monitoring and measurement of manufacturing processes
Clarification of the requirement for targeting process effectiveness and efficiency. Extension of the requirement to have effective and efficient processes instead of just having a process. Ensures that organizations support the manufacturing process through defined roles, responsibilities, and effective escalation processes to drive process capability and stability.
Corresponding clause in ISO/TS 16949:2009 - 8.1.1 Identification of statistical tools
Clarification regarding documented deployment of the use of statistical tools from DFMEA, PFMEA, and the APQP (or equivalent) process.
Corresponding clause in ISO/TS 16949:2009 - 8.1.2 Knowledge of basic statistical concepts
Clarification regarding requirements for those involved in capturing and analyzing data; previously driven across all employees regardless of relevance.
Corresponding clause in ISO/TS 16949:2009 - 8.2.1 Customer satisfaction
The requirements are the same.
Corresponding clause in ISO/TS 16949:2009 - 8.2.1.1 Customer satisfaction — Supplemental
Clarification of customer satisfaction monitoring criteria and introduction of additional focus on warranty management. Additional focus of the requirement to ensure all customer performance measures are regularly reviewed to reduce the risk of failure to achieve customer satisfaction.
Corresponding clause in ISO/TS 16949:2009 - 8.4 Analysis of data
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 8.4.1 Analysis and use of data
Emphasis change from ISO/TS 16949 “Analysis of data" to prioritization of actions based on performance and risk management.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2 Internal audit
The requirements are equivalent. The main difference is that the new standard does not require a documented procedure. See the sample document here:
Procedure for Internal Audit
. For more information, read
Five Main Steps in ISO 9001 Internal Audit
.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2.4 Internal audit plans
Strengthened the need to drive a risk-based approach to the development and deployment of an organization-wide internal audit program.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2.1 Quality management system audit
Strengthened the Quality Management System audit and the use of the process approach; further drives process improvements organization-wide.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2.2 Manufacturing process audit
Strengthened the formal approaches to ensure that the benefits of effective manufacturing process audits are achieved by organizations.
Corresponding clause in ISO/TS 16949:2009 - 8.2.2.3 Product audit
Strengthened the product audit requirements to include customer-specified approaches.
Corresponding clause in ISO/TS 16949:2009 - 5.6 Management review
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 5.6.1.1 Quality management system performance
Strengthened the organization's management review requirements, including assessment of risk and compliance with customer requirements.
Corresponding clause in ISO/TS 16949:2009 - 5.6.2 Review input
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 5.6.2.1 Review input — Supplemental
Enhanced details for management review input requirements.
Corresponding clause in ISO/TS 16949:2009 - 5.6.3 Review output
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 5.6.3 Review output
Enhanced to ensure action is taken where customer requirements are not achieved; supports continual analysis of process performance and risk.
Corresponding clause in ISO/TS 16949:2009 - Not included
The requirements in the new standard explain what should be considered in the process of improvement.
Corresponding clause in ISO/TS 16949:2009 - 8.5.2 Corrective action
The requirements are equivalent.
Corresponding clause in ISO/TS 16949:2009 - 8.5.2.1 Problem solving
Consolidation of IATF OEM customer-specific minimum requirements.
Corresponding clause in ISO/TS 16949:2009 - 8.5.2.2 Error-proofing
Previously, only mentioned the use of error-proofing methods in corrective action; new requirements strengthen the approach to error-proofing and consolidate customer-specific requirements.
Corresponding clause in ISO/TS 16949:2009 - Not included
Adds a new requirement based on the increasing importance of warranty management and consolidates IATF OEM customer-specific requirements.
Corresponding clause in ISO/TS 16949:2009 - 8.5.2.4 Rejected product test/analysis
Adds a new requirement regarding embedded software and identification of preferred approaches.
Corresponding clause in ISO/TS 16949:2009 - 8.5.1 Continual improvement
The new standard points out the need to use all available information for continually improving the QMS.
Corresponding clause in ISO/TS 16949:2009 - 8.5.1.1 Continual improvement of the organization
Clarification of the minimum process requirements.
Corresponding clause in ISO/TS 16949:2009 - 8.5.1.2 Manufacturing process improvement
Clarification of the minimum process requirements.
Corresponding clause in ISO/TS 16949:2009 - Annex A (normative) Control plan
The new version provides more details about how to develop the Control Plan.
Corresponding clause in ISO/TS 16949:2009 - Bibliography
The bibliography provides information on additional documents that can be useful during the implementation, maintenance, and auditing of the QMS.
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