· Web viewhas occurred (6.1.2.3) Evidence that expanded Plant, facility and equipment planning has occurred including risk analysis and manufacturing feasibility including capacity

Printed: May 6, 2023

Only those documents viewed through the AESOP system are officially controlled. All other copies, whether viewed through another computer program or a printed version, are not controlled and therefore NSF-ISR assumes no responsibility for accuracy of the document.

AESOP 16912; ISSUE 2; STATUS-PUBLISHED; EFFECTIVE 15 NOV 2017; AUTHORITY CARL BLAZIKThis is a confidential document and may be reproduced only with the permission of NSF-ISR. Page 1 of 15



IATF 16949 Automotive Quality Management System registration provides a set of uniform requirements for an automotive suppliers’ quality management system. A number of quality management principles including a strong customer focus, support of top management, the process approach and continual improvement form the basis for the standard.

Changes to the Standard

IATF 16949 1st edition was published on October 1, 2016 (available from AIAG) and includes the requirement to meet all applicable requirements within ISO 9001:2015. ISO 9001:2015 was published on September 23, 2015, and can be purchased through the NSF Bookstore.

These revised standards respond to the latest market developments, and are more compatible with other management systems, such as ISO 14001, thanks to an updated, higher-level structure. The new standard is less prescriptive than the previous version; instead focusing on performance through a combination of risk-based thinking and a process approach, as well as employment of the “Plan-Do-Check-Act” cycle at all levels in the organization.

Other updates include: Increased importance has been given to risk Incorporation of common customer specific requirements Greater significance of communication and awareness More emphasis has been placed on leadership and Top

Management direction

These updates, along with changes to other management system standards, include implementing similar terminology across all standards and matching sub-clauses to the top-level structure, ensuring fully integrated systems.

IATF 16949 Transition

NSF-ISR will be working with each of you (our clients) to provide a smooth transition to the new standard. We are committed to ensuring that your organization understands the updated requirements and what steps your organization may need to take to achieve conformance. We have a number of resources available to help you through the transition:

NSF-ISR Standards Updates Webpage - keep up on the latest information regarding the standard and the transition process ISO 9001:2015 and IATF 16949 Transition Webinars NSF-ISR Guide to the IATF 16949:2016 Transition


http://www.nsf.org/newsroom_pdf/ISO_IATF_16949_2016_Information.pdf

http://www.nsf.org/newsroom/pub-type/webinars/category/management-systems

http://www.nsf.org/info/iso-updates



ISO/TS 16949:2009 will not be valid after September 14, 2018. After October 1, 2017, no audits, including initial, surveillance, recertification or transfer, will be conducted to the ISO/TS 16949:2009. All transition audits will be conducted with duration of recertification audits as long as timing is met, new certificates & new 3-year cycle will begin.




IATF 16949 Upgrade Planner and Delta ChecklistInstructions:

1. Highlighted areas are to be completed by the Client Organization prior to the off-site Document review and on-site Transition Audit, and submitted to the NSF-ISR Lead Auditor for review. Full supporting evidence of documentation changes is to accompany this checklist submission.

2. The Annex A - ISO 9001: 2015 vs. ISO 9001: 2008 Comparison Table has been provided at the end of this document for information and reference purposes only.3. Completion by the Client Organization should include the final statement of readiness for Upgrade by the Top Management of the Client Organization.4. The columns for “Planned Completion Date” and Responsibility” may be used by the Client Organization to develop their plan for upgrading their QMS to the requirements of IATF 16949.5. All other areas of the Checklist are required to be completed by the NSF-ISR Lead Auditor to confirm the effective implementation of the Client Organization’s IATF 16949 Automotive Quality

Management System.6. The Lead Auditor shall sign the appropriate sections at the end of the Checklist to indicate: whether the Client Organization is Ready/Not Ready for Transition Audit (Off-site review), AND the

final approval of the QMS in meeting the requirements of IATF 16949: 2016 (during the on-site Upgrade Audit)7. This checklist shall be submitted by the NSF-ISR Lead Auditor as one of the records of the IATF 16949 Transition for the Client Organization.8. Remote Support Locations (RSLs) should be audited prior to the manufacturing site. In exceptional circumstances, where the remote supporting function has not completed a transition audit to

IATF 16949 prior to the transition audit at the relevant manufacturing site, the organization shall ensure a complete gap analysis, including a detailed action plan to fulfil the applicable requirements of IATF 16949, is available at the manufacturing site´s audit. In situations where the organization does not provide the gap analysis and detailed action plan, the audit at the manufacturing site shall be considered failed and the site shall be required to undertake a full initial audit.

Organization Name:

Organization Address:

Number of Personnel:1st Shift :2nd Shift :3rd Shift :Temp. / Part-time :

Other locations included in this registration:Has IATF 16949 Transition audit occurred? (If No, attached separate complete Delta Checklist AESOP 16912, associated detailed action plan to fulfill IATF 16949 requirements, and scheduled dates for RSL transition audit.)

RSL1 - Has IATF 16949 Transition audit occurred? Yes No



Management Contact:Name and Revision Status of QMS documentation:FRS Number:

Off-site Review Date (Desk Audit):

Audit Dates (on-site):




Lead Auditor / Audit Team:

Scope of Registration:IATF 16949: 2016 Product design (8.3) exclusion justification:Note: if product design is excluded, please state justification here.

The interval between the client Delta Review and the Upgrade Audit should not exceed 90 days.




NOTE: Please ensure that your Organization’s registered ISO/TS 16949:2009 QMS remains compliant with that version of the Standard until the Transition to IATF 16949: 2016 is complete and verified by the NSF-ISR Lead Auditor.

Question / RequirementLevel of

Completion0=Not Started

5=Completed & Implemented

QMS Process

Related to Requiremen

t(Process Name)

Planned Completion

DateResponsibility

Reference Document(Name / Rev. Level)

ORRecords

NSF-ISR Lead Auditor Review Comments

Evidence of determination of Understanding the Organization and its Context (4.1)Evidence of determination of Interested Parties and their requirements (4.2)Evidence that scope of the QMS includes applicable remote support functions and customer specific requirements. Also, if product design is excluded, has justification been documented in QMS? (4.3)QMS Documentation (7.5.1):Examples:

- Process map (or equivalent)- Process descriptions & interactions- Quality Policy- Quality Objectives- Planning of changes- Other Documentation (as

appropriate)Includes 4.4, 5.2.1, 6.2 and 6.3

ALL

Product Safety (4.4.1.2): Evidence that a documented process is implemented related to the management of product-safety related products and manufacturing processes. Note - cannot be “NA”.Evidence of Leadership and Commitment (5.1)Evidence of Corporate responsibility policies, defined and implemented. (5.1.1.1)Evidence that Process Owners are identified for all QMS processes including support processes. (5.1.1.3)Organization Roles, responsibilities and authorities (5.3.1) are assigned and documented.







QMS Process


t(Process Name)

Planned Completion

DateResponsibility


ORRecords


Evidence of Risk-Based Thinking and evidence of Actions to Address Risks and Opportunities (6.1). Risk analysis to include appropriate inputs and is documented. (6.1.2.1)Evidence that a Preventive action process exists which lessens the impact of negative effects of risk. (6.1.2.2)Evidence that expanded Contingency planning has occurred (6.1.2.3)Evidence that expanded Plant, facility and equipment planning has occurred including risk analysis and manufacturing feasibility including capacity planning (7.1.3.1)Evidence that expanded expectations regarding Calibration/ verification records have been met. (7.1.5.2.1)Evidence of Organizational Knowledge (7.1.6) management.Evidence that Internal Auditors competency requirements are captured within the QMS and implemented. (7.2.3)Evidence that Second party Auditor competency requirements are satisfied. (7.2.4)Evidence that documentation is available related to Employee awareness , Motivation and empowerment (7.3.1 & 7.3.2)Evidence that a document was created to cross reference coverage of applicable customer specific requirements within QMS. (7.5.1.1d)Evidence that expanded manufacturing feasibility analysis requirements are being met. (8.2.3.1.3)







QMS Process


t(Process Name)

Planned Completion

DateResponsibility


ORRecords


The design and development process (applies to product and manufacturing process design) shall be documented. (8.3.1.1)Evidence that the expanded criteria for design and development planning has been incorporated within the organizations approach (8.3.2.1)Evidence that the organization utilizes an appropriate process for quality assurance related to products with internally developed embedded software. (8.3.2.3)Evidence that the expanded criteria for product design inputs has been incorporated within the organizations approach (8.3.3.1)Evidence that the expanded criteria for manufacturing process design inputs has been incorporated within the organizations approach (8.3.3.2)Evidence that the process for managing special characteristics has been documented and implemented. (8.3.3.3)Evidence that the expanded criteria for design and development outputs has been incorporated within the organizations approach (8.3.5.1)Evidence that the expanded criteria for manufacturing process design outputs has been incorporated within the organizations approach (8.3.5.2)Evidence that the expanded criteria for managing design and development changes has been incorporated within the organizations approach (8.3.6)Evidence that a documented supplier selection process has been defined and implemented. (8.4.1.2)







QMS Process


t(Process Name)

Planned Completion

DateResponsibility


ORRecords


Evidence that a documented process for outsource process control has been defined and implemented. (8.4.2.1) (What are the outsourced processes and how are they controlled?)Evidence that a documented process for meeting statutory and regulatory requirements has been defined and implemented. (8.4.2.2)Evidence that the organization requires suppliers of embedded software to implement and maintain a process for software quality assurance for their products. (8.4.2.3.1)Evidence that the process for supplier monitoring has been documented. (8.4.2.4)Evidence that the organization utilizes an appropriate second party audit approach within its supplier management process. (8.4.2.4.1)Evidence that supplier development activities and expectations are determined based on performance and risk. (8.4.2.5)Is there evidence that key information is being cascaded down the supply chain to point of manufacture (8.4.3.1)Evidence that the expanded criteria for control of production and service provision has been incorporated within the organizations approach (8.5.1).Evidence that the expanded criteria for control plans has been incorporated within the organizations approach (8.5.1.1)Evidence that the elevated criteria for Verification of job set-ups has been incorporated within the organizations approach (8.5.1.3)







QMS Process


t(Process Name)

Planned Completion

DateResponsibility


ORRecords


Evidence that the new requirement of Verification after shutdown has been implemented. (8.5.1.4)Evidence that the expanded criteria for Total productive maintenance has been incorporated within the organizations approach (8.5.1.5).Evidence that the Production scheduling activities include the added relevant planning information (8.5.1.7)Evidence of robust identification and traceability practices to support industry requirements. Includes analysis of requirements and traceability plans developed based on risk. (8.5.2.1)Evidence that the expanded criteria for control of changes has been incorporated within the organizations approach (8.5.6.1)Evidence of implementation related to Temporary change of process controls within the quality management system (8.5.6.1.1)Evidence of Statutory and regulatory conformity for externally provided processes, products and services in country of manufacture and destination (8.6.5).Evidence that the expanded criteria for control of reworked product has been incorporated within the organizations approach (8.7.1.4).Evidence that the expanded criteria for control of repaired product has been incorporated within the organizations approach (8.7.1.5).Evidence that the expanded criteria for Nonconforming product disposition has been incorporated within the organizations approach (8.7.1.7).







QMS Process


t(Process Name)

Planned Completion

DateResponsibility


ORRecords


Evidence that Customer satisfaction indicators include a focus on warranty and periodic monitoring (9.1.2.1)Evidence that Analysis and evaluation additional expectations are being met (9.1.3 & 9.1.3.1)Evidence that the Internal Audit Programme follows a risk based approach for the entire organization and has been updated to consider new specific requirements. (9.2.2)Evidence that the expanded criteria for Management review has been incorporated within the organizations approach (9.3).Evidence that the expanded criteria for Problem solving has been incorporated within the organizations approach (10.2.3).Evidence that the expanded criteria for Error proofing application and control has been incorporated within the organizations approach (10.2.4).Evidence that the new criteria for Warranty management systems has been incorporated within the organizations approach (10.2.5).Evidence that the new criteria for Customer complaints and field failure analysis (embedded software) has been incorporated within the organizations approach (10.2.6).Evidence that Continual Improvement additional expectations are being met (10.3.1)




Readiness EvidenceLevel of



QMS Process

Related to Requirement(Process Name)

Planned Completion

DateResponsibility


ORRecords


Internal Audit Results (9.2)(using process-approach)- Full internal Audit to IATF 16949:

2016- Inputs, outputs, performance to

targets, process linkages / interactions.

Internal Audit Corrective Actions (9.2.2 e)- (including evidence of closure)Records of Management Review (9.3) Completed to IATF 16949:2016 requirements after completion of the Internal Audit.Organization confirmation that the QMS now complies with all requirements of IATF 16949: 2016.(E.G. Quality Manual or Documented Information addresses all clauses of the Standard).Other Client Organization-specific information about the QMS (as determined by the Client Organization)

Note: This section is optional, and may be completed if there are unique aspects of the QMS that the Client deems important in demonstrating compliance to the IATF 16949: 2016 Standard.

Approval Name / Title Signature DateClient Organization Top Management attests readiness for Transition to IATF 16949.

NSF-ISR Lead Auditor confirmation of Readiness (Document review approval).NSF-ISR Lead Auditor Approval of Compliance to IATF 16949 at On-site Transition Audit.

The completed Checklist shall be submitted by the NSF-ISR Lead Auditor as a supplement to the IATF 16949 Transition Audit Report




Appendix AISO 9001: 2015 vs. ISO 9001: 2008 Comparison Table

New or Different in ISO 9001:2015 Covered in ISO 9001:2008

Clause in ISO 9001:2015 Equivalent Clause in ISO 9001:2008

1 Scope 1 Scope1.1 General

4 Context of the organization 4 Quality management system 4.1 Understanding the organization and its context 4 Quality management system 4.2 Understanding the needs and expectations of interested parties 4 Quality management system

4.3 Determining the scope of the quality management system

1.2 Application4.2.2 Quality manual

4.4 Quality management system and its processes 4 Quality management system4.1 General requirements

5 Leadership 5 Management responsibility5.1 Leadership and commitment 5.1 Management commitment5.1.1 General 5.1 Management commitment5.1.2 Customer focus 5.2 Customer focus5.2 Policy 5.3 Quality policy5.2.1 Developing the Quality Policy 5.3 Quality policy5.2.2 Communicating the Quality Policy 5.3 Quality policy

5.3 Organizational roles, responsibilities and authorities5.5.1 Responsibility and authority5.5.2 Management representative5.4.2 Quality management system planning

6 Planning 5.4.2 Quality management system planning

6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning8.5.3 Preventive action

6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives6.3 Planning of changes 5.4.2 Quality management system planning7 Support 6 Resource management7.1 Resources 6 Resource management7.1.1 General 6.1 Provision of resources7.1.2 People 6.1 Provision of resources7.1.3 Infrastructure 6.3 Infrastructure7.1.4 Environment for the operation of processes 6.4 Work environment7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment

7.1.5.1 General 7.6 Control of monitoring and measuring equipment

7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment7.1.6 Organizational knowledge No equivalent clause

7.2 Competence 6.2.1 General6.2.2 Competence, training and awareness

7.3 Awareness 6.2.2 Competence, training and awareness7.4 Communication 5.5.3 Internal communication7.5 Documented information 4.2 Documentation requirements7.5.1 General 4.2.1 General7.5.2 Creating and updating 4.2.3 Control of documents




4.2.4 Control of records

7.5.3 Control of documented Information 4.2.3 Control of documents4.2.4 Control of records

8 Operation 7 Product realization8.1 Operational planning and control 7.1 Planning of product realization8.2 Requirements for products and services 7.2 Customer-related processes8.2.1 Customer communication 7.2.3 Customer communication8.2.2 Determination of requirements related to products and services

7.2.1 Determination of requirements related to the product

8.2.3 Review of requirements related to products and services 7.2.2 Review of requirements related to the product

8.2.4 Changes to requirements for products and services 7.2.2 Review of requirements related to the product8.3 Design and development of products and services 7.3Design and development8.3.1 General 7.3.1 Design and development planning8.3.2 Design and development planning 7.3.1 Design and development planning8.3.3 Design and development inputs 7.3.2 Design and development inputs

8.3.4 Design and development controls7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation

8.3.5 Design and development outputs 7.3.3 Design and development outputs8.3.6 Design and development changes 7.3.7 Control of design and development changes8.4 Control of externally provided processes, products and services

4.1 | General requirements7.4.1 Purchasing process

8.4.1 General 7.4.1 Purchasing process

8.4.2 Type and extent of control 7.4.1 Purchasing process7.4.3 Verification of purchased product

8.4.3 Information for external providers 7.4.2 Purchasing information7.4.3 Verification of purchased product

8.5 Production and service provision 7.5 Production and service provision

8.5.1 Control of production and service provision7.5.1 Control of production and service provision7.5.2 Validation of processes for production and service provision

8.5.2 Identification and traceability 7.5.3 Identification and traceability8.5.3 Property belonging to customers or external providers 7.5.4 Customer property

8.5.4 Preservation 7.5.5 Preservation of product8.5.5 Post-delivery activities 7.5.1 Control of production and service provision8.5.6 Control of changes 7.3.7 Control of Design and Development Changes

8.6 Release of products and services 7.4.3 Verification of purchased product8.2.4 Monitoring and measurement of product

8.7 Control of nonconforming outputs 8.3 Control of nonconforming product9 Performance evaluation 8 Measurement, analysis and improvement9.1 Monitoring, measurement, analysis and evaluation 8 Measurement, analysis and improvement

9.1.1 General 8.1 General8.2.3 Monitoring and Measurement Processes

9.1.2 Customer satisfaction 8.2.1 Customer satisfaction9.1.3 Analysis and evaluation 8.4 Analysis of data9.2 Internal audit 8.2.2 Internal audit9.3 Management review 5.6 Management review9.3.1 General 5.6.1 General9.3.2 Management review input 5.6.2 Review input




9.3.3 Management review output 5.6.3 Review output10 Improvement 8.5 Improvement10.1 General 8.5.1 Continual improvement

10.2 Nonconformity and corrective action 8.3 Control of nonconforming product8.5.2 Corrective action

10.3 Continual Improvement 8.5.1 Continual improvement8.5.3 Preventive action

Amendment Record

Version # Submitted Date Summary of Changes1 11/2016 Initial issue


Documents

· Web viewhas occurred (6.1.2.3) Evidence that expanded Plant, facility and equipment planning has occurred including risk analysis and manufacturing feasibility including capacity