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Free IATF 16949:2016 Gap Analysis Tool

Find out your level of compliance with IATF 16949

 

 

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4 CONTEXT OF THE ORGANIZATION
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT

You need to determine the external and internal issues that are relevant to your organization.

Click here to see an example: Procedure for Determining Context of the Organization and Interested Parties.


4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

You need to determine the interested parties for your QMS and their relevant requirements.

Click here to see an example: List of Interested Parties and Customer Specific Requirements.
4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

You need to determine and document the boundaries and applicability of your QMS by considering external and internal issues, requirements of interested parties, and your products and services.

Click here to see an example: Scope of the Quality Management System.
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES




5 LEADERSHIP
5.1 LEADERSHIP AND COMMITMENT




5.2 POLICY

A quality policy must be established that is appropriate for the organization, provides a framework for quality objectives, and shows commitment to satisfying requirements and continual improvement.

Click here to see an example: Quality Policy.



The organization needs to define and implement corporate responsibility policy.

Click here to see an example: Corporate Responsibility Policy.
5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES


6 PLANNING
6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

You need to plan for the QMS and consider issues and requirements that determine the risks and opportunities to be addressed.

Click here to see an example: Procedure for Addressing Risks and Opportunities.

The organization needs to determine and implement actions to eliminate the causes of potential nonconformities and document contingency plans.

Click here to see an example: Contingency plan template.

Planning must take place to address the risks and opportunities identified and to integrate these into the QMS.

Click here to see an example: Registry of Key Risks and Opportunities.

The organization needs to identify internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output, and define and document contingency plans accordingly.

Click here to see an example of a Contingency Plan.
6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

You need to establish quality objectives for the QMS that are measurable, monitored, communicated, updated, and documented.

Click here to see an example: Quality Objectives.
6.3 PLANNING OF CHANGES


7 SUPPORT
7.1 RESOURCES



You need to identify the resources needed for valid monitoring and measurement results for product and service conformity, including measurement traceability, safeguards for measurement, and organizational knowledge necessary for operations.

Click here to see an example: Procedure for Equipment Maintenance and Measurement Equipment.

The organization needs to document the scope of the internal laboratory and specify requirements for effective laboratory functioning, as well as the requirements for external laboratories.

Click here to see an example: Laboratory Management Procedure.
7.2 COMPETENCE

You need to determine the necessary competence required for the persons who will perform functions within the QMS processes.

Click here to see an example: Procedure for Competence, Training and Awareness.
7.3 AWARENESS

You need to take actions to ensure persons doing work within the QMS know the quality policy, quality objectives, and how they contribute to the QMS including the implications of non-conformance.

Click here to see an example: Awareness Training Report.
7.4 COMMUNICATION


7.5 DOCUMENTED INFORMATION

You need to set up a process to control documented information of the QMS, including creating and updating, control of use, adequate protection, control of distribution, and changes.

Click here to see an example: Procedure for Document and Record Control.
8 OPERATION
8.1 OPERATIONAL PLANNING AND CONTROL


8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

You need to implement processes for customer communication, determining requirements for products and services, reviewing requirements of products and services, and updating documents when changes occur.

Click here to see an example: Sales Procedure.
8.3 DESIGN AND DEVELOPMENT

You need to establish, implement, and maintain a design and development process for your products, services, and processes that addresses design and development planning, inputs, controls, outputs, and changes.

Click here to see an example: Procedure for Design and Development.

The organization needs to establish, implement, and maintain a product and manufacturing approval process in accordance with requirements of the customer.

Click here to see an example: Production Part Approval Process Procedure.
8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

You need to take steps to ensure externally provided processes meet requirements by determining the type and extent of control needed and the information needed for external providers.

Click here to see an example: Procedure for Purchasing and Evaluation of Suppliers.

The second-party audits must be part of the supplier management approach, and can be used for supplier risk assessment, monitoring, QMS development, product and process audits.

Click here to see an example: Second-Party Audit Checklist.
8.5 PRODUCTION AND SERVICE PROVISION

You need to implement the controlled conditions necessary for your production and service provision, including necessary documented information, monitoring and measurement, identification and traceability (if necessary), property belonging to customers or external parties, preservation of product or service, control of changes, and post-delivery activities associated with your product and service.

Click here to see an example: Procedure for Production and Service Provision.

The organization needs to develop control plans and standardized work / operator instructions, and document a productive maintenance plan.

Click here to see an example: Control Plan.

The organization needs to establish, implement, and maintain a document total productive maintenance system by identifying necessary equipment, provision of resources, documented maintenance objectives, and use of preventive maintenance methods.

Click here to see an example: MTBF and MTTR Downtime Dashboard.

The organization needs to ensure that standardized work instructions are communicated and understood by the employees who are responsible for performing the work.

Click here to see an example: Work Instruction Template.
8.6 RELEASE OF PRODUCTS AND SERVICES

You need to implement planned arrangements to verify that requirements have been met before release of products and services.

Click here to see an example: First and Last Part Approval Form.
8.7 CONTROL OF NONCONFORMING OUTPUTS

You need to implement a process to identify and control nonconforming outputs of your processes so that they are not unintentionally used until a disposition has been made, and you must maintain documented information for this process.

Click here to see an example: Procedure for the Management of Nonconformities and Corrective Actions.
9 PERFORMANCE EVALUATION
9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

You need to determine the monitoring and measurement needs, how they will be done, and when they shall be performed for the processes of the QMS and customer satisfaction. You must also analyse and evaluate the data and information arising from monitoring and measurement.

Click here to see an example: Procedure for Measuring Customer Satisfaction.
9.2 INTERNAL AUDIT

You need to have audit procedures to evaluate the QMS against the planned arrangements (including effectiveness, proper implementation, and maintenance) at planned intervals and results must be reported to management.

Click here to see an example: Procedure for Internal Audit.
9.3 MANAGEMENT REVIEW

Top management must review the data from the QMS to assess the need for change in the QMS, resource adequacy, and the effectiveness of the QMS.

Click here to see an example: Procedure for Management Review.
10 IMPROVEMENT
10.1 GENERAL


10.2 NONCONFORMITY AND CORRECTIVE ACTION

When a nonconformity occurs, you must take action to deal with the nonconformity and deal with the consequences, evaluate the need to eliminate the root cause of the nonconformity, and review the effectiveness of the corrective action taken.

Click here to see an example: Procedure for the Management of Nonconformities and Corrective Actions.


10.3 CONTINUAL IMPROVEMENT

You need to continually improve the suitability, adequacy, and effectiveness of the QMS.

Click here to see an example: Procedure for Continual Improvement.
According to our gap analysis tool you have implemented
% of the requirements of of IATF 16949 in your Quality Management System. Here are some notes on what is still needed.

NOTE: Please open all the elements that you want to be e-mailed to you.

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strahinja-iso-expert

Strahinja Stojanovic
IATF 16949 Expert

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