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Document for compliance

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Guest user Created:   May 22, 2019 Last commented:   May 22, 2019

Document for compliance

In Procedure 03_Quality Manual, Section 4.4, we do not understand the paragraph *in bold* below. There does not appear to be a form/appendix included with the package that addresses this. Can you please help us understand some typical documents or ways that companies use to capture this requirement?
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IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Ivan Pribicevic May 22, 2019
4.4. Quality Management System and its processes
Our company has established and implemented the QMS, which is maintained and continually improved according to the requirements of the IATF 16949:2016 standard and customer-specific requirements, including processes needed and their interactions.
We have determined the processes needed for the QMS and their application through the organization. Also, we have determined required inputs and desired outputs of the processes, criteria, and methods needed for effective operation and control of these processes, as well as resources needed and responsibilities and authorities for processes in the Quality Plan. Sequences and interactions between the processes are described in Figure 2: Process Map.
*Rules regarding product and process conformity to statutory, regulatory, and customer requirements are defined in [document name], including outsourced processes and service parts.*

Answer:
It is common practice that an organization has a list of laws and other legislation that is impacting the organization. In this list, the organization needs to answer if it complies with legislative in the operating country, or if it needs to apply measures in the future in order to be fully compiled. Also, this can be outsourced to other organization specialized in legislative.

This requirement is typical for all management systems and when it comes to IATF 16949 it can be more difficult if you are working in more than one country.

Document from the toolkit named “Appendix 1 – List of Interested Parties and Customer Specific Requirements“, in the folder: 04_Procedure_for_Determining_Context_of_the_Organization_and_Intereste d_Parties or https://advisera.com/16949academy/documentation/list-of-interested-parties-and-customer-specific-requirements/ can be used by identify Government as interested parties and fill all the legislative they must comply with. You can also add the level of compliance and action plan.

For more information, take a look at this article:
https://advisera.com/9001academy/blog/2017/02/14/how-to-include-statutory-and-regulatory-requirements-in-your-qms/
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May 22, 2019

May 22, 2019

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