Some ISO 9001:2015 Forms and Templates

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#3
Documented Information Matrix

Hello to all,

It is time for me to start giving back to elsmar forum because there was a time where I got all the resources I needed from this forum and made me succeed and get the company where I work certified to ISO 9001:2008 now we are transitioning to ISO 9001:2015. Thank you Elsmar!

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This guidance document highlights changes in the requirements for documented information, and includes tables of documented information that should be retained and maintained.

The extent of the documented information will differ from your organization to another because of to the size of organization and its activities, processes, products and services; the complexity of processes and their interactions, and the competence of personnel.

In ISO 9001:2008, the quality manual helped to establish and document the framework of your organization's quality management system while articulating those aspects of the QMS to any interested parties.

While there is no requirement for a quality manual or documented procedures in ISO 9001:2015, it is suggested that if they add value, then they should not simply be binned. You will be expected to maintain the integrity of the QMS during the transition process.

You do not need to renumber your existing documentation to correspond to the new clauses. It is down to each organization to determine whether the benefits gained from renumbering will exceed the effort involved. Neither do you need to restructure your management system to follow the sequence of and titles of the requirements. Providing all of the requirements contained in ISO 9001:2015 are met, your organization’s quality management system will be compliant.

Please comment if this benefited you in some way, I have more material to share with you.

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#4
ISO 9001:2015 Correlation Matrix & Change Summary

The correlation matrix compares the new requirements of ISO 9001:2015 to the requirements of ISO 9001:2008, and provides a summary of the changes.

This document provides a matrix that correlates the requirements of ISO 9001:2015 to the new requirements of ISO 9001:2008 and should be used to determine where the new and amended clauses are located. Many of the requirements from ISO 9001:2008 are present with ISO 9001:2015.

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#5
ISO 9001:2015 Gap Analysis Checklist

The self-assessment questions will help you to identify gaps between your existing Quality Management System and the requirements of ISO 9001:2015.

This gap analysis checklist highlights the new requirements contained in ISO 9001:2015, and is not intended to cover all of the requirements from ISO 9001:2015 comprehensively. The unique knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach. Armed with this knowledge, it allows you to establish accurate budgets, timelines and expectations which are proportional to the state of your current management system when directly compared to the requirements of the standards.


Your organization may already have in place an ISO 9001:2008 compliant quality management system or you might be running an uncertified system. If this is the case, you will want to determine how closely your system conforms to the requirements ISO 9001:2015. The results of a gap analysis exercise will help to determine the differences, or gaps, between your existing management system and the new requirements. Not only will this analysis template help you to identify the gaps, it will also allow you to recommend how those gaps should be filled.

The gap analysis output provides a valuable baseline for the implementation process as a whole and for measuring progress.

Try to understand each business process in the context of each of the requirements by comparing different activities and processes with what the standard requires. At the end of this activity you will have a list of activities and processes that comply and ones that do not comply.

The latter list now becomes the target of your implementation plan.

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