Project Checklist For ISO 9001 Implementation en

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The key takeaways from the document are the main phases and tasks involved in implementing an ISO 9001 Quality Management System. It outlines obtaining management support, establishing a project plan, defining processes and procedures, implementing controls, performing training and audits, and ensuring continual improvement of the QMS.

The main phases outlined are: obtaining management support and approval, establishing the project, identifying requirements, defining the scope and documentation, defining processes and procedures, implementing controls, performing training, choosing a certification body, operating the QMS, and performing audits and reviews.

Some of the key documents that need to be created include the Quality Policy, Quality Objectives, procedures for document control, internal auditing, monitoring customer satisfaction, and corrective actions.

[organization name]

Project Checklist for ISO 9001:2015 Implementation Commented [AG1]: See this article: 6 key benefits of ISO
9001:
Implementation phases Tasks Done http://advisera.com/9001academy/knowledgebase/six-key-
benefits-of-iso-9001-implementation/
Obtain management Research which benefits of ISO 9001:2015 would be applicable Commented [AG2]: See this article: How to get
support to your company. management buy-in before ISO 9001 implementation:
https://advisera.com/9001academy/blog/2014/09/02/get-
management-buy-iso-9001/
Present the benefits to the management and get their
commitment. Commented [AG3]: See this white paper: Implementing
ISO 9001 with a consultant vs. DIY approach:
http://info.advisera.com/9001academy/free-download/imp
Get formal approval for the project. lementing-iso-9001-with-a-consultant-vs-diy-approach

Commented [AG4]: See ISO 9001 Toolkits Product tour:


https://advisera.com/9001academy/product-tour/
Establish your project Decide whether you are going to use consultants or you will be
using documentation templates.
Commented [AG5]: See this information: ISO 9001: What
is it, how does it work and why use it?
Purchase the ISO 9001:2015 standard. https://advisera.com/9001academy/what-is-iso-9001/

Educate your project team. Commented [AG6]: See this helpful Project Plan for ISO
9001:2015 implementation:
http://info.advisera.com/9001academy/free-download/proj
Write the project plan, including the definition of the project ect-plan-for-iso-9001-implementation-ms-powerpoint
manager, project team, project sponsor, required resources,
Commented [AG7]: See this article: How to identify the
and milestones. context of the organization:
https://advisera.com/9001academy/knowledgebase/how-t
Define which stakeholders need to be informed about each o-identify-the-context-of-the-organization-in-iso-90012015/
step in the project. Commented [AG8]: See this article: How to identify the
context of the organization:
Organize kick-off meeting. https://advisera.com/9001academy/knowledgebase/how-t
o-identify-the-context-of-the-organization-in-iso-90012015/
Commented [AG9]: See this article: How to include
statutory and regulatory requirements in your QMS:
Identify requirements Determine the context of the organization. https://advisera.com/9001academy/blog/2017/02/14/how-
to-include-statutory-and-regulatory-requirements-in-your-q
Identify interested parties. ms/
Commented [AG10]: See this article: How to address
Identify the requirements of interested parties. risks and opportunities in ISO 9001:
https://advisera.com/9001academy/blog/2016/06/21/how-
to-address-risks-and-opportunities-in-iso-9001/
Identify applicable legal requirements.
Commented [AG11]: See this article: How to determine
Identify Risks and Opportunities of the QMS. the scope of the QMS according to ISO 9001:2015:
https://advisera.com/9001academy/knowledgebase/how-t
o-define-the-scope-of-the-qms-according-to-iso-90012015/

Commented [AG12]: See this article: How to write a good


Define the scope, Write the QMS Scope Document.
quality policy:
management https://advisera.com/9001academy/blog/2014/03/25/write
commitment, and Write the Quality Policy. -good-quality-policy/
responsibilities Commented [AG13]: See this article: How to write good
Decide on the Quality Objectives. quality objectives
https://advisera.com/9001academy/knowledgebase/how-t
o-write-good-quality-objectives/
Project Checklist for ISO 9001:2015 ver [version] from [date] Page 1 of 3

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[organization name]

Commented [AG14]: See this article: Checklist of


Mandatory Documentation Required by ISO 9001:2015
Define processes and Identify all processes and procedures necessary for the QMS. http://info.advisera.com/9001academy/free-download/che
procedures cklist-of-mandatory-documentation-required-by-iso-900120
Write the procedure for Document Control. 15
Commented [AG15]: See this article: How to structure
Write the procedure for Internal Audit. Quality Management System documentation:
https://advisera.com/9001academy/knowledgebase/how-t
o-structure-quality-management-system-documentation/
Write the procedure for Monitoring of Customer Satisfaction.
Commented [AG16]: See this article: 13 steps for ISO
Write the procedure for corrective action. 9001 Internal Auditing using ISO 19001:
https://advisera.com/9001academy/knowledgebase/13-ste
ps-for-iso-9001-internal-auditing-using-iso-19011/
Commented [AG17]: See this article: Analysis of
Implement processes, Implement all the processes, procedures, and controls defined measuring and monitoring requirements in ISO 9001:2015:
https://advisera.com/9001academy/blog/2014/07/01/main
procedures, and for the QMS. -elements-handling-customer-satisfaction-iso-9001/
controls
Maintain records of implementation. Commented [AG18]: See this article: How to proceed
once a QMS corrective action is defined:
https://advisera.com/9001academy/blog/2016/09/20/how-
to-proceed-once-qms-corrective-action-is-defined/

Perform training and Perform training for all employees who lack required skills.
Commented [AG19]: See this book: Preparations for the
awareness programs ISO implementation project: A plain English guide
Perform awareness programs for all employees and third https://advisera.com/books/preparations-for-the-iso-imple
parties that have a role in your QMS. mentation-project-a-plain-english-guide/
Commented [AG20]: See this course: ISO 9001:2015
Foundations Course
https://training.advisera.com/course/iso-90012015-foundat
Choose a certification Obtain proposals from several certification bodies. ions-course/
body
Select the certification body. Commented [AG21]: See this article: How to ensure
competence and awareness in ISO 9001:2015:
https://advisera.com/9001academy/knowledgebase/how-t
o-ensure-competence-and-awareness-in-iso-90012015/
Operate the QMS Maintain all the records required by your own policies and
procedures. Commented [AG22]: See this checklist: List of
questions to ask an ISO 14001 certification body:
http://info.advisera.com/9001academy/free-download/li
Perform corrective actions as needed. st-of-questions-to-ask-an-iso-9001-certification-body
Commented [AG23]: See this book: Discover ISO
Make sure you monitor all your systems. 9001:2015 Through Practical Examples
https://advisera.com/books/discover-iso-9001-2015-throug
Measure if you have achieved the objectives set for your QMS. h-practical-examples/
Commented [AG24]: See this article: Analysis and
monitoring requirements in ISO 9001:2015:
...
https://advisera.com/9001academy/knowledgebase/analysi
Develop the audit program.
Commented [AG25]: See this article: How to create a
checklist for an ISO 9001 internal audit for your QMS:
Perform internal audit Perform internal audit(s). https://advisera.com/9001academy/blog/2016/07/12/how-...
Commented [AG26]: See this online training: ISO
Write an internal audit report. 9001:2015 Internal Auditor Course: ...
Commented [AG27]: See this book: ISO internal audit: a
Project Checklist for ISO 9001:2015 ver [version] from [date] Page 2 of 3
plain English guide ...

©2017 9001Academy https://www.advisera.com/9001academy/


[organization name]

Perform corrective actions.

Perform management review. Commented [AG28]: See this article: How to make
management review more useful in the QMS:
Perform management Maintain records from management review. https://advisera.com/9001academy/blog/2014/01/21/make
review -management-review-useful-qms/
Perform corrective actions.

Ensure continual improvement. Commented [AG29]: See this article: How to use quality
control tools to improve your QMS:
https://advisera.com/9001academy/blog/2017/04/18/how-
to-use-quality-control-tools-to-improve-your-qms/
Perform Stage 1 certification audit.
Commented [AG30]: See this article: How to prepare
Certification audit Perform Stage 2 certification audit. your company for the ISO 9001 certification audit
http://advisera.com/9001academy/blog/2016/05/03/how-t
o-prepare-your-company-for-the-iso-9001-certification-audi
Conduct surveillance visits. t/

Commented [AG31]: See this article: How to deal with


nonconformities in an ISO 9001 certification audit:
https://advisera.com/9001academy/blog/2015/06/09/how-
to-deal-with-nonconformities-in-an-iso-9001-certification-a
For all the documents needed to implement the standard, check out this ISO 9001:2015 udit/
Documentation Toolkit.
Commented [AG32]: See this article: What is an 9001
surveillance audit?
https://advisera.com/9001academy/blog/2016/10/18/what
-is-an-iso-9001-surveillance-audit/

Project Checklist for ISO 9001:2015 ver [version] from [date] Page 3 of 3

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