Roadmap - ISO 9001:2015

1. Understand the expiration date

In order to plan, you need to understand the expiration date of ISO 9001:2008 and ISO 14001:2004.
Any certificate issued after September 15, 2015 will have an expiration date of September 15, 2018.
In order not to have a lapse in the certification, Orion wants the clients to have completed their audit
and proper actions for audit non conformances by July 13, 2018 so there will be time to process the
documentation. Thus, it is not wise to have an upgrade audit after July 1, 2018.

2. Purchase a copy of the Standard(s)

The two primary sources to purchase the standards are ANSI and ISO electronic standard stores on
their website. The ANSI Website is www.ansi.org and the ISO www.iso.org.

3. Understand the changes in the Standard(s)

There are many sources of information from training classes, web articles, and consultants. In order
to help you understand the changes in the standards, in the near future Orion will provide the
following documents:
ISO 9001 and ISO 14001 presentation on the changes titled: ISO 9001:2015 and ISO
14001:2015 Changes
Orion ISO 9001:2015 and ISO 14001:2015 Upgrade Checklists

4. Implement the changes in the Standard(s)

Provide the resources and knowledge to implement the changes of the new revisions. In order to be
certified to the new standard(s) revision(s), an internal audit must be conducted to the new standard
changes and a Management Review must be conducted which evaluates the effectiveness of the
changes to the management system(s). Orion offers a gap analysis or Pre-Assessment to review
implementation of the changes.

5. Decide on what method to upgrade the Standard(s)

Tasa has two options to upgrade to the new revisions which are: upgrade during surveillance or
upgrade during a recertification audit. The logic for which event to use is: did you rewrite your
management system documentation or did you just make changes to the management system?
a) If you rewrote the documentation, a recertification audit is required. Tasa normally will not
add any additional time for the upgrade for a recertification audit.
b) If you made changes to the documentation you can upgrade during surveillance or
recertification audit. Tasa will normally add at least day for upgrading during
surveillance.
In order to upgrade, tasa requires the following:
Complete and submit both the tasa Upgrade Questionnaire and the specific standard(s)
Footprint Chart
Identify which audit activity and when and let tasa scheduling know well in advance
Send request and documents listed above to Jerome@tasatz.com

6. Upgrade Audits Performed and Corrective Actions Completed

Tasa will perform the audit and all major nonconformances must be closed and minor
nonconformances must be acceptable before the certification to the new standard(s) can be
accomplished.
All documents referenced will be available on the O

Mandatory documents and records required by ISO

9001:2015

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 Roadmap - ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO
9001:2015. (Please note that some of the documents will not be mandatory if the company
does not perform relevant processes.):
Scope of the QMS
Quality policy
Quality objectives
Criteria for evaluation and selection of suppliers

And, here are the mandatory records (note that records marked with * are only mandatory in
cases when the relevant clause is not excluded):
Monitoring and measuring equipment calibration records*
Records of training, skills, experience and qualifications
Product/service requirements review records
Record about design and development outputs review*
Records about design and development inputs*
Records of design and development controls*
Records of design and development outputs *
Design and development changes records*
Characteristics of product to be produced and service to be provided
Records about customer property
Production/service provision change control records
Record of conformity of product/service with acceptance criteria
Record of nonconforming outputs
Monitoring and measurement results
Internal audit program
Results of internal audits
Results of the management review
Results of corrective actions

Non-mandatory documents
There are numerous non-mandatory documents that can be used for ISO 9001
implementation. However, I find these non-mandatory documents to be most commonly
used:

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 Roadmap - ISO 9001:2015
Procedure for determining context of the organization and interested parties
Procedure for addressing risks and opportunities
Procedure for competence, training and awareness
Procedure for equipment maintenance and measuring equipment
Procedure for document and record control
Sales procedure
Procedure for design and development
Procedure for production and service provision
Warehousing procedure
Procedure for management of nonconformities and corrective actions
Procedure for monitoring customer satisfaction
Procedure for internal audit
Procedure for management review

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