ISO 14000 / ISO 9000 Technacon

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03/30/2024

Have you heard about the changes to ISO 9001:2015 on climate change? Here is a quick summary:
I’ve gone through NQA’s auditor course on the added note to ISO 9001:2015 on climate change. Here are the points I think you will find important:
• The changes are due to an ISO conference in London.
• It is added as a note to sections 4.1 and 4.2 (Context of the organization and Interested parties) otherwise the content of these clauses does not change.
• The standard remains 2015 revision, there will not be a 2024 update.
• Even though it is a note which is considered guidance, the wording is “Shall”. It must be included in the audit.
• It should be addressed in External issues and interested parties such as regulatory as well as customers.
• If the company determines they have no impact to climate change, they must provide the evidence as to why this decision was made.
• Auditors are not to disproportionally emphasize climate change. They must ask if it has been addressed and how and if it is not considered relevant, why that determination was made.
• If the client determines climate change is not part of their external issues, the auditor must ask questions about regulatory requirements, supply change impacts, and if there is a plan to address severe weather/fires/droughts. The auditor must also ask if the client’s customers have any requirements for carbon neutral positioning or market their products as supporting sustainability.
• The client can address climate change, if they wish, in
o their scope
o Actions to address risk and opportunity.
o Changes to the strategic plan
o Resources
o Requirements for products and services
o Design and development.
o Externally provided processes, products, and services
o Production and service provision
o Performance evaluation
• Auditors must provide evidence in their reports that the subject has been discussed with the client and note the documented information utilized by the client to demonstrate addressing climate change or determining it is not relevant. Certifying bodies will be looking at reports from the end of February 2024 to verify the registrar is addressing the issue.
• Each registrar is handling this as their own management determination. It may be written as an observation or a minor finding. NQA will write it as an observation for the first year and a minor finding the following year.

Here is the second video on implementing ISO 13485:2016
12/16/2020

Here is the second video on implementing ISO 13485:2016

[email protected] , www.technacon.com (708) 814-3685. A set of videos for implementing of ISO 13485: 2016.Management commitment comes from an overa...

Here is a quick point you should review to prevent a potential audit finding
05/05/2020

Here is a quick point you should review to prevent a potential audit finding

www.technacon.com [email protected] (708) 814-3685 Corrective and Preventive Actions Hi this is Sherri Gallagher with Technacon Company presenting ...

Here is the next ISO 13485 video on section 6 resources.
03/31/2020

Here is the next ISO 13485 video on section 6 resources.

Technacon Company, Inc. www.technacon.com [email protected] ISO 13485: 2016 section 6 “Resource Management”. Management has two key responsibilitie...

Do you have your Certification audit scheduled while under a shelter in place order? Watch this video.
03/30/2020

Do you have your Certification audit scheduled while under a shelter in place order? Watch this video.

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Here is a quick video on Management review during a shelter in place order
03/24/2020

Here is a quick video on Management review during a shelter in place order

www.technacon.com [email protected] (708) 814-3685 Hi this is Sherri Gallagher from Technacon Company, Inc. with a Standard Minute. Let’s face it, ...

Here is an overview video on the implementation of ISO 13485:2016
02/23/2020

Here is an overview video on the implementation of ISO 13485:2016

ISO 13485 is a quality management system for medical devices, including requirements for regulatory purposes. It does not apply to pharmaceutical. Structured...

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