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Detailed Analysis of ISO 9001 | Clauses 1 to 3

Detailed Analysis of ISO 9001

This blog will be serving as a detailed analysis of ISO 9001. However, this detailed analysis of ISO 9001 is only a fraction from mini-series where we will be going through the actual details and requirements of each clause in the high level structure of ISO standards.

Transcript

Hi, in this video, I wanted to go down into the details of what the actual standard is saying when it comes to the clauses of the standard. In this first video within this series, I wanted to give a detailed analysis of ISO 9001 and explain Clauses 1, 2 and 3.

So, the first clause states that this international standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aim to enhance customer satisfaction. And as such to have a system for quality assurance when it comes to both the needs of the customer and applicable statutory requirements.

Basically, in clause one, we are just seeing an overview of what this particular standard is all about, which as can be seen, focuses on the needs of the customers, normative references, or statutory and regulatory requirements, which is another word for legal requirements for your organization. This means that for Clause 1, we don’t need to do anything to meet the requirements for this clause, because the elements that we’re going to do to meet the requirements of the management system are explained in other clauses within this particular standard.

Moving on to clause two, here we have a clause which talks about normative references. The standard says that the following documents in whole or in part, are normatively referenced in this document, and are indispensable for its application. For dated reference, only the edition cited applies. For undated references, the latest edition of the reference document applies. 

What does this mean? First of all, here we see that when it comes to ISO 9001 itself, we have to consider ISO 9000:2015, which is the standard that explains the fundamentals and vocabulary of terms that are used within ISO 9001. So, as such, ISO 9000 is just a dictionary or glossary of all the technical words that are used in ISO 9001 which are explained in this other standard, ISO 9000.

Now, when it comes to implementing ISO 9001 within your organization, I like to use Clause 2 to include all normative references or statutory and regulatory requirements applicable to your organization. This means that I use Clause 2 to list down all laws and regulations that apply to your industry, based on how you operate as a business. This will make sure that when we are implementing the management system within your organization, we are considering all of the statutory and regulatory requirements when it comes to your products and services.

Moving on to the third clause within the standard, which talks about terms and definitions. For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. Once again, the standard here is referring to the ISO 9000 standard, which has been mentioned in Clause 2 within this video okay, as terms and definitions.

When implementing this type of standard with my clients, I like to use this particular clause to list down any acronyms, complex words or technical words that are used by the organization. When someone external or a new employee is reading the Quality Management System or the Quality Manual, they will be able to understand the context in which some technical words are used, and they will be able to get familiarized very quickly with any abbreviations or acronyms that are used within your organization.

So effectively, those are the first three clauses within the ISO 9001:2015 standard. As you can see, there are no major changes that we have to make except to list down the normative references or legal requirements for the organization within Clause 2 of the standard, and in Clause 3 of the standard, we are simply explaining the terms and definitions that apply to your organization.

If you have any questions, please feel free to let me know. In the meantime, I invite you to subscribe to this channel so that you will be updated pf more videos relating to other clauses relating to ISO 9001.

If you would like more information, please feel free to get in touch. I would love to help you succeed. Thank you so much

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