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What Should You Do First?

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What is ISO 9001?

ISO 9001 is the international standard for Quality Management Systems (QMS), published by ISO (the International Organization for Standardization). The standard was most recently updated in 2008, and is referred to as ISO 9001:2008.

 

 

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Free ISO 9001 Gap Analysis Tool

An ISO 9001 tool, like our free gap analysis tool, can help you see how much of ISO 9001 you have implemented so far – whether you are just getting started, or nearing the end of your journey.

 

 

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What should you do first?

Before you can start your ISO 9001 implementation, you must first understand your issues and where you have room for improved quality management. Then you can figure out where you are in the process. You might be just starting out, and wondering whether ISO 9001 can help you with your specific issues in your company.

Or, you might be further into your journey. With step one, you can clearly define your position so you understand your next steps.

More detail and advice in our ISO 9001 Blog

List of mandatory documents required by ISO 13485:2016

The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to the medical device industry. So, here is the list – below you will see the ...Read more

How much does the ISO 9001 implementation cost?

The cost of ISO 9001 implementation is one of the first topics that come up when deciding to get into the project, and very often, the main drawback because it is very hard to make a precise estimate at the beginning of the project. The price of implementation depends on ...Read more

How do you prove to the certification auditor that QMS processes are carried out as planned?

Since its 2000 release, ISO 9001 has been focused on the process approach, and the ISO 9001:2015 updates are no different. Your Quality Management System (QMS) is made up of many different processes that need to be integrated properly, so that they will function properly. Many times, the output of ...Read more

Infographic: What’s new in the 2016 revision of ISO 13485

To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article:ISO 9001 vs. ISO 13485.   The new 2016 revision of ISO 13485, the leading international standard for medical devices, is finally in front of us. Now we can see exactly what has changed ...Read more

QMS Change Management in 7 steps

In any management system, it is important to control your changes to the management system, and there is no difference with a Quality Management System (QMS) created using the requirements of ISO 9001:2015. While QMS change management may sound like a complex activity, it can be thought of in quite ...Read more

To what extent should top management be involved in your QMS?

On the first reading of the ISO 9001:2015 standard, it seems to be rather confusing regarding what is the right extent and time in your QMS (Quality Management System) lifecycle to involve management. On the other side, there is a clear referencing to the topics that should be covered by ...Read more

Free ISO 9001 Consultation

Our resident ISO 9001 consultants are available to speak with you regarding the steps your company should take next. We understand that sometimes things get confusing, and you need advice you can trust.

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