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Look at your options

Do it alone

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This is the most difficult and time-consuming way, because it involves creating every document from scratch and figuring out all the steps on your own. Many companies try it this way, but very few are actually successful at implementation. In many cases, after months (or years) have passed, companies discover that a lot of time and money have been wasted with no real results.

 

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Pay a consultant

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Sure, a consultant will hold your hand throughout the entire process, but they’ll also send you a big bill afterward. Still, if this is the route you want to take, make sure you use our ISO 9001 consultant checklist to evaluate the consultant you choose (expertise can vary widely among consultants).

 

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Do it yourself with support

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This is how we do things at 9001Academy. We provide all the documentation templates, expert guidance, and professional support you need to earn ISO 9001 certification without hiring a consultant.

 

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Look at your options

This step involves researching your options for implementation. There are three basic routes to ISO 9001 certification for your business:

  • Do it alone – This is the most difficult and time-consuming way, because it involves creating every document from scratch and figuring out all the steps on your own. Many companies try it this way, but very few are actually successful at implementation. In many cases, after months (or years) have passed, companies discover that a lot of time and money have been wasted with no real results.
  • Pay a consultant – Sure, a consultant will hold your hand throughout the entire process, but they’ll also send you a big bill afterward. Still, if this is the route you want to take, make sure you use our ISO 9001 consultant checklist to evaluate the consultant you choose (expertise can vary widely among consultants).
  • Do it yourself with support – this is how we do things at 9001Academy. We provide all the documentation templates, expert guidance, and professional support you need to earn ISO 9001 certification without hiring a consultant.

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

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