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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

How can ISO 9001:2015 help boost your sales activities?

While ISO 9001:2015 is strictly a quality management standard, it is considered a business tool by many people in today’s business environment. The benefits of implementing ISO 9001:2015 go far beyond the management of quality; it can also help your organization to improve performance, reduce supply chain costs, retain existing ...Read more

How to include statutory and regulatory requirements in your QMS

One of the requirements that are embedded within ISO 9001:2015 is the necessity to understand and include statutory and regulatory requirements within the Quality Management System (QMS); however, many people have difficulty with understanding how to do this. To help understand this process, there are three main questions to answer: ...Read more

Case study: Design and development in the software industry

The software industry is one of the fastest-growing industries in the last few decades and although software production is regulated by its own rules, very often there is a requirement for establishing a Quality Management System according to ISO 9001. Due to the specificity of the software development industry, implementation ...Read more

How to establish process validation in the QMS

When companies are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, there is often confusion when it comes to the topic of validation. People can get confused when talking about the difference between design verification and design validation, or discussing what is considered design validation as opposed ...Read more

What is the ISO 9001 audit program, and how does it work?

One of the most important tools that you have to make sure that your Quality Management System (QMS) meets the requirements that have been identified, and is effectively implemented and maintained, is the internal audit program. Internal audits are an integral part of any management system, and thus are included ...Read more

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

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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