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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 …

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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: …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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How to become an ISO 9001 consultant

ISO 9001 is the most popular management system standard in the world, and it helps many businesses to establish a QMS (Quality Management System) and ensure quality products and services, as well as customer satisfaction. Given that this standard is used worldwide, there is understandably a constant demand by organizations …

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How to use the ISO 9001 standard to improve stock efficiency and increase profit

Most people correctly assume that ISO 9001 is purely a quality management standard, and while this is technically correct, applying the principles from the standard can bring many other benefits to a business. In our previous article: Six key benefits of ISO 9001 Implementation, we examined some of the benefits that …

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Communication requirements according to ISO 9001:2015

The new communication requirements in ISO 9001:2015 fall under the overall section on support, Section 7. This section includes all of the requirements for the processes you need to have in place to support your Quality Management System (QMS), and ensure its ability to provide products and services to meet …

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Similarities and differences in risk management in ISO 9001, ISO 31000, and ISO 27001

Are you a beginner in dealing with risk management, or do you have a bit of expertise? Either way, you may have many dilemmas. Do you want to integrate risk management concepts into your organization using standards for Quality and Information Security Management Systems, but have no idea where to …

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