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What does ISO 9001 lead auditor training look like?

There is a lot of training involved when implementing a Quality Management System (QMS) according to the requirements of ISO 9001:2015, and many companies offer many different types of training for those who will be involved in the QMS. If you look even briefly, you will find implementation training, ISO …

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How to use quality control tools to improve your QMS

One of the key benefits of any Quality Management System (QMS), especially one that has been created according to the requirements of ISO 9001:2015, is to bring a focus on continual improvement within the organization. Continual improvement is one of the quality management principles that forms the foundation of the …

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How to make your investment in ISO 9001 profitable

Implementing a Quality Management System (QMS) using the requirements of the ISO 9001:2015 standard is an internationally recognized way to focus your company efforts on customer satisfaction and drive improvements in your company, but this process does not come without a cost. For this reason, many business professionals ask what …

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ISO 9001: Requirements for the release of the product or service

With the release of ISO 9001:2015, there are specific requirements for you to include in your Quality Management System (QMS) about what you need to do when you accept your products and services for delivery to your customers. At first glance, there seems to be more requirements for the release …

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Specific use of ISO 9001 design and development in the machining process

With the updated Quality Management System (QMS) requirements in ISO 9001:2015, there have been some minor, yet important changes in the requirements for design and development activities within the Quality Management System. In the past, many companies have taken the opportunity to exclude the design and development activities required by …

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Aligning quality objectives of the QMS with the strategic direction of the company

One of the new concepts that have been brought into the latest version of the ISO 9001:2015 standard is that the Quality Management System (QMS) of a company needs to include an understanding of, and alignment with, the strategic direction of the company. The strategic direction of the company comes …

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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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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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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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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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How to define the scope of the QMS according to ISO 9001:2015

Determining the scope of the Quality Management System (QMS) has been a part of the ISO 9001 requirements for a long time. This scope is a vital part of the quality manual, as it defines how far the QMS extends within the company’s operations, and details any exclusion from the …

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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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What is an ISO 9001 surveillance audit?

Early on, when you are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, you will need to talk to a certification body to find out what you need to do to certify your management system as compliant with the requirements. During your discussions you will be …

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How to proceed once a QMS corrective action is defined?

Corrective action has always been an important process within a Quality Management System (QMS), and this does not change with the new release of the standard, ISO 9001:2015. This is why one of our first blog posts was about this important topic: Seven steps for corrective and preventive actions to …

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Strahinja Stojanovic
Lead ISO 9001 Expert,
Advisera

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