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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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How to manage knowledge of the organization according to ISO 9001

Do you know all of the organizational knowledge you need for your business? Is this knowledge readily available, or is it trapped inside one or two key employees? When you are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, you are asked to consider the organizational …

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What is the job of the Quality Manager according to ISO 9001?

The role of quality manager is common at many companies, and this individual has often been designated as the quality management representative that was required in the previous version of ISO 9001. However, now that the ISO 9001:2015 standard has removed the requirements for a quality management representative, is there …

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How to create a check list for an ISO 9001 internal audit for your QMS

One of the most important checking tools in a Quality Management System (QMS), or any management system, is the internal audit. The ISO 9001:2015 requirements are very clear that this is a critical element of your QMS; and, since you want to know how your processes are functioning, your internal audits become …

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How long does it take to implement an ISO 9001-based QMS?

Gap analysis and definition of the implementation steps can help you estimate length of the QMS set-up. See what else could help to do the estimate. When you are implementing a Quality Management System (QMS) according to the requirements of ISO 9001:2015, you will probably wonder how long this will take. …

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How to address risks and opportunities in ISO 9001

When using the ISO 9001:2015 requirements as a basis for your Quality Management System (QMS), you will find that risk-based thinking is an important new concept that has been brought into the forefront of quality planning. Along with this notion that it is important to think about risk, there are also …

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What are the benefits of ISO 9001 for your employees?

There are many reasons for a company to implement a Quality Management System (QMS) based on the requirements of ISO 9001:2015. An organization can gain better control of their processes and focus more on customer requirements, which will lead to improved customer satisfaction. However, are there benefits for the employees of …

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