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How to comply with ISO 13485:2016 requirements for handling complaints

Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and integral part of this industry. Complaint management is an important part of customer relationship management …

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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 deal with design and development changes in the technology sector using ISO 9001

The requirements of design and development are fairly prescriptive within the ISO 9001:2015 standard in terms of planning, inputs, outputs, controls, and changes to this process. For many organizations manufacturing standard products with little change, this is a vital and often straight-forward clause to follow, but when design and development …

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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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