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ISO 9001 Blog

ISO 13485:2016 nonconforming product – How to approach the post-delivery actions

Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a medical device is simply not acceptable, even after its use or after delivery. Therefore, ISO …

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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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How to use ISO 9001 to facilitate the manufacturing of a complex product

The reason for implementing a Quality Management System (QMS) is to improve the consistency of your product, but ISO 9001:2015 itself does not specify the process you need to use for manufacturing a complex product. This is due to the fact that the ISO 9001 standard is intended to be non-prescriptive, …

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Understanding Product & Service Provision in ISO 9001

Many people are confused by ISO 9001 section 7.5 on production and service provision. Some of this confusion probably comes from the fact that the international standard is trying to set requirements that are specific enough to be relevant, but general enough to be applicable to any company regardless of …

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Five Steps for ISO 9001 Nonconforming Products

Do you have difficulty with deciding what steps to follow to best deal with non-conforming products? Do you have trouble seeing how making sure this is done well can save time and customer loyalty? The process for non-conforming products is one of the most critical processes to understand and get …

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Strahinja Stojanovic
Lead ISO 9001 Expert,


ISO 9001


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