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ISO 9001 Blog

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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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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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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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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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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Five tips to ensure your ISO 9001:2015 implementation is successful

An ISO 9001:2015 implementation can be a complex and demanding process, which may take from 6 to 12 months depending on your organizational size and structure and other influencing factors. Most project managers will find many challenges during the implementation phase, which we looked at in the article What are …

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How does ISO 9001 help maintain service levels?

ISO 9001 is the international standard that sets out the criteria for a QMS (Quality Management System) that allows organizations of any size to deliver a product that is of good quality, and consistent. It is widely accepted in the global business community that implementing ISO 9001 can bring an organization …

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ISO 9001:2015 benefits for manufacturing companies

Many organizations of varying types use ISO 9001:2015 as a recognized method of delivering customer satisfaction and controlling quality of product and service within their chosen sector. From huge organizations such as Richard Branson’s Virgin enterprise to local coffee shops, ISO 9001:2015 not only can be used to deliver improvements and help …

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Gaining employee buy-in for your ISO 9001:2015 implementation

Implementing an ISO 9001:2015 compliant Quality Management System (QMS) normally requires a lot of work from a lot of people within an organization, but one aspect that it is possible to overlook is the importance of employee engagement or “buy-in.” In the previous article How to comply with new leadership requirements in …

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Making the best out of ISO 9001 Quality Plan

The new version of ISO 9001 has a new approach to documents and records (see also New approach to document and record control in ISO 9001:2015) and this opportunity should definitely be seized. Without so many mandatory procedures as the previous version of the standard, requirements for documenting processes to …

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ISO 9001:2015 – The benefits of early implementation

The ISO 9001:2015 revision was released into the public domain on Tuesday, September 15, 2015. As part of the standard there is a three-year implementation period, which allows organizations aligned with the 2008 version to have surveillance audits against the 2008 standard, allowing up to September 2018 at maximum for the …

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Does a QMS ensure 100% quality?

Every year we hear about product recalls and consumer alerts about manufactured goods that have major problems, and need to be returned to the company for replacement or refund. In this past year of 2014, there have been recalls of Hewlett-Packard power cords for notebook computers, Graco strollers, and BMW …

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Managing the QMS after your consultant leaves

Most of us, probably at a time in our career where we were less experienced, have needed the help of an ISO 9001 consultant to assist us with the implementation of the standard in the organization where we worked. When you are faced with shaping a quality system and all …

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