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How to manage the medical device sterilization process according to ISO 13485:2016

Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are diagnosed with various infections after surgery, and other complications also arise due to a lack …

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How to meet ISO 13485:2016 requirements for medical device files

The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems compliant with the rules of various regulatory bodies. Manufacturers and suppliers of medical devices must …

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Managing medical device infrastructure requirements according to ISO 13485:2016

The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure, no firm can carry out its activities. Infrastructure includes buildings, workspaces, utilities, process equipment, instruments, information technology systems, and transportation mechanisms. Similarly, all companies involved in medical device manufacturing or distribution shall maintain a …

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How to sell your ISO 9001 consulting services

ISO 9001:2015 is the premier standard for Quality Management System (QMS) and business management, and, for many organizations, it is the “entry level” to enable them to compete for business through formal tender processes with large organizations. In addition to the benefits for the organization, we also considered employee benefits …

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Where does quality management / ISO 9001 fit into your organization?

ISO 9001 is the premier business standard used to facilitate the satisfaction of customers through effective operation of a Quality Management System. More than 1.5 million certificates were awarded in 2015 (source: https://www.iso.org/the-iso-survey.html), which represented a 3% increase over the previous year; therefore, ISO 9001 continues to grow in importance …

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How can a startup benefit from ISO 9001?

ISO 9001:2015 implementation and certification may not always be at the top of a startup’s wish list, given the financial and operational pressures many new businesses find themselves under in the early stages of development. With decisions to be made in terms of what projects cost and the benefits they …

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Case Study: Transitioning to ISO 9001:2015 in a large organization

The purpose of this case study is to enable the consultants and implementers to better understand the transition process from ISO 9001:2008 to ISO 9001:2015 in large organizations, regarding some of the more ponderous changes in this standard. The emphasis is placed on the requirements that appear, or are eliminated, …

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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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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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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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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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