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4 crucial techniques to convince your top management about ISO 9001 implementation

Trying to convince top management of the importance of implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015 can be a struggle. Even if your customers have required this in their contracts, it can be hard to convince management to invest in more than just the bare …

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The 3 key Challenges of ISO 9001 Implementation for SMEs

Implementing a quality management system (QMS) in an SME (small- to medium-sized enterprise) using the requirements of ISO 9001:2015 can bring a lot of benefits. The problem is that there are also some challenges that are not as easy for an SME to overcome as they are for larger businesses. In …

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Understanding needs & expectations of interested parties in ISO 9001:2015

There is a new requirement for your quality management system (QMS) within ISO 9001:2015, and that is to understand the needs and expectations of your interested parties, but what does this mean and how can you do this? Here is a three step process to help you navigate this requirement. …

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Does ISO 9001 require a procedure for addressing risks and opportunities?

With the release of ISO 9001:2015, there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System (QMS). These new requirements have brought with them some confusion not only about what needs to be done, but also what needs to be documented …

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ISO 9001 – How to prepare for an internal audit

The role of the internal audit in the performance evaluation and upkeep of your Quality Management System (QMS) is highlighted in the ISO 9001:2015 requirements. This is one of the main tools you have in place to verify that your processes are meeting the planned arrangements you set out for …

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Why should companies perform a second-party audit of their supplier’s QMS?

ISO 9001:2015 is the most recent update in a long line of standard requirements for implementing a Quality Management System (QMS); and, from the beginning, one big selling point was that a company would not need to audit the QMS of a supplier that was certified to ISO 9001. The …

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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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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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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 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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