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ISO 9001 Blog

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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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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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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How to create a check list for an ISO 9001 internal audit for your QMS

One of the most important checking tools in a Quality Management System (QMS), or any management system, is the internal audit. The ISO 9001:2015 requirements are very clear that this is a critical element of your QMS; and, since you want to know how your processes are functioning, your internal audits become …

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What are the biggest challenges while setting up an ISO 9001-based QMS, and how do you overcome them?

Implementing a formal QMS (Quality Management System) in an organization that doesn’t have one, but hopes to be ISO 9001 compliant or certified, presents a unique set of challenges. I recently advised an organization on such a project, and was surprised at the variety of challenges such a project presented to …

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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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How ISO 9001:2015 can improve your supply chain performance in the retail sector

The ISO 9001:2015 quality management standard is designed to be applied across many sectors in the business world, and if applied correctly, can bring many benefits to the overall performance of a business. One recent sector of ISO 9001:2015 “realization” and growth is the retail industry, which is a sector of business that …

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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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Would hospitals benefit from ISO 9001?

ISO 9001 is a universally used quality management standard, adopted by organizations all over the world to standardize and improve the service given to customers. The standard is used across all sectors of business, but is more prevalent in some than others. In my time working in both the electronics and …

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ISO 9001 internal auditor training: Is it for me?

Since the internal audit is one of the most important tools for driving improvement in an ISO 9001 quality management system (QMS), it is vital that you have internal auditors who have the skills needed to properly review your processes and records and identify the strengths, weaknesses, and problems that …

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Writing a good QMS internal audit report

In ISO 9001, the process for internal audits is one of the most important ways for you to ensure that your quality management system (QMS) is functioning properly and efficiently, but what is the role of the audit report in this process? Many people who are not well versed in …

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ISO 9001 Horizontal audit vs. vertical audit

In my recent article called First-, Second- & Third-Party Audits, what are the differences? I talked about the different types of audits as they relate to who is doing the ISO 9001 audit: an independent company, a customer, or an internal person. When it comes to an internal audit, there are two …

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Gap analysis vs. internal audit in ISO 9001

If you are thinking of implementing a quality management system (QMS) according to the ISO 9001 requirements, even if you are only starting to investigate what is required, you will likely have heard the terms gap analysis and internal audit. These two topics are often thought to be interchangeable, and …

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