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ISO 9001 Blog

Carlos Pereira da Cruz

How to perform an ISO 9001 audit of top management without fear

You are a junior internal auditor and the internal audit manager assigned you the responsibility to audit top management in your organization. Are you afraid of the situation? Read this article to find out how to perform a top management audit according to ISO 9001 while doing what is expected …

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Tom Taormina

How to create beneficial supplier partnerships in ISO 9001

During implementation of ISO 9001:2015, productive supplier partnerships are a crucial part of making each party involved in the process satisfied. Clause 8.4 (Control of externally provided processes, products and services) of ISO 9001 requires extreme due diligence by the organization to ensure that all components and services used in …

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Tom Taormina

The history and future of the ISO 9000 series of standards

Those who are invested in Quality Management System implementation and operation may find that understanding its genesis can greatly enhance their ability to be more effective facilitators – especially given that some of you were born after the first version was released in 1987. In this article, you will learn …

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Tom Taormina

Bridging the communications gap with management in the context of ISO 9001

For most organizations, from the first mention of implementing a formal management system, a barrier arises between the quality professionals and senior management. If creating a certified management system is for the purpose of meeting customer or industry requirements, administration traditionally foresees only a large overhead expense that has little …

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Tom Taormina

Understanding outsourcing according to ISO 9001: A case study

Historically, outsourcing is one of the most misunderstood concepts in QMS implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in 4.1 (find more information in the article How to control outsourced processes using ISO 9001). Using a case study, I …

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Carlos Pereira da Cruz

How to get new clients for your ISO 9001 consultancy

You want to start a career as a consultant in the field of ISO 9001 and quality management. What do you have in mind to gain opportunities to present proposals and win clients and projects? Think about that … The world is full of consultants – some with a lot …

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Mark Hammar

How to create an ISO 9001:2015 human resources audit checklist

Human resources, the management of the people within an organization, is an important part of the Quality Management System (QMS), so you would expect the ISO 9001:2015 standard to have requirements for the human resources procedure. Not surprisingly, the standard does include requirements about how you need to deal with …

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Carlos Pereira da Cruz

What does “external documents control” mean in ISO 9001?

Can you imagine the possible consequences of selling a product or service that no longer complies with legislation because the seller was not aware of legislative changes? Can you imagine receiving a complaint from a customer because he claims that the product received no longer meets the last version of …

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Mark Hammar

How to identify risk controls in ISO 9001:2015

Identifying and implementing controls is a critical step in risk-based thinking for the ISO 9001:2015 quality management system (QMS). In a previous article, How to identify risk significance in ISO 9001:2015, we looked at the need to assess how significant a risk is before determining controls. With each risk you have …

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Mark Hammar

How to identify risk significance in ISO 9001:2015

With the new version of the ISO 9001:2015 standard requirements for creating a quality management system (QMS), the new concept of risk based thinking has brought with it some confusion on how to implement these new requirements. While some companies were already using a SWOT analysis (strength, weakness, opportunity, threat) …

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