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ISO 9001 Blog

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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Absar Saleh

Similarities and differences between ISO 9001 and ISO 22000

If you haven’t had a chance to review the new release of the ISO 22000:2018 version of the Food Safety Management System (FSMS) standard – Requirements for any organization in the food chain, the update in new standard is that it follows the same high-level structure (Annex SL) that is …

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Absar Saleh

Benefits of ISO 9001 implementation for small businesses

Small businesses are stressful to lead. Why? Because a small group of people are looking for so many work functions simultaneously, like government regulations, laws, production and sales, supply chains, financial issues, quality problems, the work force, etc. Now, what can lead a small business to a sustainable and continuously …

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Absar Saleh

ISO 9001 audit checklist for laboratory

An audit checklist is a key element for conducting or planning for a process audit. Considering the requirements for ISO 9001 standard, an audit checklist is a tool consisting of questions taken from the quality management system requirements, work performance criteria of the process and the documentation generated for the …

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Mark Hammar

ISO 17025 vs. ISO 9001 – Main differences and similarities

If you noticed the release of the 2017 update of ISO 17025:2017, you might wonder what this standard is all about, and how it relates to ISO 9001:2015 and the Quality Management System (QMS) in your organization. You might well ask: What is ISO 17025:2017, and how is it similar and …

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