Understanding outsourcing according to ISO 9001: A case study
Tom Taormina
Historically, outsourcing is one of the most misunderstood concepts in QMS implementation and operation. Prior to ISO 9001:2015, the requirement...
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...
How to get new clients for your ISO 9001 consultancy
Carlos Pereira da Cruz
You want to start a career as a consultant in the field of ISO 9001 and quality management. What do...
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?...
How to create an ISO 9001:2015 human resources audit checklist
Mark Hammar
Human resources, the management of the people within an organization, is an important part of the Quality Management System (QMS),...
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...
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...
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...
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...
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...
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...
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...
Similarities and differences between ISO 9001 and ISO 22000
Absar Saleh
If you haven’t had a chance to review the new release of the ISO 22000:2018 version of the Food Safety...
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...
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...
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...
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...
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...
How to know whether ISO 9001 certificate is valid?
If you are asking your suppliers to have a Quality Management System (QMS) that is based on ISO 9001:2015, you...
If you are asking your suppliers to have a Quality Management System (QMS) that is based on ISO 9001:2015, you have reasons for doing so. Maybe you want to reduce the risk of products, processes...
What has changed with quality objectives in ISO 9001:2015?
ISO 9001:2015 has included the need for quality objectives to help drive continual improvement in the Quality Management System (QMS)...
ISO 9001:2015 has included the need for quality objectives to help drive continual improvement in the Quality Management System (QMS) since the ISO 9001:2000 version of the stand was released. However, the requirements for this...
How to write a good ISO 9001 audit nonconformity?
The internal audit process is an important part of the ISO 9001:2015 requirements for implementing a quality management system (QMS)....
The internal audit process is an important part of the ISO 9001:2015 requirements for implementing a quality management system (QMS). In a previous article, Five main steps in ISO 9001 internal audit, we discussed the...
How does the ISO 9001:2015 revision affect the Quality Policy?
ISO 9001:2015 has brought many changes to the Quality Management System (QMS), as compared to ISO 9001:2008, but one thing...
ISO 9001:2015 has brought many changes to the Quality Management System (QMS), as compared to ISO 9001:2008, but one thing that has stayed constant is the need for a Quality Policy. While many of the...
Certifying different legal entities under one certification scope in ISO 9001
Many questions come up when implementing the requirements of ISO 9001:2015 for your Quality Management System (QMS), and while many...
Many questions come up when implementing the requirements of ISO 9001:2015 for your Quality Management System (QMS), and while many are easy to answer, some are not. One question that can come up for smaller...
How does ISO 9001 property clause 8.5.3 reflect on software?
There can be confusion with clause 8.5.3 of ISO 9001:2015, which discusses property belonging to customers or external providers, especially...
There can be confusion with clause 8.5.3 of ISO 9001:2015, which discusses property belonging to customers or external providers, especially for software. When creating your Quality Management System (QMS), what software is included in the...
