How to identify risk significance in ISO 9001:2015
Mark Hammar
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...
How to document roles and responsibilities according to ISO 9001
When implementing ISO 9001:2015, you will want to find a way to document the roles and responsibilities for your Quality...
When implementing ISO 9001:2015, you will want to find a way to document the roles and responsibilities for your Quality Management System (QMS), rather than just having this as verbal information, but what is the...
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...
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,...
Managing Production and Service Provision using ISO 9001
Tomislav Stosic
The need for a comprehensive production and service provision procedure goes beyond the requirements of ISO 9001. It is a...
The need for a comprehensive production and service provision procedure goes beyond the requirements of ISO 9001. It is a necessity for every organization that wants to clearly define its production process and strives towards...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Where does quality management / ISO 9001 fit into your organization?
John Nolan
ISO 9001 is the premier business standard used to facilitate the satisfaction of customers through effective operation of a Quality...
ISO 9001 is the premier business standard used to facilitate the satisfaction of customers through effective operation of a Quality Management System. More than 1.5 million certificates were awarded in 2015 (source: https://www.iso.org/the-iso-survey.html), which represented...
How can a startup benefit from ISO 9001?
ISO 9001:2015 implementation and certification may not always be at the top of a startup’s wish list, given the financial...
ISO 9001:2015 implementation and certification may not always be at the top of a startup’s wish list, given the financial and operational pressures many new businesses find themselves under in the early stages of development....
