Show me desktop version

List of mandatory documents required by ISO 13485:2016

The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to the medical device industry. So, here is the list – below you will see the …

Read More ...

How much does the ISO 9001 implementation cost?

The cost of ISO 9001 implementation is one of the first topics that come up when deciding to get into the project, and very often, the main drawback because it is very hard to make a precise estimate at the beginning of the project. The price of implementation depends on …

Read More ...

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 …

Read More ...

Infographic: What’s new in the 2016 revision of ISO 13485

To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485.   The new 2016 revision of ISO 13485, the leading international standard for medical devices, is finally in front of us. Now we can see exactly what has …

Read More ...

QMS Change Management in 7 steps

In any management system, it is important to control your changes to the management system, and there is no difference with a Quality Management System (QMS) created using the requirements of ISO 9001:2015. While QMS change management may sound like a complex activity, it can be thought of in quite …

Read More ...

To what extent should top management be involved in your QMS?

On the first reading of the ISO 9001:2015 standard, it seems to be rather confusing regarding what is the right extent and time in your QMS (Quality Management System) lifecycle to involve management. On the other side, there is a clear referencing to the topics that should be covered by …

Read More ...

How to become an ISO 9001 consultant

ISO 9001 is the most popular management system standard in the world, and it helps many businesses to establish a QMS (Quality Management System) and ensure quality products and services, as well as customer satisfaction. Given that this standard is used worldwide, there is understandably a constant demand by organizations …

Read More ...

How to use the ISO 9001 standard to improve stock efficiency and increase profit

Most people correctly assume that ISO 9001 is purely a quality management standard, and while this is technically correct, applying the principles from the standard can bring many other benefits to a business. In our previous article: Six key benefits of ISO 9001 Implementation, we examined some of the benefits that …

Read More ...

Communication requirements according to ISO 9001:2015

The new communication requirements in ISO 9001:2015 fall under the overall section on support, Section 7. This section includes all of the requirements for the processes you need to have in place to support your Quality Management System (QMS), and ensure its ability to provide products and services to meet …

Read More ...

Similarities and differences in risk management in ISO 9001, ISO 31000, and ISO 27001

Are you a beginner in dealing with risk management, or do you have a bit of expertise? Either way, you may have many dilemmas. Do you want to integrate risk management concepts into your organization using standards for Quality and Information Security Management Systems, but have no idea where to …

Read More ...

What is an ISO 9001 surveillance audit?

Early on, when you are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, you will need to talk to a certification body to find out what you need to do to certify your management system as compliant with the requirements. During your discussions you will be …

Read More ...

ISO 9001:2015 Case study: Context of the organization as a success factor in manufacturing company

Clause 4.1 of ISO 9001:2015 is causing lot of ambiguities and raising more questions than answers to most quality practitioners. Defining context of the organization basically means determining the foundation of your QMS and where your company stands in terms of internal and external issues related to the QMS. This requirement …

Read More ...

Five tips to ensure your ISO 9001:2015 implementation is successful

An ISO 9001:2015 implementation can be a complex and demanding process, which may take from 6 to 12 months depending on your organizational size and structure and other influencing factors. Most project managers will find many challenges during the implementation phase, which we looked at in the article What are …

Read More ...

How to integrate ISO 9001 and ISO 27001

ISO 27001 is one of the fastest-growing standards in the world, and I see many companies have a need for information security with increased use of information technology, clouds, etc. If you already have implemented ISO 9001 and want to implement ISO 27001, or you plan to implement both standards at …

Read More ...

How to proceed once a QMS corrective action is defined?

Corrective action has always been an important process within a Quality Management System (QMS), and this does not change with the new release of the standard, ISO 9001:2015. This is why one of our first blog posts was about this important topic: Seven steps for corrective and preventive actions to …

Read More ...

ISO 9001
FREE DOWNLOADS

 

Upcoming free webinar
ISO 9001:2015 vs. ISO 9001:2008 – The main changes
Wednesday - January 25, 2017
Request callback
Request callback

Or call us directly

International calls
+1 (646) 759 9933