Show me desktop version
CALL US +1 (646) 759 9933

What does ISO 9001 lead auditor training look like?

There is a lot of training involved when implementing a Quality Management System (QMS) according to the requirements of ISO 9001:2015, and many companies offer many different types of training for those who will be involved in the QMS. If you look even briefly, you will find implementation training, ISO …

Read More ...

How to use quality control tools to improve your QMS

One of the key benefits of any Quality Management System (QMS), especially one that has been created according to the requirements of ISO 9001:2015, is to bring a focus on continual improvement within the organization. Continual improvement is one of the quality management principles that forms the foundation of the …

Read More ...

ISO 13485:2016 nonconforming product – How to approach the post-delivery actions

Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a medical device is simply not acceptable, even after its use or after delivery. Therefore, ISO …

Read More ...

How to make your investment in ISO 9001 profitable

Implementing a Quality Management System (QMS) using the requirements of the ISO 9001:2015 standard is an internationally recognized way to focus your company efforts on customer satisfaction and drive improvements in your company, but this process does not come without a cost. For this reason, many business professionals ask what …

Read More ...

ISO 9001: Requirements for the release of the product or service

With the release of ISO 9001:2015, there are specific requirements for you to include in your Quality Management System (QMS) about what you need to do when you accept your products and services for delivery to your customers. At first glance, there seems to be more requirements for the release …

Read More ...

How to comply with ISO 13485:2016 requirements for handling complaints

Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and integral part of this industry. Complaint management is an important part of customer relationship management …

Read More ...

Specific use of ISO 9001 design and development in the machining process

With the updated Quality Management System (QMS) requirements in ISO 9001:2015, there have been some minor, yet important changes in the requirements for design and development activities within the Quality Management System. In the past, many companies have taken the opportunity to exclude the design and development activities required by …

Read More ...

Aligning quality objectives of the QMS with the strategic direction of the company

One of the new concepts that have been brought into the latest version of the ISO 9001:2015 standard is that the Quality Management System (QMS) of a company needs to include an understanding of, and alignment with, the strategic direction of the company. The strategic direction of the company comes …

Read More ...

How to deal with design and development changes in the technology sector using ISO 9001

The requirements of design and development are fairly prescriptive within the ISO 9001:2015 standard in terms of planning, inputs, outputs, controls, and changes to this process. For many organizations manufacturing standard products with little change, this is a vital and often straight-forward clause to follow, but when design and development …

Read More ...

How can ISO 9001:2015 help boost your sales activities?

While ISO 9001:2015 is strictly a quality management standard, it is considered a business tool by many people in today’s business environment. The benefits of implementing ISO 9001:2015 go far beyond the management of quality; it can also help your organization to improve performance, reduce supply chain costs, retain existing …

Read More ...

How to include statutory and regulatory requirements in your QMS

One of the requirements that are embedded within ISO 9001:2015 is the necessity to understand and include statutory and regulatory requirements within the Quality Management System (QMS); however, many people have difficulty with understanding how to do this. To help understand this process, there are three main questions to answer: …

Read More ...

Case study: Design and development in the software industry

The software industry is one of the fastest-growing industries in the last few decades and although software production is regulated by its own rules, very often there is a requirement for establishing a Quality Management System according to ISO 9001. Due to the specificity of the software development industry, implementation …

Read More ...

How to establish process validation in the QMS

When companies are implementing a Quality Management System (QMS) using the requirements of ISO 9001:2015, there is often confusion when it comes to the topic of validation. People can get confused when talking about the difference between design verification and design validation, or discussing what is considered design validation as opposed …

Read More ...

What is the ISO 9001 audit program, and how does it work?

One of the most important tools that you have to make sure that your Quality Management System (QMS) meets the requirements that have been identified, and is effectively implemented and maintained, is the internal audit program. Internal audits are an integral part of any management system, and thus are included …

Read More ...

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 ...
FREE ISO 9001 CONSULTATION
Strahinja Stojanovic
Lead ISO 9001 Expert,
Advisera

GET FREE ADVICE

ISO 9001
FREE DOWNLOADS

 

Upcoming free webinar
ISO 9001:2015 Self-implementation tips & tricks
Wednesday - May 10, 2017
Request callback
Request callback

Or call us directly

International calls
+1 (646) 759 9933