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

ISO 9001 Blog

How to sell your ISO 9001 consulting services

ISO 9001:2015 is the premier standard for Quality Management System (QMS) and business management, and, for many organizations, it is the “entry level” to enable them to compete for business through formal tender processes with large organizations. In addition to the benefits for the organization, we also considered employee benefits …

Read More ...

Where does quality management / ISO 9001 fit into your organization?

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 a 3% increase over the previous year; therefore, ISO 9001 continues to grow in importance …

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 ...

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 ...

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 ...

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 ...

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 ...

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 does ISO 9001 help maintain service levels?

ISO 9001 is the international standard that sets out the criteria for a QMS (Quality Management System) that allows organizations of any size to deliver a product that is of good quality, and consistent. It is widely accepted in the global business community that implementing ISO 9001 can bring an organization …

Read More ...

ISO 9001:2015 benefits for manufacturing companies

Many organizations of varying types use ISO 9001:2015 as a recognized method of delivering customer satisfaction and controlling quality of product and service within their chosen sector. From huge organizations such as Richard Branson’s Virgin enterprise to local coffee shops, ISO 9001:2015 not only can be used to deliver improvements and help …

Read More ...

Gaining employee buy-in for your ISO 9001:2015 implementation

Implementing an ISO 9001:2015 compliant Quality Management System (QMS) normally requires a lot of work from a lot of people within an organization, but one aspect that it is possible to overlook is the importance of employee engagement or “buy-in.” In the previous article How to comply with new leadership requirements in …

Read More ...

Making the best out of ISO 9001 Quality Plan

The new version of ISO 9001 has a new approach to documents and records (see also New approach to document and record control in ISO 9001:2015) and this opportunity should definitely be seized. Without so many mandatory procedures as the previous version of the standard, requirements for documenting processes to …

Read More ...

ISO 9001:2015 – The benefits of early implementation

The ISO 9001:2015 revision was released into the public domain on Tuesday, September 15, 2015. As part of the standard there is a three-year implementation period, which allows organizations aligned with the 2008 version to have surveillance audits against the 2008 standard, allowing up to September 2018 at maximum for 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 vs. ISO 9001:2008 – The main changes
Wednesday - July 5, 2017
Show posts:
Request callback
Request callback

Or call us directly

International calls
+1 (646) 759 9933