ISO 9001 is the international standard for a quality management system (“QMS”)

In order to be certified to ISO 9001, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is designed to help companies at many levels, including a focus on customer requirements, improving leadership within the company, finding ways to continually improve, and more (see our article about Quality Principles for more details).

There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. Typically, an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department. The current version is ISO 9001:2015, which was published in September of 2015 (thus the :2015).

A few details about ISO 9001:

• It does NOT matter what size your organization is: 1 person or 1 million people


• It does NOT matter what industry you are in (service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.


• It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.


• It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an organization or company becomes certified. Individuals, however, CAN become an ISO 9001 Certified Lead Auditor after a 5 day training course. This then allows them to audit other companies.


• There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only ISO 9001 certification.
• It is NOT a membership group – An organization cannot “join” ISO 9001. To become ISO 9001 certified, your organization must
• Follow the steps to implement an ISO 9001 quality management system.
• Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating that your organization is Registered to ISO 9001 for a three year period. (See Who is able to grant certification)
• Finally, the organization must be re-certified every three years in order to maintain their ISO 9001 certification status.

A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy example of ISO 9001 applied to making cookies.

The Definition of ISO 9001 Certification

“ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements.

Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).

What is the resource impact of ISO 9001 on my company?

As with most business processes, the more you do yourself, the less the cost, but the more time it may require. No matter how many external resources are utilized, there will need to be involvement by your employees and staff to varying degree. While there is no total “do it yourself” solution, you can go a long way on ISO 9001’s basic requirements by using pre-formatted materials for documentation and training. ) While the procedures and methods in these must be tailored to your situation, they are typically created with the goal of minimizing the changes required and maximizing the ability for others to use and comprehend them. The goal of any quality management system should not be to add unnecessary paperwork, but to make all references clear and highly usable.