Get Prepared
for ISO
Certification

These are the majority of those who apply for at least an ISO 9001 certification. Other certifications that can be considered for those that manufacture products may include AS 9100, ISO 13485, ISO 14001, and ISO 27001.

As government agencies mature, they are starting to see similarities to organizations within the public sector. The ISO 9001 Standard is one such standard that can be utilize within any type of organization. It places the requirements for addressing risks and opportunities, understanding who your interested parties are, developing processes to control: documented information and nonconformities, and the need to engage leadership and all employees to participate in the enhancement of the QMS. Many articles can be found that point to the requirements for federal agencies to use existing standards. However, over the past several years, government agencies and agencies such as the armed forces (i.e., U.S. Navy, U.S. Marines, U.S. Air Force, U.S. Army, etc.) are requiring that organizations have a certified ISO 9001 Quality Management System prior to responding to a solicitation. Reference articles:

• US-EU High-Level Regulatory Cooperation Forum
• Federal Use of Standards

From a foundational purpose, some manufacturers will start with ISO 9001 and then migrate into ISO 13485. The application/implementation of which requirements are typically determined by who the customer and interested parties are. In most cases, there may be an FDA requirement and/or approval that must be met prior to the sale of any products produced.

There are not too many professional services dispensing advice or drawings as their product who are required to have a certified ISO 9001 Quality Management System. However, there may be a marketing advantage over your competitor by having one. Examples of this can be seen in the Oil and Gas Industry where consulting services are provided at the level of inspection services or in the design of new skids / platforms. Aside from having met any PE requirements or API Standards, consulting services may take advantage of understanding the customers they provide services to by having a certified ISO 9001 QMS that matches theirs.

Just because the product build did not originate from your organization does not preclude the need to meet the requirement for a certified ISO 9001 Quality Management System. Typically, distributors must abide by a set of rules that are flowed down by their suppliers. This is especially true for those that are recognized as having that “authorized distributor” status with a well-known manufacturer. Having a certified ISO 9001 QMS communicates your organization’s commitment to quality with those manufacturers who may also have ISO 9001 certification.

As with other industries, the driving factor for having a certified ISO 9001 Quality Management System is dependent on the customers and/or other interested parties. If you are a manufacturer or distributor of telecommunication components, you will want to have a certified ISO 9001 QMS.

There are even requirements now for health care providers to become certified to ISO 9001. As government agencies mature, they are starting to see similarities to organizations within the public sector. The ISO 9001 Standard is one such standards that can be utilize within any type of organization. It places the requirements for addressing risks and opportunities, understanding who your interested parties are, developing processes to control: documented information and nonconformities, and the need to engage leadership and all employees to participate in the enhancement of the QMS.

Organizations such as temp agencies will sometimes have to meet the requirement for a certified ISO 9001 Quality Management System. Having a certified ISO 9001 QMS communicates your organization’s commitment to ensuring that you adhere to the same standard as those manufacturers you want to do business with.

All types of industries can become ISO 9001 certified. This is not limited to those who manufacture or distribute products. Sometimes that product can be in the form of currency. Often, when companies are doing business outside of the United States of America, there are other countries that may demand that your organization have a certified ISO 9001 Quality Management System.