Axenics Receives ISO 9001-2015 Certificate of Registration for Contract Manufacturing Services

Axenics is pleased to announce that we have achieved the updated certification of our Quality Management System to ISO 9001-2015. We have been ISO 9001 certified for more than 18 years, with our initial certification occurring in April 1999. On May 18, 2017, Axenics received an official certificate for the assessment and approval by National Quality Assurance, against the provisions of ISO 9001:2015, applicable to the manufacture and assembly of precision clean process piping products and specialized subassemblies for industrial and commercial industries. Our commitment to meeting industry standards, and exceeding customer expectations is evident in the quality of the work we do.

ISO 9001: 2015 Certificate of Registration

Our certification information is as follows:

Certificate Number: 10463
EAC Code: 18
Certified Since: April 2, 1999
Valid Until: May 17, 2020
Reissued: May 18, 2017
Cycle Issued: May 18, 2017

About ISO

ISO 9001 specifies the standards that organizations must meet with regards to the creation of a quality management system (QMS), with the purpose of consistently providing customers with the highest quality of products and services possible. Additional benefits often include cost savings and highly satisfied customers, employees, and members of management.

ISO 9001, as defined by NQA, “is the internationally recognized standard for Quality Management Systems (QMS). It is the most widely used QMS standard in the world, with over 1.1 million certificates issued to organizations in 178 countries.”

Comparing ISO 2008 to 2015

There are numerous distinctions between ISO 9001:2008 and ISO 9001:2015, some of which are more significant than others. Many of the differences lie in the terms and definitions used to describe specific aspects of the standard. In addition, certain requirements are further clarified in the newest standard.

Another significant change in the standard includes the requirement that an organization understands the external and internal challenges related to its overall goals and mission, prior to creating a quality management system. The new terms and requirements, though they may be challenging to adjust to at first, are designed to help organizations create a more efficient quality management system to meet their unique needs.

Risk-based thinking is a topic that is discussed considerably in the ISO 9001:2015 standard. There is a lot of emphasis placed upon the idea of anticipating mistakes, in order to prevent as many issues as possible. There is, however, no requirement to develop a formal risk management process.

One of the biggest differences between ISO 9001:2008 and ISO 9001:2015 is the overall structure of each standard. Due to the new Annex SL template, the ISO 9001:2008 standard has seven main sections (4-10), vs. the previous standard, which had only five main sections (4-8). ISO has stated that all subsequent management system standards (MSS) will be created using this new structure. While the new structure is meant to make changes to the standard easier to make in the future, it will likely take some getting used to.

Benefits of ISO 9001:2015 Certification

Our ISO certification allows us to provide our clients with contract manufacturing services that meet, and often exceed their requirements, allowing us to achieve a much higher level of customer satisfaction. Operating costs can also be significantly reduced, due to our commitment to improving the efficiency with which we operate on a continual basis. In addition, by maintaining an active ISO certification, our organization is better able to manage risks, by improving traceability and consistency of the products and services we provide.

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