What is ISO 9001:2015

FILPAL
4 min readDec 11, 2022

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When industries talk about quality, they usually talk about ISO 9001:2015. In many cases, ISO 9001:2015 is a benchmark that is used to assure and proof that a company’s product is having a high standard of quality. As a matter of fact, many businesses that seeks to expand their market into the international arena will need to be ISO 9001:2015 certified. So what is ISO 9001:2015?

History of ISO 9001

ISO 9001:2015 is a set of internationally recognized standard that helps ensure that any products and services provided by a company or organization fulfill the quality requirement to their customers and stakeholders. It is a quality measurement system (QMS) setup by the International Organization for Standardization (ISO), agreed upon and implemented by more than 160 countries.

First implemented in 1987, ISO 9001 is part of the ISO 9000 family. It deals with the very basics of QMS and its very often the first ISO certification that is obtained by a company who is serious about maintaining a high standard of quality. There are more than 20,000 different ISO standards in the world today, each focusing on different scopes in different industries ranging from medical equipment, laboratory setup, production and manufacturing, food and beverage and much more.

Revisions of ISO 9001

As technologies, methods and processes continues to evolve with time, the ISO systems also undergoes many revisions to ensure that the QMS of organizations and industries meet quality standard of modern times. ISO 9001 in particular is currently in its 5th revision. The year when the revision was implemented is usually appended to the naming of the ISO itself. Therefore, ISO 9001:2015 means that it is using the 2015 revision, which is the 5th revision. The past revision happens in 1987, when it was first implemented, followed by 1994, 2000, and 2008. You may notice that a new revision is usually roll out every 6–8 years. With the last revision being 2015. It is expected that a new revision is almost upon us.

Plan Do Check Act

If there is a simple way to summarize the entire ISO 9001:2015 objective, it would be grossly set into these 2 points:

  1. Consistent Performance
  2. Continuous Improvement

Consistent Performance. Subscribers to ISO 9001:2015 will need to implement a quality system that ensures that products made are of consistent quality. This quality system should factor in the quality objectives of the company, its available resources as well as the risks, limitations and opportunities to ensure that regardless of any possible challenges, customers’ needs and quality expectation are consistently met.

Continuous Improvement. No process is perfect. And ISO 9001:2015 factors that into consideration, with clauses expecting practitioners to continuously assess the entire process from start to the end, evaluate and identify problems or challenges and requiring the identified problems or challenges to be addressed.

To be able to meet the quality standards for consistent performance and continuous improvement, ISO 9001:2015 follows a “Plan Do Check Act” approach to its entire process. Plan: Establish the objectives and the action plan needed to achieve the desired results. Do: Execution of the action plan and ensuring its efficiency to achieve planned objectives. Check: At the end of the process, the outcome is measured to the planned objectives and all the data of the process is compiled and recorded for evaluation. Act: Any problems identified in the process is addressed and solutions implemented. The process is improved and any non conformities, inefficiencies or problems are improved on.

Audit Process

To be officially a certified ISO 9001:2015 company, the company is required to undergo an audit process. The auditor will be someone from outside the company that will come in for a few days, ranging from 3 days to a week or two depending on how much auditing is needed.

During the audit process, the auditor will cross check all company’s QMS records to the ISO 9001:2015 standards. The purpose is to make sure that there are evidences supporting that the said company has fulfilled every single clauses written down in all the chapters and sub-chapters of the ISO 9001:2015 standard. More often than not, auditors will issue “non-conformities”, which are requests for certain part of the QMS process to be addressed and fixed.

When all are finally proper, The auditor would then be able to issue a certificate produced by the national ISO certification body. With this certificate, the company would be officially ISO 9001:2015 certified.

Its definitely a “title” that can be wore proudly when marketing products/services of the company. With this certificate, the products and services of the company is recognized as having high quality standards in the eyes of the world.

FILPAL is officially ISO 9001:2015 certified starting from November 2022. This is part of our process in ensuring that our customers get the best quality products and services at all time. Cheers!

Originally published at http://filpal.wordpress.com on December 11, 2022.

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FILPAL
FILPAL

Written by FILPAL

FILPAL designs, and builds RF and Microwave software and hardware for Cellular, Military, Academia and Test & Measurement applications. http://www.filpal.com

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