ISO-9001:2015 Quality Management System ( QMS )


ISO-9001 is an internationally recognized IEEE Quality Management System (QMS) Standard. The latest revision of this standard is ISO-9001:2015 which means this latest release published in 2015. ISO-9001 is basically based customer support and risk management. However, it is a system that is tailored to the company's requirements which is called the scope. Our scope includes sales and distribution of IT related products, design, and IT support. Some of the required components of ISO-9001 consists of customer focus, satisfaction and communication, risk and opportunity management, conformity, management reviews, controlled designs and documents, customer experience objectives and measurements, corrective action reports, internaland third-party audits as well continual improvement. The ISO-9001 Quality Management System is important, valuable, and sometimes required for medium and large sized customers, especially totechnology-based businesses. The ISO-9001 does not certify products or services, but the company's Quality Management System. It helps ensures that the products and services offered are high quality, and its customers are getting the great customer satisfaction.

Customer focus, satisfaction and communication is the basis for providing a satisfying customer experience. There are instances, where a customer might not feel satisfied with a certain aspect of the product or service offered and the instance should be documented and either controlled or resolved. This is one of the main reasons why this system is in place.

Risk and opportunity management is important help to identify potential risks that the company may have. Potential risks are identified and documented. They are also mitigated and if the risk is activated then hopefully a plan to address it is in place. An opportunity risk is also a risk, but it happens when a good event occurs. For instance, you can get a large order such as a $100,000 order on a NET 30 basis but there is a risk that your do not have either the funds or stock to handle this order on time.

With regards to conformity, there are basically two types: conformance and nonconformance. Conformance means that something is working or functioning properly and nonconformance means that the is a problem or something is not working properly. At least in our case, there are two main types of nonconformances: the first to the products, which are defective or untested and in an unknown condition which should be in a separate area from functioning products, and second to the management system itself, which normally a corrective action report (CAR) is created, and when it is scheduled to be addressed.

If your company is certified to perform designs, there is a certain procedure your chief Engineer would have to follow. This procedure includes input and output documents that are used with your customer, a requirement, specification, design review, test plan, verification, and validation testing. For further clarification, design reviews need to be done by someone else other than the designer, the verification test is a test of how the product works on an overall basis while validation test is performed to make sure the product works for the customer's application while verification and validation tests should be done on both the prototype as well as the production unit.

Quality objectives and company performance measurements are also very important to the Quality Management System. They are metrics that are selected and used to show trends of potential problems and growth. Two such measurements, can be late shipments and nonconforming customer returns. Late shipments can show problems such as supply chain issues and order fulfillment performance issues while excessive returns could show a possible problem with a product design or vendor product quality.

Another important aspect of the quality system are management reviews which are typically performed every six months or so and company audits. The management review usually documents the past period's QMS requirements and performance. Audits are presently done in three-year cycles. The first year is a full audit of the quality management system and the next two years consist of surveillance audits, where the auditor my pick and choose what they intend to audit. There are two types of audits an internal audit and a third-party audit. An internal audit is kind of a practice audit by an experienced auditor to find any nonconformances prior to the third-party certification audit. The certification audit needs to be done by a certifying company that has the authority to issue you the ISO-9001 upon completion of the audit. One important part of the audit is to show continual improvement, which is a requirement of the standard. One interesting thing about the audit is that the auditor also must be audited as well. So, if you are a one-man operation and is audited by a hired internal auditor, then after he is done with the audit you will have to audit the auditor.


Not all third-party auditors are equal in their reputation, expertise, and adherence to the ISO-9001 QMS Standard. Our company has been using, TUV Rheinland as our third-party certifier. TUV Rheinland is considered as one of the most distinguished and strictest certifying companies in the world, for many IEEE standards, not only, ISO-9001. Experienced quality management engineers recognize the accomplishment of being ISO-9001 certified by TUV Rheinland. As an IT a high-quality product provider, we are looking for vulnerabilities or nonconformities in our management system and ways to improve our company operations, provide the highest quality products and the best customer support we can.

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