Quality of the product or service is the foremost concern that influences consumer decision whether common folks buy grocery from a store or a specialized surgeon uses a allis forceps or scissor for surgical procedures. Variability in the product actually damages the quality. Companies manage and sustain quality of a product with the help of management system which is widely known as the quality management systems.
The International Organization for Standardization (ISO) is popular for standardization worldwide. ISO has made a standard for developing and maintaining quality management system i.e. ISO 9001. ISO made ISO 9001 by bench-marking global best practices for quality management systems. ISO 9001 is the most common standard globally. The standard is applicable for both big corporate giants and small companies. It is a voluntary standard that requires organizations to maintain minimum requirements for maintaining quality management systems. Thus customers have the necessary confidence on ISO 9001 implementing organizations.
The standard for ISO 9001 was revised in September 2015, and the new version integrated vital changes with new concepts. The new concepts integrated changes that now offer a systematic way to manage strategic quality management issues though the management of organizations’ context. Organizations looking to sustain and expand their market share in the arena should implement the new requirements and concepts. ISO 13485:2016 is an extension of ISO 9001 for medical devices. Surgical instruments manufacturing and supplier firms usually comply to both ISO 9001 and ISO 13485.
Are you looking to learn more about ISO 9001 and the key changes made in 2015? Start right here with a new course offered free at Alison: ISO 9001:2015 Fundamental Concepts.
It is vital to learn ISO 9001:2015 to flourish your businesses. Employed professionals can also be more productive to companies if they understand new requirements.
About the Author: S. M. Waqas Imam is a certified lead auditor for ISO 9001:2015 and is a certified IOSH Safety Professional. Moreover, he has experience in implementing the requirements of ISO 9001, ISO 13485, ISO 14001, OHSAS 18001, and FDA 21 CFR Section 820.