Exoexcellence Consultants provided crucial guidance and expertise to Tecno Pack Industries (TPI) when they faced significant challenges during the Stage-1 audit for ISO 9001 certification. The audit highlighted non-conformities related to the ‘context of the organization’, a crucial component of the ISO 9001 standard that requires organizations to understand the internal and external factors that…
What is ISO 45001? ISO 45001:2018 is an international standard for occupational health and safety management systems. It is the first standard published by International Organization for Standardization on occupational health and safety management system. Prior to this publication of ISO 45001, OHSAS 18001:2007 which was a British standard was used as a system for…
OHSAS 18001:2007 is the most widely used British standard for occupational health and safety management system. Since it was a British standard and in past it was not incorporated by the International Organization for Standardization i.e. the ISO. Therefore there was always a need that ISO should made a worldwide standard for occupational health and…
ISO 9001 and ISO 14001 are most widely used standards worldwide as quality management system and environment management system respectively. ISO 45001 is a recent release on occupational health and safety management system. Although all these three standards are revised in recent three years i.e. from 2015 to 2018, ISO 45001 is the latest release…
Medical devices companies can voluntarily adopt ISO 13485:2016 standard for Quality Management Systems of medical device manufacturers and suppliers. It is utilized globally for creating and maintaining the system that satisfies the requirements of the market of medical devices. One of the core reasons that ISO 13485 was revised in 2016 is the configuration of…
The new ISO 13485 is revised on the structure of ISO 9001:2008, which concludes that the requirements for documentation are founded on the needs of the earlier version of ISO 9001, with the inclusion of additional documents related to the medical and surgical devices industry. So, let’s have the list below which are the mandatory documents, but you…
The global standard for Occupational health and safety management system i.e. ISO 45001:2018 has been published. Now many implementers of OHSAS 18001:2007 wonder what has changed. Implementers are provided with three years for migration to the new standard. Those who are complying with OHSAS 18001:2007 can upgrade to ISO 45001:2018 with little guidance since many…
The globally awaited International Standard for occupational health and safety management system (OHSMS) is now published, and is meant to define occupational health and safety practices worldwide. ISO 45001:2018, Occupational health and safety management systems – Requirements with guidance for use, offers a strong and efficient collection processes for upgrading job safety in international world. It is meant…
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…
ISO 13485:2016 demonstrates needs for a quality management system where a company requires to show its capability to supply medical instruments and concerning services that regularly meet customer satisfaction and related regulatory concerns. Such companies can be a part of supply chain in one or more phases of the product cycle for example in design…