Empowering HOPES Diagnostics Lab Towards ISO 9001, ISO 15189 Certification

In the session conducted by Exoexcellence Consultants with the Hopes Diagnostics lab, the role of leadership in ISO 9001 implementation have been discussed. The session was conducted on a partnership proposal from Hopes Lab that they need to implement standards. In this regard, they were in communication with Exoexcellence Consultants for a long time.  Within…

Crucial Guidance to Tecno Pack Industries (TPI) for ISO 9001 Certification

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…

The Top 5 Skills You Gain from ISO 14001 Training Certification

Introduction ISO 14001 training is not merely focused on ISO 14001. Although it’s the core of the ISO 14001 training, i.e. to be focused on the standard requirements. And that is one top skill you gain from ISO 14001. However, there is a lot more to that. By reading this blog, you will take the…

Pakistan International Bulk Terminal (PIBT) – ISO 9001, ISO 14001 & ISO 45001 Certification

Exoexcellence Consultants, a renowned management consultancy firm, recently played a pivotal role in guiding the Pakistan International Bulk Terminal (PIBT) to secure the Integrated Management System (IMS) certification, and successful validation for ISO 9001, ISO 14001, and ISO 45001. This prestigious accomplishment significantly boosts PIBT’s status, cementing its reputation as a quality-driven, environmentally conscious, and…

ISO 45001 – What’s new for Organizations & Professionals

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…

Comparison matrix on ISO 45001:2018 & OHSAS 18001:2007

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…

Comparison Matrix on ISO 9001, ISO 14001 & ISO 45001

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…

FDA 21 CFR Part 820 Versus ISO 13485 – Relationship Comparison

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…

ISO 13485:2016 – Mandatory Documents List

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…

ISO 45001:2018 List of mandatory documents

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…