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

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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 […]

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

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Introduction 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 […]

Comparison Matrix on ISO 9001, ISO 14001 & ISO 45001

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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 […]

FDA 21 CFR Part 820 Versus ISO 13485 – Relationship Comparison

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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 […]

ISO 45001:2018 List of mandatory documents

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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 […]

ISO 13485:2016 – Mandatory Documents List

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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 […]

ISO 13485:2016 Quality management systems & Requirements for regulatory purposes of Medical devices

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest 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. […]

Surveillance Visits vs. Certification Audits

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Surveillance visits and certification audits often differ significantly. This explanation covers why and highlights the differences. These points apply not only to ISO 27001 and ISO 22301 but also to standards like ISO […]

Business Integration for Management Systems in Companies

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Almost in all management system standards, ISO technical committees added a terminology (requirement for Leadership) i.e. management system should be integrated with business functions. The management system shouldn’t be operated as stand-alone system […]

Monitoring and Measurement in ISO 13485

Home Blog Categories Latest Post Have Any Question? Got a question? We’re here to help! +92334 2798703 info@exoexcellence.com Facebook Twitter LinkedIn Pinterest Monitoring and measurement focus on the quality of products and services, reflecting the effectiveness of the Quality Management System (QMS). In simple terms, it tells us whether our products meet expectations in quality, […]