Harmonizing QMS with ISO13485

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Harmonizing QMS with ISO13485

  1. 1. Harmonizing QMS Model to Meet ISO13485 Regulations ISO 13485 - a regulatory standard focus on meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. ISO 13485 is structured the same way as ISO 9001:2008, and is in fact about 90 % the same as this general standard for quality management systems. The reason for the differences between ISO 13485, ISO 9001 and the FDA QS reg., can be understood by looking at the differences in their objectives. This Two day course has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers. Hasnain Gardezi has successfully guided, trained and assessed organizations from  Senior Management manufacturing, service and development sectors  Quality Managers  Regulatory Affairs Managers in gaining strategic and operational advantages  Internal and External Auditors through responsive organizational structures,  Anyone involved with the efficient business processes and enhanced implementation of the standard internal / external customer orientation. He believes in conducting impact oriented trainings with quality, passion and energy that helps the people to build their competencies. their competencies. people to build Gardezi has trained more than 1000 professionals on a variety of topics from different organizations like Pakistan Atomic Energy Commission, Baluchistan University of IT, HEC, Askari Cement, Fecto Cement, Lafarge Cement, Crescent Bahuman, Jaffer Brothers, Millac Foods, FERTIL-2, B-Braun, Barkeley Water, Banu Mukhtar, SKB Pumps, Sight Savers International, Excel Labs, Marine Security, AKSA-SD, Hope’87, Oxfam Novib, SPARC, ASK Development, MEDA, World Vision, Muslim Aid, Sycop, HEC-FAD, Idara-e-Taleem-o-Aagahi, Sindh Education Foundation, FATA Development Program, HDF, VDO, FOCUS, just to name a few. Gardezi has a great professional experience, enriched with extensive academic credentials, including two Master degrees in Business Management (HRM & Marketing), he is a Certified Lead Auditor in Quality Management Systems and Certified Lead Assessor on Business Excellence Model (PMQA) besides other significant qualifications. Along with serving In O’ Vative Consultants as Operations Head, he is currently adding value as a professional member in Assessors’ Team at Prime Minister Quality Award (PMQA). He is also an Associate Editor Publications at Quality and Productivity Society of Pakistan (QPSP), and an active member of National Mirror Committee on HR Standards, HR Forum Islamabad, Pakistan Human Resource Network (PHRN) and National Outreach Program (NOP). He remains part of Technical Committee at QPSP Excellence Model Award.

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