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.