Category: ISO

How to conduct Failure Mode and Effect Analysis, FMEA

How to conduct Failure Mode and Effect Analysis, FMEA By Mahmoud Elhefnawi What is FMEA? The System FMEA is a team-oriented methodology for minimising the risk of the development and it stimulates the interdisciplinary co-operation between the affected areas already in […]

ISO 9001:2008 requirements , By MIE

This is an overview of ISO 9001:2008 requirments, no details mentioned here, and the contents starts with section 4, other parts are not included here 4.GENERAL REQUIREMENTS   4.1 DEVELOP YOUR QUALITY MANAGEMENT SYSTEM (QMS)   Establish your organization’s process-based […]

Document control procedure template, By MIE

  This is a simple template for a document control procedure as part of ISO9001 requirments , it can be adopted to suite the organization requirements A- Objective this procedure describes the process steps of creating document, these steps are […]

Process Capability Applications in ISO 13485 Following ISO/TR 10017 – Webinar By GlobalCompliancePanel by Dan OLeary

  You can improve the implementation and effectiveness of your Quality Management System (QMS) by using statistical techniques. The techniques are broadly applicable across the QMS. ISO provides a technical report that explains a number of statistical techniques. The report […]