Divergence and Significance between ISO 13485 & ISO 9001: 2015

1. DIVERGENCE AND SIGNIFICANCE BETWEEN ISO 13485 & ISO 9001: 2015 Call / Whatsapp - 9325283428 www.operonstrategist.com

2. ISO 13485 VS ISO 9001 • QMS (Quality Management System) is a organized method or process wrapping all characteristics of design, supplier management risk management, manufacturing. QMS system is the most important part of any quality and agreement process. • It is the regulatory requirement that FDA (Food Drug Administration) / ISOauditors state as critical. It improves product quality and safety, and assures ISO and FDA agreement.A QMS does the part of collecting business process mainly concentrated on fullfiling consumers needs and intensify their satisfaction. • Before Quality management systems focused expected consequences for an industrial products product line using simple methods and usual sampling. In today’s time profits were generally the most costly inputs in the industrial societies so it started focusing the team collaboration and dynamics.QMS has frequently coincided with confirmable and clear initiatives, for both the customer satisfaction and quality is attached do this factor. Call / Whatsapp - 9325283428 www.operonstrategist.com

3. ISO 9001:2015 • ISO 9001is globally known standard to describe the requirements for quality management system in all industries. ISO 9001 provides effectual Risk assurance basedQUALITY MANAGEMENT SYSTEM.QMS mainly focuses on enhancing customers satisfaction. • ISO 9001 2015allows risk-based thinking while executing QMS, this means to recognize risk and chances in the processes to grow an efficientISO 9001:2015QMS with a strong customer focus. • ISO 9001 standard helps to: Organize processes Improve the efficiency of processes Continually improvement Call / Whatsapp - 9325283428 www.operonstrategist.com

4. WHAT IS ISO 13485 FOR? • ISO 13485 is the worldwide acknowledged standard by International Standards Organization for medical device Quality Management Systems. • Initially started in1996, the standard states the things required for QMS that helps companies execute and exhibit the abilities to provide high quality medical devices that reach up to customers and regulatory requirements. • ISO 13485 can be used by any company involved in the transfer of medical devices at any point while the products lifecycle (encircle the design, manufacturing, providing, support phases.) Furthermore it can also be used by internal and external auditors to support inclusive audit process. Call / Whatsapp - 9325283428 www.operonstrategist.com

5. ISO 13485 : 2016 (Required Processes) When it comes to QMS requirements Clauses 1-3 are introductory clauses as they describe the reason and use of the standard .In clauses 4-8 there are several additions made which contains requirements that needs to be fulfilled. • CLAUSE 4 Quality Management System • CLAUSE 5 Management Responsibility • CLAUSE 6 Resource Management • CLAUSE 7 Product Realization • CLAUSE 8 Measurement Analysis and Improvement There are many similarities and differences between ISO 9001 2015 & ISO 13485, and many organizations want to know what they are. These two are the biggest quality standards, (ISO 9001 2015) goes to a new high level pattern, not similar to (ISO 13485 2016), making the two standards split, going on their own way. The differences between these two standards have made the organizations concerned about how to bring them together. Call / Whatsapp - 9325283428 www.operonstrategist.com

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