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. Quality Management System • 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) / ISO auditors 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. • At this point of time there are number of changes colliding with the medical device industries, containing a remarkable update to the industries fundamental QMS standard ISO 13485, with two new terms of regulations in Europe. Call / Whatsapp - 9325283428 www.operonstrategist.com

3. ISO 9001:2015 • ISO 9001 is globally known standard to describe the requirements for quality management system in all industries. ISO 9001 provides effectual Risk assurance based QUALITY MANAGEMENT SYSTEM.QMS mainly focuses on enhancing customers satisfaction. • ISO 9001 2015 allows risk based thinking while executing QMS, this means to recognize risk and chances in the processes to grow an efficient ISO 9001:2015 QMS with a strong customer focus. • ISO 9001 standard helps to : • Organize processes • Improve the efficiency of processes • Continually improvement • ISO 9001 2015 specifies requirements for a quality management system when an organization, • Needs to examine the ability to continuously supply product and services that meet customers and is applicable to legislation and regulatory requirements. • Aims to increase customer satisfaction through the effective application of the system, and including the processes for improving the system and ensuring of conformity to the customer and applicable to the regulatory requirements. Call / Whatsapp - 9325283428 www.operonstrategist.com

4. WHAT IS ISO 13845 FOR? • ISO 13485 is the worldwide acknowledged standard by International Standards Organization for medical device Quality Management Systems. • Initially started in 1996, 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. • Major importance of this standard is firstly due to the fact that agreement with it is a precondition to premarket authorization in diverse part of the world. Particularly ISO 13485 is Coordinated with EU regulations, in obedience with the standard is necessary for premarket authorization. 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 4 forms the common requirements for an efficient QMS. Essentially this part of ISO 13485 calls out the organization to recognize or describe the processes, that makes up the Quality Management System. The company also needs to apply actions based on a risked procedure to control this processes. Call / Whatsapp - 9325283428 www.operonstrategist.com

6. CLAUSE5 Management Responsibility Enlarged significance on regulatory requirements. This clause calls up for high management to supply proof of its allegiance to develop and maintain an efficient QMS. It means that in practice they need to grow and communicate a standard strategy with clear quality objectives. Clause 5 also issue advice on defining, documenting, communicating, responsibilities and charge in the organization CLAUSE6 Resource Management Normally structuring and continuing an efficient QMS needs supplies to be committed to this task. Clause 6 also gives requirements on resource management, consisting of HR, work environment, infrastructure. This clause needs the organization to verify personnel with established proficiency. This clause also mainly states the norm to control infection with micro-organisms. Call / Whatsapp - 9325283428 www.operonstrategist.com

7. CLAUSE7 Product Realization This clause gives complete requirement on the operation of the organization relating to its product. The company will decide the quality objectives and bring forth processes and documents for the whole development lifecycle (design, planning, and development and storage and distribution.) Also parts such as product cleanliness, installation and service distribution are discussed in ISO 13485. CLAUSE8 Measurement Analysis and Improvement This clause of ISO 13845 states how a company detects, calculates, and examines the process to exhibit QMS conformity and efficacy. Particularly there sections on detecting, calculating with (Feedback), handling complaint, internal audits, data analysis and improvement. This clause is also calls for the growth of processes and to acquire and detect consumers feedback and to handle the complaints. Call / Whatsapp - 9325283428 www.operonstrategist.com

8. 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. If situations come when you might consider of certifying both, like organizations provide related services such as contract manufacturers, suppliers, distributors may certify to ISO 13485 in addition of maintaining ISO 9001 agreement. But in general medical device manufacturers would normally choose one or the other as their structural differences would make it complicated to certify both. By understanding the differences and similarities makes the processes easier. Call / Whatsapp - 9325283428 www.operonstrategist.com

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