QMS Certification Services for Medical Devices

QMS is a pivotal phase for an organization. QMS is an integral and important part of medical device manufacturing. As a medical device manufacturer, it’s the responsibility of the manufacturer to ensure the safety of the medical device which they are placing on the market. Our team provides training and guidance for the proper QMS implantation to manufacturers.  

What is QMS-Quality Management System?

Quality management system is a structured process which contains all aspects of design, manufacturing, clinical data, risk management and more.  one can say that QMS is a tool. The objective of QMS is to improve the quality of products and related services and regulations. When we talk about international markets like the US and Europe, ISO13485 standards & US FDA’s Quality system regulation i.e 21CFR Part 820 should be considered. We as ISO 13485 medical device consultant guide our clients about the documents & the correct implementation process needed.

Why Quality management system is important for organizations? 

  • A QMS process helps to coordinate and direct the organization’s activities and to meet customer’s regulatory requirements and to make it effectual and improve its efficiency on a continuous basis.  
  • Implemented and maintained Quality Management Systems have the power to affect all aspects of the organization’s performance. 
  • QMS process is a set of policies or procedures mainly needed for the planning or execution of the business or in the organizations. 
  • The documentation of the QMS process is to be maintained and controlled, that can impact the organization’s ability to meet the customer’s requirements. 

The conventional methodology for building up a quality management system is that of tending to compliance to guidelines – once in a while bringing about direct forth of requirements characterized in ISO 13485: 2016 and other quality system requirements and regulations. 

Regulation Governing With Medical Device QMS For Medical Devices:

Different certification services in QMS includes ISO 9000 series (counting ISO 9000 and ISO 9004), the ISO 14000 series (ecological administration frameworks), ISO 13485 (quality administration frameworks for medical devices), ISO 19011 (inspecting the executives’ frameworks), and other. The medical device manufacturers in Europe follows ISO 13485 standard whereas UK based companies follow USFDA’s Quality System Regulation (QSR). 

 The ISO 13485 standard is an international quality management system standard followed by the Europe, Australia and other market. The US FDA QSR also known as the US regulation number 21 CFR part 820. If the outside countries want to sell their device in UK market they need to comply with US QSR. The requirements of ISO 13485 and USQSR are very much similar. 

US FDA 21 CFR Part 820 Quality System Regulations: This process covers the facilities and control used for the design, manufacturing, packaging, labelling, storage, installations for medical devices .

21 CFR Part 210 & 211 Quality Assurance: 21 CFR Part 210 and 211 Process deals with manufacturing, packaging, or holding if drugs and pharmaceuticals. 

 ISO 9001 qms certification: is a globally required standard to describe the requirements of a quality management system in all industries. ISO 9001:2015 provides effectual risk assurance-based Quality Management System.  

ISO 15378 Certification: This QMS certification is for packaging materials, for medicinal and pharmaceuticals products. Primary packaging materials for medicinal products which meet customers’ requirements as well as regulatory requirements and international standards relevant to primary packaging medicinal materials. ISO 15378 Certification is QMS certification for primary packaging materials for medicinal products particular requirements for the application of ISO 9001:2008, with reference to GMP. 

 Every component of a quality management system accomplishes the general objectives of meeting the clients’ and association’s needs. The common elements of QMS can be: 

  • The organization’s quality arrangement and quality goals 
  • Quality manual 
  • Consumer loyalty from item quality 
  • Quality examination

What Is Quality Management System certification? 

Quality Management Systems (QMS) certification is the requirement of every business process who needs to comply with an arrangement of complex and challenging regulatory requirements. QMS is defined to help streamline and reinforce the internal process, or procedure. The QMS certification is a planned method for customers to receive what they expect and it is necessary to implement the quality system.

What do (QMS) Quality Management System certification consultants do? 

QMS consultants determine the design stages, validate the documents, provide training and guide organizations to attain the standards of quality, quality control, quality system and quality management. According to SFDA rule the regulatory authority will perform a rigorous assessment of documents submitted by the entity.  These consultants assist manufacturers in auditing processes so that they easily get the certificate   from the regulatory authority. The audit of the QMS of establishment and overseas manufacturer shall take place before the SFDA authorizes the devices to be placed on the USA market.  

What is our role as QMS certification consultant?

As QMS certification consultants we analyze the problems & issues which bother clients. As a medical device regulatory consultant Our QMS consulting services include layout designs, QMS certification training, manufacturing process and regulatory approvals. We have an experienced team who is having good hand in auditing, executing and maintaining all features. 

our team involves in U.S. FDA, EU notified bodies, QMS certification body. We have well-built technical expertise to assist and protect your quality systems that can follow with the toughest regulatory inspection.  

Why choose Operon Strategist for QMS certification? 

Operon Strategist has substantial experience in regulatory areas required for Quality Management System certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products and combination products. We have handled national as well as international projects and Our presence in USA proved ourselves best. Any ambiguity with the QSR compliance can be successfully and easily solved with our experienced team which makes justice to your time and money. We also provide QMS services for India, Saudi Arabia & Egypt. 

What are the benefits of QMS? 

QMS is important to build trust as a design or as manufacturing company. 

  • It improves processes and increases efficiency. 
  • It ensures the consistent quality of products and services. 
  • It helps to build a reputation and it creates trust among the customers. 

Frequently Asked Questions : (FAQ’s) 

  • What is QMS Service? 

These are the set of policies and procedures which enable organizations to identify, control and improve business processes which leads to improved business performance.  

  • Which ISO covers a quality management system for medical devices? 

For medical devices, the Quality Management System is implemented according to ISO13485 standard.