ISO 13485 Certification

ISO 13485 Certification provides a comprehensive framework for medical device manufacturers, suppliers, and any other third-party involved in the production of medical devices to ensure product quality and regulatory compliance with the standard.

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ISO 13485 Certification is essential for medical device companies to demonstrate compliance with regulatory requirements, also known as the law of the land. Quality management is a multifaceted and non-negotiable issue in the life and health sciences industry, encompassing more than just ensuring that a finished product meets certain expectations and is safe for use. 

Implementation of ISO 13485 Certification 

1) Obtain management approval. This is the first step for a reason: without management support, your ISO 13485 implementation project will fail (if it gets started at all). You'll need to prepare a well-thought-out presentation outlining the benefits your company can reap from ISO 13485 implementation.

2) Determine the requirements. The next critical step toward a successful implementation is determining all of the requirements that your QMS must meet. Legal and regulatory requirements, customer requirements, and other requirements vary depending on your company's needs and culture.

3) Establish the scope. You don't want to apply the QMS to areas of your business that have nothing to do with quality, but you also don't want to make the scope so narrow that the company sees no benefit

4) Establish processes and procedures. The ISO 13485 standard specifies certain mandatory procedures that must be included in your QMS, but you must also determine which processes and procedures within your organization.

5) Put processes and procedures in place. Most businesses only need to document existing processes and procedures to ensure consistent quality that meets requirements. 

6) Implement training and awareness campaigns. Every employee in your organization must understand how the Quality Management System works and how they fit into the equation for the QMS to be successful.

7) Select a certification organization. Because this is the company that comes in after your implementation to audit your Quality Management System and determine whether or not it meets ISO 13485 requirements, choosing the right certification body can make all the difference.

8) Run the QMS and measure the system. This is when you will collect the records that will be required in audits to demonstrate that your processes meet the requirements, that they are effective, and that improvements to your QMS are made as needed. 

9) Carry out internal audits. After operating the QMS for the required period of time, before the certification body conducts its audit, you must conduct an internal audit of each process. This will tell you whether or not the processes are working as they should.

10) Carry out a management review. Management must not only be supportive of the company's ISO 13485 implementation; they must also be involved in the ongoing maintenance of the Quality Management System.

11) Implement corrective measures. This is the stage at which you look for the root cause of problems discovered during internal audits, measurements, and management reviews, and then take the necessary action to correct the problems at their source. 

12) Complete the certification audit. Now is the time for the auditors from your chosen certification body to review your documentation and ensure that your QMS meets all of the ISO 13485 requirements. You can learn more about ISO 13485 certification here.

Cost  of ISO 13485  Certification 

Certification Bodies (CBs) will take several factors into account. It will be determined by when ISO 134845 certification is carried out.

  • Your organization's size
  • How many certified locations are required?
  • How many principles must you be insured against?
  • What are the risks associated with your company?
  • If we're in a high-risk industry, CBS will generally cite a little more. They might need to spend a little more time nearby.

Benefits of having ISO 13485 Certification

Enhance your company's credibility and identity.

The ISO 13485 certificate is the internationally recognized standard for quality in the medical device industry. This certification proves to customers that the organization adheres to high-quality standards and informs them that they have a standard in place to do so.

Decision-making based on evidence

With the ISO 13485 certification in place, the company can remain focused on quality objectives. Data is continuously provided to management. These facts and data can be used to make decisions that are more in line with the strategic goals and objectives of the business

Continuous enhancement

One of the fundamental principles of ISO quality management systems is continuous improvement. When a QMS is implemented in any organization, it results in a cultural shift in which management and employees are constantly looking for ways to improve.

increased employee participation

Employees can understand their role in ISO 13485 implementation with proper documentation and process control. When asked to look for ways to improve the processes, they do so. feel ecstatic and provide the best insight that can aid the company's success

Customer satisfaction has increased.

Customer satisfaction is one of the core principles of ISO 13485 implementation. Customers regard companies that are ISO 13485 certified as more trustworthy than those that are not. This is because customers are confident that the company has a good QMS in place.

How to get ISO 13485 Certification

Certvalue's registration services have a stellar track record of customer satisfaction. A friendly approach to audits and a dislike of bureaucracy have resulted in unprecedented growth in satisfied clients' referrals. Certvalue only hires auditors who are familiar with this approach. Auditors are carefully assigned based on their prior experience in the industry being audited. As a result, a practical, meaningful audit is conducted in an atmosphere of mutual respect. Please visit www.Certvalue.com for more information on the company and its services. 

PLAN

Conduct Gap Analysis to find any Shortcomings from the standard requirements.
 

DO

Policies, procedures, Work Instructions, Evidences, Records, Training

CHECK

Conduct frequent internal audit and management review meeting.

ACT

Apply corrective actions on the identified root cause or shortcomings

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ISO certification is a tool to streamline and enhance the process performed internal to the organization. Certvalue indulges in inculcating best industry practices.

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ISO certification is a basic requirement to bid or participate in any tenders floated by government or private sector. And ISO certification from Certvalue is an assurance win over the tenders.

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Testimonials

Our Client Reviews

Sobiya Rajesh
Sobiya Rajesh
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We are happy on Certvalue services. The team guided through applicable SOPs, forms and policies to implement QMS and manage it effectively so as to comply with ISO requirements. It included training part as well. Hence we are satisfied and recommend anyone who seek professional service.
Dhruv Parekh
Dhruv Parekh
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Certvalue team was very professional in their approach from the time we engaged them. Special mention to Ms. Jeevika Uchil who consulted and worked extensively with our team.
Anita Okonigene
Anita Okonigene
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CyberDome Nigeria Limited. CertValue made the acquisition of our ISO 27100 certification seamless. The person assigned to us Jeevika Uchil was very helpful.
Neeladri Bose
Neeladri Bose
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Amazing organisation to work with! Certvalue is definitely the best of the best. Thank you Certvalue Team!
Shehan Athukorala
Shehan Athukorala
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Certvalue is a very professional and responsive consultation firm. It did show us the right direction towards the ISO and GMP certifications for the PPE devices we are manufacturing. Hoping to work with them for ISO 13485 /CE and FDA as well. Well recommended for all.
Aditya vakoda
Aditya vakoda
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We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
Mounika Kona
Mounika Kona
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Thank you certvalue, we have built information security management system in our organization with the help of certvalue. They were really help to get certified under iso 27001. Thank you.
somraj daroji
somraj daroji
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Very professional in consultation, documentation etc right from the first point of meeting with them. . .thank you certvalue for all the support !
Pushkar Patwardhan
Pushkar Patwardhan
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Certvalue team was very responsive right from the time we contacted them for the first time. Consultants who worked with us were very professional and demonstrated a lot of patience to get us through required documentation / requirments for the certification. Thank you Certvalue!
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