Medical Devices – Quality Management System
ISO 13485 Certification
For Small, Medium, and Large Organizations.
What is ISO 13485: 2016?
Introduction to ISO 13485 Certification
ISO 13485:2016 is developed and published by International Organization for Standardization [ISO]. ISO 13485:2016 is the recent version of the Quality Management System standard for medical devices. The ISO 13485 Standard is provides requirements for regulatory purposes for any organizations that are into the manufacturing, production, design and development, distribution or service of any kind of medical devices. The Standard is applicable to supplier of the medical devices and related technical support providers.
Like all ISO Standards, ISO 13485:2016 is written based on High-Level Structure with the principles of Deming Cycle [Plan-Do-Act-Check]. The Deming Cycle is the best management tool that ensures the smoother and most effective operations in any organizations that minimizes the environmental impacts, this makes the ISO 13485:2016 more precisive tool to trust with and to implement for guaranteed success for Businesses and helps organizations to showcase their ability to provide quality services by ensuring the safer medical devices.
Plan - Context of Organization, Risk assessment, Determining Controls, Legal and Other Requirements, Objectives and Planning.
Do - Roles, Responsibilities, Accountability, Authority, Competence, Training & Awareness, Communication, Documentation & Data Control, Operational Controls.
Check - Internal Audit, Performance Measurement & Monitoring, Evaluation & Assessments, Corrective actions and Preventive Actions.
Act - Management Review, Leadership, Continual Improvements.
***ISO itself does not issue any Certificates or conduct any conformity assessment. ISO Only publishes the Standards.
Organizations who want to implement and get Certified with ISO Standards, will need to contact a Certification Body, accredited by Accreditation Bodies recognized or a member of the International Accreditation Forum (IAF).
What is the process of ISO 13485 Certification?
Process of ISO 13485 Certification
Bureaumen International has a better and faster approach for ISO 13485 Certification Process. With us, we ensure you the 100% ISO 13485 Certification guarantee along with the robust quality management system. To understand the ISO Certification Process, Visit the page; ISO Certification Process.
What are the benefits of ISO 13485 Certification?
Benefits of ISO 13485 Certification
Improved Internal Management System
Safer Medical Devices, hence profit
Legal & Regulatory Compliance
Global Recognition & Improved Reputation
Continual Improvement Culture in Business
Increased Customer Satisfaction
How Much Does ISO 13485 Certification Cost?
Cost of ISO 13485 Certification
The cost of ISO 13485 Certification and Implementation is defined based on several factors. Bureaumen International calculates the cost involved in ISO 13485 Certification considering the following factors.
- Current Management System Complexity.
- Number of Employees (Required to calculate Auditors Man-day).
- Number of Processes (Required to calculate Auditors Man-day).
- Number of Locations to be implement and audit.
- Selected Certification Body & Accreditation Body.
how to get iso 13485 certification?
Getting ISO 13485 Certification for a Company
Bureaumen International – the premium ISO certification agency – helps you to get your ISO 13485 Certification hassle-free and faster. With our proven methodologies and approaches, it the easier to get ISO 13485 Certification for your organization.
- Prepare for Documentation & Implementation.
- Submit the ISO Registration Application.
- Submit the Legal Documents.
- Get audited by Certification Body.
- Get your ISO 13485 Certification.
- Start growing your business.
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FAQs
ISO 13485:2016 Frequently Asked Questions.
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How Long Does ISO 13485 Implementation or Certification Take?
Tine taken for implementation and Certification of ISO 13485 is depends on the following factors,
The complexity & Size of your Current Management system.
Nature of your Business (manufacturing, distribution, Technical Support, Storage & Distribution etc.).
The support from your Management.
strength and availability of the Current Resources.
The most of the time-period will consumed in the preparation of QMS Procedures, policies, SOP’s and risk registers. However, the audit process will take very less time compare to the implementation.
What Are the Benefits of ISO 13485 Certification?
There are tons of advantages are there for your organization when you get ISO 13485 Certified.
- You can ensure the Brand Reputation by providing quality products or services for medical Equipment’s.
- Reduced Production costs yield the increased Profits of the Business.
- Ensures the best recycling methods and reduced wastage in operation.
- Complied with the legal and regulatory laws (International, EU Laws and other governmental requirements).
- Advantages over competence in your business cycle.
- Shows your responsibility for sustainable & healthier future.
Why Choose Bureaumen international?
Bureaumen Internationalis the Leading Organization, has expertise in Implementation and Certification of wide range of ISO standards and other International Standards. Our processes are simple, easy-to-use and most effective. Bureaumen experts helps you to all-in-one solutions to build, implement and maintain the most trusted and stronger management system.
- With Bureaumen, we ensure you the first-attempt Certification guarantee.
- Our Support is excellence and available for you 24×7.
- Our certification and Implementation support extends to entire Certification Period.
- Bureaumen International ensures the 100% involvement in all processes to guarantee you the Certification success.
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