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ISO 13485:2016 Medical Devices – Quality Management Systems

ISO 13485 : 2016 Medical Devices - Quality Management Systems

ISO 13485 : 2016 Medical Devices - Quality Management Systems

What Is ISO 13485 Certification?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

It is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.

An organization can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

Benefits of ISO 13485 Certification

Legal Compliance

Demonstrate your management system complies with the international standard

Improve Brand Image

Build trust and brand integrity by providing assurance that your management system qualifies the requirements of the international standard

Customer Satisfaction

Ensure customer satisfaction by assessing customer needs and expectations and striving to meet them

Improve Processes

Identify and eliminate waste within and between processes, reduce errors, and avoid rework

Competitive Advantage

Market your products and services more efficiently and enjoy the competitive advantage that comes with meeting the set standards

Better Employee Engagement

The more your employees understand their roles in delivering quality products and services, the more engaged they are.

Take a Deep Dive Into ISO 13485 Certification

Looking to implement an ISO 13485 Medical Devices – Quality Management Systems but not sure where to start? Take a look at our ISO 13485 guide here. The free guide will give you a great insight into this certification. +

ISO 13485 Certification – Quality Management Systems – IRQS

Apply for ISO 13485 Certification : 2016 Medical Devices – Quality Management Systems with IRQS. 25+ yrs experience of handling 5k+ clients across the globe.

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Understand the role of a Lead Auditor & gain expertise needed to perform the MD-QMS audits

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

What does it mean to be ISO 13485 certified?

ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.

What is the difference between ISO 9001 and ISO 13485?

ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.

How long does it take to get ISO 13485 certified?

Implementation usually takes 4-6 months for companies with fewer than 50 employees. Larger firms with more than 50 employees and/or multiple locations require more written procedures and involve more people, so implementation usually takes 6-12 months.

Is ISO 13485 mandatory for medical devices?

This global standard is mandatory in some countries, and in the U.S. the FDA has proposed a rule which would harmonize U.S. FDA 21 CFR 820 with ISO 13485:2016, making ISO 13485 the FDA’s mandatory QMS for Medical Devices (the rule is expected to be released in 2019).

Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program, or “MDSAP” Audit.

ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

ISO 13485 certification is a requirement for medical device companies that wish to market their products in Europe and around the world.

Why do you need ISO 13485?

Who is ISO 13485 for? ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Do you need ISO 13485 certification?

The short answer is no, ISO 13485 is not mandatory. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them.

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ISO 13485 – Medical Devices Quality Management Systems Requirements for Regulatory Purposes

ISO 13485:2016 Training – Medical Device QMS Training

Get in-depth understanding of MD-QMS requirements for regulatory purposes (ISO 13485:2016) Enroll for this intensive course from IRQS and become a registered Lead Auditor. Customer Support. Virtual Classes Available. Sample question papers.

Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.

Which ISO covers quality management system for medical devices?

What is ISO 13485? ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers.

What is a medical device quality management system?

In simple terms, a medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.

Is ISO 13485 A QMS?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment.

What is the ISO standard for medical devices?

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

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Steps to ISO 13485 Certification

Step - 1
Application

Application for ISO 13485 : 2016 certification from new (Fresh) client and existing client.

Step - 2
Offer Submission

After understanding your business, we create an offer that helps you to attain ISO 13485 : 2016 Certification without hassles.

Step - 3
Offer Acceptance

Acceptance of Offer by client and Confirmation of agreement by both client organization and IRQS.

Step - 4
Certification Audit

Conduct of Initial Certification audit – (Stage 1 + Stage 2) for new (Fresh) clients / Re-Certification audit (For existing clients).

Step - 5
Approval

Issuance of the “Certificate of approval” on successful completion of the initial / Re-certification audit process.

Step - 6
Surveillance

Surveillance audits are undertaken annually to ensure that compliance to the chosen Standard(s) is maintained throughout the three-year certification cycle.

Step - 7
Recertification

The recertification audit process is to be initiated 3 months prior to the expiry of the certificate.

Want to Transfer Your ISO 13485 Certification?

You can transfer your ISO Certification from one Certification Body to another at any stage you wish, you are not tied into any contract. You need a trusted certification body and we’ll help you transfer to us quickly and easily.

If you would like a free quotation for the transfer of your certification then please complete the form and we will be able to provide you with a quotation.

Save Time & Money When You Audit Two Standards

Did you know ISO 13845 and other standards like ISO 14001, ISO 9001, ISO 45001, etc. share the same structure? You can save time and money when you audit any two standards at the same time.

ISO 13485 Remote Audits - Online

Your company is not easily accessible? No worries. Our auditor will engage with you on any online video conferencing platform that is convenient to you. Remote auditing is the only option to circumvent the challenges we are facing due to the pandemic.

Expand Your Knowledge About ISO 13485
With Our Popular Training Courses

Profoundly understand the ISO 13485 standard from our subject matter experts and put your knowledge into practice. Check out our popular ISO 13485 training courses that help you realize your potential, upgrade your skills and remain competitive.

Client Case Study

Implementing ISO 13485:2016 can help ensure that your customers get high-quality products and services consistently. The following ISO 13485 case studies offer a look at the difference ISO 13485 made for organizations in terms of customer satisfaction, overall process efficiency and revenue.

Frequently Asked Questions

How can I get ISO 13485 certificate?

The ISO 13485 certification is not for an individual and it is attainable by an organization dealing with the production of medical device and accessories. The systematic steps of getting the ISO certificate are convenient to follow if you have the right information about the framework, compliance and auditing requirements. Firstly, it is ideal to conduct an internal audit to recognize the gaps and shortcomings. If your organization is prepared for the professional third-party audit, you can apply and submit certification request. On a successful completion of audit and satisfactory reports, you get the certificate, issued by the standardization body.

Who needs ISO 13485 certification?

The norms of the certification, ISO 13485 was developed to facilitate and strengthen the operations and quality of medical device manufacturers. The framework helps construct a QMS or quality management system and maintain the effectiveness of the operational process. Thus, the certification is critical for any organization related to the sector of medical device or equipment production. It increased the brand value and creates a credible brand image for better operations in the professional sect.

What are the requirements of ISO 13485?

The key elements of ISO 13485 framework include a robust quality management system in the organization, a responsible and efficient maintenance system, optimal resource management for efficient management, product planning and realization, and lastly, performance measurement and analysis. These are requisites of attaining a satisfactory audit report, thereby attaining the certification from the ISO body. These are parts of developing the robust QMS in the organization and facilitating the production quality.

Related ISO 13485 Contents

ISO 9001:2015 Quality Management System Foundations

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