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ISO 13485 Certification

Medical devices - Quality management systems

ISO 13485 Certification

About ISO 13485 standard

ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity of EN ISO 13485:2012 stated as 31 March 2019.

Harmonization of standards allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively.

Find out more about MDR transition and IVDR transition.

About ISO 13485 Certification:

ISO 13485 Certification is an activity of verifying the organization through planned and informed ISO audits to confirm that the organization complies with the standard requirement of ISO 13485.

ISO 13485 certification for medical devices is an internationally recognized quality standard that affirms the requirements of the Quality Management System standard for Medical Devices (QMS) for the design and manufacture of Medical Devices anywhere in the world.

ISO 13485 certification is a symbol of the stability and continuity of your organization’s performance to reach and outshine customer expectations. Nowadays Customers are not ready to take a chance, to reduce the risk of purchasing low-quality products they always look for the best quality ISO-certified products and services. ISO 13485 certification for business is a powerful tool to increase the credibility of the organization by showing that your products or services meet the expectations of your customer.

ISO 13485 certifications help to expand your business locally and in overseas markets and also definitely help to impress your clients with the quality of the business and its products and services.

IAS can now offer UQAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. To find out more about our Certification procedure.

To know more about ISO 13485 – Quality Management System standard for Medical Devices and its certification, click here.

The process to obtain an ISO 13485 Certification:

The ISO 13485 certification process is a never-ending process since the requirements of the standard are dynamic and changes regularly. Therefore, an organization under Certification needs to regularly monitor the changing requirements and regularly assess its performance against those requirements.

An organization has to make sure that its products meet all of the regulatory standards; applicable laws and ethical guidelines, that are relevant to the medical devices that the organization manufactures.

Organizations under ISO 13485 certification have to provide valid evidence of their compliance with the regulation by satisfying the requirements of the standard. An auditor will scrutinize all records related to compliance, Quality Management systems, and other documents for their validity during an inspection audit. A certificate will be awarded only to those organizations that meet all the requirements of ISO 13485.

For more information about ISO Certification Services by IAS, email us at enquiry@iascertification.com 

Click here, For more information on the application and frequently asked questions

Quality Management System EN ISO 13485 certification

Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provide an indispensable foundation on which to build your business. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard.

The EN ISO 13485 certification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production, and customer care.

As a well-respected and globally recognized Notified Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop-shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs.

Benefits of EN ISO 13485 certification

Medical devices (including Class I) benefit greatly from a manufacturing line that includes an EN ISO 13485 certified quality management system (QMS). The certification framework allows for additional product opportunities and global market access approval. Manufacturers and sub-contractors of medical devices may use their certified QMS status to obtain specialized certifications such as TCP, MDR.

The EN ISO 13485 certification empowers a company to take advantage of its early years when it comes to growth and expansion. The audit may provide an opportunity for all those in the medical devices sector to improve QMS procedures and processes.

Why IAS for ISO 13485 Certification

  • Reliable, Easy, fast, responsive, and delivers certification on time.
  • Remote audits as per the IAF guidelines.
  • Achieved more than 6000+ clients across the globe and covering various schemes.

We understand the culture and nature of the local market and execute the Audit in an effective and reliable manner.

Benefits of obtaining ISO 13485 certification:

  1. The most well-known ISO 13485 certified company is regarded to be the world’s most reputable. ISO 13485 Certification may help you improve overall performance, remove uncertainty, and increase market possibilities by obtaining this certification. Companies with this accreditation demonstrate their commitment to quality both with customers and regulators.
  2. The process-oriented QMS elevates the organization’s authority to determine, evaluate, manage, and enhance the fundamental business operations that will lead to higher earnings.
  3. Mandatory for CE marking Medical Device Manufacturers, drugs, cosmetic items, etc. reduce risk of non-compliance, be accountable with compliance data.
  4. The use of ISO 13485 will enable you to expand the business in new international markets and have a major competitive advantage over those who are not certified.

What an Organization should do to achieve ISO 13485 certification?

Four steps to ISO 13485 certification:

Optional preliminary audit

Checklist for Auditors and Quality Assurance Auditors This document covers everything you need to know about conducting a site inspection and documenting the results. It also includes an assessment of your readiness for full-scale Phase I & II audits

Audit: Stage I

The decision whether or not to accept a candidate for certification is based on an audit of their certification, quality management documentation analysis, and company evaluation.

Audit: Stage II

Quality management system for excellence in areas of applied practice and efficiency was examined on-site.

Certification

IAS will evaluate your quality management system and total conformity with the requirements.

Cost of ISO 13485 Certification?

There is no additional cost to you for the audit. Once we have your approval, IAS will handle everything from start to finish.

Our goal is not only to prepare you for certification but also to ensure that your quality management system operates as efficiently as possible once it has been certified. We tailor our services so they meet your needs and exceed your expectations.

After we receive your approval, we will contact you with the required forms and provide a schedule for your on-site audit. We keep you fully informed throughout the certification process and provide:

  • On-site assistance during the Phase, I Audit
  • A timely report of findings
  • Schedule for the Stage II Audit in 2-3 months after completion of Stage I Lessons learned.
  • Audit fee in four installments, payable when you receive our invoice (payment plan is available)

If you are interested in ISO 13485 Certification services please don’t hesitate to contact us .

Whatsapp : +65 3159 1803 / Mail : enquiry@iascertification.com