What is ISO 13485?
ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipments. The most important aim of this standard is to facilitate harmonized excellent management system requirements for regulatory functions within the medical devices industry.
ISO 13485 is an excellent system standard designed for medical device firms. It’s by far the most frequent route to satisfy the Quality Management System (QMS). The medical apparatus demands in Europe, Canada, and Australia, also functions as the foundation for QMS compliance in different nations like Japan, Korea, and Brazil.
How ISO 13485 certificate advantages your organization?
If you make or promote a Class II or a greater danger classification device and market it outside the United Arab Emirates, you must likely be ISO 13485 accredited. ISO certification may also expand your marketplace access and enhance your organization’s profitability. Here are a few of the Advantages of ISO 13485:
- It’s the actual standard for international medical apparatus QMS compliance for medical apparatus, and it’s a necessity for access to many major markets globally.
- ISO 13485 certification demands dedication and effort to achieve, so it provides you further credibility with potential clients.
- An elegant QMS system increases efficiency, improves product quality, and enhances customer service in your business.
We will help you apply ISO 13485 or update in ISO 9001
We focus exclusively on medical devices and in vitro diagnostic device companies, thus we know the special requirements and manufacturing situations of the business. With 10 years of experience , our group of seasoned QA advisers has helped tens of thousands of medical devices and IVD manufacturers attain ISO 13485 certification. Here we can help you:
- We’ll completely personalize your ISO 13485 quality program to satisfy your demands and be certain that you’re prepared for a certification audit.
- Our ISO 13485 consulting and project management teams work closely together with you to execute your QMS in time and on budget.
- We can recommend qualified third-party testing and testing companies which specialize on your device group.
- Nathan ISO Consulting will perform ISO 13485 training to your employees.
Common Questions:
- Can any ISO Consulting companies issue ISO 13485 certificate?
No – just licensed Notified Bodies/Registrars are approved to audit and certify your company to the ISO 13485 standard.
- How much time does it take to accomplish ISO 13485 certificate if we don’t have any system set up?
Implementation usually takes 4-6 weeks for businesses with over 50 workers. Bigger companies with over 50 workers and/or several places require more written processes and involve more people, so execution generally takes 6-12 weeks. Complex manufacturing procedures (example: sterilization) may also prolong the execution procedure.
The time frame for certificate can also be contingent on the accessibility of Notified Body/Registrar auditors to audit and certify that your organization — in certain markets it might take at least involving 6 — 9 weeks to schedule an onsite audit so it’s essential that these associations be engaged as early as you can to confirm their availability.
- When will ISO 13485:2016 be required?
March 1, 2019 is the close of the transition interval for upgrading certificates into the new edition. Producers seeking ISO 13485 certificate for your first time ought to implement procedures and systems which comply with new variant requirements. Find out more about ISO 13485:2016.
Key benefits of ISO 13485
Meet regulatory requirements and Demonstrate that medical devices are produced safely
Increase device sales by accessing more markets
What further advantages can I expect?
- Reduced operating costs
- Improved stakeholder relationships
- Legal compliance
- Improved risk management
- Proven business credentials
- Openings in new markets
- Customer satisfaction
Benefits of working with KCS
- Network of Overseas Strategic Partners
- Accredited Certification
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- Industry Experienced Audit Team
- Defined & Agreed Project Timescales
- Fixed Cost & Competitive Quotations
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How is ISO 13485 structured?
ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets. Having certification demonstrates your commitment to meeting your customer requirements.
Who can apply for ISO 13485 certification?
ISO 13485 is applicable to all manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices. For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices.
Requirements of the ISO 13485 standard
- Risk management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
- Implementation of a quality management system with several enhancements.
What is the certification process?
The certification process is in three simple steps:
Application for certification
Complete the on line form for KCS to send a quotation.
Initial Certification Audit
The assessment process is based on a 2 stage approach as follows:
Stage 1 – a basis audit to check whether the organisation is in a state of readiness for the stage 2 audit and involves the following:
- Confirm that the quality manual conforms to the requirements of the ISO 13485
- Confirm the scope of certification including any justifiable exclusions
- Check legislative compliance
- Production of a report that identifies any non-compliance or potential for non-compliance and
- Agree a corrective action plan if required.
- Production of an assessment plan and confirm a date for the stage 2 assessment visit.
Stage 2 – the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 13485 in practice and involves the following:
- Undertake sample audits of the processes and activities defined in the scope of assessment
- Document how the system complies with the standard
- Report any non-compliances or observations
- Produce an audit programme and confirm a month and year for the first surveillance visit