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ISO13485 Certification


ISO 13485 specifies the requirements for a quality management system that any organization operating in the medical devices sector needs to demonstrate. Certification demonstrates your organization's reliability, proving your commitment and abilities to provide design, manufacturing, testing and sales services that consistently meet customer needs and regulatory requirements.

The Benefits of Certification:

1.Win new business – you can beat the competition in procurement processes when ISO 13485 certification is a requirement.
2. Improve processes – with ISO 13485, you can identify areas for improvement in your management processes, ensuring they are internationally accepted.
3. Reduce costs – by highlighting where your processes can be improved, ISO 13485 helps you cut operating, manufacturing and energy costs. 
4. Meet customers'needs – with a focus on customers, ISO 13485 lets you set out goals for meeting customer needs.
5. Demonstrate your commitment to quality – ISO 13485 certification shows customers, partners and employees that you are committed to continuous improvement.
6. Improve competitiveness – ISO 13485 certification helps you enter new global markets and supply chains and forge new partnerships.
7. Monitor and improve performance – ISO 13485 helps you analyze your processes and monitor customer opinion.
8. Manage your supply chain – ISO 13485 covers supply chain management, helping you improve your processes and maintain quality throughout the value chain.
1. Make contact

Get in touch and tell us what you need, so we can identify the best services for your organization. We’ll then give you a proposal detailing the cost and time involved in a formal assessment.

2. Meet your assessment team

We’ll assign you a dedicated Client Manager, who will be your main point of contact throughout the process and beyond. They’ll be familiar with your business area and will support you as you move forward to assessment and certification.

3. Pre-assessment(option)

We can do a pre-assessment of your existing management system against the requirements of the standard and identify any omissions or weaknesses that need resolving before formal assessment.

4. Formal assessment

A formal initial assessment will be carried out on site within an agreed timescale.

5. Certification and follow-up matters

Once the assessment has been successfully completed, we’ll issue a certificate of registration, clearly outlining the scope of your certification. We will carry out re-certification based on your certification cycle and support your continual improvement activities.

Please contact us for details. (Service Hotline: 400-016-9000)

Please contact us for details. (Service Hotline: 400-016-9000)

Please contact us for details. (Service Hotline: 400-016-9000)