1. What is ISO 13485:2016?

ISO 13485:2016 is an international standard applicable to quality management systems in the production of medical equipment and related services. This standard focuses on ensuring that medical products meet legal requirements and requirements for the safety and effectiveness of the manufacturing process.

2. Requirements that need to be prepared before ISO 13485:2016 certification

Before proceeding with ISO 13485:2016 certification, businesses need to prepare the following steps:

1. Staff training: Ensure employees have sufficient knowledge of ISO 13485:2016 and quality management requirements.
2. Set up a quality management system: Develop processes and guidance documents to comply with ISO 13485:2016 standards.
3. Internal inspection and evaluation: Carry out assessments to ensure the quality management system operates effectively and complies with regulations.

3. Documents according to ISO 13485:2016

To meet the requirements of ISO 13485:2016, businesses need to prepare the following documents:

• Quality policy: Statement of management’s commitment to continuous quality improvement and compliance with the requirements of ISO 13485:2016.
• Scope of the quality system: Clear description of the scope of the quality management system applied in the organization.
• Documentation system and document management: Includes processes and instructions on how to manage, store, preserve and update documents related to the quality management system.
• Risk management: Includes processes to identify, evaluate and control risks in medical device manufacturing.
• Management of measuring and testing equipment and instruments: Includes procedures to ensure measuring and testing equipment and instruments meet product requirements.
• Control of non-conforming products: Includes procedures for handling, reporting and preventing products that do not meet requirements.
• Records of design and development: Includes documents related to design requirements, design risk analysis, and technical specifications.
• Production records: Includes manufacturing processes, work instructions, and records related to medical device manufacturing.
• Inspection records: Includes inspection results, inspection methods and related records.
• Records of equipment maintenance: Includes procedures and instructions for maintenance and servicing of equipment related to medical products.
• Training records: Includes training plans, training manuals, records of training activities and evaluation of training effectiveness.
• Records of internal quality management: Includes meeting minutes, internal reviews, and improvement measures taken within the organization.
• Records of complaint handling and remedial measures: Includes processes and records related to handling customer complaints and related remedies.
  

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ISO 13485:2016 certification fee

ISO 13485:2016 certification fees depend on many factors such as the size of the organization, the scope of certification, and the certification organization chosen. Typically, the fee will include:

• Preliminary assessment fee
• Official assessment fee
• Annual monitoring fee

Businesses should contact certification organizations directly to receive specific quotes.

Benefits of ISO 13485:2016 certification

ISO 13485:2016 certification brings many benefits to businesses, including:

• Meet legal requirements: Ensure that medical products are manufactured in compliance with legal regulations.
• Enhance reputation and image: Enhance the trust of customers and partners in product quality.
• Strengthen risk management: Minimize risks and incidents during the production and supply of medical products.
• Save costs: Optimize production and inspection processes, minimize waste.

Why choose an accredited ISO 13485:2016 certification organization that recognizes IAF globally?

Choosing an IAF-accredited certification body ensures that your ISO 13485:2016 certification will be globally valid and widely recognized. These organizations often have experience and high reputation in assessment and certification, providing maximum support to businesses during the certification process.

Choosing an IAF accredited certification organization will bring long-term benefits to businesses, helping to enhance reputation and expand business opportunities in the global market.

Frequently asked questions when certifying to ISO 13485:2016

Question 1: How long does ISO 13485:2016 certification take?

• Certification time may vary depending on each certification organization and the size of the business. Typically, this process can take anywhere from a few months to a year.

Question 2: What is the cost of ISO 13485:2016 certification?

• Certification costs depend on many factors such as business size and scope of certification. Businesses should request detailed quotes from certification organizations for an accurate assessment.

Question 3: Does ISO 13485:2016 apply to all types of medical devices?

• ISO 13485:2016 applies to the manufacturing and supply of medical devices and related services. However, there may be different specific requirements for each product type.

Instructions documents