ISO 13485 Consultancy: Medical Device Quality Management

ISO 13485 is the international standard for quality management systems in the medical device sector. The current edition is ISO 13485:2016. It applies to organisations that design, manufacture, store, distribute, install or service medical devices, and to those that supply them with materials, components or services. With CE Danışmanı (CE Consultant) you get your ISO 13485 certificate through a single point of contact for the whole process.

What ISO 13485 covers

A medical device must perform safely for its whole service life. ISO 13485 sets the requirements for the management system behind the device, from design and development through production, storage and transport. Its purpose is to show that the organisation consistently meets customer requirements and the regulatory requirements that apply to medical devices and related services.

The standard is based on ISO 9001, with its scope adapted to medical devices and with specific requirements for sterile devices.

Who needs it

• Medical device manufacturers
• Importers and distributors
• Sales companies
• Suppliers of raw materials and components for medical devices
• Providers of services to the medical device sector
• Service, maintenance and installation companies

Is ISO 13485 mandatory?

Medical devices placed on the EU market fall under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Turkey applies the same rules through the Ministry of Health. Both regulations require the manufacturer to operate a quality management system, and ISO 13485 is the standard normally used to show that this requirement is met. In practice it is one of the first documents asked for when a medical device is exported, and it makes the CE marking process for a medical device considerably easier.

How ISO 13485 differs from ISO 9001

• It is written only for medical devices, so it is more specific than the general ISO 9001.
• It focuses on meeting customer and regulatory requirements. Customer satisfaction, a core idea of ISO 9001, is not the main measure.
• Because the products affect human health, regulatory requirements carry much more weight.
• It asks for more documentation.
• It requires the quality management system to be maintained and kept effective. ISO 9001 puts the emphasis on continual improvement.

Setting up the system

1. Analysis of the current situation
2. Appointing the project manager and the project team
3. Defining the processes
4. Defining acceptance criteria
5. Selecting the critical control points
6. ISO 13485 training for staff
7. Internal auditor training
8. Preparing the quality manual and the procedures
9. Putting the system into practice
10. Review of the application documentation
11. Review of the preparations before the certification audit

How long this takes cannot be stated in advance. It depends on the size of the company, on how complete the documentation already is and on how quickly open issues are resolved.

What a company gains

• Activities are tracked systematically, so errors are found and corrected quickly
• Orderly records make inspections by the authorities easier
• Consistent product quality and a lower risk of harm caused by a device
• Fewer product defects, fewer complaints and a lower risk of recalls
• A structured way to follow the legal requirements, which reduces legal exposure and the cost that comes with it
• An easier route to CE marking for medical devices
• A stronger position in the supply chain and with customers abroad
• Staff who are more aware of hygiene and sanitation

Who issues the certificate?

Certificates are issued by certification bodies accredited by a national accreditation body (TÜRKAK in Turkey). The certification body sends an application form, reviews the records kept under the quality management system and audits the company on site.

Validity

ISO 13485 certificates are valid for three years. During that period the certification body carries out a surveillance audit at least once every 12 months, and the outcome of those audits determines whether the certificate stays valid.

How CE Danışmanı helps

• Gap analysis against the requirements of ISO 13485
• Quality manual, procedures and records prepared with your team
• Standard training and internal auditor training
• Internal audit and preparation for the certification audit
• Support with the technical file where the device also needs CE marking

Tell us about your company and we will reply with our offer as soon as possible.

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