ISO 13485:2016

ISO 13485 is an international quality management standard for organizations involved in the manufacturing, distribution, servicing and disposal of medical devices.

Organizations with ISO 13485 certification are commonly recognized to produce medical devices that are at par with world class industry standards.

Consulting Services

Scientists Sanctuary can assist in the implementation and maintenance of your ISO 13485 Quality Management System.

We will look at how your business is currently run before deciding on what steps need to be carried out and make suitable recommendations for compliance to the relevant standards.

As a business, you can then choose from the various options we offer depending on your size, budget and level of input required.

External Auditing Services

Scientists Sanctuary can perform an objective and professional third-party audit (also known as external audits) for those companies that are ISO 13485 certified or nearing their certification audit.

These audits will help determine the status and health of your current Quality Management System to ensure that compliance to the ISO 13485 standard is adhered to.

We can also perform targeted process audits that are more tailored to your known areas of non-compliance or in areas where your own internal auditors cannot audit due to lack of auditor impartiality.

Do It Yourself: Shop Our Ready-To-Edit Templates

Organizations can also choose to purchase our ready-to-edit ISO Quality Management System templates from our online shop.

These templates are aligned to relevant ISO Standards and are easy to populate with prompts that guide you through the documentation process.

Contact us today if you require a consultant to help with implementing, updating or auditing your Quality Management System against ISO 13485.