ISO 13485 – Medical Devices – Quality Management System
ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. It contains requirements essential for organizations operating at any tier in the medical device and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and, as a result, it includes some particular requirements for manufacture, installation and servicing, such as added requirements on record control, sterilization and risk management.
It is based on ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.
Organizations can register to ISO 13485 as a standalone or in conjunction with ISO 9001 or another registration. An ISO 13485 certification from us demonstrates your organization's commitment to provide products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.
Benefits of ISO 13485
Harmonized regulation
ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.
Regulatory support
A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance can be used in support of regulatory compliance.
ISO 9001 benefits
It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.
Competitive advantage
Consistent management approach
Ensures a consistent and effective approach to business management.
Lower risk
Reduces risk factors via the use of risk management techniques.
Top management involvement
Engages top management.
Product consistency
Provides a robust framework for assuring product consistency.
How it works
TOV America Process
TOV has a unique approach to certification which complies with the requirements for bodies providing audit and certification of management systems.
Enquiry & quote
Tell us about your organisation, scope and sites. We send a clear, fixed quotation.
Application review
We confirm scope, competence and audit time, then agree the audit programme with you.
Stage 1 audit
Documentation review and readiness check of your management system.
Stage 2 audit
On-site audit of how the system is implemented and how effective it is.
Certification decision
An independent reviewer decides on certification and your certificate is issued.
Surveillance audits
Annual audits confirm the system is maintained and keeps improving.
Recertification
A full re-audit in year three renews the certificate for another cycle.
FAQ
Frequently asked questions
Can I certify ISO 13485 together with ISO 9001?+
Yes. Organizations can register to ISO 13485 as a standalone or in conjunction with ISO 9001 or another registration.
How long is the certificate valid?+
A management-system certificate is valid for three years, with annual surveillance audits to keep it active and a recertification audit before it expires.
How long does certification take?+
It depends on size and readiness. Once your system is implemented, the Stage 1 and Stage 2 audits and the certification decision typically take a few weeks.
Can several standards be audited together?+
Yes. Standards built on the common Annex SL structure, such as ISO 9001, ISO 14001 and ISO 45001, can be audited together in an integrated audit.
How can my customers verify my certificate?+
Anyone can confirm a certificate with our online certificate search using the company name or certificate number.