Quality Management
Systems Certification

ISO 13485
Quality of medical devices

Having a certified Quality Management System is a guarantee for standing out in the market!

ISO 13485 is an international standard for Quality Management Systems (QMS) of healthcare devices, based on ISO 9001.

An ISO 13485 certificate gives credibility to the organization, proves its commitment to quality and continuous improvement of its processes and medical devices, demonstrating that its QMS has been evaluated and approved in accordance with regulatory requirements.

ISO 13485 certification also opens new doors for business expansion, facilitating access to international markets that require high quality standards.

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ISO 13485
Quality of medical devices

Having a certified Quality Management System is a guarantee for standing out in the market!

ISO 13485 is an international standard for Quality Management Systems (QMS) of healthcare devices, based on ISO 9001.

ISO 13485 certification also opens new doors for business expansion, facilitating access to international markets that require high quality standards.

REQUEST YOUR PROPOSAL

ISO 9001
Quality Management Systems

ISO 9001, an internationally recognized standard, is a seal of global recognition that brings numerous advantages to your business.

Unlike ISO 13485, specific for healthcare devices, ISO 9001 is a general standard applicable to the QMS of companies with different scopes, from different market sectors.

With the ISO 9001 certification, you will be able to streamline operations, reduce costs, and make your organization more competitive nationally and internationally!

REQUEST YOUR PROPOSAL

ISO 9001
Quality Management Systems

ISO 9001, an internationally recognized standard, is a seal of global recognition that brings numerous advantages to your business.

Unlike ISO 13485, specific for healthcare devices, ISO 9001 is a general standard applicable to the QMS of companies with different scopes, from different market sectors.

With the ISO 9001 certification, you will be able to streamline operations, reduce costs, and make your organization more competitive nationally and internationally!

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BENEFITS OF THE CERTIFICATION

ISO 13485 and ISO 9001 certifications are valuable differentiators for organizations seeking to
stand out in the national and international market!

ACCESS TO
GLOBAL MARKETS

BESTOWS
CREDIBILITY AND NOTORIETY

INCREASES PRODUCTIVITY AND EFFICIENCY

COST REDUCTION

A certified QMS contributes to continuous improvement of overall performance, reducing uncertainties and opens new business opportunities.

Certified companies demonstrate to their customers and regulatory bodies their commitment to high quality and safety standards.

STEPS OF THE CERTIFICATION PROCESS

STEPS OF THE CERTIFICATION PROCESS

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CERTIFICATES ISSUED BY QC CERT

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FAQ

What is QMS?

QMS, or Quality Management System, is a set of organizational policies, procedures and practices implemented by a company to ensure that its products or services meet customer expectations and requirements.

What is ISO 13485?

ISO 13485 is an internationally recognized standard. It establishes requirements for QMS applicable to companies that manufacture medical devices. The standard was created to be used by organizations for the design and development, production, installation, maintenance, commercialization and distribution of medical devices.

What is ISO 9001?

ISO 9001 is an international standard that establishes the requirements for a QMS in an organization. It is a general quality management standard and can be implemented by any company, regardless of its sector or size. In short, it defines the good practices that a company must follow to guarantee the quality of its products and services.

What is the difference between ISO 13485 and ISO 9001?

The main difference is that ISO 13485 is specific to medical devices, while ISO 9001 is a generic quality management standard, applicable to various industries.

Why should I certify my QMS?

A certified QMS can be very advantageous! It will set the certified company apart from its competitors, eliminating uncertainty and reducing costs. The certification also bestows credibility to the organization, transmitting confidence to its customers and partners, proving its commitment to the continuous improvement of its processes, products and services. It also opens new doors for business expansion, facilitating access to national and international markets.

What is OMD?

The OMD, or Certification Body of Health Product Management Systems, is an entity accredited by Inmetro. In other words, the OMD is recognized and accredited by Inmetro to act within its scope of services. Through audits and documentary analyses, the OMD verifies and certifies that the organizations' QMS meets the high regulatory standards in force, according to the ISO 13485 standard.

What is OCS?

The OCS, or Certification Body of Quality Management System, is an entity accredited by Inmetro. In other words, the OCS is recognized and accredited by Inmetro. Through audits and documentary analyses, the OCS verifies and certifies that the organizations' QMS meets the high regulatory standards in force, according to the ISO 9001 standard.

How long does the certification process take?

The deadline for the complete certification process according to ISO 9001 and ISO 13485 varies greatly, depending largely on the structure and size of the organization being evaluated. Contact us contact to learn more!

What are the steps in the certification process?

In short, the certification process of a QMS according to ISO 13485 or ISO 9001 consists of three stages: Audits, Document Analysis (Audit Reports and organization documents), and Issuance of the Certificate of Conformity.

What documentation is needed?

The necessary documentation varies depending on the type of certification and structure of the organization being evaluated. Contact us to find out more about your project!

What is the validity of the Certificate of Conformity?

The ISO 13485 or ISO 9001 Certificate of Conformity is valid for three years. Annual maintenance audits are required to ensure continued compliance with the applicable standard requirements. After three years, the company must undergo a new recertification audit to renew the certificate.

CLEAR YOUR DOUBTS AND REQUEST A PROPOSAL

Quality Management
Systems Certification

ISO 13485
Quality of medical devices

ISO 13485
Quality of medical devices

ISO 9001
Quality Management Systems

ISO 9001
Quality Management Systems

BENEFITS OF THE CERTIFICATION

STEPS OF THE CERTIFICATION PROCESS

STEPS OF THE CERTIFICATION PROCESS

CERTIFICATES ISSUED BY QC CERT

FAQ

CLEAR YOUR DOUBTS AND REQUEST A PROPOSAL

Address

Telephone

E-mail

Quality ManagementSystems Certification

ISO 13485Quality of medical devices

ISO 13485Quality of medical devices

ISO 9001Quality Management Systems

ISO 9001Quality Management Systems

BENEFITS OF THE CERTIFICATION

STEPS OF THE CERTIFICATION PROCESS

STEPS OF THE CERTIFICATION PROCESS

CERTIFICATES ISSUED BY QC CERT

FAQ

CLEAR YOUR DOUBTS AND REQUEST A PROPOSAL

Address

Telephone

E-mail

Quality Management
Systems Certification

ISO 13485
Quality of medical devices

ISO 13485
Quality of medical devices

ISO 9001
Quality Management Systems

ISO 9001
Quality Management Systems