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The ISO 13485 standard specifies requirements especially to improve the quality of medical devices and equipment.

The ISO 13485 standard specifies requirements especially to improve the quality of medical devices and equipment. This standard has a similar connection to ISO 9001. But the main difference is that ISO 9001 provides requirements to improve the Organization's Quality Management System, while ISO 13485 includes requirements to develop the quality of medical devices and equipment.

It also presents guidelines for manufacturers to reduce risks in the manufacturing process and improve product quality and management system performance. Additionally, ISO 13485 helps organizations drive improvements in the manufacturing, installation, and maintenance process.

About ISO 13485 certification and its importance

ISO 13485 certification is a representation of the organization that has well-designed medical devices and equipment. This Quality Management System certification ensures employee safety and improves customer satisfaction. It promises consistency in product quality and develops organizational competencies. In addition, ISO 13485 certification promotes business and brings global recognition to the organization.

Integrated Assessment Services (IAS) is an ISO 13485 certification body accredited by UQAS. We are a versatile platform for auditing and issuing ISO management system certifications across numerous ISO standards and product certifications.

ISO 13485 in Mexico

“ISO 13485 Mexico” is sought after by organizations that want to be certified in Mexico against this standard and people seeking training and certification in the field are also looking for ISO 13485 in Mexico.

Training on ISO 13485 in Mexico

It is essential that all companies seeking ISO 13485 Certification in Mexico train and know the implementation of MD-QMS. Individuals, too, can enhance their skills by applying their experience to put MD-QMS into practice for training, allowing them to earn ISO 13485 certification in Mexico.

Our goal is to provide the best training for ISO 13485 in Mexico, with real-time professionals and specialists who can teach you about all the concepts related to the risk assessment of medical devices, combinations, etc.

IAS provides ISO 13485 Lead Auditor Training, ISO 13485 Internal Auditor Training. For more information about ISO 13485 Training contact: investigacióncertiascertificació

ISO 13485 certification in Mexico

IAS certifies organizations with ISO 13485 certification in Mexico based on the results of the audit of the ISO 13485 system implemented in the organization. Our ISO 13485 certification audits are carried out by experienced and qualified auditors.

ISO 13485 certification

ISO 134850 certification enhances customer confidence in your business process and management system. This internationally recognized certification guarantees continuous improvement of the quality management system for medical devices. Protect your organization's reputation and promote your business globally. Additionally, ISO 13485 certification in Mexico increases stakeholder confidence and increases new business opportunities.

Benefits of ISO 13485 certification

ISO 13485 certification offers the following benefits to the organization.

Admission to new markets: Healthcare regulators and standards bodies around the world require an ISO 13485:2003 certified organization before they will accept your medical equipment or devices. The main reason is that it guarantees a high level of quality and safety for patients and healthcare professionals. It also ensures consistent product performance, reliable supply and improved patient outcomes.

Production process improvement: Although ISO 9001 and ISO 13485 focus on different elements, they share a similar connection. ISO 9001 focuses on the organization's Quality Management System, while ISO 13485 standardizes requirements for apparatus and equipment manufacturers to improve their production process and reduce risks.

Quality-oriented services and more business opportunities: Healthcare organizations pay more attention to quality-based services than traditional service providers. This act helps the organization stay ahead of the competition and reach new markets.

Improving customer satisfaction: The main objective of ISO 13485 is to reduce customer dissatisfaction by improving product quality, reducing risks, increasing productivity and improving organizational performance. This standard offers manufacturers numerous ways to improve marketing strategies, customer service, and product performance. By promoting confidence in the market, it improves customer satisfaction.

Quality system approach: The organization must have a complete understanding of ISO 13485 before requesting an audit. They must develop risk-based procedures to manage their daily operations. This helps prevent issues and achieve the highest level of customer satisfaction.

Risks associated with non-compliance: An organization may face legal and financial consequences if they do not comply with ISO 13485 requirements. Although most healthcare professionals understand its importance, many organizations do not comply with the requirements of this standard.

ISO 13485 certification is a must: Understating ISO 9001:2015 and 13485:2016 allow organizations to identify areas where improvements can be made to their Quality Management System. It helps identify critical areas for improvement in areas such as product quality, risk management, customer service, and regulatory issues.