Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

ISO 13485

Medical devices industry has certain non-negotiable policies especially when it comes to safety and quality of the product. With the regulatory requirements getting stringent at every step of a medical product’s life cycle from manufacturing till delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

What is ISO 13485:2016 Certification?

ISO 9001:2015 is designed to specify requirements for a quality management system wherein an organization needs:

  • To show its ability to provide medical devices & the relevant services that can consistently meet the customer requirements while complying with applicable statutory & regulatory standards.
  • To focus on customer safety by ensuring that the products they deliver fulfills the safety requirements while assuring the conformity of products based on the function it is intended to serve.

All the requirements specified under ISO 13485:2016 are specific. This certification can be used by suppliers or external parties who are in medical devices business, including the ones providing services related to the quality management system.

What are the benefits of having ISO 13485:2016 Certified QMS Software?

Some of the benefits of having ISO 13485:2016 Certified QMS Software:

Qualityze Solution Information Matrix for ISO 13485

Qualityze quality management software for medical devices is designed to help an organization to comply with 13485 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Requirements Section Description Qualityze Modules
Section 4: General Requirements: Quality Management System Provides requirements for the overall Quality Management System from quality manual documentation to the control of documents and records.

Document Management

Change Management

Section 5: Management Responsibility Provides requirements for Management’s role and commitment in the QMS.

NC/Complaints Management

CAPA Management

Change Management

Document Management

Audit Management

Training Management

Section 6: Resource Management Provides the guidelines for resources to perform the job competently and in safety.

Document Management

Training Management

Section 7: Product Realization Provides the guidelines for customer related processes, design and development and purchasing

NC/Complaints Management

CAPA Management

Document Management

Audit Management

Section 8: Measurement, Analysis and Improvement Gives ISO requirements on monitoring processes and improving those processes such as customer satisfaction, internal audit, control of Non-Conforming Product, Corrective and Preventive Action (CAPA) and
continual improvement

NC/Complaints Management

CAPA Management

Document Management

Audit Management

Dashboard & Reports

eQMS Suite & User Portal