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.

21 CFR 820

Managing the quality processes in the medical devices industry is getting tough with the standards going stringent and involvement of technology. Once the medical device companies comply with the standards of ISO 13485. The next immediate step they need is to adopt FDA 21CFR Part 820. Only then, they get an opportunity to market the medical devices commercially in the U.S.

What is 21 CFR 820 Certification?

The 21 CFR 820, also referred as Quality System Regulations (QSR), took effect on June 1, 1997, to provide a framework of a basic minimum requirement for manufacturers to establish an Enterprise Quality Management System (QMS).

FDA 21 CFR Part 820 specifies the requirements for the quality system to meet FDA regulations, commonly referred to as cGMP (current good manufacturing practices). It shares some similarities with ISO 13485 especially when it comes to the requirements for the quality system. It includes other parts as well like

  • Part 810 – It specifically deals with the recall procedure of medical device(s)
  • Part 830 – It deals with unique device identification of medical devices.

FDA 21 CFR Part 820 enables organizations to;

  • Align their documentation structure, which is merely an external condition by U.S. govt., for standardized processes and workflows.
  • Commercially distribute their devices on a larger scale.

All the requirements defined under 21 CFR 820 are quite generic. This certification matters for attaining compliance while ISO 13485 helps to attain the state of conformance.

What are the benefits of having 21 CFR 820 Certified QMS Software?

Some of the benefits of having 21 CFR 820 Certified QMS Software:

Qualityze Solution Information Matrix for 21 CFR 820

Qualityze eQMS is designed to help an organization to comply with 21 CFR 820. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Requirements Section Description Qualityze Modules
820.20 Management Responsibility Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.

Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.

Quality system procedures. Each manufacturer shall establish quality system procedures and instructions.

Change Management

Document Management

Dashboard & Reports

EQMS Suite & User Portal

820.22 Quality Audit Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.

Change Management

Document management

Training Management

Audit Management

820.25 Personnel  Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

Document Management

Training Management

 

820.40 Document controls Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. Each manufacturer shall maintain records of changes to documents.

Change Management

Document Management

820.90 Non-Conforming Product Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.

Nonconformance Management

CAPA Management Software

Document Management

Training Management

820.100 Corrective and Preventive Action Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. All activities required under this section, and their results, shall be documented.

CAPA Management

Document Management

Training Management

820.180 General requirements All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer

Change Management

Nonconformance Management

CAPA Management

Document Management

Training Management

Audit Management

Supplier Management

Complaint Management

820.198 Complaint Files Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

CAPA Management

Document Management

Training Management