ISO 13485 Standard

Quality / Regulatory Management Systems

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s).

The FDA has identified in the QS regulation the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices.

Medical device RA/QA training from QSG delivers the skills and knowledge you need to comply with global requirements and improve your organization’s performance. QSG offers a complete medical device regulatory affairs and quality assurance (RA/QA) consulting and training curriculum. Our courses cover the key medical device sector regulations and show students how to develop processes that satisfy these requirements.

ISO 13485:2016

ISO 13485 is the most common medical device QMS regulatory standard in the world. It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets. The guidelines for maintaining effective quality management processes outlined in ISO 13485 are all geared toward the safe design, manufacture and distribution of effective medical devices. In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation. This in turn provides economic benefits in the form of reduced scrap and general process efficiencies.

FDA QSR (21 CFR Part 820)
The FDA’s QSR is structured differently than ISO 13485 but they have no conflicting requirements. And because the QSR is a regulation, it is often more specific than ISO 13485. For instance, the QSR has more detailed requirements in the areas of complaint handling and reporting requirements. Therefore, conformity to ISO 13485 does not sufficiently demonstrate to the FDA that a manufacturer is in full compliance with the QSR.
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are participating in the MDSAP include:
  • Therapeutic Goods Administration of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
  • U.S. Food and Drug Administration
QSG can support your organization with the following FDA Quality Systems Regulations services:
  • Conduct a gap assessment of all SOPs and processes with an eye toward risk
  • Develop and implement a comprehensive risk assessment program
  • Ensure employees are fully competent in the MDSAP requirements
  • Perform a preliminary preparatory audit by experienced third party consultants

Designed to facilitate and enhance the dialogue among medical device professionals from both the manufacturing and regulatory environments, QSG’s comprehensive and interactive FDA Quality Systems Regulations training programs provide a unique learning experience for quality assurance/regulatory affairs professionals: design, human factors, process, and software engineers; risk management managers; process owners of CAPA or supplier/purchasing activities; document control specialist; compliance officers; and standards application managers.

QSG’s offerings include:

Design Controls Requirements And Implementation
EU Regulation 2017/745 – Technical Documentation of Medical Devices & Impact on the EUDAMED database
FDA Regulatory Approval Process Workshop
FDA Mock Audits (QSIT Audit) Workshop
GDP Good Documentation Practices
GMP Compliance, Regulatory Affairs & Validation Consulting and Training
ISO 13485:2016 Requirements Workshop

ISO 13485:2016 Internal Auditing
ISO 13485:2016 Lead Auditor Training
ISO 14971:2019 Risk Management Requirements Workshop
Process and Software Validation
Process Validation: Principles and Protocols
Process Validation for the Medical Device and Pharmaceutical Industries
Purchasing Controls Introduction
Software Development for Medical Device Manufacturers

In addition, QSG can support your organization with Risk Management , Change Control Program,  FDA 483 Response Support, Process Validation, and 510(k) submissions.

Follow QSG on LinkedIn!
Become a QSG Member today!

Always Keep Improving!