ISO 13485 Prerequisites Top Medical Device Quality Management Standard: FAQ

A medical device can be as simple as a bedpan or as complex as an individually designed sensor that remotely monitors the functionality of organs in breathing individuals. All medical devices, however, have one thing in common: they all strive to meet the highest level of internationally recognized quality standards when they are created by businesses that adhere to the ISO 13485 medical device quality management standard. The standard is solidifying its stature and ubiquity around the world with the anticipated harmonization of ISO 13485 and 21 CFR Part 820.

A quality management system (QMS) that complies with ISO 13485 Certification regulations does not merely happen if your company is involved in the creation of a medical device. It requires a focused organizational effort, careful planning, and comprehensive comprehension of the work.

What are ISO 13485 Requirements?

All of the ISO 13485 medical device guidelines for maintaining a strong QMS are focused on the secure development, production, and distribution of high-quality medical device goods. The requirement sets forth expectations for the core components of quality management, specifically:

  • The QMS’s basic and documentation standards.
  • Management obligation (in terms of commitment, customer focus, quality policy, planning, responsibility, authority, communication, reviews, etc.).
  • Resource administration (i.e., infrastructure, involvement of human resources, and provision of other resources).
  • Realization of the product, including planning, design/development, buying, manufacturing, controlling equipment, etc.
  • Evaluation, improvement, and measurement.

Device producers who adhere to the ISO 13485 quality system standards for medical devices have a variety of production advantages, including reduced variation. The reduction of scrap and general improvement of quality procedures due to standard compliance also has an economic impact.

What Markets/Regions Are Affected by ISO 13485 Compliance?

Companies in Saudi and near member states are obligated to comply with ISO 13485 requirements in the production of the majority of Medtech products. The standard is adhered to by all 165 members of the International Organization for Standardization (ISO).

Is Compliance With ISO 13485 Requirements Recognized by the FDA?

The standards outlined in the 21 CFR Part 820 – Quality System Regulation serve as the foundation for the U.S. Food and Drug Administration’s (FDA) quality system requirements for medical devices (QSR). However, the organization just unveiled a draught rule that would align Part 820’s criteria with those of ISO 13485.

Device manufacturers seeking to distribute products in regions and markets under FDA supervision must still abide by the regulations as separate regulatory advice is still in force at this time. Device manufacturers who want to sell their goods globally should adhere to Part 820 and ISO 13485 regulations.

What Differs About ISO 9001 Requirements From ISO 13485?

The criteria of ISO 9001, the global benchmark for quality management systems, served as the foundation for ISO 13485. For many Medtech organizations, however, ISO 9001’s broad objectives for customer satisfaction and ongoing improvement may be too subjective or challenging to evaluate. The goal of ISO 13485 is to maintain the efficacy of QMS by focusing on satisfying certain metrics that assess medical device quality management performance.

Two further key distinctions exist between ISO 13485 criteria and those outlined in ISO 9001:

As was already noted, ISO 13485 focuses more emphasis on risk management.

Additional guidelines for documenting procedures are included in ISO 13485.

Who Enforces ISO 13485 Certification Requirements?

The ISO only develops and upholds ISO standards; it is not an enforcement body. An authorized third-party certification body’s audits are used to verify compliance with ISO 13485 regulations. These organizations confirm that the medical device quality management system under audit complies with the standard after a successful audit. The validity of that certification is three years.


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