ISO 13485 Certification Requirements

The worldwide market of medical devices is consistently extending because of the rising rate of constant illnesses and the developing attention to telemedicine among the overall population. Consistent with the ISO 13485 Standard permits a medical device producer to create and sell protected and excellent medical devices for different purposes.

ISO 13485 Certification: an outline of the most recent modification

ISO 13485 is the worldwide quality management standard for medical devices, given by the International Organization for Standardization (ISO). It depends on the overall quality management standard ISO 9001 (more specifically, on its version ISO 9001:2008) which is industry-independent. ISO 13485 Standard was created and distributed by ISO in 1996 and has been modified a few times from that point forward. The most recent modification of the standard was delivered in March 2016.

ISO 13485:2016 applies to medical device producers who need to change their Quality Management System (QMS) and cycles as per worldwide necessities all through all phases of a medical device life cycle. The stages incorporate the plan, development, production, storage, conveyance, and technical support, and disposal of a medical device.

Also, Check –>> Benefits of ISO 13485:2016

ISO 13485:2016 key requirements

ISO 13485:2016 applies to organizations playing different parts in a medical device production life cycle, irrespective of their size and type (public or private), except if explicitly demonstrated in the text of the standard. The requirements of the standard are likewise applicable to the connected services given by the organization. For instance, if an organization that makes lab magnifying instruments additionally offers the types of assistance of their alignment and fix, the ISO 13485 prerequisites range to the administrations also.

ISO 13485 Certification comprises of eight sections: parts 1-3 are starting, and parts 4-8 depict the obligatory necessities for the medical device makers’ QMS. Let us investigate more about parts 4-8 in more detail.

Section 4. Quality Management System

This segment of the standard sets out the overall necessities for the QMS and its documentation, to be specific, the quality manual and the medical device record.

Section 5. The Management Responsibility

As indicated by this piece of the standard, notwithstanding the execution of the quality management system, the organization chiefs should set up the quality approach and destinations and consistently audit the QMS cycles to recognize inadequacies and fix them.

Section 6. Resources Management

The prerequisites of this part of the standard apply to all assets of an organization, including framework, structures, staff, workplace, and assets required for environment control.

Section 7. Product Realization

As per this piece of the standard, the manufacturing organization needs to satisfy a few significant states of product acknowledgment. In the first place, the maker needs to plan and control such phases of a medical device life cycle as plan and improvement (including the examination of each stage with a sign of its participants and dates), the device check, approval, and the technique for managing changes.

Section 8. Estimation, Analysis, and Improvement

This part of the standard specifies measures and cycles that should be applied to the medical device production cycles to guarantee QMS congruity. It considers the degree of consumer loyalty with the nature of the bought medical device, internal review (e.g., for checking and surveying the cycles of risk management, assessing worker satisfaction with the functioning conditions), and so forth.

The above are the requirements of ISO 13485 Certification. Follow the below steps to acquire ISO 13485 Certification for your organization.

Also, Check –>> ISO 13485 Certification Cost

ISO 13485 Certification process

To make the ISO 13485 Certification process simple and quick. Hiring a consultant will guide you and your business through the following steps to achieve ISO 13485 Certification by providing.

  1. Gap Analysis Training
  2. Testing
  3. Documentation & Test Report
  4. Process Audit
  5. External Audit
  6. Certification and beyond

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