One large sector of the
economy is the medical industry. To help individuals combat unusual health
conditions and live comfortable, simple lives, the medical industry sector is
the next large rising market globally.
Quality and safety are
paramount when it comes to medical devices. To ensure that their products fulfil
the legal and quality requirements, manufacturers and suppliers adhere to
severe restrictions. Medical device QMS (quality management system) is one area
covered by the ISO 13485 standard.
ISO 13485:2016
Certification: What Is It?
For medical equipment, ISO 13485 is the main
Quality Management System (QMS) standard; other countries have their regulations.
In the United States, the FDA's (Food and Drug Administration) rules for
medical devices are in line with ISO 13485. The most recent version, ISO
13485:2016, was published in March 2016.
ISO 13485:2016 addresses every stage of a
medical device's life cycle, including development, manufacturing,
distribution, storage, installation, and servicing. Providing associated
services like technical support or designing and creating is also included.
ISO 13485: A QMS-Based Specialized Standard
for Medical Devices
A quality management system (QMS) is used by
an organization to plan, implement, monitor, and enhance performance to achieve
its objectives. Policies, practices, procedures, processes, and resources are
gathered into QMS standards. It benefits a company in the following ways:
·
With the
use of a QMS based on ISO 13485:2016, it creates a methodical and consistent
approach to managing its operations.
·
It
demonstrates the company's ability to provide linked services and dependable,
safe medical equipment.
·
Customers
are happier because it satisfies their requirements and expectations.
·
It aids
organizations in identifying and seizing opportunities and risks.
·
It
continuously improves the QMS and overall performance of an organization.
·
It
facilitates people's access to the market and complies with pertinent legal
requirements.
Medical Device Industry Importance of ISO
13485 Certification
An organization should adhere to the ISO
13485:2016 standard for the following reasons:
·
The safety
and effectiveness of medical devices and related services are improved by ISO
13485. A methodical strategy for implementing suitable quality control and
continuous improvement is also provided by the certification for organizations.
·
Organizations
can comply with pertinent international and regulatory requirements about
medical devices by using the ISO 13485 standard. The standard moreover offers
an extensive framework that helps organizations comply with regulations and
facilitates audits and inspections.
What are the 5 Key Elements of ISO 13485
Standard?
These are the 5 pillars of ISO 13485
certification for Medical Devices- Quality Management Systems are as follows.
§ Quality Management System
§ Management Responsibilities
§ Resource Management
§ Product Realization
§ Measuring, Analysis and Enhancement
What are the Similarities Between ISO 9001 and
ISO 13485?
Medical devices – QMS systems
- Requirements for regulatory purposes are the specifications that medical
device manufacturers need to include in their ISO
13485 documents or
management systems to comply with the QMS for the manufacturing of medical
devices.
§ Businesses can implement a quality management
system with the assistance of ISO 9001 and 13485 standards.
§ To reduce potential dangers and errors in the
management system, the two standards emphasize the importance of undertaking
risk assessments.
§ To manufacture high-quality products, an
organization must discover mistakes and inadequacies in its business
operations, according to ISO 9001 and 13485 standards.
§ The Plan-Do-Check-Act (PDCA) cycle is a useful
tool for implementing the continuous improvement principle. It is used in ISO
9001 and 13485 standards.
§ Both standards are focus on the infrastructure
and competency for delivering products.
For medical device quality
management systems, organizations have to abide by ISO certification
13485:2016. To provide safe and effective medical equipment and guarantee the
safety and well-being of its clients, the organization can establish and
maintain a strong quality management system thanks to the criteria of ISO
13485. Organizations can demonstrate a commitment to reaching the intended
goals and objectives, lower risks, and increase customer satisfaction.
Source
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