ISO 13485 2016 Overview of Medical Device Standard

 This page provides an overview of the ISO 13485 2016 medical device standard.

Overview of ISO 13485 Medical Device Standard

4. Systemic Requirements

Section 4 provides a general overview of the entire ISO 13485 standard.
The rest of the standard discusses this material in greater detail. It starts
by asking you to establish a quality management system (QMS) that meets
all applicable regulatory requirements and complies with the new ISO 13485
standard. It then asks you to identify and support the processes that your
needs, to specify how they are interconnected, to apply a risk based
approach to them, and to monitor and control any outsourced processes
that could affect product conformity. And finally, it asks you to clarify your
documentation requirements, to establish a file for each family of medical
devices, to prepare a quality manual, to maintain quality records, and to
control all of these documents and records.

5. Management Requirements

Section 5 starts by asking top management to make a commitment to
quality management, to establish a quality policy, to set quality objectives,
and to plan the development of a quality management system (QMS).
It then asks them to define and document all QMS responsibilities and
, to appoint a management representative, and to carry out
management reviews at planned intervals.

6. Resource Requirements

Section 6 asks you to provide the resources that your QMS needs.
It asks you to identify the people and the work that could affect product
safety or performance and then to make sure that all of these people
are competent. It also asks you to provide the infrastructure and the
work environment that you need in order to meet product safety and
performance requirements, to identify your health, cleanliness, and
clothing requirements, and to establish arrangements to control
products that are or may be contaminated.

7. Realization Requirements

Section 7 is the largest section. It asks you to develop product realization
processes and to plan how products will be realized by setting product
quality objectives, by identifying product realization requirements, and
by establishing arrangements for communicating with customers and
regulators. It also asks you to establish your design and development
procedures and to organize your design and development activities.

Section 7 also discusses purchasing and production and service
provision. It asks you to prepare purchase procedures, to control the
selection of suppliers, to monitor supplier performance, to plan product
purchases, and to verify purchased products. It then asks you to plan,
monitor, and control medical device production and service provision, to
define requirements for cleanliness or contamination controls, to specify
product installation and verification requirements, to develop servicing
procedures and reference materials, to validate processes used for
production and service provision, and to facilitate product traceability.

And finally, it asks you to determine your monitoring and measuring
requirements, to select suitable monitoring and measuring equipment,
to establish monitoring and measurement procedures, to prepare
calibration and verification plans, and to protect your monitoring
and measurement equipment.

8. Remedial Requirements

Section 8 starts by asking you to plan how your organizationís
monitoring, measurement, and analytical processes will be used
to ensure conformity and effectiveness. It then asks you to establish
feedback methods and procedures, and to investigate complaints, take
action, and report results. It also asks you to plan and perform internal
audits, to find out whether processes are achieving planned results, to
monitor and measure medical device characteristics, and to prevent
the unintended delivery or use of nonconforming products.

Then it asks you to analyze data about your organizationís QMS in order
to evaluate its suitability and effectiveness. And finally, it asks you to take
corrective and preventive action and to make any changes that must be
made in order to maintain QMS suitability and effectiveness and ensure
product safety and performance.


Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Checklist

ISO 13485 2016 Quality Management Gap Analysis

Updated on April 17, 2021. First published on June 30, 2015.

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