ISO 13485 2016 Plain English Introduction


ISO 13485 2016 is a quality management standard for
medical devices. It defines a set of quality management
requirements. These requirements can be found in
the following five sections:

  1. Systemic requirements

  2. Management requirements

  3. Resource requirements

  4. Realization requirements

  5. Remedial requirements

The purpose of this quality management standard is to help
both medical device suppliers and service providers to meet both
customer expectations and regulatory requirements. According
to ISO 13485 2016, any medical device supplier or service provider
can achieve these objectives if it establishes a quality management
system (QMS) and if it continually tries to improve the suitability,
adequacy, and effectiveness of this system.

ISO 13485 2016 is based on the ISO 9001 2008 standard. Both
standards are organized in the same way and use much the same
numbering system. In addition, many of the ISO 13485 requirements
are taken directly from ISO 9001 without modification. However, some
ISO 9001 requirements were modified and others were excluded.
And, of course, ISO 13485 2016 also includes an extensive set of
requirements specifically related to medical devices.

In general, the new ISO 13485 standard is more flexible than
the old. In the past, organizations could only exclude section 7
requirements. Now, organizations may exclude any requirement
in sections 6, 7, or 8 if they can justify doing so because of the
nature of their activities or products and if doing so does not
undermine regulatory compliance. The new standard also says
that organizations may exclude “design and development
if regulations permit them to do so and may
refer to these regulations to justify their decisions.


ISO 13485 2016 applies to medical device suppliers and medical
device service providers of all kinds. It applies to organizations
that participate in one or more stages of the product life-cycle.
It applies to organizations that design, develop, produce, store,
distribute, install, or service medical devices and to organizations
that design, develop, or provide related medical device support
service activities. It may also apply to external suppliers that
provide products or services to these organizations. These
external suppliers may choose to comply with the standard
or be contractually obligated to do so.

Regulatory bodies often expect organizations to define the
roles they play in the medical device supply chain. You may, for
example, be expected to specify whether you're a manufacturer,
an importer, a distributor, a representative, a developer, or a
designer of medical devices. Because of this, ISO 13485 2016
expects you to identify the roles you play, the regulatory
requirements that apply in your case, and to build these
requirements into your organization's QMS.

HOW TO USE ISO 13485 2016

Use ISO 13485 2016 to develop a quality management system for
medical devices and related services and then use this system to:

  • Show that your organization is consistently capable
    of providing medical device products and services that
    meet customer requirements and comply with all relevant
    regulatory requirements.

  • Assess your organization's ability to consistently provide
    medical device products and services that meet customer
    requirements and comply with all relevant regulatory

You can also use ISO 13485 2016 to get certified. Once you’ve
established a QMS that complies with the ISO 13485 standard, you
can ask a registrar (certification body) to audit your system. If you
pass the audit, your registrar will issue an official certificate that
states that your QMS complies with the ISO 13485 standard.

How you choose to meet the ISO 13485 2016 requirements, and
to what extent, will depend on and be influenced by many factors.
It will depend on your organization’s environment, its structure,
its compliance obligations, its activities and processes, its size and
complexity, its needs and objectives, and its products and services;
and will be influenced by its many risks, threats, and opportunities.
Consequently, quality management systems can vary quite a bit.

In fact, ISO 13485 2016 section 0.1 explicitly states that “It is not the
intent of this International Standard to imply the need for uniformity in
structure of different quality management systems, uniformity of
documentation or alignment of documentation to the clause structure
of this International Standard.”
ISO 13485 expects you to establish
a QMS that is unique to your organization and its circumstances.
It does not want all organizations to structure their QMS or
their documentation in the same way.

MORE ISO 13485 2016 PAGES

Outline of ISO 13485 2016 Standard

Overview 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

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

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