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Vsevolod Chernov
Vsevolod Chernov

ISO 13485:2016


All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.




ISO 13485:2016



ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.


Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.


The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.


If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.


If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.


In Spain, medical devices are named in ISO-13485 as "Sanitary Products" as Castellano-language translation of ISO-13485, but in Mexico they are known as "Medical Devices" and correspond to those used in medical practice and that meet the definition established by NOM-241 as: Medical device, to the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its proper use or application), used alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes. Medical devices include products of the following categories: medical equipment, prostheses, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products.ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.


ISO 13485:2016 is very much a bridge. What I mean is that this bridge explicitly describes and defines current QMS expectations for medical device companies. Prior to these refinements being formally defined and documented in the standard, many of the best practices being advised and adopted were very ad hoc in nature and often seemed to be based on auditor opinions.


The common approach for satisfying the guidelines of ISO 13485:2016 for a quality manual is creating a lengthy policy-level document that breaks down various sections of the standard and describes from a high-level how the medical device company addresses the clauses. This approach is fine.


The guidelines in ISO 13485:2016 for product realization includes resources and processes required for defining customer needs, design and development, purchasing, production, and field support. From a high-level, product realization includes:


Validation also applies when you use software in production, installation, and servicing activities. This software should be validated prior to initial use. The depth and detail for software validation under ISO 13485:2016 needs to be risk-based. Be sure to document the rationale and validation approach.


ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system, and how to demonstrate compliance to meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Estimated to take up to 15-hours to complete.


While ISO 13485:2016 remains a stand-alone document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.) This is because it does not follow the high-level structure (Annex L) of the latest version of ISO 9001 (which is 9001:2015). In addition, the documentation and safety requirements are much greater under ISO 13485:2016, whereas ISO 9001:2015 puts focus on customer satisfaction and continuous improvement.


ISO 13485 is the main Quality Management System (QMS) standard for medical devices, although several countries have their own set of regulations. As an example, the United States plans to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485. The scope of the QMS can be tailored for an organization, particularly in Section 7. The current version is ISO 13485:2016, which was published in March of 2016 (thus the: 2016).


This document was published after the 2007 release of ISO 9001, making only minor adjustments. At the time, there were not enough adjustments to justify a new revision of the standard, but in 2016 ISO released a new revised standard ISO 13485:2016.


ISO 13485 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices. ISO 13485 was first published in 1996 and has since been revised in 2003 and 2016. The current version, ISO 13485:2016, came into effect in March 2016. The aim of these requirements is to ensure that medical devices and services consistently meet customer expectations and relevant regulatory requirements.


MDR (Medical Device Reporting) should include events and annual reports as detailed under FDA CFR 803.17 and ISO 13485:2016. 9 steps to prepare for ISO 13485 certification 16 Written procedures and systems are critical for compliance with record-keeping guidelines for MDR.


While ISO 9001:2015 covers a broad range of businesses and industries, ISO 13485:2016 has a narrower focus on the medical device industry. By adhering to the guidelines set out in ISO 13485:2016, your organization can enjoy several benefits, including:


ISO 13485:2016 is the latest edition of ISO 13485, which, as we know is the principal international QMS (Quality Management System) standard for medical devices companies. All medical device companies wishing to sell their devices in the European Union (EU) must pass an ISO 13485:2016 audit that is conducted by a Notified Body.


All medical device companies that sell their products in the EU must pass an ISO 13485 audit that is conducted by a Notified Body. As a medical device company, you will need to pass the ISO 13485:2016 certification audit and acquire the CE mark before you can sell your products in the EU.


On the other hand, if you are planning to sell your medical devices in the EU, you need to conform to the standards defined by ISO 13485:2016. If you do not get an ISO 13485:2016 audit done, you cannot sell your products in certain international markets.


As per ISO 13485:2016 requirements, you will perform regular internal audits to appraise conformity, identify areas for improvement, and check the effectiveness of your QMS. Your company needs to have a formal internal audit program in place and meticulously document all policies, protocols, and records of internal audits done.


A certification audit is conducted by a selected registrar to verify that you are conforming with the ISO 13485:2016 standard before you are issued with the official ISO 13485:2016 certificate.


The off-site review of all your quality documentation will determine whether or not your QMS conforms to all necessary requirements for ISO 13485:2016. The Notified Body not only will check every QMS document, but will also check that all QMS procedures and protocols are in place throughout the lifecycle of the product. 041b061a72


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