ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes

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Overview

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The ISO 13485 standard 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

• Design and development or provision of associated activities (e.g. technical support).

 

ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

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Certification to the ISO 13485 Standard

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Since ISO 13485 is based upon ISO 9001 . Some companies are interested in integrating both Quality Management Standards into their business, and therefore it is important to compare ISO 9001:2015 and ISO 13485:2016. From a high-level perspective, the latest version of the above two standards differ in intent, content, and structure.

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The requirements of ISO 13485 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 the standard that are applicable to the organization, but are not performed by the organization, are:

• The responsibility of the organization

• Accounted for in the organization's quality management system, by monitoring, maintaining, and controlling the processes.

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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.

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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.

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Checking that the Quality Management System (QMS) is correctly implemented, and is effective in meeting the set objectives is very important.

• To ensure that the QMS is functioning properly, it is strongly recommended that an organization performs regular internal audits.

 

It is a business decision to:

• Invite an independent certification body (registrar), to verify that the QMS is in conformity to the standard; however, this is not a requirement.

• Invite its clients to audit the QMS for themselves.

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Our Training Courses

 

FabAcademy, provides training in the ISO 13485 standard at four (4) knowledge and competency levels:

• Foundation

• Lead Implementer

• Internal Auditor

• Lead Auditor.

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For specific course details, please follow one of the above links.

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Prerequisites

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The following are general prerequisites for attending our training courses:

• Proficiency in the English language

• Consideration for other course participants

• Willingness to actively participate during the training sessions, and an open mind to learn.

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​Training Delivery Options

 

Although, primarily, we deliver training to corporate clients, we also train small-size (min. 3 delegates) groups of individual learners, who are interested in updating, or upgrading their knowledge and skills, and advancing in their careers. This training is delivered online (virtual classroom) and is instructor-led.

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We do deliver on-site, close group training, as well as online instructor-led training, for corporate/ business clients (B2B).

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Book now to reserve, as applicable, an on-site or online instructor-led training event of your choice.

 

For more details about our:

• List of training courses please click here.

• Consulting services please click here

• Workshops please click here.

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For queries, including non-obligation quotes, please contact us.