ISO 13485 (Medical Devices - Quality Management Systems)
ISO 13485 Certification with National Accreditation of United Kingdom saving you the most cherished of resources – time & money
ISO 13485 (Medical Devices - QMS)
ISO 13485 contains the requirements of ISO 9001 plus additional medical device industry requirements. ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. It can also be used to assess the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.
CBs applying for ISO 13485 accreditation must conform to ISO/IEC 17021-1. ISO 13485 is a base standard program in Schedule.The convenient, effective and affordable way to manage your ISO 9001: 2015 transition.
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ISO 13485:2016 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world. Certification to ISO 13485 requires its quality system to pass a 3rd party MDSAP audit.
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.
ISO 13485 = ISO 9001 + Additional Medical Device Requirements
ISO 13485:2016 is the latest, and most current version of ISO 13485, (learn about the differences here). While it remains a stand-alone document, the latest version aligns with ISO 9001:2008 (Yes, 2008, not 2015). Meaning that 13485 does not follow the high level structure (Annex SL) of the latest version, ISO 9001:2015. (See ISO 9001:2015+13485:2016 QMS) There are some additional clauses as well as the removal of some requirements.
There are many different stages of medical device development from design and development to distribution and servicing, and this standard was developed to be used in organizations no matter what their role in the life-cycle.
ISO 13845:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products.
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, they apply equally to associated services as supplied by the organization. The requirements may vary based upon the class of medical device – from a wheelchair to a pacemaker.
How to comply With regulatory Requirements
ISO 13485:2016 covers regulatory requirements in the same breath as customer requirements right from the start. Clause 0.2 Clarification of Concept states: “When the term ‘regulatory requirements’ is used, it encompasses requirements contained in any law applicable to the user of this International Standard (e.g. statutes, regulations, ordinances or directives). The application of the term ‘regulatory requirements’ is limited to requirements.”
The reason for this is the impact that regulatory requirements have on an organization’s ability to provide its products or services. The standard requires the organization to determine which regulatory requirements are relevant to its Quality Management System (QMS), and the effects they can have on the QMS.
In some countries, Acts or Directives regulate the provision of medical devices and services. One such Directive is the European Commission’s Medical Device Directive (Council Directive 93/42/EEC), which sets requirements related to expected levels of durability and performance in medical devices in Europe. Like the regulatory requirements mentioned above, there can be high costs associated with failure to comply with Acts and Directives.
Correlation between regulatory requirements and ISO 13485
Certification according to ISO 13485, as with any other international standard, shows stakeholders and interested parties that an organization goes over and above applicable legal requirements, holding itself to a higher standard. A company cannot be compliant with the standard if it does not meet regulatory requirements.
ISO 13485:2016 includes a handful of requirements that deal with the knowledge you should have gained while identifying applicable regulatory requirements. After all, you will have to understand such requirements in order to carry out your QMS processes properly.
A properly planned QMS includes
The first step along your path of ISO 13485 implementation, and becoming more competitive in your market, is understanding and complying with regulatory requirements. By doing so, your company will be well equipped to provide safe products and services, and prevent the problems (and penalties) associated with noncompliance. The ISO 13485:2016 standard gives you a solid foundation for identifying applicable regulatory requirements, and assessing your organization’s level of compliance. Now, that’s in everyone’s best interest.
Why do I need to demonstrate my core Stage 1 Health and Safety competence?
Clients with duties under CDM 2007 must satisfy themselves that the businesses they engage or appoint are competent. This means that they must make reasonable enquiries to check that the organisation or individual has an appropriate Health and Safety management system in place and is competent to do the relevant work.
How long will the 13485 Certificate last?
The Certificate will last for 36 months from the date of assessment. For more information contact info@isonauk.co.uk.
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