En Iso 13485 2016 Pdf

Medical devices. Quality management systems. Requirements for regulatory purposes

ISO are granted a three-year transition period to migrate to the new edition of the standard. After this time, if you wish to obtain third-party valida - tion, you will have to seek certi - fication to the new version. For more details about transitioning to ISO, talk to your certification body. ISO 13485 Third edition 2016-03-01 Reference number ISO (E) Licensed to Red Star Contract Mfg / Barry Leffers (barry@redstarcontractmfg.com) ISO Store Order: OP-125087 / Downloaded: 2016-02-29 Single user licence only, copying and networking prohibited. Sommario: ISO 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. ISO 13485 Third edition 2016-03-01 Reference number ISO (E) Licensed to Red Star Contract Mfg / Barry Leffers (barry@redstarcontractmfg.com) ISO Store Order: OP-125087 / Downloaded: 2016-02-29 Single user licence only, copying and networking prohibited.

ISO 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.

This is the internationally recognized quality management system (QMS) standard for the medical device industry. It has more than 27,000 accreditations worldwide. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose.

It can be used by any organization involved in one or more stages of the lifecycle of a medical device, including:

• Design and development
• Production
• Storage and distribution
• Installation or servicing
• Final decommissioning
• Design, development or provision of associated activities (such as technical support)

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

ISO 13485:2016 can be used to test an organization’s ability to meet both customer and regulatory requirements. Certification is not a requirement and organizations can reap the benefits of the standard without being certified.

Its use shows a commitment to quality, however, and users will be able to:

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of quality management system practices that consistently yield safe and effective medical device s
• Manage risk effectively
• Improve processes and efficiencies
• Gain a competitive advantage

What’s changed since the last update?

This revision ensures that the standard provides a quality management system that’s kept up with the evolving directives and other international regulatory changes that have occurred since 2003. Some of the key changes include:

• Harmonization of regulatory requirements
• Inclusion of risk management throughout the quality management system
• Additional clarity with regard to validation, verification and design activities
• Strengthening of supplier control processes
• Increased focus regarding feedback mechanisms
• Harmonization of the requirements for software validation for different software applications

This standard BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes is classified in these ICS categories:

• 03.120.10 Quality management and quality assurance
• 11.040.01 Medical equipment in general

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.

ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

The current ISO 13485 edition was published on 1 March 2016.^[1]

Background[edit]

Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.^[2]

Reason for use[edit]

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.^[3]

Other specific differences include:

Iso 13485 2016 Free Download

• the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
• controls in the work environment to ensure product safety
• focus on risk management activities and design control activities during product development
• specific requirements for inspection and traceability for implantable devices
• specific requirements for documentation and validation of processes for sterile medical devices
• specific requirements for verification of the effectiveness of corrective and preventive actions

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971.^[4] Although the European Union Directives do not mandate certification to ISO 9001 and/or ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certifying organizations known as 'Registrars'. Several registrars also act as Notified Body. For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s).

This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.^[5]

En Iso 13485 And 2016 And Pdf

ISO 13485 is now considered to be inline standard and requirement for medical devices even with 'Global Harmonization Task Force Guidelines' (GHTF).^[6] The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices. The GHTF has been replaced in the last few years by the International Medical Device Regulatory Forum (IMDRF)^[7] and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system (regulators & non-regulators were equal in voting rights) that worked reasonably well, but somewhat slow.

This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC.^[8]

Mexico published in October 11, 2012 a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados a la Fabricación de Dispositivos Médicos.^[9] The scope of application is mandatory in the national territory, for all establishments dedicated to the process of medical devices marketed in the country. The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This standard is partially in line with ISO 13485: 2003 and ISO 9001: 2008.

In 2017, The Farmacopea de los Estados Unidos Mexicanos (United Mexican States Pharmacopoeia), medical industrial sectors and Cofepris are working together for updating NOM-241 Standard, putting special attention on managing risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes. This standard will be published in August 2018, and 180 days after publication it will become mandatory for the industry.

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.

Chronology[edit]

Bs En Iso 13485 2016 Pdf

See also[edit]

References[edit]

1. ^'ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes'. www.iso.org. Retrieved 2016-03-24.
2. ^'IATF 16949:2016 Automotive Quality Management System - BSI America - BSI America'. www.bsiamerica.com.
3. ^'Understanding ISO 13485'.
4. ^'ISO 9001'.
5. ^'Summary list of titles and references of harmonised standards related to medical devices - DG Enterprise & Industry. European Commission'. Archived from the original on 2009-02-01.
6. ^'GHTF is no longer in operation'. www.ghtf.org.
7. ^'International Medical Device Regulators Forum'. www.imdrf.org.
8. ^'CENELEC - Standards Development - List of Technical Bodies -'. www.cenelec.eu.
9. ^'NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos'. www.dof.gob.mx. Retrieved 19 October 2017.

External links[edit]

Bs En Iso 13485:2016 Pdf

• CFR - Code of Federal Regulations Title 21, Food and Drug Administration's Quality System Regulation

Iso 13485 2016 Pdf Download