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ISO 13485ISO 13485Quality managementfor medical devices
ISO 13485ISO 13485, Medical devices –Quality management systems –Requirements for regulatorypurposes, is an internationallyagreed standard that sets outthe requirements for a qualitymanagement system specificto the medical devices industry.
It is designed to be used by organizations throughoutthe life cycle of a medical device, from initial conception to production and post-production, including finaldecommission and disposal. It also covers aspects suchas storage, distribution, installation and servicing, andthe provision of associated services.In addition, the standard can be used by other internaland external parties, such as certification bodies, to helpthem with their certification processes, or by supply chainorganizations that are required by contract to conform.ISO 13485 helps an organization design a quality man-agement system that establishes and maintains theeffectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effectiveproducts to market.ISO 13485, Medical devices –1
What is amedical device ?A medical device is an instrument,apparatus, implement, machine,implant, in vitro reagent, or othersimilar article, that is intended foruse in the diagnosis, prevention andtreatment of disease or other medical conditions.There is a huge variety of medical devices, ranging from basichand tools to complex computercontrolled machines. These includesimple devices like wound dressingsand scalpels ; durable devices likewheelchairs and dentist chairs ;implantable devices like cardiacpacemakers and monitors, prosthetic limbs and prosthetic joints ;life-supporting devices like respirators and lung ventilators ; sophisticated, software-controlled deviceslike CT scanners and MRI machines ;and in vitro diagnostic reagents andtest kits.2 – ISO 13485, Medical devices
What is a qualitymanagement system ?A quality management system (QMS) is aset of policies, processes and proceduresthat help an organization meet the requirements expected by its stakeholders. It isbased on the Plan-Do-Check-Act cycle, afour-step management method used inbusiness for the control and continualimprovement of processes and products.In the medical devices industry, a QMS isrequired by regulators in most countries.ISO 13485 enables an organization to con-sistently provide safe and effective medicaldevices and fulfil customer and regulatoryrequirements. It is also flexible enough tomeet the individual needs of different typesof medical devices organizations.Regulations differ widely from one countryto another. For this reason, ISO 13485 doesnot set detailed requirements, but asks amedical devices organization to identifythose regulatory requirements that arerelevant to its individual situation andincorporate them into its QMS. Moreover,the standard is compatible with an organization’s other management systems.ISO 13485, Medical devices –3
What benefits will it bringto my organization ?Safety and performance of medical devices are paramount in this highly regulated industry ; this is why quality management systems are a regulatory orlegal requirement in many countries. ISO 13485 can help organizations involvedin any part of a medical device’s life cycle : Demonstrate compliance withregulatory and legal requirementsEnsure the establishment of QMSpractices that consistently yieldsafe and effective medical devices Manage risk effectivelyImprove processes andefficiencies as necessaryGain a competitive advantage
Why was ISO 13485 revised ?All ISO standards are reviewed and revised regularlyto make sure they remain relevant to the marketplace.ISO 13485:2016 responds to the latest QMS practices,reflecting the evolution in medical device technologyand changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards,including the new edition of ISO 9001.
What are the key improvements ?The new version of ISO 13485 places greater emphasis on risk management and risk-based decision making for processes outside therealm of product realization. The focus is on risks associated withthe safety and performance of medical devices and compliance withregulatory requirements. In addition, the standard asks organizationsto be more stringent when it comes to outsourcing processes by putting into place controls, such as written agreements, for assessingtheir suppliers – again based on risk.6 – ISO 13485, Medical devices
ISO 13485 also reflects the increased regulatory require-ments for organizations across the medical devices supply chain, namely : A greater emphasis on appropriate infrastructure,particularly for the production of sterile medicaldevices, and additional requirements for the validation of sterile barrier properties Increased alignment with regulatory requirementsand, in particular, regulatory documentation More focus on post-market activities, includingcomplaint handling and regulatory reporting Broadening of the standard’s application to encompass organizations that interact with the medicaldevices manufacturer, including those involved in : Design and development or repair and maintenance of medical devices Supply of raw materials, components orsubassemblies Performance of services such as contract manufacture, sterilization, logistics or calibration ofmeasurement equipment Import or distribution of medical devices Additional requirements in the design and development of medical devices, taking into considerationtheir usability, the use of standards, and a morerobust planning for the verification, validation,transfer and records maintenance of the design anddevelopment activitiesHarmonization of validation requirements for different software applications, such as QMS software,process control software, software for monitoringand measurementISO 13485, Medical devices –7
I am certifiedto ISO 13485:2003,what does itmean for me ?Certification is not a requirement of ISO 13485, and organizations can reap the benefitsof the standard without beingcertified. However, third-partycertification – where an independent certification body auditsyour compliance to the standard– can be a way of demonstratingto stakeholders and regulatoryauthorities that you meet therequirements.Organizations certified toISO 13485:2003 are granted athree-year transition period tomigrate to the new edition of thestandard. After this time, if youwish to obtain third-party validation, you will have to seek certification to the new version. Formore details about transitioningto ISO 13485:2016, talk to yourcertification body. Additionalinformation may be obtained atwww.iso.org/iso/certification.
Relationship with ISO 9001While ISO 13485 is a stand-alone standard, it is similar in scopeand intent to ISO 9001, Quality management systems. It containsadditional requirements specific to organizations involved in thelife cycle of medical devices, while other elements of ISO 9001 havebeen removed that are not relevant as regulatory requirements. Likeall ISO management system standards, it is designed to be integratedinto an organization’s existing management systems.More information ISO Website ISO Website section on health ISO Website section on management standards www.iso.org/iso/management-standardsISOfocus /iso/healthISO 13485, Medical devices –9
About ISOISO (International Organization for Standardization)is an independent, non-governmental internationalorganization with a membership of 162* nationalstandards bodies. Through its members, it bringstogether experts to share knowledge and developvoluntary, consensus-based, market-relevant International Standards that support innovation andprovide solutions to global challenges.ISO has published more than 21 000* InternationalStandards and related documents covering almostevery industry, from technology to food safety, toagriculture and healthcare.For more information, please visit www.iso.org.*January 2016International Organizationfor StandardizationISO Central SecretariatCh. de Blandonnet 8Case Postale 401CH – 1214 Vernier, GenevaSwitzerlandiso.org ISO, 2016All rights reservedISBN 978-92-67-10658-8
ISO 13485 helps an organization design a quality man-agement system that establishes and maintains the effectiveness of its processes. It reflects a strong com-mitment to continual improvement and gives custom - ers confidence in its ability to bring safe and effective products to market. ISO 13485, Medical devices – 1File Size: 430KBPage Count: 12Explore furtherFree download of ISO 13485 & other medical device standardsadvisera.comISO 13485 documents with manual, procedures, audit checklistwww.documentationconsultan ISO - ISO 13485 — Medical deviceswww.iso.orgISO 13485:2016 Quality Systems Manual13485store.comWhat is ISO 13485? Easy-to-understand explanation.advisera.comRecommended to you b
