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PRACTICAL GUIDE TO UNDERSTANDING ISO 13485
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and place onto the market. it is designed for regulatory compliance. installation. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system. It ensures the consistent design. development. These groups encourage the convergence in regulatory practices related to ensuring the safety.PRACTICAL GUIDE TO UNDERSTANDING ISO 13485 The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. medical devices that are safe and fit for their intended purpose. The Global Harmonization Task Force (GHTF) and the Asian Harmonization Working Party (AWHP) are two international working groups with representatives from national medical device regulatory authorities and the regulated industry. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). and quality of medical devices. While ISO 13485 is based on the ISO 9001 process model concepts of Plan. Check. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. and delivery of medical devices that are safe for their intended purpose. Act. Do. What is ISO 13485? ISO 13485 is a stand-alone QMS standard. produce. effectiveness. production. 2 BSI Management Systems ISO 13485 . derived from the internationally recognized and accepted ISO 9000 quality management standard series. and recognize and support the use of ISO 13485 as the basis for a global solution to quality management requirements. The regulatory requirements are intended to ensure that manufacturers consistently design. performance.
In addition. BSI. ISO 13485 is being required. ISO 13485 and CE Marking ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. and ensuring effectiveness. manufacturers. BSI Management Systems ISO 13485 3 . When it comes to medical device manufacturing. It provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. stakeholders. Increasingly. When it comes to medical device manufacturing. and maintenance of your quality management system is critical to customers. including the Health Canada Canadian Medical Device Regulations and CMDCAS Recognized Registrar program. control. Although ISO 13485 is not a requirement for CE Marking medical devices under the European Medical Device Directives. it is recognized as a harmonized standard by the European Commission. in supporting regulations around the world. but also in providing a tool for a thorough audit of the system to test the effectiveness of the system. suppliers can enhance an organization's marketability as more and more manufacturers require certification in order to do business as a vendor. It is also useful as a quality management system accepted as the basis for CE Marking medical devices under European Directives. and regulatory agencies The value of ISO 13485 is not just in the implementation. patient safety greatly depends on the quality and consistency of medical products. Also it can help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation. as one of the leading Notified Bodies for CE Marking. and distributors of medical devices.The Importance of ISO 13485 ISO 13485 is important to designers. patient safety greatly depends on the quality and consistency of medical products. or is at least beneficial. Therefore compliance with ISO 13485 provides a presumption of conformity with the basic European Union (EU) quality assurance requirements for CE Marking (additional EU requirements apply). can help guide medical device manufacturers on selecting the most efficient conformity assessment routes to achieve CE Marking.
BSI auditors focus on what is important. and business processes is unsurpassed. and was designed to be compatible with ISO 13485. guidance. but full risk management systems throughout the entire life cycle of the medical devices they manufacture. practical. We provide our customers with unsurpassed experience in training clients and assisting them in developing effective quality management systems. It is a helpful tool for manufacturers in identifying and controlling not only the risks associated with their medical devices. Australian MRA and many other and developing services to help your organization get its products to market in a timely manner. FDA Accredited Persons. invasive. BSI offers systems and processes for any healthcare service function. Hong Kong CAB. and fair. and implantable medical devices. stability. JPAL. combination.About BSI British Standards Institution (BSI) is a world leader in the international standards industry. ISO 14971 Risk Management. is becoming an international requirement for medical device manufacturers to meet regulatory expectations. We support manufacturers in developing effective quality management systems to ensure consistent safety and quality in the medical device industry. BSI understands your business and the global medical device marketplace. Achieving ISO 13485 certification from BSI inspires confidence in the manufacturer and its products. providing valuable feedback on where improvements are needed to maintain the system. ISO 14971 satisfies the risk management requirement for IEC 60601-1 for medical electrical equipment and systems. in the footsteps of ISO 13485. as well as expertise in high-risk. Our experience in assisting organizations in developing. ISO 14971 Risk Management Risk management is a key component and requirement for ISO 13485 certification. highly competent assessors that support a manufacturer's own quality and regulatory team. and product evaluation throughout the assessment and certification process. and fairness. and certifying to management systems to improve efficiencies. We understand that medical device manufacturers need robust audits conducted by independent. China SDFA. 4 BSI Management Systems ISO 13485 . auditing. BSI provides a full portfolio of standards-related services to medical device manufacturers through extensive training. Increasingly. Why BSI BSI is an accredited registar and European Notified Body with an outstanding reputation for thoroughness. implementing. It helps manufacturers meet the increasing global requirements and expectations to implement not only quality. with over 100 years of experience in developing standards for a variety of industries and fields for organizations all around the world. CMDCAS. FDA 510K. In addition to ISO 13485. ISO 14971. thereby helping to ensure the protection of patients as well as the reputation of the manufacturer. corporate performance. including CE Marking. but also evaluating interactions with other devices. ISO 14971 is a risk management system standard. integrity.
development. and production of medical devices that perform safely and effectively. designed to integrate a combination of management systems to improve business operations and efficiencies more effectively all in one place. • Ensures safe. quality medical devices • Helps secure an organization's economic growth and corporate reputation Certification provides the highest level of confidence in a quality assurance system and informs the world that a manufacturer is committed to quality. Gaining certification through BSI provides the highest level of confidence in a quality assurance system and informs the world that a manufacturer is committed to quality. Certification to the standard clearly demonstrates an organization's commitment to ensuring the design. BSI Management Systems ISO 13485 5 .Compatibility of ISO 13485 ISO 13485 is compatible with a number of non-quality standards such as the environmental management system standard ISO 14001 and the occupational health and safety management standard OHSAS 18001 to facilitate managing multiple systems. BSI's award-winning Entropy SoftwareTM is an effective solution for managing multiple systems. ISO 13485 Benefits • Establishes an effective quality management system • Allows an organization to meet regulatory and customer requirements • Increases the efficiency of its processes and reduce waste • Improves staff morale • Enhances focus on risk management • Gains awareness of improvement opportunities • Increases responsiveness to issues and nonconformities Benefits of ISO 13485 Certification ISO 13485 is intended to maintain your organization's effectiveness of processes and to ensure safe medical devices.
read the requirements in terms of inputs and outputs. accredited. Key Activities for ISO 13485 Get Top Management Involved Top management involvement is a requirement for ISO 13485 and must be clearly demonstrated by providing evidence of its commitment to the standard by determining customer requirements. Check. Once a medical device quality management system has been developed and implemented. resource management. BSI will issue a certificate to the standard which you can then use to promote your business and products as an objective. Act methodology. and measurable objectives. a BSI Client Manager can conduct a fair and thorough assessment of the system against the requirements. useful.. and each key area of the standard. Upon satisfactory completion. Only through careful study and understanding of the process model can one achieve this effective thinking approach. and measurement. as well as the laws and regulations the standard helps to address. such as quality system. product realization. We provide training courses that can help you develop a thorough understanding of the complexities of complying with the standard. Important questions to consider for inputs are: • Who does this process? • How are they trained? • What records are kept? Important questions to consider for outputs are: • How are customer concerns captured? • How are they summarized? • Who receives the summary report? • What metrics are outputs of the process? 6 BSI Management Systems ISO 13485 . ISO 13485 uses the Plan. BSI's business development staff can help you and your organization understand each phase of the assessment and certification process to ensure you fully understand the ISO 13485 certification process and its available guidelines. Do.e. representation. measurements). communication. as well as focusing on responsibility.Your Path to Certification BSI provides the full range of services to support the path to certification. and ensuring relevant. management responsibility. and review of medical devices. establishing quality policy.. resource requirements) and outputs to the requirement (i. must be read in terms of inputs to the requirement (i. Adopt the Process Model Rather than focusing on each individual clause of the standard.e. and globally-recognized evidence of your company's commitment to quality systems and maintaining patient safety.
com. and customized events for the healthcare and medical device industry to provide your organization with the tools necessary to develop and maintain your quality management system. not just to your organization and its economic growth but also in your people. and skills you need to succeed. There are four steps to conducting a complete and effective internal audit: Plan. Measure. You will gain the understanding of how utilizing the standard will provide a documental ROI for your organization. and quality management system requirements established by the organization. In addition to the courses specific to your industry. and understanding and measuring the effectiveness of the internal audit process. Questions to consider are: Have deficiencies been corrected? Were they corrected effectively and in a timely manner? Were the causes well understood and eliminated? Were there any trends noted in the process or in the product? Correct The final step in conducting an effective internal audit is focusing on understanding and measuring the effectiveness of the actions taken. Why BSI Training During hard economic times. This is in addition to all of the activities related to the product. an organization must press on and conduct its internal audit plan. Organizations must consider product realization. as well as the capability to identify risks that may affect your organization's ability to meet objectives and mitigate the effects of quality risk issues within your supply chain. Our training professionals possess extensive knowledge in the healthcare and medical device industry and will provide you and your organization with a complete understanding of ISO 13485's concepts. knowledge. Plan Planning is an important component to the ISO 13485 standard. Questions to consider here are: Do we need more people? Do we have the right people? Are the people trained effectively? Are we seeing and understanding the right areas of the organization to detect and see the corrections that will make our devices safer and prevent defects from getting on the market? BSI Training BSI offers a number of on-site and public instructor-led training courses. investing in training goes a long way in demonstrating your commitment.com/healthcare or contact us at healthcare@bsigroup. which includes a commitment to an effective internal audit program. To find out more information on ISO 13485 and how it can benefit your organization. the driving force of your organization. documenting. However.bsiamerica. and measuring. BSI Management Systems ISO 13485 7 .Conduct an Internal Audit When an organization adopts ISO 13485. production. e-learning programs. and Correct. it commits to establishing. and maintaining a quality management system. such as planning of the product. webinars. visit us on the web at www. customer requirements. and any additional requirements. As costs rise and enthusiasm for an effective system fades. implementing. design. the results are reported. the ability to use the ISO 13485 standard as a tool for improvement in your organization and in your supply chain. in order to maintain an effective quality management system. Measure Once an audit is conducted. ISO 13485 in its entirety. organizations begin to falter. as well as the ability to use the standard as a guide in defining your management systems. we provide courses on a wide range of topics from management and leadership to business continuity and environmental issues to help you and your staff gain the confidence. storage. Conduct. Conduct Conducting the internal audit is one of the biggest areas of nonconformity seen in support of the ongoing process over time. and actions to correct deficiencies must be processed immediately and any causes for nonconformities must be eliminated. purchasing.
Suite 102 Mississauga.com BSI Management Systems Canada 6205 Airport Road.br BSI Management Systems .firstname.lastname@example.org.BSI Management Systems 12110 Sunset Hills Road.msamericas@bsi-global.F. Paseo de la Reforma No.msamericas@bsi-global. C.ca/ www.México Torre Mayor Av. VA 20190-5902 USA Tel: 1 800 862 4977 Fax: 1 703 437 9001 Email: inquiry. ON L4V 1E1 Canada Tel: 1 800 862 6752 Fax: 416 620 9911 Email: inquiry.com Web: www.mx/ The BSI certification mark can be used on your stationery.bsigroup.bsiamerica.com Web: www. Cuauhtemoc.msamericas@bsi-global. 505 Piso 41 -Suite CCol. D.com.com www.ca/fr-ca/ BSI Management Systems .com. Suite 200 Reston.P. 06500 México. BSI Group: Standards • Information • Training • Inspection • Testing • Assessment • Certification BSI/USA/168/MS/0309/E . Sao Paulo SP Brasil Tel: +55 13 3223 5770 Fax: +55 13 3223 3851 Email: informacao.bsigroup.° 1400 – 1° Andar – CEP: 04571-000 Brookline.com Web: www. literature and vehicles when you have successfully achieved certification.Brazil Avenida Eng Luis Berrini N. México Tel: +52 55 5241 1370 Fax: +52 55 5241 1374 Email: informacion.
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