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QualityManagementSystem (QMS)CertificationUnderstanding Medical Device QMSCertificationMedical device manufacturing is one of the most regulated sectors in which significant qualitysystems and product requirements must be satisfied. The regulatory requirements are intended toensure that manufacturers consistently design, produce and place onto the market medical devicesthat are safe and fit for their intended purpose.“Successfully certified organizations are able to demonstrate the effectiveinterconnectivity of their processes. It is essential to be able to demonstrate howoutputs from complaints, for example, feed into management review, improvementprocesses, Technical Documentation and risk management updates, to name a few.”Teresa PerryGlobal Quality and Accreditation Manager – Medical Devices.making excellence a habit.

Introduction to a medical device QMSThe ISO 13485 standard is an effective solution to meet the comprehensive requirementsfor a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers toaddress the regulations and responsibilities as well as demonstrating a commitment tothe safety and quality of medical devices.What is ISO 13485?BSI's approach to excellenceISO 13485 is a stand-alone QMS standard, derived from theinternationally recognized and accepted ISO 9000 qualitymanagement standard series. ISO 13485 adapts the previousversion of ISO 9001, ISO 9000:2008 process-based model for aregulated medical device manufacturing environment. While ISO13485 is based on the ISO 9001 process model concepts of Plan,Do, Check, Act, it is designed for regulatory compliance; thereforeit is more prescriptive in nature and requires a more thoroughlydocumented QMS.BSI selects and recruits professionals to conduct ISO 13485audits. Candidates must have design, manufacturing or processknowledge in addition to general knowledge on use of medicaldevices. Our assessment staff come to BSI with exceptional realindustry experience. They then go through rigorous internaltraining and BSI qualification processes including best practicequality systems auditing techniques, understanding criticalmanufacturing processes and interpretation of regulatorycompliance expectations.ISO 13485 was written to support medical devicemanufacturers in designing a QMS that establishes andmaintains the effectiveness of their processes. It ensures theconsistent design, development, production, installation anddelivery through to disposal of medical devices that are safefor their intended purpose.BSI auditors are experts in current state-of-the-art and areconstantly trained on new requirements and future changes.BSI is always looking ahead to ensure that our clients areprepared and well placed for future changes to compliance andthe regulatory landscape“As I look over the 20 years that 3M Unitekand BSI have worked together, it has beena very satisfying part of my career. Theprofessional and collegial atmosphereBSI brings to these audits stronglyencourages us to want to continuallyimprove our quality managementsystem. Please convey my greatappreciation to you and yourcolleagues for this.”Jerry Horn, PhDManager, Quality and Regulatory3M Orthodontic ProductsCall us now on 44 345 080 90002

A medical device manufacturer’s quality management system is the foundation formaintaining regulatory compliance, driving improvement and effectiveness, andachieving stakeholder confidence in the manufacturer and their products.High performing organizations expect ISO 13485 auditingto be thorough, competent, relevant and challenging of themanufacturers' QMS. Effective auditing provides significantbenefits for the manufacturer.The beneficial outputs of an effective audit include: Meaningful feedback on the effectiveness of the qualitymanagement system Confidence in compliance with regulationsIdentification of areas requiring attentionDetection of areas of non-compliance and riskReporting and certification that is valuable and recognizedRisk Management ISO 14971Risk management is a key component and requirement forISO 13485 certification. ISO 14971 is a risk management systemstandard, which was designed to be compatible with ISO 13485.It helps manufacturers meet the increasing global requirementsand expectations to implement not only quality, but full riskmanagement systems throughout the entire life cycle of themedical devices they manufacture.ISO 14971 satisfies the risk management requirement forIEC 60601-1 for medical electrical equipment and systems. It isa helpful tool for manufacturers in identifying and controllingthe risks associated with their medical devices, but alsoevaluating interactions with other devices. Increasingly,ISO 14971, in the footsteps of ISO 13485, is becoming aninternational requirement for medical device manufacturersto meet regulatory expectations globally.Medical Device Single Audit ProgramThe Medical Device Single Audit Program (MDSAP) allows asingle audit of a medical device manufacturer's QMS whichsatisfies the requirements of multiple regulatory jurisdictions.Audits are conducted by Auditing Organizations (AO), such asBSI, authorized by the participating Regulatory Authorities (RA)to audit under MDSAP requirements.MDSAP is a way that medical device manufacturers can beaudited once for compliance with the standard and regulatoryrequirements of up to five different medical device markets:Australia, Brazil, Canada, Japan and the United States.A BSI MDSAP Audit can also be combined with assessment forCE and ISO 13485.MDSAP audits can be performed by a recognized MDSAP AO,such as BSI, which has performed MDSAP audits worldwideand issued a significant number of global sites with MDSAPcertifications; we are currently processing many more.bsigroup.com/mdsapVisit bsigroup.com/medical3

The importance of ISO 13485ISO 13485 is important to designers, manufacturers, anddistributors of medical devices. In addition, suppliersand service providers can enhance an organization'smarketability as more and more manufacturers requirecertification in order to do business with a vendor.with a higher level of confidence in the ability to consistentlyachieve and maintain compliance with regulatoryrequirements. It can also help to minimize surprises andfailures which might adversely affect patient safety anddamage a manufacturer's reputation.When it comes to medical device manufacturing, patientsafety greatly depends on the quality and consistencyof medical products, and ensuring effectiveness, controland maintenance of your QMS is critical to customers,stakeholders, patients and users, and regulatory agencies.The value of ISO 13485 is not just in the implementation,but also in providing a tool for a thorough audit to test theeffectiveness of the system. It provides the manufacturerWhen it comes to medical device manufacturing, patient safety greatlydepends on the quality and consistency of medical products.ISO 13485 and CE markingISO 13485 is the best internationally-accepted modela medical device organization can implement to helpdemonstrate compliance to laws and regulations ofthe medical device industry. ISO 13485 is the qualitymanagement system standard accepted as the basis forCE marking medical devices under European Directivesand Regulations.Although ISO 13485 certification is not mandatory forCE marking medical devices under the European MedicalDevice Directives (AIMDD, MDD, IVDD), it is harmonized,which allows the presumption of conformity to theDirectives.ISO 13485 is also not mandatory for CE marking underthe European Medical Device Regulations (MDR, IVDR).Although there are currently no standards harmonized tothe Regulations, ISO 13485:2016 remains a state-of-theart document. BSI, as one of the leading Notified Bodiesfor CE marking, can verify medical device manufacturers’selection of the most efficient conformity assessmentroutes to achieve CE marking.Where to find moreinformationBSI has developed a suite ofmaterials, including webinars,whitepapers and training coursesto help you understand ISO 13485.bsigroup.com/ISO-13485Call us now on 44 345 080 90004

Your path to certificationBSI provides a full range of services to support your path to certification. BSI's businessdevelopment team can help you and your organization fully understand the ISO 13485certification process and its available guidelines. We provide training courses that cansupport you in developing you develop a thorough understanding of the complexities ofcomplying with the standard, as well as the laws and regulations the standard helpsto address.Once a medical device QMS has been developed andimplemented, a BSI Client Manager can conduct a rigorousassessment of the system against the requirements. Uponsatisfactory completion, BSI will issue a certificate to thestandard, which you can then use to promote your businessand accredited products, providing globally-recognizedevidence of your company's commitment to quality systemsand maintaining patient safety.Key activities for ISO 13485Get top management involvedTop management involvement is a requirement for ISO 13485.Involvement must be demonstrated by providing evidenceof its commitment to the standard by determining customerrequirements, establishing a quality policy, and ensuringrelevant, useful, and measurable objectives. Top managementneeds to focus on responsibility, representation, communication,and review of medical devices.The third revision of ISO 13485 doesNOT align with the revised structure ofISO 9001:2015. For those medical devicemanufacturers who hold dual certification,you will need to be aware and plan yourinternal procedures to take into account thedifferences.Inputs such as the following could be considered: Regulatory requirementsInternational or national standardsCustomer product or service requirements including:-usability requirementscustomer complaintsfeedbackbenchmarkingmarket trends, statistics and forecast informationExamples of activities to process these inputs include: Design and development processRisk managementManagement reviewComplaint investigationsCorrective action or preventive actionAdopt the process modelAs an output, your organization can consider such things asdecisions and actions related to:Rather than focusing on each individual clause of the standard,read the requirements in terms of inputs and outputs. ISO13485 uses the Plan, Do, Check, Act methodology; each keyarea of the standard, such as quality system, managementresponsibility, resource management, product realization,and measurement, must be read in terms of inputs to therequirement (i.e. resource requirements) and outputs to therequirement (i.e. measurements). Only through careful studyand understanding of the process model can you achieve thiseffective thinking approach. Design and development of new productExisting product redesignNew or revised labellingAdvisory notices or other actionsRisk management reports/filesImprovementQuality planningPolicy, process or procedure revisionVisit bsigroup.com/medical5