A Practical Guide to Understanding ISO13485

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PRACTICAL GUIDE TO UNDERSTANDING ISO 13485

ISO 13485 – QUALITY MANAGEMENT SYSTEMS

2 BSI Management Systems ISO 13485

The medical device manufacturing sector is one ofthe most regulated sectors in which significantquality systems and product requirements must besatisfied. The regulatory requirements are intendedto ensure that manufacturers consistently design,produce, and place onto the market, medical devicesthat are safe and fit for their intended purpose.

The ISO 13485 standard is an effective solution tomeet the comprehensive requirements for a qualitymanagement system (QMS). Adopting ISO 13485provides a practical foundation for manufacturers toaddress the regulations and responsibilities as well asdemonstrating a commitment to the safety andquality of medical devices.

What is ISO 13485?ISO 13485 is a stand-alone QMS standard,derived from the internationallyrecognized and accepted ISO 9000 qualitymanagement standard series. ISO 13485adapts the ISO 9000 process-based modelfor a regulated medical devicemanufacturing environment. While ISO 13485 is based on the ISO 9001process model concepts of Plan, Do,Check, Act, it is designed for regulatorycompliance. Thus it is more prescriptive in nature and requires a more thoroughlydocumented quality management system.ISO 13485 was written to support medicaldevice manufacturers in designing qualitymanagement systems that establish andmaintain the effectiveness of theirprocesses. It ensures the consistent design,development, production, installation, anddelivery of medical devices that are safefor their intended purpose.

The Global Harmonization Task Force(GHTF) and the Asian HarmonizationWorking Party (AWHP) are twointernational working groups withrepresentatives from national medicaldevice regulatory authorities and theregulated industry. These groupsencourage the convergence in regulatorypractices related to ensuring the safety,effectiveness, performance, and quality of medical devices, and recognize andsupport the use of ISO 13485 as the basis for a global solution to qualitymanagement requirements.

PRACTICAL GUIDE TO UNDERSTANDING ISO 13485

BSI Management Systems ISO 13485 3

The Importance of ISO 13485ISO 13485 is important to designers, manufacturers, anddistributors of medical devices. In addition, suppliers can enhancean organization's marketability as more and more manufacturersrequire certification in order to do business as a vendor.

When it comes to medical device manufacturing, patient safetygreatly depends on the quality and consistency of medicalproducts, and ensuring effectiveness, control, and maintenanceof your quality management system is critical to customers,stakeholders, and regulatory agencies

The value of ISO 13485 is not just in the implementation, butalso in providing a tool for a thorough audit of the system to testthe effectiveness of the system. It provides the manufacturer ahigher level of confidence in the ability to consistently achieveand maintain compliance with regulatory requirements. Also itcan help to minimize surprises and failures which might adverselyaffect patient safety and damage a manufacturer's reputation.

ISO 13485 and CE MarkingISO 13485 is the best internationally-accepted model a medicaldevice organization can implement to help demonstratecompliance to laws and regulations of the medical deviceindustry. It is also useful as a quality management systemaccepted as the basis for CE Marking medical devices underEuropean Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around theworld, including the Health Canada Canadian Medical DeviceRegulations and CMDCAS Recognized Registrar program.

Although ISO 13485 is not a requirement for CE Markingmedical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the EuropeanCommission. Therefore compliance with ISO 13485 provides apresumption of conformity with the basic European Union (EU)quality assurance requirements for CE Marking (additional EUrequirements apply). BSI, as one of the leading Notified Bodiesfor CE Marking, can help guide medical device manufacturers on selecting the most efficient conformity assessment routes toachieve CE Marking.

When it comes to medical device manufacturing, patientsafety greatly depends on the quality and consistency of medical products.


About BSIBritish Standards Institution (BSI) is a world leader in the internationalstandards industry, with over 100 years of experience in developingstandards for a variety of industries and fields for organizations allaround the world. Our experience in assisting organizations indeveloping, implementing, and certifying to management systems toimprove efficiencies, corporate performance, and business processes isunsurpassed.

BSI provides a full portfolio of standards-related services to medicaldevice manufacturers through extensive training, guidance, auditing,and product evaluation throughout the assessment and certificationprocess. We support manufacturers in developing effective qualitymanagement systems to ensure consistent safety and quality in themedical device industry.

Why BSIBSI is an accredited registar and European Notified Body with anoutstanding reputation for thoroughness, integrity, stability, and fairness.Achieving ISO 13485 certification from BSI inspires confidence in themanufacturer and its products. We understand that medical devicemanufacturers need robust audits conducted by independent, highlycompetent assessors that support a manufacturer's own quality andregulatory team. BSI auditors focus on what is important, practical, andfair, providing valuable feedback on where improvements are needed to maintain the system, thereby helping to ensure the protection ofpatients as well as the reputation of the manufacturer.

In addition to ISO 13485, BSI offers systems and processes for anyhealthcare service function, including CE Marking, CMDCAS, JPAL, ISO 14971 Risk Management, FDA 510K, FDA Accredited Persons, Hong Kong CAB, China SDFA, Australian MRA and many other anddeveloping services to help your organization get its products to marketin a timely manner. We provide our customers with unsurpassedexperience in training clients and assisting them in developing effectivequality management systems, as well as expertise in high-risk, invasive,combination, and implantable medical devices. BSI understands yourbusiness and the global medical device marketplace.

ISO 14971 Risk ManagementRisk management is a key component andrequirement for ISO 13485 certification.ISO 14971 is a risk management systemstandard, and was designed to becompatible with ISO 13485. It helpsmanufacturers meet the increasing globalrequirements and expectations toimplement not only quality, but full riskmanagement systems throughout theentire life cycle of the medical devices they manufacture.

ISO 14971 satisfies the risk managementrequirement for IEC 60601-1 for medicalelectrical equipment and systems. It is ahelpful tool for manufacturers inidentifying and controlling not only therisks associated with their medical devices,but also evaluating interactions with otherdevices. Increasingly, ISO 14971, in thefootsteps of ISO 13485, is becoming aninternational requirement for medicaldevice manufacturers to meet regulatoryexpectations.


Compatibility of ISO 13485ISO 13485 is compatible with a number of non-quality standards such as the environmental management systemstandard ISO 14001 and the occupational health and safetymanagement standard OHSAS 18001 to facilitate managingmultiple systems.

BSI's award-winning Entropy SoftwareTM is an effective solutionfor managing multiple systems, designed to integrate acombination of management systems to improve businessoperations and efficiencies more effectively all in one place.

Benefits of ISO 13485 CertificationISO 13485 is intended to maintain your organization'seffectiveness of processes and to ensure safe medical devices.Certification to the standard clearly demonstrates anorganization's commitment to ensuring the design,development, and production of medical devices that performsafely and effectively. Gaining certification through BSI providesthe highest level of confidence in a quality assurance system andinforms the world that a manufacturer is committed to quality.

ISO 13485 Benefits• Establishes an effective quality management system

• Allows an organization to meet regulatory and customerrequirements

• 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

• 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.


Your Path to CertificationBSI provides the full range of services to support the path tocertification. BSI's business development staff can help you and your organization understand each phase of the assessmentand certification process to ensure you fully understand the ISO 13485 certification process and its available guidelines. We provide training courses that can help you develop athorough understanding of the complexities of complying with the standard, as well as the laws and regulations thestandard helps to address.

Once a medical device quality management system has beendeveloped and implemented, a BSI Client Manager can conducta fair and thorough assessment of the system against therequirements. Upon satisfactory completion, BSI will issue acertificate to the standard which you can then use to promoteyour business and products as an objective, accredited, andglobally-recognized evidence of your company's commitment to quality systems and maintaining patient safety.

Key Activities for ISO 13485Get Top Management InvolvedTop management involvement is a requirement for ISO 13485and must be clearly demonstrated by providing evidence of itscommitment to the standard by determining customerrequirements, establishing quality policy, and ensuring relevant,useful, and measurable objectives, as well as focusing onresponsibility, representation, communication, and review ofmedical devices.

Adopt the Process ModelRather than focusing on each individual clause of the standard,read the requirements in terms of inputs and outputs. ISO 13485uses the Plan, Do, Check, Act methodology, and each key areaof the standard, such as quality system, managementresponsibility, resource management, product realization, andmeasurement, must be read in terms of inputs to therequirement (i.e., resource requirements) and outputs to therequirement (i.e., measurements). Only through careful study and understanding of the process model can one achieve thiseffective thinking approach.

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?


Conduct an Internal AuditWhen an organization adopts ISO 13485, it commits toestablishing, documenting, implementing, and maintaining aquality management system, which includes a commitment to an effective internal audit program. There are four steps toconducting a complete and effective internal audit: Plan,Conduct, Measure, and Correct.

PlanPlanning is an important component to the ISO 13485 standard.Organizations must consider product realization, ISO 13485 in itsentirety, and quality management system requirementsestablished by the organization. This is in addition to all of theactivities related to the product, such as planning of the product,customer requirements, design, purchasing, production, storage,and measuring, and any additional requirements.

ConductConducting the internal audit is one of the biggest areas ofnonconformity seen in support of the ongoing process over time.As costs rise and enthusiasm for an effective system fades,organizations begin to falter. However, in order to maintain aneffective quality management system, an organization must presson and conduct its internal audit plan.

MeasureOnce an audit is conducted, the results are reported, and actionsto correct deficiencies must be processed immediately and anycauses for nonconformities must be eliminated. Questions toconsider are: Have deficiencies been corrected? Were theycorrected effectively and in a timely manner? Were the causeswell understood and eliminated? Were there any trends noted in the process or in the product?

CorrectThe final step in conducting an effective internal audit is focusingon understanding and measuring the effectiveness of the actionstaken, and understanding and measuring the effectiveness of theinternal audit process. Questions to consider here are: Do weneed more people? Do we have the right people? Are thepeople trained effectively? Are we seeing and understanding theright areas of the organization to detect and see the correctionsthat will make our devices safer and prevent defects from gettingon the market?

BSI TrainingBSI offers a number of on-site and public instructor-ledtraining courses, e-learning programs, webinars, andcustomized events for the healthcare and medical deviceindustry to provide your organization with the tools necessaryto develop and maintain your quality management system. In addition to the courses specific to your industry, weprovide courses on a wide range of topics from managementand leadership to business continuity and environmentalissues to help you and your staff gain the confidence,knowledge, and skills you need to succeed.

Why BSI TrainingDuring hard economic times, investing in training goes a long way in demonstrating your commitment, not just toyour organization and its economic growth but also in yourpeople, the driving force of your organization.

Our training professionals possess extensive knowledge in the healthcare and medical device industry and will provideyou and your organization with a complete understanding ofISO 13485's concepts, as well as the ability to use thestandard as a guide in defining your management systems.You will gain the understanding of how utilizing the standardwill provide a documental ROI for your organization, theability to use the ISO 13485 standard as a tool forimprovement in your organization and in your supply chain,as well as the capability to identify risks that may affect yourorganization's ability to meet objectives and mitigate theeffects of quality risk issues within your supply chain.

To find out more information on ISO 13485 and how it can benefit your organization, visit us on the web atwww.bsiamerica.com/healthcare or contact us [email protected].

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A Practical Guide to Understanding ISO13485

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