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IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTS5.1 COMMITMENT REQUIREMENTS1Demonstrate your ongoing commitment.2Support the development of your QMS.3Ensure that a quality policy is established.4Ensure that quality objectives are established.Part 5.1 requirements must be metby your organization’s top managers.Part 5.3 discusses the requirementsthat your policy must comply with.Part 5.4.1 discusses the needto establish quality objectives.Support the implementation of your QMS.5Communicate your commitment to quality.67Explain why it's important to meet customer requirements.8Explain why it's important to meet regulatory requirements.Part 6 asks you to ensure thatQMS resources are provided.Provide suitable implementation resources.9Support the maintenance of your QMS.1011Conduct management reviews.12Provide maintenance resources.5.2 EXTERNAL REQUIREMENTS13Ensure that external requirements are determined.14Expect customer requirements to be determined.15Expect regulatory requirements to be determined.16Part 5.2 requirements must be metby your organization’s top managers.Ensure that external requirements are being met.17Expect customer requirements to be met.18Expect regulatory requirements to be met.5.3 POLICY REQUIREMENTS19Part 5.3 requirements must be metby your organization’s top managers.Plan your quality policy.20Make sure that it supports your organization's purpose.21Make sure that it can be used to set quality objectives.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 50

IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTSMake sure that it can be used to review objectives.222324Make a commitment to comply with requirements.25Make a commitment to maintain QMS effectiveness.26Apply your quality policy.Communicate your quality policy.27Ensure that it's understood within your organization.2829A quality policy should express topmanagement's commitment to the qualitymanagement system (QMS) and shouldallow managers to set quality objectives.Draft your quality policy.Review your quality policy.Make sure that your policy is still suitable.305.4 PLANNING REQUIREMENTS5.4.1 ESTABLISH QUALITY OBJECTIVES31Make sure that your quality objectives are effective.32Make sure that your quality objectives are measurable.33Make sure that objectives are consistent with quality policy.3435Part 5.4 requirements must be metby your organization’s top managers.Plan the establishment of quality objectives.A quality objective is a quality result thatyou intend to achieve. Quality objectivesare generally based on or derived froman organization’s quality policy and mustbe consistent with it. They are usuallyformulated at all relevant levels within theorganization and for all relevant functions.Establish quality objectives for your organization.36Set objectives needed to meet product requirements.37Establish product oriented objectives in relevant functional areas.38Establish product oriented objectives at relevant organizational levels.39Set objectives needed to meet regulatory requirements.40Establish regulatory objectives in relevant functional areas.41Establish regulatory objectives at relevant organizational levels.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 51

IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTS5.4.2 CARRY OUT QUALITY PLANNING42Plan how you're going to develop your QMS (per 4.1.1).43Plan how you're going to document your QMS (per 4.1.1).44Plan how you're going to structure your QMS (per 4.1.2).Plan how processes will interact with one another (per 4.1.2).4546Plan how you're going to manage your QMS (per 4.1.1).Plan how you're going to apply a risk based approach (per 4.1.2).4748Plan how you're going to comply with process requirements (per 4.1.4).49Plan how you're going to manage changes to your processes (per 4.1.4).50Plan how you're going to validate and revalidate software (per 4.1.6).51Plan how you're going to monitor your QMS (per 4.1.1).52Plan how you're going to monitor quality objectives (per 5.4.1).53Plan how you're going to monitor outsourced processes (per 4.1.5).54Part 5.4.2 expects top managers to ensurethat QMS planning is carried out in orderto meet the requirements listed in parts4.1 and 5.4.1. We have, therefore, listedthese requirements here so that you don'thave to keep flipping back and forthbetween sections (section numbers areshown in parentheses for your convenience).According to ISO 13485 2016, when theterm risk is used it refers to the need tothink about what could potentially happenwhen a manufacturer fails to meet productsafety or performance requirements or failsto comply with all applicable regulatoryrequirements.According to the ISO 14971 riskmanagement standard for medicaldevices, the concept of risk combines twovariables: the probability of harm and theseverity of harm. For more information,see www.praxiom.com/14971.htmPlan how you're going to control your QMS (per 4.1.1).55Plan how you're going to control the setting of quality objectives (per 5.4.1).56Plan how you're going to develop actions to achieve objectives (per 5.4.1).Plan how you're going to modify actions to achieve objectives (per 5.4.1).57Plan how you're going to control changes to your QMS (per 5.4.2).58Plan how you're going to protect the integrity of your QMS (per 5.4.2).59Plan how you're going to control outsourced processes (per 4.1.5).6061Plan how you're going to implement your QMS (per 4.1.1).62Plan how you're going to maintain your QMS (per 4.1.1).63Plan how you're going to support your processes (per 4.1.3).64Plan how QMS integrity will be protected when changes are made (per 5.4.2).ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 52

IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTS5.5 MANAGERIAL REQUIREMENTS5.5.1 CLARIFY RESPONSIBILITY AND AUTHORITY65Document your organization's QMS responsibilities and authorities.66Communicate responsibilities and authorities within your organization.67According to ISO 13485 2016 section 0.2,“When a requirement is required to be‘documented’, it is also required to beestablished, implemented and maintained”.Maintain documents that define QMS responsibilities and authorities.6869Part 5.5 requirements must be metby your organization’s top managers.Define QMS responsibilities and authorities.Document how QMS personnel are interrelated.Consider people who manage work that affects quality.70Consider how these managers relate to other personnel.7172Ensure that managers have the independence they need to do their work.73Ensure that managers have the authority they need to do their work.Consider people who perform work that affects quality.74Consider how these workers relate to other personnel.7576Ensure that these workers have the independence they need to do their work.77Ensure that these workers have the authority they need to do their work.Consider people who verify work that affects quality.78Consider how these people relate to other personnel.7980Ensure that these people have the independence they need to do their work.81Ensure that these people have the authority they need to do their work.5.5.2 APPOINT MANAGEMENT REPRESENTATIVE82Appoint a member of management to oversee your organization's QMS.83Give management representative the necessary authority and responsibility.84Assign authority and responsibility for documenting your QMS.85Assign authority and responsibility for documenting processes.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 53

IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTSAssign authority and responsibility for maintaining process documents.8687Assign authority and responsibility for reporting to top management.88Ask your representative to report on the effectiveness of the QMS.89Ask your representative to report on the need for improvement.Assign authority and responsibility for promoting corporate awareness.9091Ask your representative to make people aware of applicable requirements.92Make your personnel aware of all applicable regulatory requirements.93Make your personnel aware of all applicable QMS requirements.A note to this section says that you could alsomake your management representativeresponsible for liaising with regulatoryauthorities and other external parties.5.5.3 ESTABLISH INTERNAL COMMUNICATIONS94Establish appropriate internal communication processes.Encourage communication about the effectiveness of your QMS.955.6 REVIEW REQUIREMENTS5.6.1 PERFORM REGULAR MANAGEMENT REVIEWS96Establish management review procedures.Document your management review procedures.9798Make sure that your QMS is still suitable.99Make sure that your QMS is still adequate.100Make sure that your QMS is still effective.101The purpose of a management review isto evaluate the suitability, adequacy, andeffectiveness of an organization's qualitymanagement system, and to look forimprovement opportunities. Managementreviews are also used to identify and assessopportunities to change an organization’squality policy and quality objectives, toaddress resource needs, and to look foropportunities to improve its products.Schedule your reviews at planned intervals.Document your management review schedule.102103Part 5.6 requirements must be metby your organization’s top managers.Review your QMS at planned intervals.104Review the need to change your QMS.105Review the need to change your quality policy.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 54

IS O 13485 2016 TRANS LATED INTO P LAIN ENGLISH5. M ANAGEM ENT REQU IREM ENTSReview the need to change your quality objectives.106107Review the need to improve your QMS.108Maintain a record of management reviews.See section 4.2.5 for more on record keeping.5.6.2 STUDY MANAGEMENT REVIEW INPUTS109Study information about your QMS (inputs).110Review previous management reviews.111Review previous follow up actions.112Review the results of previous audits.113Review monitoring and measurement activities.114Review process monitoring and measurement.115Review product monitoring and measurement.116Review complaint handling activities.117Review previous remedial actions.118Review previous corrective actions.119Review previous preventive actions.Review new or revised regulatory requirements.120121Review reports to regulatory authorities.122Review recommendations for improvement.123Review changes that could affect the QMS.5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS124Generate management review outputs.125Generate decisions and actions to improve your QMS.126Improve the suitability of your organization's QMS.ORGANIZATION:YOUR LOCATION:COMPLETED BY:DATE COMPLETED:REVIEWED BY:DATE REVIEWED:MAR 2016PLAIN ENGLISH QUALITY MANAGEMENT STANDARD FOR MEDICAL DEVICESPART 5COPYRIGHT 2016 BY PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.EDITION 1.0PAGE 55