- How to Conduct a Management Review
- ISO clause 9.3 Management Review – Integrated Management Review Process
- ISO 9001:2015 Management Review (and how to do internal audit on MR)
- MANAGEMENT REVIEW – 8 ACTION ITEMS FOR A SUCCESSFUL MANAGEMENT REVIEW OR EXECUTIVE MEETING
- How to prepare your Management Review? [Quality Management System]
- Review Management
- Managementbewertung | Management Review | Das fordert die ISO 9001
How to Conduct a Management Review
hello Im going to introduce you today,to one of the most important parts of,any ISO management system the management,review will focus on a quality,management system as defined by iso 9001,2015 but the same principles apply to,any ISO management system were going to,look at the following aspects of a,management review what is a management,review and who should take part how,often should it take place what should,be included how do I conduct the,management review how might I fail an,audit because of problems with a,management review how can I receive,further help from QMS so what is a,management review and who should take,part ISO 9001 states that top management,shall review the organizations quality,management system at planned intervals,to ensure its continuing suitability,adequacy effectiveness and alignment,with the strategic direction of the,organization top management means that,the organizations senior management,needs to be actively involved because,the success of the organization might,well be dependent upon how well the,quality management system is being,utilized how often should it take place,the management review should take place,at the interval defined in your quality,manual this should be at least annually,but is very often quarterly especially,in the early days of the management,system we recommend that you hold your,first management review within two,months of certification as this is often,the time at which most decisions will be,needed what should be included section,9.3 of your quality manual is likely to,look similar to this iso 9001 defines,those topics which need to be covered in,the agenda of the management review so,you should consult your quality manual,to determine what those are its,important to note that the agenda right,are not optional every item needs to be,discussed even if the conclusion is that,theres nothing to discuss the quality,manual also states that you must retain,a copy of the agenda and minutes from,each management or review how do I,conduct the management review in order,to help you conduct the management,review we provide you with a template,which will look similar to this its not,mandatory to use this template but lets,take a look at it to see how it might,help you firstly you should record the,names and job titles of those who are,attending the meeting followed by the,date time and venue you will then need,to do some preparation its best to,start this at least several days before,the meeting as you might need time to,prepare any missing information as,suggested in the box on the template you,are likely to find that youll need to,do at least the following review all the,management system documentation is the,quality manual still up to date review,and analyze any internal and external,audits which have taken place since the,last management review you obtain,feedback on the extent to which quality,objectives have been achieved and,analyzed the feedback have corrective,actions been successfully implemented if,not why not have risks and opportunities,been taken into account during,decision-making what is the evidence for,this and what are the outcomes review,customer feedback and analyze it obtain,any policies which are relevant to the,operation of the quality management,system continue your preparation by,ensuring that appropriate materials are,available and not forgetting how youre,going to present them for example,verbally on paper or electronically the,template suggests the following minutes,of previous meetings all relevant,so 9001 system documentation for example,the quality manual internal and external,audit reports relevant quality record,files for example customer feedback non,conformance reports etc register of,legal and other obligations were,relevant analysis of complaints if any,records of corrective actions and,management information reports raised,since the last management review review,of relevant policies if applicable none,of the above are exhaustive you may wish,to extend the preparation further,bearing in mind the objective of the,meeting review of the ISO 9001,management system to ensure suitability,adequacy and effectiveness the review is,to include the assessment of,opportunities for improvement and any,potential changes to the quality,management system and its alignment with,business objectives and strategy the,template continues by allowing you to,document the minutes of the meeting and,the actions to be taken and,communications required its important,to note that the minutes are not,intended to be a detailed account of,everything which has been said at the,meeting only the outcomes and decisions,arising from the discussions are,necessary to record its then also,important to document the actions to be,taken who will take those actions and,any communications which might be,required they are likely to find that,the value of the management review is,reduced considerably if actions are not,determined and allocated as everyone,will tend to assume that someone else is,taking responsibility when they also,wish to set a time scale for actions,depending upon their nature and urgency,as I mentioned earlier every agenda item,should be discussed and an outcome,recorded finally you should determine,the date of the next meeting if possible,to do so and record this in the box at,the end of the forum,its then normal for the draft minutes,to be circulated to the attendees for,comment in case anything has been missed,or misinterpreted then signed off by a,director and the quality manager you can,choose different signatories if you,prefer how might I fair one audit,because of problems where the management,review issues which might cause you to,foul on water include management review,vote performed at all management reviews,not performed at the prescribed,frequency prescribed items missing from,the agenda or not discussed minutes not,taken and retained how can I receive,further help from QMS I hope you found,this overview useful youll find many,other topics in our video series but if,you have any further questions please,dont hesitate to call or email us on oh,one six oh three six three oh three four,five or inquiries at QMS UK comm we can,even prepare for and carry out your,management reviews for you on a,consultancy basis if you would find that,helpful,thank you
ISO clause 9.3 Management Review – Integrated Management Review Process
welcome to a short training video on how,to implement an integrated management,system we will focus on ISO Clause 9.3,management review according to iso 9001,ITF 16949 ISO 14001 and ISO 45,000 and 1,management review is now easier to,implement with help of the new ISO an,XSL structure it was designed to create,the common framework to all management,standards and into a line of the various,applicable standard clauses,which secures a better alignment with,the strategic objectives and the,direction of the business by identifying,the risks and opportunities and,incorporating the PDCA approach to,ensure continuous improvement,the first step is to make a gap analyses,for the management review clauses of the,quality safety and environment standards,to compare the similarities and the,unique requirements between the,different management standards to,develop a framework for defining and,documenting an integrated management,review procedure that address all the,requirements from the different,management standards,having a management review procedure for,each ISL management standard you,implement one integrated management,procedure,some organizations call it a shock,management system,step schedule your integrated management,review meeting at the frequency to find,in your procedure at least once a year,the top management shall review the,organizations integrated management,system at plan intervals,to ensure its continuing suitability in,managing the changes in the organization,to meet the stakeholders requirements,the adequacy to ensure that sufficient,resources in terms of people process,infrastructure and operating environment,the effectiveness to ensure that the,planned activities are realized and that,the results will be achieved changes,within the QM ends must be aligned with,a strategic direction of the,organization the management review shall,be conducted at least annually the,frequency of management review shall be,increased based on risk to compliance,requirements resulting from internal or,external changes impacting the,integrated management system and,performance related issues,the management review,and carried out according to a set,agenda including the requirements,described in clause 9.3 from each of the,following management standards,so 9001 the quality management,requirements,I ITF 16949 the automotive quality,requirements ISO 14001 the environmental,requirements,so 45,000 and won the occupational,health and safety requirements,good practice to retain an attendant,register with the date,functions and signatures of the managers,whom attended the meeting,we will now focus on the content of the,management review meeting related to,quality the environment and the,occupational health and safety,requirements the sh eq manager will,first present the status of the,effectiveness of actions from the,previous management review and present,the changes related to the external and,internal issues that had an impact on,the integrated management system on,achieving its objectives for example if,there were changes to the environmental,aspects or labor law or the customer,specific requirements,performance and effectiveness of the sh,eq management system including trends in,achievement of the objectives related to,customer satisfaction,locations,patient results,number of incidents and accidents,audit results,of external providers non-conformities,and corrective actions monitoring and,measurement results the adequacy of,resources and the effectiveness of,actions taken to address risks and,opportunities the ietf 16949 has n,supplement clause 9.3 to 1 with,additional 11 topics to review related,to the automotive specific requirements,typical organization the outputs of a,management review is to review the,achievement results against the,strategic objectives of a company as a,business activity irrespective of,whether an organization is ISO 9001,45,000 or 14,000 certified,and then to determine the actions when,objectives are not achieved and to,identify the resources needed to achieve,the objectives and to decide what,changes needs to be implemented to,improve the integrated management system,the management review minutes should be,distributed to all appropriate members,of staff because it include decisions,and actions to be implemented and as,this will ensure that the integrated,management system is operating,effectively and all stakeholders are,informed the success of the integrated,management process is linked to the,commitment of the senior leadership of,the company and sure that your,management is trained by an organization,who understand how to implement a,practical integrated management system,your success is our priority
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ISO 9001:2015 Management Review (and how to do internal audit on MR)
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MANAGEMENT REVIEW – 8 ACTION ITEMS FOR A SUCCESSFUL MANAGEMENT REVIEW OR EXECUTIVE MEETING
So today weve had the catch-up session quarterly catch-up session with our,executive team so this is us, what youre going to see here is us executing our,planning phase and review phase of our business plan, so for those of you in the,ISO world this is our management review, we do our management review quarterly, so,if you look at any of the ISO standards they talk about management review so,what youre seeing here is our management review cycle in place, us,following the ISO standard so were talking about you know, how have we been,performing, were looking at our statistics, were looking at the results,of audits, were looking at you know how out team have been going, weve been,looking at our process performance and conformance and how were tracking,against our plan and what we said we would do, were looking at all of those,inputs that youll see in ISO 9001 or ISO 14001 or the new standard thats,just about to come out ISO 45001, so youre looking at,management review and business planning, so weve reviewed the last quarter, weve,also looked at the last three years so at every one of these sessions that,were doing in terms of management review and management planning on a,quarterly basis, we still do look back, its not just the last quarter but,weve focused on the last quarter and were focusing on the next quarter,so weve reset our actions and the things were going to implement and,execute to improve our performance, were looking at staff training, were looking,at process improvements, were looking at product development, systems development,and were looking at services development, so its been a really great,session, its been really good energy today, youll see that in the team its,been absolutely fantastic. Weve got, weve now reset our plan for the next,quarter, weve reset some numbers, the forecasting that were,doing in terms of our performance and how were tracking is getting more and,more accurate and and forecasting is a difficult thing to do, but the more we do,this the better we get and so thats what Id probably say to you guys out,there is the more that you do what the better youll get so just get out and do,it, and youll probably hear that quite consistently so for,us, what does this mean for Best Practice? It means more of the same with some,subtle changes in some subtle improvements, not big improvements not,global shifts, were in a consolidation phase and that consolidation phase is,going to marry up with the growth phase so were expecting significant growth,in q3 and q4 which will be the you know the first part of 2018, so were,gearing up for that, weve got q2 so were at the beginning of q2 but,moving into q3 and q4 is where were forecasting that will see big growth,again in this organization so were sort of consolidating making sure were,getting our training right weve been working on our database internally and,some of the operational systems that run this organization, so we really want to,try and finish off some of the training and development work that,were doing in this quarter to allow us to put all of our energy into to the,growth that we expect to see you in q3 and q4 which is really exciting. Bunch of,new people starting, more people coming and joining the Best Practice family,which is really exciting, so you know, the energy is some is,is feeling really good here in the business at the moment and Im quite excited.
How to prepare your Management Review? [Quality Management System]
welcome to the medical device made easy,podcast here is mineralization from,easymedicaldevice.com,and today we will talk about a certain,process that you have to follow under,iso 13485 or even under qsr which is the,management review so um i wanted today,to just have a kind of an explanation of,this process because i had a lot of my,customers that are contacting me and,saying okay what should i do for this,what should i provide what are exactly,the process to to do,so,the idea of today is to explain to you,what is a management review why this is,so important what should be,in terms of documentation available,for review and uh so yeah i hope this,will be really helping you because this,is a key process when you are trying to,get uh iso 13.5 certified,so um i wanted to start first by,explaining to you uh that um the,management review is,mainly mentioned in the iso 13.5 and you,have to have,a procedure that is existing where its,telling exactly how you will execute,this management review,and this match interview is like a,meeting so if you have never been,participating to a management review,its a meeting that is under the,responsibility of the top management and,where the top management has to,evaluate review check your quality,management system they have to verify,that this is working well or if there is,any change to do etc so i will go,through all the inputs and outputs of,your uh quality of your management,review but first,first you have as i said to create this,procedure the procedure should tell you,exactly um how you are executing this,management review and it should not,mandatory but its better to have that,specify also some formulas or,templates or forms,that will be used during this exercise,of management review because its not an,example that you are doing only once you,have to do that periodically the period,can be once every year or twice per year,or once every quarter you can define,this periodicity but you have to justify,also why why once a year why once a year,sufficient so many this is the idea of,saying yes once you are sufficient,because maybe you dont have enough data,or its um within one year that you,really get a lot of information to do,this evaluation because yeah if you do,that every quarter but you dont have,too much data to to review it would be a,waste of time,so when you get,those,forms available then you have to use,them and those forms are really to,gather the information that you are,executing the management review per,process your pair what you are writing,on the procedure so its why those forms,are really interesting because uh then,you can if i can say always follow the,same process to do the management review,which is something that is really,important when you have a quality,management system to not um once,gathered this information another time,another information or another way to,present which can be confusing for for,everyone so you have this management,review that will be,planned then,um once a year or twice a year etc,and,you have also to have people,participating to this management review,so for people that are participating to,this management review they have also to,be trend,it means that you have to have a proof,that they have been trained to the,procedure to the formula of the forms,templates etc so that they are really,understand what is the objective of this,management of you why they are doing,that and which information they should,provide to it so its important to have,this information of i mean this training,done and available so that when people,will be executing and be participating,to this management review they have a,proof that they have been trained to,that so this is something that should,not miss also,one thing also that is important is to,define the quorum so what is the minimum,number of people that should attend this,management review as we said its the,top management,this objective of the management is,mainly for the top management its not,just for anybody its just for top,management to review and assess that,everything is fine within the quality,management system so if the top,management is not present during this,meeting then you cannot do,this management review if maybe one top,management is available maybe its not,sufficient so you have to define a,quorum which is kind of like how many,people and what kind of people are we,looking for for example,at a minimum there should be the ceo,the ceo and the quality uh the vice,president of this country you can,mention those kind of names or you can,say three management with executive,responsibilities etc that should be,available so if those three management,with executive responsibilities are not,available then you cannot perform the,management review and this is something,that is important to have so that when,you are signing the attendance list,those names are there and those people,are also trained as ive told you before,so everything then is working so,mentioning on the procedure the minimum,number of people is really important so,that you you have to cancel the meeting,and you have a justification why you,cancel the meeting if you cannot do it,because the people are not are not,available also,um what you have also to understand is,that a management review is not just a,meeting that you are just,having one once and say oh lets have,the meeting tomorrow and lets uh review,our quiet management system no you have,to prepare this meeting so it can be,maybe one or two months of preparation,sometime where you gather all the data,and we look at after the inputs the data,that you should gather and then youll,gather all those data you will analyze,those data and you will show that to the,top management to tell them here is the,situation for this and that and here is,what we can say about it and then there,should be a discussion its not just a,presentation like um i tell you and you,listen and then you sign the document,you leave no its a discretionary,meaning here are the data do you have,some questions do you maybe something,that is not correct here etc and then,you can you should make it like a living,meeting its not like just a,presentation somebodys showing and you,just uh saying yes yes yes so its why,the preparation is also something key so,you have to have your team that is,preparing that are preparing the data,and uh there will be some quality,information there will be some,production information there will be,some um regulatory information so,therell be information coming from,different places so you have to make,each of your team members involved on,the preparation of this uh slides,usually what we are doing is that,we have this presentation and each time,we speak about a topic the responsible,of this topic is coming and explaining,and answering question of the top,management related to that so this is,mainly what what we are also expecting,from you so,when you are starting your,uh management review first you have to,send an agenda to people so this is,first document number one an agenda,which shows exactly what you will be,looking at what is the period we are,covering uh who should be there etc so,an agenda,then,you are preparing this presentation i,said usually what we are using is like a,power point like a slide deck,presentation and we are providing,information about uh this first topic,the second topic you thought okay and,each time as ive said people are coming,and talking about that so we have a,slide deck of presentation then we have,a report,the report should be providing,information about maybe discussion that,there have been uh also about actions to,perform so you say oh on this slide i,didnt like this way can you gather more,information on this on that or can you,show me this and that so then you can,have an action that is an outcome of,this of this meeting also that you have,to then execute and the last one is the,attendance list so many mainly you are,placing here a list of who attended and,signature and date for those pe
Review Management
Managementbewertung | Management Review | Das fordert die ISO 9001
ein enthusiastisches hallo und,willkommen zu einem neuen video,[Musik],heute habe ich eine frage zum thema,management bewertung also management,review für dich die frage kommt von,thomas und lautet wie folgt ich,persönlich habe jedes jahr wieder die,herausforderung mit dem management,review,bei uns in der firma erfolgt die,erstellung über mich selbst in klammern,qmb und die geschäftsleitung ist dagegen,so gut wie gar nicht beteiligt,normal sollte das ja bekanntlich anders,laufen ich weiß nicht so recht wie ich,es schaffe hier zu einer verbesserten,art und weise zu gelangen,lieber thomas vielen dank für diese,frage ich denke viele qualitäts,managerinnen und qualitätsmanager kennen,diese situation,wir geben uns viel mühe alle normen,konformen eingaben und noch vieles,darüber hinaus zusammenzustellen in,schöne grafiken zu verpacken und am ende,des tages interessiert keine sau außer,vielleicht den auditor aber das ist,nicht der sinn und zweck des management,reviews das management review ist,vielleicht das missverstanden,der werkzeug überhaupt und ich könnte,mir vorstellen in vielen organisationen,wird es überhaupt nicht als werkzeug,verstanden weil es so missbräuchlich,genutzt und aus meiner sicht,missverstanden wird,schauen wir uns zu beginn an was,eigentlich die iso 9001 in bezug auf die,management bewertung fordert in kapitel,9.3 punkt eins heißt es die oberste,leitung muss das,qualitätsmanagementsystem der,organisation in geplanten abständen,bewerten um dessen fortdauernde eignung,angemessenheit und wirksamkeit sowie,dessen angleichung an die strategische,ausrichtung der organisation,sicherzustellen,in den weiterführenden abschnitten gibt,es einige bedeutende punkte,ich möchte hier mit dem punkt der,eingaben beginnen also es müssen,bestimmte eingaben sprich kennzahlen,oder informationen vorliegen damit eine,solche bewertung überhaupt durchgeführt,werden kann,darunter gehören der status von,maßnahmen seit der letzten management,bewertung die veränderung von internen,und externen themen in bezug auf das,qualitätsmanagement informationen über,die leistung und wirksamkeit des,qualitätsmanagementsystems zum beispiel,bezogen auf kunden qualitätsziele die,prozessleistung nicht konformität,ergebnisse aus überwachung und messung,auf die ergebnisse und die leistung von,externen leistungen,sie ist also an dieser stelle werden,ganz viele punkte gefordert die aber aus,meiner sicht auch alle sinnvoll sind um,festzustellen ob unser system angemessen,funktioniert außerdem sind noch wichtig,die angemessenheit von ressourcen,also ob wir für das was wir in sachen,qualität planen auch angemessene,ressourcen in form von zeit personal,maschinen infrastruktur oder sonstiges,haben die wirksamkeit von maßnahmen im,umgang mit risiken und chancen und zu,guter letzt ganz wichtig die,möglichkeiten zur verbesserung der,zweite wichtige bestandteil ist das,ergebnis also sind die ergebnisse die,aus dieser management bewertung,hervorgehen hier sind drei aspekte,entscheidend,der erste aspekt betrifft die,notwendigkeit der änderung des systems,der zweite aspekt beschäftigt sich mit,den verbesserungen nicht nur im system,und am system sondern auch in den,angrenzenden bereichen,und der dritte betrifft den bedarf an,ressourcen also dass ich für die,aktivitäten die wir in diesem management,review festlegen auch die notwendigen,ressourcen schaffe und zwar bei allen,beteiligten die wir dafür brauchen eine,weitere vorgabe der iso 9001 betrifft,die dokumentierten informationen wir,müssen also aufschreiben was wir in,dieser management bewertung gesprochen,haben natürlich müssen die ergebnisse,dann auch entsprechend festgehalten,werden und die heißt das ganz konkret,das dokumentierte informationen als,nachweise der ergebnisse aufbewahrt,werden müssen nun stoße ich immer wieder,auf mythen in bezug auf die management,bewertung und auch thomas hat in seiner,frage eines solchen mythos angesprochen,nämlich den mythos dass die oberste,leitung eigentlich die management,bewertung schreiben müsste das steht in,der iso 9001 aber gar nicht es ist also,durchaus legitim wenn der,qualitätsmanagementbeauftragte die,eingaben sammelt und alles grafisch,schön aufbereitet dass in der,letztendlichen bewertung wie auch immer,ihr euch entscheidet dass sie,durchgeführt wird,alle informationen zur verfügung haben,damit entsprechen die leistung des,systems bewertet werden kann,die bewertung der leistung muss sehr,wohl von der obersten leitung erfolgen,es geht also nicht wenn du hier ein,papierdokument erstellst das,verschwindet dann im schrank oder nur,ausgezogen wenn der zertifizierungsaudit,ohr zum nächsten mal an die tür klopft,ein weiterer wichtiger punkt ist dass,die iso 9001 keine frequenz vorschreibt,es steht hier nämlich nicht geschrieben,wie häufig die management bewertung zu,erfolgen hat sondern es steht dort nur,dass sie in geplanten abständen erfolgen,muss ein weiterer punkt der die rolle,der obersten leitung unterstreicht ist,dass die strategie des unternehmens mit,einfließen muss also das,qualitätsmanagementsystem muss der,strategie des unternehmens,ähnlich seien dafür angemessen sein und,ihr zu arbeiten wenn sich diese beiden,also qualitätsmanagementsystem und,strategie in unterschiedlichen welten,unterschiedlichen universen bewegen,dann kann das zu einem großen problem im,unternehmen werden also ganz genau hin,die iso 9001 gibt nicht vor wer die,eingaben erfasst wer und wie,dokumentiert und wie häufig sondern sie,gibt nur vor dass es gemacht werden muss,welches genau die notwendigen eingaben,sind und dass die oberste leitung die,bewertung vornehmen muss du hast jetzt,verschiedene möglichkeiten du kannst da,die management bewertung auch in form,einer powerpoint präsentation,vorbereiten in einer besprechung die,eigentliche bewertung durchführen und,ein kurzes protokoll verfassen aus dem,die maßnahmen notwendige änderungen und,der ressourcenbedarf hervorgehen und,dann ist die laube im prinzip gegessen,ihr könnt ist das unternehmen selbst,entscheiden um jetzt noch ganz konkret,auf die frage von thomas einzugehen wie,motiviere ich die oberste leitung dazu,sie ihrer rolle gerecht zu werden ganz,einfach macht es ihnen so leicht wie,möglich,dazu musst du verstehen was leicht für,die oberste leitung bedeutet das kann,nämlich sehr individuell sein,auf jeden fall solltest du nicht,verlangen dass die oberste leitung einem,großen text verfasst,du solltest auch nicht erwarten dass die,oberste leitung die eingaben selbst,zusammen sammelt aus meiner sicht,beinhaltet eine gute management,bewertung wenig text viele grafiken,damit schnell sichtbar ist wo liegen die,probleme,wo war die leistung wo lag die leistung,in den vorangegangenen bewertungen und,wir haben wir uns dort verändert,verbessert oder verschlechtert wähle ein,format mit dem die oberste leitung,ohnehin schon arbeitet wenn ihr ein auf,excel basiertes kennzahlen wie es,betreibt also zum beispiel dass das,finanzcontrolling ich schon hat dann,richtet die management bewertung ähnlich,darauf aus dass es keinen systembruch,ist und sich die oberste leitung auch,bei der beschäftigung dieser materie so,wohl fühlen kann wie nur möglich in,keinem fall sollte die oberste leitung,diese management bewertung als lästig,empfinden sondern es ist ja ihre,möglichkeit zu korrigieren wie das,management system in zukunft arbeiten,soll,um die strategie des unternehmens,bestmöglich zu unterstützen was du auch,machen kannst ist die ergebnisse der,management bewertung in einer checkliste,zusammen,du kannst hier die eingangs besprochenen,themen also eingaben und notwendigen,ergebnisse der iso 9001 super als eine,art checkliste verwenden dann vergisst,du nichts und es ist sehr einfach durch,die oberste leitung dieser checkliste,durchzugehen und eine ganz kurze,bewertung hierfür zu verfassen,nur vergiss bitte auch die maßnahmen,nicht die daraus hervorgehen soll also,nur bewerten hilft nichts die maßnahmen,sollten auch gemeinsam mit der obersten,leitung definiert werden,ich hoffe das war