Introduction to ISO 9001; Free ISO training

hi i'm adam fez from speed limited whether you're just starting out on your iso 9001 journey or you're a seasoned professional just looking for a bit of a refresh we hope you enjoy this short free course on iso 9001 and how to implement it in this course what we're going to cover is the structure and overview of iso 9001 the principles and approaches that you need to consider and also a clause by clause breakdown and the typical documents and information that you're going to need to compile let's get started so let's start with what actually is iso 9001 iso 9001 is an international standard that brings together a series of requirements that aim to improve the quality of your organization so by quality of the organization what we mean is that you aim to ensure that you consistently provide products and services that meet customer requirements that you're consistently meeting applicable statutory and regulatory requirements in other words you're complying with legislation and you also facilitate opportunities to enhance customer satisfaction in other words are you satisfying your customers now and into the future looking at the structure of iso 9001 it's been organized into 10 clauses in 2015 the major iso management standards were all aligned so that these clauses all fitted together this made it really helpful then to integrate with other standards but also means that if you're developing a policy for one standard it means that you can add on those other elements let's look at the clauses though for iso 9001 there are 10 clauses within iso 9001 the requirements really start at clause 4 where clauses 0 to 3 are more introductory starting at clause 4 then what we have is the context of the organization which means that you need to determine what goes on in your organization five is about leadership and the requirements that your management team need to provide and clause six is about planning so how are you gonna plan to manage the operations to manage your support and then also manage your improvement processes in clause 7 the requirements for support are set out this includes the resources such as infrastructure but also people resources and competence training communication processes and also what information are you going to need to document and keep as evidence not only to demonstrate you're running a great management system but also if regulators come visiting or you need to provide information to customers in clause 8 this is the heart of the iso 9001 standard as far as your operations are concerned so your operations in any business will probably begin with your customer inquiry processes through to procurement through to the provision of your services or your production and then how do you release products or how do you provide the services to customers that is the focus of clause eight in clause nine we're looking at performance evaluation so having understood what we're doing having laid out those processes for management how are we actually doing against what our desired objectives were and for clause 10 which is about improvement what can we do to either correct issues that have happened or to put them right let's look at the principles of iso 9001 there are seven fundamental principles that iso 9001 has been developed on if you were going to set up a business from scratch you would probably look at those principles and say yes those are things that i could build a business on they will cover such issues as customer satisfaction working with people whether it's your workforce or whether it's your suppliers and building great relationships and also considering things like the process approach so that you understand what happens from start to finish in your company let's look at those principles in a bit more detail the seven principles as outlined in this diagram as i said already customers focus is absolutely crucial to your quality management system you're thinking about your customer needs now and in the future it's important to have really good leadership without leadership a management system with will fail a management system needs leadership to provide resources it needs it to provide direction and clear objectives about what you want to achieve the leadership team will also help you as a quality manager or your teams to make sure that any issues are resolved and that they're given the clarity and direction that are needed to ensure they resolve the third fundamental principle of iso 9001 is about the engagement of people we can put in software management systems until we're blue in the face ultimately businesses are all around people and people deal with people so how you engage with them how you engage with your workers how you engage with regulators or interested parties is really important the process approach a further principle within the management system is about understanding what your processes are in your company from start to finish and understanding how one feeds into another if you can do this successfully then you're on to a really good thing because often what happens is that you might have a department that runs a very effective process and then it fails because it fails to hand over the information or the resources to the next department in order to do their job the fifth principle of iso 9001 is that of improvement the idea is you're going to continually improve your processes and the standard really sets out the minimum requirements of what you need to achieve rather than the ultimate requirements of what you're going to achieve we're going to talk about the process approach a bit more we're going to talk about plan do check act so we'll come back to that concept of improvement a sixth principle is the evidence-based decision making so what facts are you basing your improvement decisions on you need to think about what the information is you're gathering whether it's through your monitoring and measurement of your processes whether it's information that you've gathered from customers on their feedback or whether it's information you gain from internal audits you can use all of that to make an a decision based on fact to improve and a final principle is that of relationship management no company stands as an island and it needs really good relationships with its supply chain so from its customers through to its direct suppliers and in some cases the indirect supplier the further second and third tiers in the supply chain all of those relationships are crucial to helping you achieve your quality goals as i said before in 2015 the iso management standards were reviewed to something called annex sl and what this did was it aligned all of the clauses within the iso management standards so they all fitted the same format effectively as we've looked at clause 4 clause 5 clause 6 those are the same in other standards for environment for health and safety for energy management information security and business continuity and it means that you can align your management systems and manage them more effectively let's look at those other standards just very quickly with iso 9001 we're looking at our quality management so what's your performance now and in the future to ensure customer satisfaction whereas with environmental management you're probably thinking about your environmental issues so how do you prevent pollution and how do you maximize sustainability with iso 27001 you're thinking about your information security so managing your information so that it's confidential it's available and you maintain its integrity with the iso 45001 system and occupational health and safety that system really aims to support you to manage your occupational health and safety systems so that you ensure safe working practices and you meet your legal and other requirements it also ensures really good levels of worker participation so getting the feedback from your workers on the best way to manage those issues that could affect health or safety and finally the business continuity standard which is different to other standards because whereas the other ones are looking at maybe the risks or the opportunities business continuity is is really challenging you to say right what happens if there is an external issue or an internal issue that could cause a failure to the business what could actually be lethal to this business and what are the processes that we're going to put in place to mitigate those issues and how do we then start to recover back to our desired outcome so with this alignment of all these management standards once you've done your iso 9001 implementation you're in a really good place to then build and build those other management standards on top of it and integrate them there are a number of approaches that you have to adopt as part of iso 9001 the first of these that we're going to look at is that of the risk-based approach so the risk-based approach really enables you as an organization to identify and prioritize those issues that most affect quality issues now as a result the decision making is then going to be squarely in the hands of a team of informed managers and will enable you to focus on your critical issues so we had a brief introduction to the clauses and we'll look at those again in a minute but within clause 4 you're going to set out the context of your organization within that you're going to look at the issues that can affect not only your organization but also the needs and expectations of your interested parties all of those things in in that set of information you'll be able to look at and say how likely is this to happen what would be the severity if it went wrong or what's the opportunity that could i could maximize from it assessing that consistently perhaps using a likelihood and severity type risk assessment like we've got um described here really gives you a it helps you to quantify what the issues are so that you can then prioritize them so if something is more likely to happen or it's going to have a more severe outcome if it goes wrong then you know that you need to put your resources onto managing that before something that is less likely to happen or has a less severe outcome so it's about common sense the second approach to adopt within the iso 9001 system is that of the plan do check act about continual improvement and this really helps cement that it's about process not perfection the plan do check act cycle will get you and your team into the habit of reviewing your activities and ensuring that they're capable of achieving their purpose so the planning is really establishing what do you need to do for example that could deliver customer satisfaction if you were looking at the planning of your sales operation you would say what do i need to do to run an effective team or run an effective process so then having planned that you would then do that you would carry out those processes and in carrying out that processes what you're able to do is generate data that you can monitor and measure so have i followed those processes as i said i would have i done it the the level of quality that i expect has it happened within the certain amount of time that i expected it to did it take the certain amount of time that i expected it to or was i able to do it within the cost or budget that i had initially determined using that monitoring and measurement information you can then check what's going on so in checking what you're going to say is what do i know now that i didn't know then and then you're in a really good position to take action so the final part of the plan do check act obviously is taking action and those things could be about putting right something that you haven't followed that you hadn't done as you had originally planned or about improving the situation so you might say here was my first plan here's what i did but i could do it better my actions are going to be let's do that better and then you go back into the planning cycle and you say right this is how we're going to do it this time round and that circle of evaluation and improvement is fundamental within iso 9001 the iso 9001 standard sets out the requirements that are really the minimum level of quality that you need to achieve within other standards in the 9001 family there's there's a standard called iso 9004 which looks at a maturity model the maturity model is about how you can improve from that baseline through to a really optimized and highly performing process so looking at this diagram of maturity step one might be where you've got a process in place but maybe it's a bit ad hoc you would hope that once you've got a process in place you're a bit beyond that and you're actually on step two which is where it's repeatable you can do it time and time again step three is about defining maybe some targets to improve or defining the process a bit better so that people are really clear about what they need to do and that you've got a really solid base for training and development step four takes you on a little bit further and says right is your process more tested have you operated your process have you put it under pressure and have you started then to maybe look at what you could do to improve it and as a result you'll start to achieve step five which is optimization this is where you start to say right my process has been tested people really understand what they're doing and even more than that your team or your workers will then be telling you what you can do to improve it and it almost takes on a life of its own on this continual improvement journey iso 9004 is a supplementary standard to iso 9001 so it's not one that you can get certification for but it's certainly a really useful tool to look at and it gives you a it lays out a journey for improvement and you don't have to apply that to every single part of the 9001 system but for those areas where you do want to improve and where you do want to optimize it's a useful reference so let's look at an overview of the standard and let's just bring all of those kind of concepts that we've talked about already together let's bring together some of these concepts that we've got with the iso 9001 standard we can see here from this diagram that we have a plan do check act embedded within the structure and the framework of the iso 9001 standard the first three clauses well clause 4 for the context clause 5 for leadership and clause 6 for planning really constitute planning type activity clauses seven and eight which are about support measures and also the operations are your operation clause nine which is about monitoring and measurement really covers the check elements and then clause 10 which is about improvement is the acting so you can see how it's embedded within that let's look at the detail within each of those areas we'll look a bit more in detail here at the planning clauses clause 4 5 and 6 so within clause 4 what you're going to do is you're going to set out a description of the business and identify the key issues that could affect quality using that information in subsequent planning will help you focus the attention on the critical issues using that risk-based approach that we talked about now the typical documents that you're going to need to pull together for your system will be a manual which could include a clause by clause description and a scope statement and also if it's necessary if your organization is large enough a separate documented context of the organization which includes a register of interested parties and maybe a table that defines their needs and expectations those things will be really helpful when it comes to clause 6. in clause 5 which is about your leadership that's a little bit more difficult to document but you would expect as a minimum that you have a quality policy and an organization chart that defines the roles and responsibilities of people that are going to manage your quality system in clause 6 for planning the typical documents that you're going to create will be a risk assessment process a risk and opportunity register an objectives register and also a change management procedure that will help you make changes to the iso management system itself so having looked at the planning clauses let's look at those doing clauses clause 7 for support and clause 8 for operations so within support that clause really sets out the requirements that are going to help the management team and the business to implement and maintain an effective management system there are five clauses or sub-clauses within clause 7 that break out the elements such as maintenance the calibration the infrastructure management processes and you'll need to keep records such as your fixed wiring or maybe your calibration records and evidence that you've actually done it and importantly what you're going to have to also have in this cl for these clauses are your staff management and training processes so how are you going to determine and evaluate the levels of competencies of your staff what competencies do you need them to achieve what training or support or mentoring are you going to give them to achieve that and how are you going to know at the end of any particular cycle that they are actually operating with those competencies how effective has it been you're also going to need some communication processes so how are you going to manage internal and external communications in regard for quality so who would be your point person for complaints or who would be the person that an internal worker or employee would go to if they've got a suggestion for improvement so those are processes you're going to need and finally for clause 7 you're going to need some processes that help you define and manage your documented information so documented information doesn't need to necessarily be actual hard copy documents but it could be your electronic information it could be maybe the integrity and security of your databases and how are you going to make sure that anyone who needs that information has access to it there are some overlaps with information security in this and a typical question or audit might be how do you back up that information or how do you protect it from being deleted for example by someone who is unauthorized to the second section of this is is clause 8 which is operations and this really as i said before is the heart of your day-to-day operations so what is for example your sales and ordering processes if you are designing product or services what are your is for this how do you manage your suppliers how do you carry out your day-to-day production or delivery of service if it's appropriate how are you storing or distributing your products and really importantly for quality how do you manage your complaints and how do you manage those product faults that could occur day to day so now we've looked at planning and we've also looked at the doing let's look at the checking clause which is clause nine within clause 9 which covers the monitoring and measurement evaluation and analysis elements of your activities what you're going to need to do is think about the data you're going to collect what data are you going to use to monitor and measure your processes within this clause as well you've got a sub clause for internal audits so understanding your internal audit program and how you're going to set it so what are the processes going to be with your management team that they can say right these are the areas we want to look at and also the subclause 9.3 for management review so who in your management team will be getting together to look at all of this data and understand all of the elements of the management system and make sure that it's operating effectively importantly as well that management team will give you really good input into the priorities that they see for maybe some corrective actions or some improvement objectives so what leadership are they giving you to go through that cycle again to make those actions to start replanning and then to make your processes and operations better so now we've looked at planning we've looked at doing and we've looked at checking now let's look at acting which in the iso 9001 standard is clause 10 for improvement this final clause in the standard really concludes the plan do check act cycle and puts the processes for corrective action and improvements in place the corrective action processes are going to be those things that help you manage the issues that you might have found through internal audits or your issues from complaints or customer feedback things that you're going to need to put right you're going to be able to write those down to understand them and then be able to look for trends across them as well so not only solve the individual problems but then start to be able to see are there actually issues that are occurring and there's a theme and the improvement actions this really ties in with your objectives so those things that the management team wanted to improve the improvement actions really this gives you the governance to make sure that those things happen so who's going to be involved have you set a smart target for example is it specific measured is it achievable is it realistic and is it timed those improvement actions are absolutely crucial and this information from clause 10 all about improvement is great to go back to your teams with and say look this is how we're improving because it helps engage them in the whole process and gives them confidence that you're improving the business and where they work that's the end of the introduction to iso 9001 but let's just take a minute to look at the certification process because ultimately you've embarked on this iso 9001 journey and you probably want to get the reward of recognition to say that you are a internationally recognized organization that is meeting those quality standards so certification will happen once you've got your management system in place and you're able to demonstrate and provide evidence that it's working the certification process has to be carried out by an accredited certification body in the uk certification bodies are awarded this accredited status by an accreditation body and in the uk the uk government has appointed ucas as that body so your certification body will quote you the initial certification which is usually split over two audits so you've got a stage one audit and a stage two audit the stage one audit will look at the documentation that you've put in place for your management system and the stage two audit will look at how it's being operated so together those two audits will then give the auditors confidence that you're meeting the requirement the auditors will be able to put together a report which they will send to a certification committee they will review it and make sure that the due process has been followed and that there is evidence that you meet all of the requirements and at that point you'll get a certificate usually if you're looking to if you're looking to understand how long it takes to actually implement a management system you're looking at a process that could last anywhere between three and six months sometimes it can be done quicker sometimes you can take longer but what you'll need to do is make sure you've got a management system set up you'll have the stage one audit and then typically you'll need to leave a gap of about three to six weeks so that you can start to gain evidence that those processes you've documented are actually being followed so if you were setting out in january to set up an iso 9001 system you would probably expect that your stage one audit could occur in for example march or april you could have your stage two in june to july and at that point then you'd be certified from that point the certificate is valid for three years and annually you'll have a surveillance audit so the first surveillance audit will happen a year after the second surveillance audit will happen the year after that and then in the third year which is when the when the certificate is due to expire you'll have a re-certification audit the surveillance audits are done by sample and we'll probably look at about a third of your processes and they'll always look at your internal audits and your management reviews and your recertification audit will look at your processes it will also look at all of the audits that you've done over the three years and your management reviews and really try to take a strategic view to say what do you do now that you didn't know back when you first implemented the system and what have you done as a result what should have been your journey of continual improvement we really hope you've enjoyed this short introduction on how to implement an iso 9001 system we hope it's given you an insight to some of the services that speeden can offer you we offer a range of instructor-led courses or we can do some bespoke activities at your site to help you and your team to develop your skills please check out our website www.speedn.com and call or email us if you'd like a chat just informally about how we can help you and your business

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Id: uwKl2FvEoYw

Length: 27min 56sec (1676 seconds)

Published: Thu Aug 13 2020