Iso 9001 managementImplementing a quality management such as ISO 9001:2008 requires transforming theculture. It will affect the entire company, not just the quality department. More people inthe organization are affected by it than just the management representative, or the personspearheading the effort. Implementing a quality system to the point of certification andregistration is a daunting task but is achievable with your current resources.Implementation times can vary but it can be accomplished.When considering implementation of a quality system such as ISO 9001:2008 you shouldconsider "why are you doing it?" Companies pursue quality system implementation forvarious reasons, to become better, their customers are requesting it, they are havingquality problems or they would like the recognition of being certified. In either scenario,the circumstances are different as will be the driving force to implement the qualitymanagement system. An organization should consider the benefits of having an ISO9001:2008 quality system and are not concerned about flying the flag. The followingsteps best describe the implementation process:1. Why do you want to implement an ISO quality system?2. Educate Top Management3. Commitment from Top Management4. Select a Management Representative5. Select Implementation Team6. Understand the current system and processes7. Understand the Standard8. Gap Analysis9. Create an Implementation Plan10. Employee Training11. Monitor12. Internal Auditor Training13. Internal Audits
14. Select Registrar15. Management Reviews16. Continual Improvement17. Pre-Assessment Audit18. Registration AuditWhy implement a quality management system such as ISO 9001:2008 To understandwhy you would consider implementing a quality management system, let us understandthe various quality management systems. There is the ISO 9001:2008 standard along withthe industry specific standards such as ISO/TS 16949 (Automotive), TL 9000(Telecommunications) and AS9100 (Aerospace). In addition to these standards is theMalcolm Baldrige Award.The ISO 9000 standards cover all areas of control which has a potential to impact thedegree of compliance of a product or service. The standard is not a cookie cutter qualitysystem that means you will have the same quality system as your competitor, orcustomer. It means you will have quality systems that meet the minimum requirementsbut the details of how the requirements are met can vary dramatically.There are several misconceptions surrounding the standard, one is it creates a great dealof non value added paperwork, another misconception is it does not provide any valuebecause all I have to do is "say what I do and do what I say" and they third misconceptionis it restricts creativity by burdening employees with structured approaches.Addressing the first concern of generating non value added paperwork. The belief is youmust document, document, document everything you do. Actually, the standard requiresone quality manual, six procedures, instructions where necessary and 26 records. Thismay sound like a lot but it really is not. The need for extensive documentation can bemitigated with a thorough training program that reinforces what is to be done and how itshould occur. It is common for companies to utilize more documentation than thestandard requires, simply because they find it valuable. When you are in an environmentof continuous change and improvement, processes, duties and tasks are continuallychanging to keep pace with improvement. It could be extremely hard to know what theagreed upon method was without a formal documentation and change process. The endprocess would drift because the tasks within the process drift. It would be analogous tonot having maximum speeds posted; they would be verbally communicated from area toarea.The second misconception is that the standard does not really benefit a company becauseit simply means you documented what you do (even if it is wrong) and you can show youdo it. I recall an example when I was touring a manufacturer and I could see they werelacking in quality systems. I asked the Vice President of Quality if they considered
adopting an ISO quality system. He replied, "ISO is nothing more than doing what yousay youll do. We could make cement life jackets and we could get certified. Ourcustomers wouldnt buy cement life jackets". I listened to what he said (laughing inside)and suggested he get some training on the standard, because that is not the intent. Thecurrent standard focuses on ensuring you provide a product or service that continuallymeets the requirements of the customer with the aim of improving customer satisfaction.To make a long story short you could have a system that is extremely well documentedand everyone follows the procedures and instructions. If this system is not producing anoutput that is meeting the requirements of your customer you will not get certified, end ofstory. Understand, the documentation portion of the standard is a tool or method, the endgame is customer satisfaction and meeting you business goals.The third misconception perceives the standard as restrictive in that it binds employeesinto a specific, structured way to do their job. It removes creativity and replaces it with amundane repetitive approach. This is to some degree true and dependent upon theorganization. The level of control is at the discretion of the company. My experiencesupports having a level of structure that is consistent with achieving the desired output ofthe process. For example, if the process is purchasing, the desired output is to havequality product delivered on time in the correct quantities.The ISO 9001:2008 quality system standard provides an organization with a solid qualitymanagement system to build upon and improve. The objective of the ISO 9001:2008standard is to provide a guideline which enables an organization to deliver a consistentproduct or service that meets the customers requirements and strive to enhance customersatisfaction. The requirements within the standard are developed for a company tomaintain a predictable output from their key business processes and continually improvethose processes.ISO 9000 is a combination of three quality system standards, ISO 9000, ISO 9001 andISO 9004. The ISO 9000 standard covers the concepts and vocabulary. The ISO 9004standard is guideline for improvement. The ISO 9001 standard is for quality systemrequirements and is the only standard with requirements. ISO 9001:2008 means the ISO9001 standard with the revision year of 2008. From this point forward when I referencethe standard I am referring to the ISO 9001:2008 requirements standard.Is an ISO 9001 quality system right for you? To answer that you must first answer whyare you going to implement and possibly get certified to the standard? Let me give you afew scenarios that may help.Scenario 1 Your company is doing well. Your sales are increasing, you have little or nocompetitive pressure to reduce costs and upper management is happy with the currentstate of the company and the business climate. Your customers are not requesting you tobecome certified and do not perceive a competitive advantage with having an ISO9001:2008 certification. Implementing and becoming certified to the standard is probablynot right for you at this time. Chances are you will not get the support you need orconvince anyone in upper management there is a need. Could implementing an ISO 9001
quality system improve your current situation? Absolutely, you could see cost savingsand improvements in all types of areas. Implementation is more of timing thing and rightnow sounds like the wrong timing.Scenario 2 Your company is doing well. Your sales are increasing, you have competitivepressure but your current business practices are able to keep you competitive. Uppermanagement is happy with the current state of the company, but your customers arerequesting it of you. You are pursuing ISO 9001:2008 certification because yourcustomers require it. I have experienced this difficult situation many times. The majorobstacle is that nobody in the organization wants it or realizes a need for it. The drivingforce is external. An ISO 9001 quality system will probably be implemented andcertified. The big question lies in the long term effectiveness and sustainability of thesystem or is it only needed to "fly the flag". You can approach this by learning as muchas you can about the standard so you can speak intelligently about it. You will continually"sell" this program to upper management to obtain their buy in. Once the benefits of theprogram begin to surface, your selling efforts will diminish.Scenario 3 Your company is doing marginal to bad. Sales are level to decreasing; youhave quality problems that are adding a lot of cost. You are experiencing pressures fromglobal competitors. Upper management is not content with the current state of thebusiness, but they are unsure what to do. The climate is good for implementing an ISO9001 quality system. If you can convince top management of the benefits and expectedresults of having a quality system this can be very good environment for implementation.You can choose to not become certified, you will gain benefits by simply having a qualitysystem modeled after ISO 9001:2008. The benefits of having a structured quality systemwill provide the incentive and reward. Having implemented ISO 9001 quality systems inall three scenarios, experience has proven scenario 3 is the best. It is much easier toachieve buy in and commitment from the top.The overwhelming question for top management to answer is "why are we doing this andwhat do we want from it?" Understand why you are doing it and be fair regarding whatyou want from it. Dont go in with expectations of an elite quality system generating agreat deal of benefits if youre going to seek the path of less resistance towardimplementation and registration.Educate Top Management The education process for top management is a two-partapproach. One part is to educate them on what ISO 9001:2000 is, the benefits, how it fitsinto your current business and what it will take to implement the system and be certified.The second part is to educate them and ensure they understand why they are doing it andwhat the challenges are.What are the ISO 9000 standards? We discussed this previously; ISO 9000 is acombination of three quality system standards, ISO 9000, ISO 9001 and ISO 9004. TheISO 9000 standard covers the concepts and vocabulary. The ISO 9004 standard isguideline for improvement. The ISO 9001 standard is for quality system requirementsand is the only auditable standard.
The ISO 9000 standards are internationally recognized. They are developed, maintainedand revised by the International Organization for Standardization or ISO. ISO maintainsthousands of standards. The ISO 9000 standards deal with quality management. You mayhave heard of ISO 14000 which deals with environmental management.The ISO 9001:2000 standard is adopted as a national quality system in more than 100countries throughout the world. There are over 700,000 ISO 9001:2000 certificates issuesin more than 140 countries worldwide. The number of certificates in Europe exceeds200,000; the number in the US is over 60,000 with an estimated 30,000 organizationscurrently pursuing ISO 9001:2000 certification.The benefits of an ISO 9001:2008 quality system The soft benefits of an ISO 9001:2008quality system are improved quality and customer satisfaction. The hard savings come inthe form of a tangible reduction in the cost of quality. Appraisal costs will decreasesignificantly as will failure costs. A slight increase in prevention costs should beobserved, which is desired, but the savings in the other two areas will overshadow theslight increase you see in prevention costs. For a quick review, appraisal costs are thosecosts associated with inspecting, evaluating and testing. Failure costs are costs associatedwith scrap, both internal and external along with warranty. Prevention costs areassociated with quality planning, fmeas, control plan development and qualityengineering. Depending upon your companys current situation including market, size,business practices and culture, it should be safe to estimate a savings in the area of 1% ofsales. There is no reason why you cant realize savings of up 2 - 5% of sales. Thisamounts to approximately $1,250,000 annually for a $50,000,000 company. On averagefor a $10,000,000 company you could expect savings in the $250,000 range. Where dothe savings come from? They are in the form of reduced inspection, rework, scrap,warranty and handling customer complaints. How does the implementation of an ISO9001:2008 quality system realize cost savings? It is estimated that approximately 75% ofthe total quality costs are the result of internal and external failures. For a manufacturingcompany, failure costs are associated with sorting or reworking product. For a servicecompany, examples of failure costs would be working with a customer to resolve aproblem or revising documents because they were not done correctly. Having a qualitysystem in place will reduce significantly the amount of failure costs incurred. You willalso be able to reduce the amount of appraisal costs or how much you test, inspect orvalidate the product or process. Below is an example of the savings realized by acompany after implementing an ISO 9001:2008 quality system.A study was completed that showed a company reduced its total cost of quality from$1,323,302 to $748,567. These are staggering improvements. Keep in mind that salesremained level but direct labor hours did not. A reduction in direct labor hours wasobserved due to process improvements. The cost of quality breakdown does not includefinancial gains in productivity, inventory reduction and reduction in changeover time. Animportant feature to recognize in the chart above is the shift in costs from appraisal andfailure category to prevention.
The important thing to remember is the savings are only visible if the accounting systemsare in place to accurately report them. The process to capture, report and analyze the costof quality is very detailed and beyond the scope of this article. There is a financial rewardfor implementing an ISO 9001:2008 quality system.How ISO 9001:2008 fits into your current business model The thought of a qualitymanagement system similar to ISO 9001:2008 brings fear to people because they believethey have to adopt someone elses program, or force a system or method to work forthem. The intent of the standard is to adopt a system that works for you. You couldbenchmark a company and observe how they determine customer satisfaction and yourfirst thought is, "that would never work at our place". That is alright, there is more thanone way to "skin a cat".Here is the best piece of advice I can offer, there is no best way to implement a process orcreate a system. There is no single best method or the right way to do it. That is wherecontinual improvement becomes important. Dont become overwhelmed with trying tofind the one correct method, get something implemented and continually improve it. Thepower and value with the standard is that you start somewhere and improve. Noteveryone starts at the same place or ends at the same place. This endeavor to implementan ISO 9001:2008 quality system does not end with certification. Not all ISO 9001:2000registered companies quality systems are the same. Just like not all doctors, lawyers,teachers or car mechanics are the same. They all have certifications and credentials butdifferentiation lies in their approaches to the job.The implementation and maintenance of a quality management system can be tailored toa specific company. Dont confuse this with allowance to not meet the requirements. Itmeans there are many ways to meet the requirements. You can choose to meet therequirements or you can choose to exceed the requirements. It is dependent upon theorganization. My hope is that should you adopt the ISO 9001:2008 standard andimplement it, your decision is to do more than just simply meet the requirements of thestandard. This is where so many companies fall short in realizing gains from a qualitymanagement system. They do just enough to meet the requirements but never pushthemselves to exceed. The implementation of a quality management system is likeanything else in life, you get out of it what you put in.What it will take to implement ISO 9001:2000 This is dependent upon how fast you wantto go, status of your current business practices and what type of resources you have. Atypical timeline would be a year. I see no reason why you cant go from where you arenow to certification in one year. Can you do it quicker, say six months, three months, yes.It just takes time and money. Time and money can cure just about anything. I wish itcould cure everything, but unfortunately it cant. From a human resources standpoint, fora single location company of about 500 people it will take about 4500 man-hours toimplement on your own. Keep in mind a portion of that time will be consumed becauseits new to you. It wouldnt take a consultant or someone with experience that longbecause theyve done it before. If you hire a consultant you can reduce the amount of timeit takes, but you will spend it in consulting fees. A good estimate would be about 8 man-
hours per employee to complete it in a year by yourself. At an estimated cost of $25 perman-hour, you may look at it as $20,000 for a 100 person operation (8 x 100 x 25) =20,000. One thing to keep in mind is the people working on the project are there anyway,you are not hiring extra people. You are going to temporarily reassign resources toaccomplish the goal.Now lets look at the cost to get certified. Depending on the registrar you select and welltalk about that later, the costs can vary slightly. A good baseline for costs to becomecertified and maintain certification, are as follows:Document Review $750 onetime cost, pre Assessment Audit $4,500 Registration Audit$7,500 one time cost Surveillance Audits $4,500 ongoing annual costTraining costs should be in the $1,400 - $10,000 range for internal auditor training. Youcan cut some costs of training by having one person in your facility trained and then havethem train your internal auditors ($1,400) or you can have all of your internal auditorstrained by an outside source ($10,000).Commitment from top management I cant teach you how to get commitment from topmanagement, Im not that good, and nobody is. What I can teach you is how important itis, what it means and how to tell if top management is really supporting theimplementation of a quality system. Can you implement an ISO 9001:2008 qualitysystem without top management support and commitment? Yes, but the resultant qualitysystem will not be as effective as it could be and you will probably find yourself askingwhere the benefits are. You will question the validity of the standard and the qualitysystem because you wont see a dramatic change in your complaints, quality levels,quality costs and warranty. You can implement a system, pass a registration audit and getyour company ISO 9001:2008 certified. I have seen a large number of companies that arecertified but are not reaping the benefits of the standard or the quality system. The rootcause of this is most often top management support.In an attempt to avoid this scenario, it is important to educate top management of thecommitment requirement and the ramifications of falling short. Educating topmanagement does not guarantee the commitment. When the results are not there andpeople begin to question the initiative, you can point to this as a possible way to right theship.Top management commitment does not mean they verbalize it. When it comes to anendeavor such as implementing an ISO 9001:2008 quality management system, peoplewill not care what you say; they want to see what you do. It will be extremely difficult toget momentum when top management talks the talk but will not walk the walk.Employees at all levels of the organization will be watching to see if this is real, or is itanother "flavor of the month". They wont look at the management representativesingularly; they will be watching the members of top management and particularly thehighest ranking individual at that site.
That individual must provide continual support for the implementation process. Theyachieve that with actions that are consistent with what is spoken. For example, a situationexists where an area is having problems with a specific supplier. This has been occurringfor six months and no activity is taking place. People will not believe top management isserious or supports the implementation of a quality system if this occurs. Take the samescenario but now the top ranking individual communicates to the employees what isbeing done and when. This is a big step. The biggest step is doing something to correctthe problem.The key for top management is to be visible and active in the effort and have their actionsconsistent. If this hasnt been a characteristic of top management at your facility then theyneed to change. Can it be implemented without this, yes but as we stated above it will bemuch more difficult and the results you get will be significantly reduced. This effort cantbe viewed as something the quality manager, improvement manager or any otheranointed person does. This must be an effort spearheaded, guided and monitored by topmanagement. If it is not, everyone associated will know and the progress will be slow, theresults will be substandard and your frustration level will be high.Select Management Representative and Implementation Team The managementrepresentative is the person who has the responsibility to report on the status of thequality system and is most often the person who will spearhead the efforts. This personoversees the implementation process and is responsible to ensure management is aware ofthe condition of the quality system in order to facilitate continual improvement. It is notimperative this person is part of top management, but it does help. If the managementrepresentative is not a member of top management make certain they have direct report tosomeone in top management. The management representative is to the ISO 9001:2008implementation what a black belt is to a six sigma project. They are the catalyst thatmakes the reaction move. Important characteristics of a management representative areforward thinking, change agent, and embody continual improvement, positive thinkingand not content with just getting by.The next step is to identify the implementation team. This can vary depending upon thesize of the organization. A 500 person facility could have an implementation team ofperhaps 10 - 15 people. A 50 person facility could manage with an implementation teamof 1 to 2 people. For the implementation team youre looking for some resources thatcould carve 1 - 2 hours per day out of their schedule and work on the ISOimplementation. You are also looking for change agents within the company. You do notwant to fill your implementation team with individuals who are antagonistic, negativethinking and happy with simply doing what it takes to meet the requirements.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards