To become ISO 9001:2008 registered, your organization will need to implement a Quality Management System that complies with the requirements of ISO 9001:2008, run that system and collect records, then have a 3rd party auditor, called a Registrar come and audit your system.
If they find that you are complying with ISO 9001:2008 requirements, you will become ISO 9001:2008 registered. The registrar will come back every 6 months or year to make sure you stay in compliance.
I recommend looking at our All-in-one Package for a complete solution to preparing for registration.
Will your products assist in developing and implementing ISO 9000 to meet requirements gain certification?
Yes, our products have helped thousands of companies all over the world successfully implement and register to ISO 9001:2008. Using our products gives you the information, training and confidence you need to lead your company to registration. I recommend our All-in-One package; it is our most comprehensive package, giving you everything you need to implement ISO 9001:2008. It is the best value package on the site.
You need knowledge of the ISO 9001 requirements, a Good project plan and tools to help you build your Quality Management System. We provide these to you here, giving you the confidence you need to complete your project. Our Quality Manual, Procedures and Forms give you a completely documented Quality Management System that meets the requirements of ISO 9001:2008. Use this as a foundation for your system; edit it easily in Microsoft Word to make it your own. Use our Employee Training to educate your project leader and team and introduce ISO 9001 to your employees. Use our All-in-One Documentation and Training Package to combine all of our tools in one money saving package. Remember all of our products include technical support from our ISO 9001:2008 experts.
When ISO 9001:2008 is implemented in an organization there are many benefits including: Well defined and documented procedures improve the consistency of output Procedures ensure corrective action is taken whenever defects occur Defect rates decrease Defects are caught earlier and are corrected at a lower cost Defining procedures identifies current practices that are obsolete or inefficient Documented procedures are easier for new employees to follow Organizations retain or increase market share, increasing sales or revenues For more on this topic visit our page on the Benefits of ISO 9001:2008 read more about the benefits
ISO 9000 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001 is one of the documents in this set; it contains the actual requirements an organization must be in compliance with to become ISO 9001 Registered. We can help you with your ISO Project. I recommend starting with our Free Tools: Free Basics of ISO 9001 Tutorial
Ok, let’s get you started. First of all, if you are new to ISO 9001:2008 I recommend you go through our Basics of ISO 9001:2008 Tutorial. That will give you an overview of what ISO 9001:2008 is, and what it means to your organization. Next, subscribe to our newsletter and receive a "Quick Start Guide" Print your guide and review the steps to Implementation. To get your project off to a great start, order our All in One Documentation and Training Package
When you become registered, your Registrar will tell you how you can use the logo.
The words are used interchangeably, but a company registers for ISO 9001.
ISO 9000 is often used to refer to the set of ISO Quality Management System documents. ISO 9001 is the document that contains the requirements for the Quality Management System. You will register to ISO 9001. ISO 9000 is a guidance document on the fundamentals and vocabulary for quality management systems. ISO 9002 and ISO 9003 are no longer in use. All companies register to ISO 9001.
No, there is no requirement for a certified project manager or a certified lead auditor.
An ISO 9001:2008 registered company has implemented a Quality Management System that meets the requirements of ISO 9001. They have been audited by a 3rd party, called a Registrar, and obtained registration. ISO 9001:2008 Registration shows that the company has an effective quality management system in place.
Well, we have some great information to get you started on your ISO 9001 project. If ISO 9001:2008 is new to you, start with Introduction to ISO and our Basics of ISO 9001:2008 Tutorial. For guidance on Implementation of ISO 9001:2008, go to ISO 9001 Step by Step. And for our most complete package of all the tools you will need for your project visit our All-in-One Package information page.
"International Organization of Standardization" Instead of using an acronym (IOS) they used the Greek word for equal, which is ISO.
Yes, ISO 9001 is relevant to even the smallest companies. You are able to make the system simple, to suit your small organization.
Companies need ISO 9001 Registration for several different reasons. One reason is Market Pressure, a customer of yours asks you to become ISO 9001 Registered. Customers ask for ISO 9001 to make sure that their suppliers have a good quality management system in place. Another reason companies register is for the internal benefits. Registered companies experience internal improvements and increased profitability. Click Benefits to read more about this.
The ISO 9001:2008 standard requires a Quality Manual, Quality Goals and Objectives, a Quality Policy and specific procedures for Document Control, Control of Quality Records, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits. These are the specific procedures mentioned by the standard, and you must have these procedures, but you must also pay close attention to the clause that requires documents needed by the organization for effective planning and control of processes. This means that even though only six procedures are specifically mentioned, your organization must determine what other procedures are required for your organization. We have used 22 procedures to build our ISO 9001:2008 Quality Management System. Customers may use some, or all of these, depending on the complexity of the organization. We find that our customers typically use all of the procedures that apply to the scope of their business. Documentation is an effective way of controlling processes.
There are costs associated with the implementation and maintenance of the system. You will need to have a Registrar come every 6 months or year to make sure your system still meets requirements. Most companies find that the improvements within the company pay for these costs.
ISO 9001 was developed by technical experts from the member countries of ISO. ISO is an international organization that develops all sorts of international standards. You will find their web site at www.ISO.ch
ISO 9001 is very applicable to small business; many businesses as small as 2 to 10 people are registered. We can help small businesses register by saving them the expense of using a consultant.
Yes. We provide tools and knowledge to help you get registered without using a consultant. I recommend our All in one package to provide you with everything that you need.
ISO 9001 contains requirements for a Quality Management System. The requirements are broken down into 5 sections covering: Quality Management System, Management Responsibility, Resource Management, Product Realization and Measurement Analysis and Improvement. Try our Basics of ISO Tutorial.
ISO 9001 applies to R&D functions. For the R&D functions you would need to address the requirements under "Design and Development" We have a process for meeting these requirements documented in our Design and Development procedure. It is available for purchase individually or as part of our Documentation Package.
I'm interested in a 15-20 minute video tape that addresses the basics of ISO9001 in terms of what it is why it would benefit my company etc.
We have a CD Employee Training that can be used to train a group using a computer and projector, or train individually using a computer. It is a half hour long program with audio explanations.
To implement ISO 9001 2000 in your organization you will need to put quality processes in place to address the requirements of the standard, and then follow those processes, collect records and pass an audit by a registrar. I recommend a few steps to get started. Purchase a Copy of the Standard
Visit our free Tutorial
Look at Our All in One Package
ISO is applied to all companies in a similar manner, you will need to design and implement quality system processes to address the requirements of the standard. For medical device industries, you may need to consider an industry specific standard 13485. Check to see if this standard is more applicable to your company.
We use a Quality Manual, 22 Procedures with approximately 30 related forms. You will also have work instruction level documents. The number will depend on the number of processes you have.
ISO 9001 registration shows that an organization has a comprehensive quality management system in place, and that they comply with that system.
ISO 9002 is no longer in use. It was the standard that applied to organizations that did not do design or development. It was made obsolete with the 2000 year revisions. Now companies that do not do design are registered to ISO 9001; they include a "Permissible Exclusion" in the Quality Manual stating that design and development do not apply and are not included in the Quality System.
The ISO 9000 Series was developed by an ISO technical committee. TC 176 is responsible for the ISO 9000 series. Technical committees are made up of industry professionals from member countries. They set up working groups to draft the standard. The standards are circulated and reviewed until there is consensus. Members then vote on adoption of the document as an international standard.
Any company can apply for ISO Certification.
The amount of time required to register will depend on the state of your current Quality System. You will need to have processes in place to meet the requirements of the standard, so getting ready to be registered can take anywhere from about 3 months to 18 months depending on the complexity of your organization and the status of your current quality system.
The way to see the text of the standard is to purchase it from www.asq.org , www.techstreet.com or www.ISO.ch It is a copyrighted document, so you will not find the text online, however you can get a download version so you can review it right away.
The elements are:
4 Quality Management System Requirements
5 Management Responsibilities
6 Resource Management
7 Product and Service Realization
8 Measurement Analysis and Improvement
The best way to find out if a company is ISO Certified is to ask them. If they are certified they will be able to provide you a copy of their certificate.
Any one in the organization can lead the ISO project. The management representative is a typical choice. The management representative is a person with responsibility to make sure the Quality Management System is implemented and maintained, report on the performance of the system to Management and to communicate the importance of meeting customer requirements throughout the company. The management representative also coordinates/communicates with the Registrar.
ISO 9000 and 9004 have further guidance on Quality Management Systems. ISO 9000 has definitions and general guidance, and ISO 9004 provides guidance for performance management. They are not "Normative Standards", that is they do not provide requirements for your quality management system, but more information and guidance for you to use to develop your QMS.
We assist many small companies. There is a lot of information for you on our site. Start by subscribing to our newsletter at: Subscribe and you will receive an Implementation Kit to get you started. Visit our Basics of ISO 9001:2008 free tutorial for an introduction to the standard and the project. Go to our Step-by-step page for Implementation Steps.
Products themselves do not get certified. An organization gets Registration for its Quality Management System. Any type of organization can get registration.
Any company is eligible. The company must build a Quality Management System to meet the requirements of ISO 9001, and have a Registrar come and audit.
When a company is registered, the registrar will give the company a logo or mark that can be used to show that the company is registered.
ISO 9001 Quality Management Systems- Requirements
Any type of company can be registered. There is no requirement to be registered it is always a choice. If you are being asked by customers to be registered, it is a business choice for you to make. Many companies register because of customer demand and market pressures, many register for the internal improvements.
To be a lead auditor, you will need to take a Lead Auditor Training Course, offered by registrars and quality organizations like ASQ . You need to follow up your training with audit experience, observed by a lead auditor. After you get the required amount of experience you can apply to RAB or IRCA to be a Lead Auditor.
ISO 9001:2008 is the latest revision. The next revision will not be out until 2008 at the earliest.
Not usually, at first they are hesitant because another new program must mean more work. But we find that as the system develops and is used they see the advantages, and it helps make their job easier. Then support builds. It is up to Management to see that the program is presented to employees in a way that will get them to support the program and see its benefits.
Yes. There are no limits on size.
It is up to you what you release. It is typical to give the Quality Manual out on request. It is your business decision to release any documentation.
A better question may be "Why not ISO 9001?” It would be difficult to run a business without addressing the management aspects covered by ISO 9000. If ISO 9000 is not used, you will need to develop something that will end up looking very much like ISO 9000. ISO 9000 has done this development for you. Experts world wide have worked on this system for years now, determining what a successful business needs to have in place to achieve that success. You can benefit from this expertise by following the system they have developed: ISO 9001:2008.
ISO has thousands of standards. They number them to keep track, and the 9000 series is all Quality Management. 9001 is the standard with the requirements that you must meet to become registered.
It means that you have a quality management system in place that meets the requirements outlined in ISO 9001, and that it has been verified by a Third Party Registrar.
The current version is ISO 9001:2008. The earliest the next version will be out is 2008
AS9100 includes all of the requirements of ISO 9001:2008 and some additional requirements specific to the Aerospace Industry.
The certificate is for a three year period. The registrar will continue to audit your company throughout that three year period, and then you will need to renew it at the end of the three years.
To become ISO 9001:2008 registered, your organization will need to implement a Quality Management System that complies with the requirements of ISO 9001:2008, run that system and collect records, then have a 3rd party auditor, called a Registrar come and audit your system. If they find that you are complying with ISO 9001:2008 requirements, you will become ISO 9001:2008 registered. The registrar will come back every 6 months or year to make sure you stay in compliance.
That is flexible. You will work with your registrar to determine if you apply it to more than one facility. You can do one facility or many facilities.
ISO is an international group that develops standards of all types. ISO 9001 is the quality management standard that gives the requirements for building and maintaining an effective quality management system. ISO Registration shows your customers and potential customers that you have a good quality management system in place.
Any company can benefit from an ISO 9001 Quality Management System. To answer if you need ISO 9001 Registration, you need to look at your own situation. Some companies are asked by their customers, or their market puts pressure on them to get registered. Some companies need ISO 9001 because they need improvement in their operations.
ISO 9001 applies to the organization as a whole, not just a department.
It expired in 2000. Now you must use 9001:2008.
What happens to your ISO 9001 registration if you are acquired by a company that does not have registration?
It is possible that the certified portion of the company may still maintain the certificate. You would have to meet with the registrar to discuss it with them.
Design is a process that transforms requirements into characteristics.
ISO 9003 is an obsolete version of ISO 9001. The current version is ISO 9001:2008, and it does not have a document numbered 9003.
ISO 9004 is a guidance document that gives you more detailed guidance on quality management systems, useful when implementing ISO 9001. It is "QMS-Guidelines for performance improvements".
Any organization can benefit from ISO 9001. Many companies are asked by customers or their market demands ISO 9001 certification to be competitive. Some industries require certification, for example the automotive industry, aerospace industry and medical device industries have some requirements for their suppliers to be registered to ISO 9001 or industry specific quality management system standards.
Any company can benefit from Registration. ISO 9001 can help you improve your internal operations. If you are asking if you "must" register the answer is if your customers are looking for ISO 9001 registration from their suppliers. You need ISO 9001 Registration if:
- Your customers ask you to become registered
- Your market demands it (competitors are registered, customers like to see or are used to seeing registration)
- You supply the automotive, aerospace, or medical device industries (If you do you want to find out exactly what is required for your company. There are industry specific standards to be aware of. They may apply)
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Most companies take 6 to 12 months. It will depend on the complexity of your organization and status of your current quality system. Read more: How Long Does it Take
You "apply" by selecting a Registrar. The Registrar is the company that will come and audit your organization and grant the ISO 9001 Registration. We have a list of Registrars at: Registrars Before the Registrar comes to audit, you will need to put an ISO 9001 Quality Management System in place.
That would depend on your situation. The time it takes depends on your current quality system, the size and complexity of your organization and the resources you are able to devote to implementing the system. I have seen companies do it in 3 months if they had a good quality system in place already, and put the people needed on the project to get it completed. Read more: How Long Does it Take
No, they are separate systems. AS9100 is based on ISO 9001 but is a different standard.
Yes. Registration is recognized internationally. Be sure to discuss specific accreditations with your registrar.
That is a similar standard with additional requirements for the Medical Device industry.
There are three types of costs that you need to consider.
Cost of Tools: Documentation and Training Tools (This is what we provide on this site) Cost of the Registrar
Internal costs: employee time
The cost of the Registrar will depend on how big and how complex your organization is. The Registrar will charge you depending on how many audit days they spend at your organization. There will be travel costs if the Registrar is not local, and there are administrative and accreditation fees as well. Contact a few Registrars in your area to discuss registration and get quotes for their services.
The other costs depend on if you decide to use a consultant, or if you will be doing this on your own. You can save quite a bit of money if you do not need a consultant. Many companies use tools such as prepared Documentation and Training Tools to enable them to do it on their own. The last cost to consider is the time your employees will need to spend building and implementing the system. Our free Implementation Kit guide can help you estimate the time needed from employees throughout the project.
Yes. We have an Internal Auditor Training Materials package. This is a set of materials for conducting a day and a half long group training session. It includes a Trainer's Guide, PowerPoint presentations, exercises and a set of Documentation for your students to audit. There is a Quality Manual, Procedures, Forms and Records, all with hidden non conformances for your auditors to find. They will plan the audit, hold opening and closing meeting, document non conformances and write a final audit report. Everything you need to conduct an engaging, effective Internal Auditor Training course.
Yes, we offer a Computer Based Training Program to train your employees. It is a general introduction to ISO 9001:2008 and the employee's responsibilities. It is a half hour long course, with quizzes after each section to measure effectiveness of the training. The employee must pass the quiz to proceed in the training. At the end of the training they are able to print a Training Certificate.
We offer a Computer Based Training Program to train your employees. It is a general introduction to ISO 9001:2008 and the employee's responsibilities. It is a half hour long course, with quizzes after each section to measure effectiveness of the training. The employee must pass the quiz to proceed in the training. At the end of the training they are able to print a Training Certificate.
Our training products help you learn about ISO 9001:2008, and train others in your organization. Understanding the Standard is a computer based course for those who will be closely involved in the ISO 9001:2008 implementation project. Introduction to ISO 9001:2008 is a computer based course for all employees to get a basic introduction to the standard.
There are several types of training that you will need to consider. Your project leader, your employees and your internal auditors will all need specific training. You may also need to train Management on what ISO 9001:2008 is, and what their role is during implementation and after registration. We provide training in two formats. We provide computer based training that people can work through on their own, giving you the convenience of each person being able to choose a convenient time, and avoiding pulling people out of the working environment in groups. Computer based training courses are: Understanding the Standard, a 2 to 3 hour course for your project leaders
Introduction to ISO 9001:2008, a half-hour course for all employees
We also provide Training Materials to enable you to present training to a group. Training Materials available are :
Introduction to ISO 9001:2008 Presentation, a PowerPoint presentation and speaker notes covering each clause of the standard.
Internal Auditor Training, a day and a half long program to train your audit team.
What is the difference between the computer based Understanding-ISO-9001-2000 and the 58 slides training An -introduction-to-the-standard?
The PowerPoint slide presentation goes through the standard, and the requirements of each clause. It has speaker notes so a presenter can explain each slide. You can train groups of people on the requirements of the standard with this presentation. The Understanding the Standard is computer based and includes exercises, quizzes, and audio to explain the standard and its requirements. It covers similar topics as the presentation, but in an interactive way. This CD trains one person at a time, and is meant for in-depth training for project leaders.
External auditors (3rd party auditors) must be registered lead assessors. That means RAB training, an exam, and a specified number of hours of 3rd party auditing under the observation of another registered lead assessor. The best place to find the Lead Assessor Training is from a Registrar.
Our most detailed training program is our Computer Based " Understanding ISO 9001:2008”. This program explains the ISO 9001 Standard, its requirements and how you can meet those requirements in your organization. It includes examples and exercises for the student to work through. There are quizzes to measure effectiveness of the training, and a certificate if you pass the quizzes and a final test. This training is meant for those who will be closely involved in the ISO 9001:2008 implementation project.
We have a computer based Introduction to ISO 9001:2008 training program. This is a great way to train all of your employees on the basic requirements of ISO 9001, and what the employee's roles and responsibilities are in the ISO 9001:2008 Quality Management System. This is a half-hour course, with quizzes to measure effectiveness of the training, and a training certificate if the training is successfully completed.
I recommend using one of the following : ISO 9001:2008 Presentation Materials. This is a PowerPoint presentation with speaker notes that prepares you to present ISO 9001 Training to a group. This presentation can be 1 to 2 hours long, and covers the details of the standard. Understanding ISO 9001:2008 is a computer based training that people work through independently. It runs 2 to 3 hours long, includes audio explanations, exercises, quizzes and examples. It covers the details of the standard and how to implement it in your organization.
You will need to train new employees on ISO 9001 as they are hired. You will also need to continue to train employees on the processes they are performing. If an employee is asked to perform a process that is new to them, you must ensure that they will be trained first. If processes are changed, employees will need to be informed of or trained on the changes.
You will need to have training records that show each employee has had the training required for their position and responsibilities.
Is an ISO registered company required to conduct on going training in their process and if so how much?
Yes. Ongoing training is required to make sure that employees are trained as required on the processes they are responsible for. If a process is changed, employees must be trained. If an employee changes responsibilities, they must be trained. New hires must be trained on ISO 9001 an on their responsibilities.
You can evaluate the effectiveness of training in any number of ways. Some examples are: a written test (good for group classroom training), observation of a person performing a task they were trained on (good for on the job training), inspection of product that a person made, having the trainee demonstrate what they learned to an experienced person, certification programs, probationary periods with review of performance.
That package includes materials to conduct group training. The training is designed to be one and a half days long. The material includes a trainer's guide, presentations (PowerPoint), student manuals and exercises, and documentation for the students to audit (Quality Manual, Procedures, Records and Forms) Internal Auditor Training Details
A Quality Management System Standard has requirements for an effective Quality Management System. If a company implements processes to address all the requirements they will have an effective quality management system in place to achieve quality, continual improvement and customer satisfaction.
ISO has thousands of standards. They number them to keep track, and the 9000 series is all Quality Management. 9001 is the standard with the requirements that you must meet to become registered.
Procedures can play an important role in business performance. If the procedures are developed carefully, approved by management and communicated to employees procedures will help ensure that processes are performed in a correct and consistent manner. This will lead to constant quality product or service. It will also allow you to control changes to lead to improvements. As a change to the process is made, it is approved and documented. You can then measure the affect of the change.
ISO 9001 is the document that contains the actual requirements for your Quality Management System. There are supporting documents that give you additional information that you can use to improve your quality management system.
There are five elements that contain requirements for your quality management system. Elements 4 through 8 contain requirements.
ISO 9001 applies to the software industry, as well as many others. There is a guidance document, ISO 9000-3 to help you apply ISO 9001 to the software industry.
You can purchase the standard at: Techstreet
Measurement management systems -- Requirements for measurement processes and measuring equipment
We have a link to a site that does: Visit Techstreet
We have a package of procedure templates for the ISO 9001 quality management system processes. You can find more detail at: Quality Manual and Procedures
Here are the procedures that make up our QMS. They are all available for purchase, either individually or as a package. Document Control,
Control of Quality Records
Competence, Awareness and Training,
Infrastructure Planning of Product Realization Processes
Customer Related Processes
Design and Development
Control of Production and Service Provision
Identification and Traceability
Preservation of Product
Control of Measuring and Monitoring Devices
Monitoring, Measuring and Analysis of Customer Satisfaction
Monitoring, Measuring and Analysis of Product and Realization Processes
Control of Nonconforming Product
You need to schedule management review meetings on a regular basis, quarterly is usually effective. You need to review the performance of the QMS. Review data from corrective action, internal audits, supplier performance, measurement of QMS process, and evaluate how you are doing in meeting quality goals.
You need to schedule management review meetings on a regular basis, many companies fine that Quarterly meetings are effective. You need to review the performance of the QMS. Review data from corrective action, internal audits, supplier performance, measurement of QMS process, and evaluate how you are doing in meeting quality goals.
Your organization can determine the appropriate time frame, but quarterly meetings are very common and are effective. Be sure to hold them at regularly scheduled intervals, and often enough to continually improve the quality management system.
Top management, the management representative and management or leadership from the different areas of the company should attend. You want to make sure that you have included people that will be responsible for devoting resources to the quality management system. Management review meetings will result in actions being assigned to correct problems and make improvements to the system. This could include any area of the company, and it is good to have good representation at the meeting.
No. It is not enough to be effective and lead to improvement of the quality management system. We recommend quarterly or monthly management reviews. Quarterly is the interval we see used most often.
Yes. If you do not do design and development then you may exclude it. You do this by writing a "permissible exclusion" in your Quality Manual. This means you would write in the design section of the manual that you do not do design and you are excluding it from your quality management system. You may do this for any requirement in section 7 that is not applicable to your company. You may only exclude things that do not apply to your organization. If you do design, it must be included.
I would like to know what are the difficulties for small business in obtaining ISO 9001-2000 quality management system?
The biggest hurdles are usually having the technical expertise to run the project, and the time to implement the system. We are here to help you overcome both of those hurdles with our All-in-One Documentation and Training Package Follow that link to see how this package can provide you with the technical information you need, and reduce the time required from you and your staff for implementation.
The management representative is a person with responsibility to make sure the Quality Management System is implemented and maintained, report on the performance of the system to Management and to communicate the importance of meeting customer requirements throughout the company. The management representative also coordinates/communicates with the Registrar.
Management must set a quality policy, identify quality goals and objectives, conduct management review, provide resources for the QMS and make sure that customer requirements are identified and met. Would you like a procedure detailing how to meet these requirements?
A quality management system is a Management System. It covers top level planning, operational performance, quality, service, administrative functions, and measurement analysis and improvement.
An ISO 9001:2008 Quality Management System is a comprehensive management system that leads a company to continual improvement using a process management approach.
Audit questions will be determined by your processes. You will need to ask questions that will demonstrate if the process is being done in planned consistent manner and meeting requirements. We have a checklist that you can use to start your audits.
Process management is managing your business as a system of interrelated processes. If you design your Quality Management System based on ISO 9001:2008, you will be using a process approach.
Integrated Management Systems enable you to have a quality management system and another management system such as environmental, and have them integrated into one management system that will cover both aspects. The integrated management system will work to address both environmental and quality management.
Think of top management as the function that provides all the resources for the quality management system. Who will approve spending?
Top management is critical in providing the resources needed and in making the project a priority for people.
The ISO 9001:2008 standard requires specific procedures for Document Control, Control of Quality Records, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits. These are the specific procedures mentioned by the standard, and you must have these procedures, but you must also pay close attention to the clause that requires documents needed by the organization for effective planning and control of processes. This means that even though only six procedures are specifically mentioned, your organization must determine what other procedures are required for your organization. We have used 22 procedures to build our ISO 9001:2008 Quality Management System. Customers may use some, or all of these, depending on the complexity of the organization. We find that our customers typically use all of the procedures that apply to the scope of their business. Documentation is an effective way of controlling processes.
Our procedures are all written in Microsoft Word and Excel, so they are easily edited to make them your own. We have developed these documents based on a decade of consulting experience, working with a wide variety of industries. Our system evolved as we used it in more and more types of companies over the years, resulting in an effective and efficient Quality Management System. We found that when we went in to a company as consultants, we worked most effectively and efficiently when we started with this proven Quality Management System and tailored it to the individual company. You can do the same thing. Start with this proven system, and make it your own. We are here to answer your questions as you implement the system in your company. I recommend looking at our two Packages; these give you the best value on our products.
Quality Manual and Procedures Package this package includes the Quality Manual, Procedures, and all related Forms to build your system.
All-in-One Documentation and Training Package this package includes all of the documentation listed above, and training tools to train your project leaders, employees and internal auditors. It also gives you additional audit tools, planning tools, presentations, and communication tools.
The Quality Manual and Procedures are all in Microsoft Word and Excel so they are easily edited for your organization.
The people performing the procedure must be able to access it. If they can access it on a computer (conveniently) then you would not need a hard copy. If there is not a computer for easy access, you would need to provide a hard copy.
Procedures describe a process such as "Purchasing". They describe an overall process, where as work instructions would describe a more detailed portion of the procedure such as "Completing a PO" or "Ordering supplies". Procedures are used for all of the Quality System Processes. You are required to have a procedure wherever they are necessary to ensure that the process is performed correctly and consistently. We have prepared procedures for all of the Quality System Processes.
Yes. By using our procedures as a foundation, you will be writing effective, efficient procedures for your Quality Management System.
QS9000 is a quality management system, similar to ISO 9001, but with additional specific requirements for the automotive industry. It is now known as 16949.
Our procedures include sections on responsibilities, definitions, a step by step description of the process, and related forms and required records.
Not at this time, but you can use the ISO 9001 procedures as a foundation and add in the 17025 requirements.
Documented Quality Procedures will help you control your processes, helping to ensure that they are done in a planned manner, consistently, and according to criteria.
We have a Free Quick Start Guide that explains how to implement the ISO 9001:2008 procedures in your organization. You can get this by Subscribing or by emailing a request to firstname.lastname@example.org
You will need to evaluate and approve your suppliers, and continually monitor their performance. You need to review and approve purchasing documents before release.
To obtain ISO 9001 you need to implement a documented quality management system that meets the requirements of ISO 9001, run that system, and then have a Registrar audit the system. If your system complies with the requirements, the Registrar will grant you registration (certification). For details see: Basics of ISO 9001:2008
The AS9100 standard requires specific procedures for Document Control, Control of Quality Records, Control of Nonconforming Product, Corrective Action, Preventive Action, and Internal Audits. These are the specific procedures mentioned by the standard, and you must have these procedures, but you must also pay close attention to the clause that requires documents needed by the organization for effective planning and control of processes. This means that even though only six procedures are specifically mentioned, your organization must determine what other procedures are required for your organization. We have used 24 procedures to build our AS9100 Quality Management System. Customers may use some, or all of these, depending on the complexity of the organization. We find that our customers typically use all of the procedures that apply to the scope of their business. Documentation is an effective way of controlling processes.
ISO 9001:2008 requires a Quality Manual. Our manual meets the requirements of the standard, and simplifies the task of writing a Quality Manual for your company. Instead of starting from scratch, you will use our fully written manual as your starting point. The manual describes what your company must do to meet the requirements of the standard. You edit the manual so it describes your organization. The information in the manual helps you determine how to structure your ISO 9001:2008 Quality Management System.
The Quality Manual is 35 pages long. Our manual meets the requirements of the standard, and simplifies the task of writing a Quality Manual for your company. Instead of starting from scratch, you will use our fully written manual as your starting point. The manual describes what your company must do to meet the requirements of the standard. You edit the manual so it describes your organization. The information in the manual helps you determine how to structure your ISO 9001:2008 Quality Management System.
That is an electronic file. You can download it immediately after purchasing it. You may also request that a back up CD is shipped to you. The manual does not come in Hardcopy, because you will need to edit it to make it your own.
A Quality Manual describes your company's overall Quality Management System. It states, in a general way, how your company meets the requirements of ISO 9001:2008. A Quality Manual is required by the standard and must include a reference to the procedures of the Quality Management System, and identify the interrelation of the Quality Management System Processes (often handled in a flow chart).
I recommend starting with our Quality Manual to benefit from our years of ISO 9001 experience and save time and resources. A Quality Manual describes your company's overall Quality Management System. It states, in a general way, how your company meets the requirements of ISO 9001:2008. A Quality Manual is required by the standard and must include a reference to the procedures of the Quality Management System, and identify the interrelation of the Quality Management System Processes (often handled in a flow chart). The Quality Manual is also where you identify requirements that do not apply to your company. For example, if you do not do design or development you would write a "permissible exclusion" in your Quality Manual stating that the clause does not apply.
We can help you out with that. We have a fully written Quality Manual that you can use. You will edit this manual in Microsoft word to make it your own. Quality Manual This manual is easy to use, and has guidance on how to tailor it for your company. The manual is 35 pages long, and is in Microsoft Word. It will save you much time compared to starting on your own; it will also make sure you are starting off on the right track with your quality management system.
Yes. The manual must be controlled. For more detail on Document Control, try our Document Control Procedure.
Quality Manuals are typically structured similar to the ISO 9001 Standard, this is not a requirement, but is a common effective approach. Each section briefly describes how your organization meets the requirements of the standard, and references the quality system procedures related to that section. The quality manual will also describe the interrelation of the quality system processes. This is often done in a flow chart.
Does the ISO 9002 2000 Quality Manual and Procedure package includes a hard copy manual and a back up CD?
The package is electronic. You can download it immediately after you purchase. When you order you will see a "Back up CD" in your cart. If you leave that in you will be sent a CD by mail. We do not send a hard copy. You will need to edit these documents so a hard copy will not be useful to you. You will print your manual and procedures after you edit them for your organization.
I recommend starting with our Template: Quality Manual You will save a tremendous amount of time. To write a quality manual from scratch, outline how your company meets the requirements of the ISO 9001 standard. The information in the Quality Manual is a general summary of your processes. Refer to Quality System procedures throughout your manual.
The role of the Quality Manager can be defined by your Quality Management System. Many companies make the Quality Manager the Management Representative, but there is no requirement for this. Some companies create ownership of the system outside of the Quality Department by making someone else the Management Representative.
Following the requirements of section 5 of ISO 9001 will help management promote quality improvement:
Establish a quality policy
Implement and maintain a quality management system to meet the quality policy. Support the quality policy with quality goals and objectives
Communicate the importance of meeting customer requirements throughout the organization
Provide resources for the Quality Management System.
Explain the philosophy of total quality management as applied to a manufacturing organization.
A Quality Management System is used to address customer satisfaction. It does this by focusing on the 8 quality management principals.
The Quality Management Principles are:
Customer Focus- understand your customer needs, meet requirements and strive to exceed customer expectations.
Leadership- Top management establishes the direction and purpose of the organization. Create an organization where everyone is involved in achieving objectives.
Involvement of People- People at all levels of the organization are important and are fully involved in meeting goals and objectives and customer requirements.
Process Approach- activities are managed as a process
System approach to management- the organization is managed as a system of interrelated processes.
Continual improvement- continual improvement is a permanent objective for the organization
Factual approach to decision making- data is used for effective decisions.
Mutually beneficial supplier relationships- the organization and suppliers are interdependent, beneficial relationships create value.
The ISO 9001:2008 general criteria are to meet customer requirements and continually improve customer satisfaction. The elements that you need to have in place to achieve this are detailed in the Standard.
A quality policy covers the whole organization, has to do with the purpose of the organization, the commitment to comply with requirements and continually improve. Quality objectives are more specific, are set at all levels of the organization, are measurable, and when achieved support the quality policy.
Some typical quality objectives are: Decrease nonconforming product by X% Increase customer satisfaction by... Decrease turnaround time/delivery time etc.. Improve corrective action response time... Increase efficiency of X process... Remember; make your goals and objectives measurable.
Clause 5 details the responsibilities of Management. Management must set a quality policy, identify quality goals and objectives, conduct management review, provide resources for the QMS and make sure that customer requirements are identified and met. There is a procedure at: Procedures For actual requirements see ISO 9001:2008.
Management must show commitment to development and implementation of ISO 9001. For example: set a quality policy and quality objectives, make sure the QMS is established to meet those objectives, provide resources, decide on actions for continual improvement, and conduct management review. For actual requirements, see ISO 9001:2008.
Clause 5.2 covers customer focus. Management must make sure that customer requirements are determined and met. The first step is to make sure that the needs and expectations of the customer are determined; there must be a process for obtaining this information and communicating it throughout the organization. For actual requirements see ISO 9001:2008.
Clause 5.3 is about the Quality Policy. The highest level of management is responsible for developing and implementing the Quality Policy. The Quality Policy must address the purpose of the organization, a commitment to comply with requirements, continual improvement of the quality management system, and the framework for quality objectives. The policy must be communicated and understood throughout the organization, and be reviewed for continuing suitability. For actual requirements see ISO 9001:2008.
Top management must make sure that quality objectives are established at relevant functions and levels within the organization. Make sure the quality objectives are measurable, attainable and realistic. For actual requirements see ISO 9001:2008.
Customer satisfaction requirements are found in 8.2.1. This clause requires that your organization monitors information relating to customer satisfaction. Does the customer perceive that all requirements were met? For actual requirements see ISO 9001:2008.
Clause 7.5.4 requires you to have processes in place to handle product or other customer property. You must protect it from damage or loss, and report any damage or loss to the customer. For details, see ISO 9001:2008.
Organizations depend on their customers and therefore should understand current and future customer needs, Meet customer requirements and strive to exceed customer expectations.
Clause 7.2.3 requires your organization to have effective processes for communicating with customers. This process must include: product information, questions, contracts, orders, amendments and feedback including complaints.
Customer satisfaction can be measured in surveys, interviews, focus groups, general phone calls, returns, complaints, compliments and any other feedback that you receive from customers.
You need to get their feedback. A survey is one option. Phone calls and regular communication are also methods. Most organizations will find that several methods are needed to get feedback.
Start by setting goals and objectives for your processes. Then identify a measurement for that goal. Set up a process to collect data on the measurement. Report on the measurement, and take action if you are not meeting your goals.
By building an ISO 9001:2008 based quality management system, you will build processes that lead to continuous improvement. Processes driving improvement include: Internal Audits, Corrective and Preventive Action, Management Review, and Measurement, Analysis and Improvement of Processes. You will also drive improvement by setting quality goals and measuring performance against those goals and making changes and improvements as needed to meet those goals.
If our company does a corrective action, and it prevents the problem from reoccurring, is this considered preventive action?
No, your corrective action is taken to prevent reoccurrence of the problem; it is part of the corrective action process. In order to be considered preventive action you must be preventing a problem from occurring in the first place. One good place to determine preventive action is during management review, when you review data from the QMS. You can look at that data to see what problems might occur in the future, and take action to prevent them from occurring. You might also find opportunities for preventive action by reviewing corrective actions to see if the information shows you other problems that might occur, and take action to prevent them.
This requirement is found in Customer Related Processes; these are “implicit” requirements. What do you know about your product that the customer does not need to specify, or may not even know themselves? You know the intended use of your product, and are the expert on the product. If a customer in a luggage shop requests “Carry on Luggage”, they may not know what the acceptable size is to be able to carry on the bag. But the company that sells their bag as “Carry on Luggage” should know what the restrictions are, and meet those restrictions even though the customer did not know the size they needed.
The most common aspects of performance that are measured are quality, service and price. What can you put goals and numbers to that will tell you how the supplier is performing in each of these areas? Decide what the most critical aspects are to you, is it an item that you can get from a number of different suppliers? Is price, or on-time delivery the deciding factor? Or is it an item or material that can vary in quality and will affect the quality of your product? In this case, the supplier with the most consistent quality may be the best source, regardless of the price. Measure what is most important about what is being supplied.
In 7.5.1 the requirements focus on the processes that actually create your hardware or your service that is delivered to your customers. You are required to follow the plan that you created based on requirements in 7.1A written procedure for this section will be useful in defining how you are meeting these requirements. By clearly documenting the way that you are satisfying the requirements of 7.5.1 you will ensure that the requirement are understood and followed consistently.
Most organizations will also need documentation in the form of work instructions to control these processes. Your planning in 7.1 will determine where these are needed; to meet the requirements of 7.5.1 these must be in place, available to employees performing the process. Instructions can take many different forms: written steps, pictures, drawings, prints, travelers or flow charts are some of the methods used. Specify in your procedure what documents are necessary for the control of your processes.The procedure should also state how you ensure that suitable equipment is used, and how release, delivery and post-delivery activities are controlled.