TQM Assignment

1) What is ISO? ISO (International Organization for standardization) is the worlds largest developer and publisher of international standards. The ISO 9000 family of standards relates to quality management systems and is designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002 [1] ). The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems (Tsim et al, 2002 [2] ), including the eight management principles (Beattie and Sohal, 1999;[3] Tsim et al, 2002 [2]) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide [4] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized[5][6] as being wasteful and not being useful for all organizations.

2)How many times were the standards revised ?

4 times ISO was revised in 1987,1994.2000&2008

3) Write the historical background of ISO 9000 and provide details about the origin of quality and the evolution of ISO 9000. The ISO 9000 family of standards relates to quality management systems and is designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002 [1] ). The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems (Tsim et al, 2002 [2] ), including the eight management principles (Beattie and Sohal, 1999;[3] Tsim et al, 2002 [2]) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.

Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide [4] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized[5][6] as being wasteful and not being useful for all organizations.[7]

Evolution 1987 version ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:

ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.

ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.

ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced. ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL

SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent 1994 version ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating

shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system 2000 version ISO 9001:2000 combined the three standards9001, 9002, and 9003into one, called 9001. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimization of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit. The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard. ISO 9001:2008 only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

Worldwide total of ISO 9001:2000/2008 certificates

Dec Dec Dec Dec Dec Dec Dec Dec Dec 2000 2001 2002 2003 2004 2005 2006 2007 2008

Dec 2009

457,8 510,3 561,7 497,9 660,1 773,8 896,9 951,4 982,8 1,064,7 34 49 67 19 32 67 29 86 32 85

5) Discuss the quality management principles on which the QMS standards are based ? Principles Quality management adopts a number of management principles. That can be used by top management to guide their organizations towards improved performance. The principles include: Customer focus Since the organizations depend on their customers, therefore they should understand current and future customer needs, should meet customer requirements and try to exceed the expectations of customers. An organization attains customer focus when all people in the organization know both the internal and external customers and also what customer requirements must be met to ensure that both the internal and external customers are satisfied. Leadership Leaders of an organization establish unity of purpose and direction of it. They should go for creation and maintenance of such an internal environment, in which people can become fully involved in achieving the organization's quality objective. Involvement of people People at all levels of an organization are the essence of it. Their complete involvement enables their abilities to be used for the benefit of the organization. Process approach The desired result can be achieved when activities and related resources are managed in an organization as process. System approach to management An organization's effectiveness and efficiency in achieving its quality objectives are contributed by identifying, understanding and managing all interrelated processes as a system.

Continual improvement One of the permanent quality objectives of an organization should be the continual improvement of its overall performance. Factual approach to decision making Effective decisions are always based on the data analysis and information. Mutually beneficial supplier relationships Since an organization and its suppliers are interdependent, therefore a mutually beneficial relationship between them increases the ability of both to add value.

6) Discuss the requirements of ISO 9001 QMS.

ISO 9001:2008 specifies requirements for a quality management system where an organization

needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and

aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

3) What are the documentation requirements of QMS? Clause 4.2.1 specifies all the different types of documentation needed for your QMS. You must have documented statements of your quality policy and objectives. Specific requirements for these documents are stated elsewhere in clause 5 of the standard.

You must have a documented Quality Manual. There are many ways to document your Quality Manual; and this would be determined by the size, structure and complexity of your organization. Clause 4.2.2 specifies more requirements for the contents of the quality manual. This standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. The nature and extent of such documentation will vary from organization to organization, based on factors listed below.The need to have additional documentation beyond those specified in this standard may depend

upon - customer, regulatory and your own organizational requirements. Other factors to consider may include - complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel; workforce stability and past quality problems and nonconformities. General documentation shall include o Statements of a quality policy and quality objectives. o A quality manual o Required documented procedures and records o Needed documents to ensure effective planning operation and control of processes and records.

7) Name the six mandatory procedures of QMS. Within ISO 9001 there are only six procedures that are mandatory, This does not mean that you can , the procedures you need will very much depend on the size and complexity of your organization, these six however are the ones that you must have. 4.2.3 Control of Documents A written procedure to control the approval and re-approval of procedures prior to issue as well as ensuring that the current revision status is displayed. To ensure that documents are legible and that the current versions are available at point of use. To also ensure that obsolete documents are controlled and documents from external parties such as your customers. 4.2.4 Control of Records A procedure to control the identification, storage, protection, retrieval, retention and disposal of records. 8.2.2 Internal Audits A procedure to define a planned program of audits to ensure that your processes meet both ISO 9001 requirements and your own requirements. Also for the reporting, follow up and records of these audits. 8.3 Control of Non-conforming Product A procedure to ensure that non-conforming product is not used and action is taken. 8.5.2 - Corrective Action A written procedure to ensure that root causes of problems are identified and actions taken to correct them, actions must be verified to ensure effectiveness 8.5.3 Preventive Action A written procedure similar to that for corrective action but the organization should take steps to identify POTENTIAL problems and eliminate them before a problem occurs.

9) Explain the steps in preparation and implementation of ISO 9001. Step 1: Preparation This step is the preparation for your ISO 9001 implementation. Its not difficult but its important and should not be missed. Get an Understanding of ISO 9001:2008 ISO 9001:2008 is a world-wide accepted standard for quality management requirements. As such, ISO 9001:2008 focuses on a large variety of business activities not merely on quality testing! Implementing ISO 9001:2008 will affect virtually all business processes. Note: "ISO 9000", "ISO 9001" and "ISO 9001:2008" all mean the same: the ISO 9001:2008 standard. For a good overview, please review the following:

Our Important Startup Documents (which come with the Complete Package) contain a good summary and overview of ISO 9001:2008.

In addition, we recommend that you obtain the actual ISO 9001:2008 standard (see our Resources section) and review it.

ISO 9001 Management Representative First, appoint the ISO 9001 Management Representative. This is typically a quality manager or senior manager of your company; it needs to be somebody who has sufficient authority to change the way that the company works. This person is responsible for the ISO 9001 implementation. A Role Description for the Management Representative is included in our Important Startup Documents (which come with the Complete Package). We wrote this short guide as if you, the reader, will be the Management Representative. Larger companies may appoint a Management Representative for each physical location or for each business unit; a corporate Management Representative would then coordinate among all local Management Representatives. Note that our Quality Manuals are based on a system of local and

corporate Management Representatives (which can very easily be modified to a single Management Representative). Training Next, the Management Representative needs to get some training. A Training Plan for Management Representatives is included with our Forms Collection. Get Buy-In Further, you should ensure that the company executives completely support the ISO 9001 effort. You may need to explain to them the advantages, requirements and costs. See our Resources section for useful information. Finally, you should inform all employees. Its important that the employees dont feel threatened by ISO 9001. In our Important Startup Documents (which come with the Complete Package) youll find a brief Employee Intro To ISO 9001, as well as an ISO 9001 Summary; also our Resources section contains useful information. Step 2: Quality Manual, Quality Policy and Procedures Developing the various documents required by ISO 9001:2008 is for most companies the most difficult part of the ISO 9001 implementation. The main reasons are that these documents have to meet the rather hard-to-understand requirements of the ISO 9001:2008 standard, and that writing these documents is at the beginning of the ISO 9001 implementation thus presenting a big initial hurdle. Which Documents are required? (1) Quality Manual (2) Six Quality Procedures (3) Quality Policy (4) Quality Objectives (5) Process Flowchart In addition, ISO 9001:2008 indirectly requires the following:

(6) Work Instructions Work Instructions are detailed step by step instructions on how to perform a particular work process. ISO 9001:2008 does not include an absolute requirement for Work Instructions; however, section 7.5.1 requires Work Instructions where they add value to the company. (7) Forms ISO 9001:2008 does not specifically require forms but they can be considered both work instructions (before they are filled in) and records (after they are filled in). For this reason, good forms save time and provide many more benefits. Choose the right Documentation Template The secret to easy ISO 9001 implementation is the use of good templates. Good templates will not only help you develop a business-friendly ISO 9001 quality management system, they will also make the development of all required documentation a rather easy task. Both our Implementation Manual and our Streamlining Manual contain and fully integrate the following documents: Quality Manual, Six Quality Procedures, Quality Policy, Quality Objectives, Process Flowchart. In addition, many Work Instructions and additional Procedures are included. Both our Implementation Manual and our Streamlining Manual come with comprehensive customization instructions that make it really easy to develop the required documentation. Easy Documentation Development It is particularly easy to develop the entire documentation required by ISO 9001:2008 if you customize the Implementation Manual or the Streamlining Manual using the included detailed customization instructions. Just follow them step by step, and you will achieve your own, complete ISO 9001 documentation quickly and easily. Once done, get your new ISO 9001 documentation approved by the president of your company. Step 3: Implementation, Training and Work Instructions Now its time to implement your ISO 9001 quality management system. During this phase you introduce the new requirements included in our Implementation Manual, you train employees, and

you get them to adjust their way of working to any new requirements. This step will be much easier if you did a good job in Step 1 One Step at a Time Take one step at a time in your implementation process. You may want to start with the section on Document Control. Explain the requirements in a meeting or memo, or have the appropriate department managers explain to their staff. Training and Work Instructions go Hand in Hand As you implement your ISO 9001 quality management system, virtually all employees have to change the way they work at least to some extent. At the same time, ISO 9001:2008 calls for standardization and for work instructions. Our Implementation Manual and Streamlining Manual point out where work instructions are required. We recommend that you assign the writing of work instructions to those who actually do the work. Instruct them to write up the best way of doing the work. If your Quality Manual calls for a change in their work, introduce those new requirements and make the employees incorporate them into their work instructions. Review the work instructions to make sure that they meet the requirements of your Quality Manual. Step 4: Internal Audits Internal audits are performed by somebody within your company (or by a subcontractor). The job of the auditor is to verify that your company meets the requirements of ISO 9001:2008 as they are described in your Implementation Manual or Streamlining Manual. The Auditor In most cases the ISO 9001 Management Representative is also responsible for internal audits. In this case, the Management Representative audits the entire company except his/her own work, and another employee audits the work of the Management Representative. Our Forms Collection contains an invaluable Audit Checklist. Larger companies often appoint and train several internal auditors. This is an excellent opportunity for cross-training and for staff of different departments to learn what other departments are doing.

Audits as Training Tool We recommend that you start Step 4 even before Step 3 is complete. Audits are an excellent way of training; they will help with your implementation efforts Once you have performed a complete internal audit that didnt uncover any significant problems, you are probably ready for the certification audit Step 5: Certification Now its time to select your registrar! There are many companies offering certification services but be careful: some are not accredited! Start your search on the Internet and compare the different registrars. Our Forms Collection contains a Registrar Evaluation Form; our Important Startup Documents (which come with the Complete Package) also contain very valuable Audit Preparation Tips. Reaping the Marketing Benefits Once you successfully passed the certification audit, you should leverage your new ISO 9001 certification in marketing. You may want to prepare a press release, send notification cards to your customers, print your certification mark on business cards and letterhead, add your ISO 9001 certification mark to your advertisement, display a banner outside your office building and last but not least, recognize your employees for the hard work they put into this effort. Our Important Startup Documents include valuable ISO 9001 Marketing Tips. Maintaining Certification Remember, ISO 9001 certification is not the end, and your ISO 9001 registrar will perform a surveillance audit once or twice a year to verify continued ISO 9001 compliance. Your ISO 9001 system is designed to continually improve itself. Make sure it remains implemented, continue your internal audits, and we are convinced youll see your companys performance improvements at the bottom line! In section 8.5.1, ISO 9001:2008 requires to "continually improve the effectiveness of the quality management system". Most auditors would expect you to revise your ISO 9001 Quality & Procedures Manual as your ISO 9001 quality management system matures and the detailed explanations of the

initial Quality & Procedures Manual are no longer needed. The Streamlining Manual is ideal to meet this improvement requirement. In addition, the Streamlining Manual will provide you with even more streamlined and efficient processes. 10) What are the important benefits from certification? The ISO 9001 standard outlines a process approach to implementing and supporting a quality management system. As a result, there is increased involvement of top management with regards to the Quality Management System. Top Management is engaged for the setting of the Quality Policy and Quality Goals and Objectives. It continues with Management Review looking at data from the QMS, and taking actions to make sure that Quality Goals are met, new Goals are set, and continual improvement is achieved. The Results of Certification to ISO 9001

Well defined and documented procedures improve the consistency of output. Quality is constantly measured 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. The Ongoing Benefits of ISO 9001 Certification A well designed and implemented Quality Management System, based on ISO 9001 has been shown to provide organizations with the following benefits:

You will have consistent, repeatable processes and a common system. You will have fewer problems with failures in service or product quality. Your people know what to do and how you want it done.

You will have more business, because you can sell to new markets or having the endorsement will distinguish you in the marketplace.

You'll know more quickly if things are going wrong, and where; you stop spending money or wasting time on the same old problems. Many problems will disappear because you know how to prevent them; if they do come up, you'll know how to fix them faster.

Better management control and reporting - which means that you know how your business is doing. 12) What are the ISO 9000 series of standards? Developed by the ISO Technical Committee 176, published in 1987 and updated approximately every five years, the standards comprise five documents whose focus is Quality Assurance Systems. These five documents are: a)ISO 9000-Quality Management and Quality Assurance Standards - Guidelines for selection and use b) ISO 9001 Quality systems - Model for quality assurance in design, production, installation and servicing. This is the most comprehensive standard with 20 clauses. c) ISO 9002 - Quality systems - model for quality assurance in production and installation. This standard has 18 clauses. d) ISO 9003 - Quality systems - Model for quality assurance in final inspection and test. Requires conformity with 12 clauses. e) Quality management and quality system elements - Guidelines.

13) What is the scope of ISO 9001 2008? ISO 9001:2008 - Scope This section still explains that ISO 9001 specifies requirements for a quality management system. It refers to the product as meeting customer and applicable regulatory requirements, as well

as, enhancing customer satisfaction by assuring conformity to customer and applicable regulatory requirements. ISO 9001:2008 has expanded the uses of "regulatory" to "statutory and regulatory". a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. The Note at this General section used to say the term "product" applied only to the product intended for, or required by, a customer. ISO 9001:2008 has expanded Product to include any intended output resulting from the product realization processes. NOTE 1: In this International Standard, the term product only applies only to - a the product intended for, or required by, a customer, - any intended output resulting from the product realization processes. A second Note has been added to explain that statutory and regulatory requirements can be expressed as legal requirements. NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements. 15) What is meant by quality policy of an organization?

ISO 9001 quality policy 5.3 Top management must ensure that the quality policy: o appropriate to the organization o includes a commitment to requirements and continual improvement o provides a basis for establishing and reviewing quality objectives o communicated and understood o periodically reviewed for suitability

16)What is purpose of the quality manual? o Describe your quality policy and procedures o Describe your quality system o Define the quality standards that will be used o Explain how quality requirements will be met o Prove that your quality system is documented o Control quality work practices and activities o Teach people about your quality requirements o Guide the implementation of your quality system o Serve as a stable definition of your quality system o Show that your quality system meets requirement 17)Why should any organization implement ISO 9001 2008 QMS? Without satisfied customers. To keep customer satisfied, the organization need to meet their requirements. The ISO 9001-2008 standards provide a tried and tested framework for taking a systematic approach to managing the organizations processes so that they consistently turn out product that satisfies expectations.

18)What is the purpose and scope of ISO 14000 standards?

The ISO 14000 environmental management standards exist to help organizations (a) minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land) (b) comply with applicable laws, regulations, and other environmentally oriented requirements, and (c) continually improve in the above. ISO 14000 is similar to ISO 9000 quality management in that both pertain to the process of how a product is produced, rather than to the product itself. As with ISO 9000, certification is performed by third-party organizations rather than being awarded by ISO directly. The ISO 19011 audit standard applies when auditing for both 9000 and 14000 compliance at once.

ISO 14001 specifies the following EMS components: o Environmental policy definition o Environmental planning o EMS implementation and operational control o Assessing conformity to the standard's requirements and undertaking corrective action in the case of nonconformity o EMS management review The environmental policy must be appropriate to the nature and scale of the organization's activities, products and services. It must include a commitment to continual improvement, pollution prevention and compliance with relevant environmental legislation and regulations. Planning focuses on actions and activities that initiate, maintain and promote the environmental policy. An organization identifies significant environmental impacts associated with its operation as well as pertinent laws and regulations.