1. Introduction Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose. For example, the format of the credit cards, phone cards, and 'smart' cards that have become commonplace is derived from an ISO International Standard. Adhering to the standard, which defines such features as an optimal thickness (0, 76 mm), means that the cards can be used worldwide.
International Standards thus contribute to making life simpler, and to increasing the reliability and effectiveness of the goods and services we use. ISO 9000 is primarily concerned with 'quality management'. Like 'beauty', everyone may have his or her idea of what 'quality' is. In plain language, the standardized definition of 'quality' in ISO 9000 refers to all those features of a product (or service) which are required by the customer. 'Quality management' means what the organization does to ensure that its products conform to the customer's requirements. (web web site of International Organization for Standards) The ISO 9000 Standard was written by representatives from the United States and 14 European countries and published in 1987 (the same year the Malcolm Baldrige Award started) by the International Organization of Standards in Geneva, Switzerland.
The requirements of the Standard are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages, from production through servicing. The requirements include management, leadership, a pro-active and well-trained work force, customer feedback, measurement, documentation, internal audits, continuous improvement, and third party validation. Total Quality Management is a broad based quality management theory where as ISO 9000 is a quality management which defines the critical aspects of process for ensuring quality in goods and services. It can be applied to any kind of product and it is applicable to both small and large companies, including service providers and distributors. Companies usually initiate an ISO 9000 project due to customer demand, to get European business and for the purpose of advertising. These are all valid reasons, but many companies miss out on the most important reason to follow the ISO 9000 standards: 'to make sure their business is run in an orderly manner that will assure continued success.
' Along the way they discover that, when properly implemented, the ISO 9000 management system saves money, reduces costs, and increases product quality and employee productivity QS 9000 is a more mature version of ISO 9000. It is the shorthand name for 'Quality System Requirements QS-9000. ' It is the common supplier quality standard for Chrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001 (to be discussed later), but it contains additional requirements that are particular to the automotive industry.
These additions are considered automotive 'interpretations' by the ISO community of accreditation bodies and registrars. QS-9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services. It does not, therefore, apply to all suppliers of the Big Three. The need to obtain ISO 9000 or QS 9000 registration by many companies is growing daily as pressure from both customers and competitors are increasing. ISO 9000 certification is, or soon will be, necessary to do business in the EC, Japan, with the US Government, the Big Three automakers, and several other industries. ISO History The International Organization for Standardization, in existence since 1946, has published many manufacturing or product standards.
Today the most powerful quality initiative around the world is the set of ISO 9000 international standards for quality management. These guidelines help companies compete in the new business world. In North America the first companies to adopt these international quality standards were the ones interested in the global market, business leaders such as Du Pont, Monsanto, Eastman Kodak, 3 M, Hewlett-Packard, AT&T and Nortel. The American National Standards Institute has adopted the ISO 9000 series as national standard Q 9000. The United States largest single consumer, the Department of Defense, developed the new handbook MIL-HDB K-9000 based on the international standards. Federal agencies such as NASA, the Federal Aviation Administration, and the Food and Drug Administration have integrated the ISO 9000 standards into their contractual requirements.
Winners of the Malcolm Baldrige National Quality Award such as Xerox, Motorola, Federal Express, IBM, and others are adopting them and starting to require their suppliers to adhere to them. Finally, the Big Three automakers - Ford, Chrysler and General Motors - have integrated the ISO 9001 and 9002 standards with their own QS-9000 standards. The standards Council of Canada (SCC) has acted similarly, adopting the ISO 9000 standards locally as Q 9000 for the use and benefit of Canadian companies. The Canadian government has already underscored the importance of the international standards for its economy, and federal and provincial agencies are gradually introducing the ISO 9000 standards into their purchasing conditions. In Europe, the European Committee for Standardization (CEN / CEN ELEC) has adopted the ISO 9000 series as European standard EN ISO 9000 in replacement of each European country's national standards. In response to the creation of a common market consisting of 340 million people, and a potential market of 800 million people (European Union in 2020), it is emphasizing the advantages of the ISO guidelines for quality management to simplify trade.
Consequently, for companies of the European Union, this series has become both a trade and a marketing tool. The North Atlantic Treaty Organization (NATO) has also decided to replace its own quality standards. As a result, the defense departments of the sixteen members will use for their procurement the new edition of the Allied Quality Assurance Publications (AQA P) standards which are, by and large, the ISO standards. The Pacific Rim's 'tigers' (Japan, Korea, Singapore, Malaysia, Taiwan, Hong Kong, China, Australia, and New Zealand), which encompass more than two billion people, already comply to these standards.
As for developing countries, the international standards give them access to the European Union, to North America, and to the Pacific Rim markets. This constitutes an important factor in efforts undertaken to improve the economies of a large number of these nations. Globally, companies in more than 80 countries use ISO 9000. All the above examples show how important ISO 9000 has become in today's global market. What is ISO 9000 series?
Occasionally perceived in the US as a European standard, the ISO 9000/Q 90 series of standards is in fact an international set of documents written by members of a worldwide delegation known as ISO / Technical Committee 176. The ISO 9000 series consists of five documents: three core quality system documents which are models of quality assurance, namely 9001/Q 91, 9002/Q 92 and 9003/Q 93 and two supporting guidelines documents, 9000/Q 90 and 9004/Q 94. The models are contract-audit able, which means a registered company must have addressed and resolved every requirement within the standard. Registrars expect to see a quality manual that describes how the company actually applies their own processes in their own context to meet the requirement of the standard. In contrast, guidelines are documents that provide ideas and advice to help companies interpret and apply the standards.
Registrar auditors may ask questions related to the guidelines, but the guidelines contain no requirements and auditors cannot use the guidelines to assess the company's implementation of a quality assurance process. (Russo, C.W. Russ, Russo, Tracy Callaway, Interpreting ISO 9000 for services, Solutions from registered organizations, 1998, page 6) The major difference between the models are its scope. ISO 9001 sets out the requirements for an organization whose business processes range all the way from design and development, to production, installation and servicing; for an organization which does not carry out design and development, ISO 9002 is the appropriate standard, since it does not include the design control requirements of ISO 9001 - otherwise, its requirements are identical; ISO 9003 is the appropriate standard for an organization whose business processes do not include design control, process control, purchasing or servicing, and which basically uses inspection and testing to ensure that final products and services meet specified requirements. So, an organization chooses that its quality system be certified against ISO 9001, ISO 9002 or ISO 9003 according to the business processes covered by the quality system. 2.
Advantages and Disadvantages of Certification When companies aim for customer satisfaction and competitive advantage, registration becomes an important step in their quest. On one hand it instills confidence and decreases the need for external audits, which are costly for both customer and the supplier. On the other hand, it becomes a good tool for employee motivation by encouraging people to attain a quality level in a tangible fashion. Most North American companies celebrate their certification by throwing a celebration event which gives the owners, senior management, customers, and suppliers a means of recognizing the employees' work through the local press, thus increasing personnel satisfaction. As one quality manager notes, it is not the American, Canadian, Asian, or European customers who read the newspaper headlines on certified companies, but rather the shop employees who are very proud to see their firm in the local press. In short, the advantages of the certification translate into both external (market) and internal (people) benefit to the company.
However, third-party certification (registration) has its disadvantages. Certain companies go through the motions only to get the ISO certificate and not to improve quality and competitiveness. This is sometimes called a 'paper certificate'. Since the objective is to satisfy the requirements of the registrar in the short term, this approach can easily create problems with customers in the long term. Companies that do this also run the risk of documenting, standardizing and certifying processes, products, and services that no longer correspond to customer needs and are not competitive. Many quality experts argue that a certification based on the ISO 9000 standards is a necessary tool to obtain the desired results.
But it will be a source of problems and will do more harm than good if it is not applied correctly. Companies must constantly bear this in mind while implementing ISO standards. Above all, ISO certification is an expensive and time / energy consuming process 3. Procedure for becoming ISO 9000/QS 9000 certified The establishment of a quality system in a private or public organization requires a structured approach. This includes (1) preparation, (2) implementation and (3) continuous review & support. Preparation The decision to submit a company's activities to one of the ISO standards rests with executive management.
The decision can result from internal or customer demand, from pressure of competition, or simply from a desire to satisfy the requirements of a national or international standardization program. Much attention must be paid to the preparation of the implementation process. It is important to answer the following questions: Why? Where are we?
Where do we want to go? How? With what means? With what resources?
In what time frame? How much will the implementation cost? What will the benefits bit? (Todo rov, Branimir, ISO 9000 Required, 1996, Page 54).
Sensitization, Management Commitment and Training To get the full benefits of ISO 9000, executive management must play a leadership role in the implementation process. To ensure that the quality system meets the company's economic needs, it is essential that higher management fully comprehend its own role, the potential benefits of the system, the commitment necessary to implement the system, and also the resources required for implementation. Therefore management needs to form a steering committee and convene a brief training session so that it is sensitized to the issues just mentioned. The committee must also designate a quality coordinator, who is a management representative.
Generally, this person is a member of the steering committee and has the necessary autonomy to execute his or her functions. The person coordinates but is not responsible for the implementation of the quality systems. The steering committee must systematically analyze the status of the quality system and the degree of staff involvement and employee motivation during its regular meetings devoted to quality. These management reviews, which are indispensable for maintaining implementation, are a powerful tool for strategic quality planning and for continuous improvement of the company. They are useful in protecting the company from bad management decisions, which can be very costly.
Once the decision is made, the company prepares for and plans its approach. All employees must be involved, from executive management to staff and line employees. Everyone needs to understand the standards in general as well as their specific application to the activities of the organization. Various specialized courses dealing with ISO 9000 concepts and its application are available.
Choice of the Model The company must choose the quality norm that best agrees with its activities. To reassure its customers and to obtain certification, a company chooses between the models for quality systems. Implementation of the Quality System Generally the implementation of a quality system unfolds in six stages, from the company review up to certification. The pace of implementation must be determined at the outset. An example is Hewlett-Packard (HP), which set up a worldwide certification program. In 1991, its French division started with ISO 9002 for its maintenance laboratories.
In 1992, it continued ISO 9002 in its medical services and chemical analysis operations. Finally, this program continued until all entities were certified. HP's quality coordinator recognized that a company can not do everything right away. In his opinion, it was preferable to comply to ISO 9002 in two years rather than commit to ISO 9001 in four year.
In small businesses, constraints in available resources impose a gradual approach to implementation of a quality system. It is recommended to adapt the implementation process to the work pace and to the real needs for the company's evolution. The company review Before taking action the company must review its business plan, policies, strategies and activities. In fact, policy and process planning and validation are primordial.
They are an effective means to avoid failures brought about by bad strategies or bad processes. For this type of work, competitive benchmarking is a useful tool. The preliminary audit and cost of action plan To assess the organization's present level of quality with respect to the chosen standard's requirements, a preliminary audit must be conducted. This audit can be executed by external consultants or auditors, or by a qualified in-house quality coordinator. With the help of a prepared audit questionnaire, the lead auditor produces a report detailing the major gaps. During these first steps, it is often useful to get help from an external expert for management sensitization, staff involvement, choice of model, the company review, the preliminary evaluation, the study of costs of non quality, personnel training, creation of an action plan, cultural changes required, and any company-specific issues that arise.
Establishment of Action Plan The gaps between the existing system and the chosen model is identified by the preliminary audit which helps to confirm the choice of ISO model and to identify corrective actions to be taken. The list of corrective actions forms the basis for an action plan which includes the milestones, the work groups involved, the assigned responsibilities, the resources, the estimated budget, and the target dates. Approval of this action plan by the steering committee constitutes the real startup of the ISO 9000 implementation process. The total time span of the action plan depends on many variables, including the model used, the company's size, the internal organization, and the level of the current quality system. In practice there are companies that achieve ISO 9002 in six months and others that attain ISO 9003 in two years.
In reality, the execution of the action plan is establishment of the quality system. Drafting of quality documentation Document structure and Hierarchy The foundation of a quality system is its quality documentation, i. e., the manuals, procedures, work instructions, quality plans and quality records. These documents correspond to three hierarchical levels of the organization-executive management, middle management, and work management-and to the product itself. The quality manual defines the quality policy, the quality goals and objectives, the organizational structure, and the integration of the ISO 9000 requirements. This is the policy deployment for all value-added activities of the company (horizontal deployment). The quality manual also contains the documentation structure which permits the hierarchical deployment of objectives to the three levels of the firm (vertical deployment).
To illustrate this policy deployment, let's take the example of an airport where everyone can consult the posted 'objectives,' i. e., flight departure and arrival times. The pilot is responsible for transporting his or her passengers from one airport to the other at the right time; and the flight crew, both control towers, and the support personnel of both airports must work together to reach his common objective. Procedures are reference documents that explain the flow of the company's processes. For example, an airplane's takeoff encompasses the following activities: loading of the passengers' luggage, verification and preparation of the aircraft's control systems, preparation of the passengers, flight crew instructions, authorization by the control tower and others. All these activities can be documented by one procedure.
Work instructions detail the elementary tasks and operations of each activity within the company. They help personnel do things right the first time. Before takeoff, the pilot executes various tasks according to an instruction. Passengers follow another instruction when they secure their safety belt, and flight attendants follow still another instruction relative to their own activities.
Quality plans define the quality requirements for the products, services, or other activities. For example, the quality of the food served in flight and the quality of the airport's reception service are covered by quality plans. Quality records are documents that preserve pertinent information of activities carried out or results obtained. The company must keep records of audit reports, management reviews, process controls, non- found, preventive and corrective actions taken, personnel training courses, and other information.
Like the aircraft's 'black box', these records make up the company's memory and are retained for a predetermined period. Write down what you do The ISO 9000 standards require that all work affecting quality be documented. They facilitate the organization of a company's documentation and reduce the number of useless papers. As a first step, it is important to establish the company's internal guidelines detailing the rules for documentation, i. e., the drafting, management, approval, verification, modification, and distribution of the documents. In other words, this is the document control procedure.
Hence, all documents must be numbered and presented in a preliminary version. Also, their contents must be approved before distribution and utilization. Establishment of the quality documentation requires employee involvement and attribution of responsibility. The quality coordinator is responsible for the write-up of the quality manual. It is the responsibility of each departmental or business unit manager, not of the quality department, to lead the write-up of his or her procedures, technical specifications and quality plans so as to manage the quality assurance for the whole unit. The manager or process engineer approves the new procedures which must then be verified by an internal quality system coordinator.
The people involved in the application of a procedure must be designated in a precise manner within the procedure's responsibility section. Each procedure must contain a table of contents and a distribution list including the recipients' title and department. Generally, a procedure contains the goals, scope, responsibilities, process flowchart and references to other documents. It answers the following questions: why? , who does what? , how? , when? , where? In practice, companies already have internal procedures in place before implementing a quality system. It is therefore necessary to compare and classify these procedures according to the chosen standard and to the new quality policy manual for revision or redesign.
But for new procedures created to cover undocumented activities, the methods used by the personnel must be understood before they are put into writing. Then an independent ISO coordinator verifies that the documents satisfy the established rules and are in compliance with the chosen standard. New procedures should be complete, explicit, and in agreement with the culture of the company. One should never draw up for an un validated process or create a document that is difficult to understand.
To ensure that a document is adequate, it is preferable that it is approved and used only after it has been validated with a practical test. Most ISO experts agree that it takes 40 hours to create a 15-page draft document. Installation of quality documentation Next step is to do what's been written down. The personnel must begin to work in accordance with the new written procedures. Also the quality documentation must be tested to see if it is complete and adequate. This is a delicate exercise of linking the people with the established quality system.
Possible can occur from absence of training, from documents not being understood clearly, or from incomplete information. Certain problems can also surface as a result of cultural resistance and old habits of the employees. It is therefore important to find time to train employees. Training must be provided each time a new document is approved. Documents must be configured with precision for the personnel that use them. As the standards stipulate, only the latest version of manuals, plans and procedures can circulate within the company.
Documents must be accessible to all affected personnel, at all necessary points of usage. For example, the person in charge of classifying and archiving records cannot leave on a trip without leaving the keys to his or her work site. The executive management plays an important role in the installation of the documentation. It conducts regular management reviews to determine priorities and to ensure that the quality system is running smoothly. These reviews, based on the analysis of collected information and data, determine which business decisions to make. The quality coordinator conducts internal audits to verify and improve the implementation of documents.
First and foremost, he or she must prevent or at least identify what is not working, and take actions so that it does not recur. To ensure the smoothness and effectiveness of the quality system, qualified personnel must regularly conduct internal audits. Corrective or preventive actions must be taken and followed up in order to meet the quality objectives. Quality System Startup Within a quality system, it is important for all people to assimilate their roles and responsibilities.
Each activity must correspond to the policies of the quality manual; each department must obey the established procedures; each employee must follow the work instructions; each product must respect its plan; and, finally, each supplier must comply with the company's business processes. The launching of the quality system represents more than a 'documentation project'. As the company is defining its tasks and choosing its policy, it is creating a solid knowledge base. The preparation, use, and application of manual, procedures, work instructions, and quality plans constitute a knowledge building process. Once a quality system is running, the company can call on costumers or a third-party certification body for an external audit. Confirmation of conformity, by either of the two, represents the official startup of the quality system.
The Third-Party Certification Process The standards of the ISO 9000 family do not describe how to certify a company. Certification of quality systems is carried out independently by registrars according to the ISO standards, not by the International Organization for Standardization. The certification process is similar for most certification bodies; all have responsibility for their own activities. First, the company asks a registrar to certify its quality system. The registrar then supplies information regarding registration modalities; the costs, the registrar's accreditation, the steps of the certification process, and the international recognition of the certification. After the company's request and application, the certification process contains two phases: the documentation review and conformity audit.
The documentation review is an assessment by the registrar of the quality manual and procedures. The registrar verifies that the quality documentation complies with all the requirements of the standard. Following this evaluation, the company must take into account non- found and put in place corrective actions to make the documentation comply with the requirements and criteria of the examining body. As for the conformity audit, the registrar comes on-site to verify that the activities comply with the documentation. A team of auditors performs the audit in accordance with ISO 10011 series. If are raised during the audit, the registrar can give company a time limit to perform the necessary correction actions.
After this period has passed, the registrar returns to audit only the elements that were found noncompliant and to verify the new status of the quality system. If the audit results are positive, the registrar certified the company's quality system according to the chosen model. The registrar then issues the company an accreditation number, which the registrar publishes in a list the customer can consult. The certificate is valid for a predetermined period (generally three year), so long as the company respects the registrar's specific requirements relative to the conformity of the quality system. Most registrars require a minimum of three to six months experience as evidence that the quality system is operational and effective before they conduct a registration audit and issue a certificate of registration. (Russo, C.W. Russ, Russo, Tracy Callaway, Interpreting ISO 9000 for services, Solutions from registered organizations, 1998, page 26) Cost of Implementation The global costs of the implementation process vary according to several factors: the firm's size, the complexity of the processes, the initial status of the quality system, the chosen model, and the pace of implementation.
It is desirable to integrate estimation of implementation costs include all external resources (consultants, speakers, registrars, and auditors) and internal resources (personnel, training, equipment) involved in the implementation process. The certification costs are relatively minor when compared with the total costs of implementation. Some experts use the equivalent of person-days involved in all implementation steps to obtain a precise estimate; person-years is sometimes used for an approximate calculation. These approaches can be used in tandem to compare and confirm the estimated total costs.
Some companies have invested as much as a $100,000, others much less and still others substantially more. The registration and implementation costs for a 100-300 employee site can range anywhere from $26,000 to $45,000. (Lamprecht, James L., ISO 9000 Preparing for Registration, 1992, Page 17) Operation of the Quality System Internal Follow-up and Empowerment In practice, implementation of the ISO 9000 standards often represents a radical change for companies. The system must be maintained so that the company does not backslide. Old habits and work methods come creeping back very quickly as a result of lack of follow-up and support. Much as learning a new language requires constant practice, operation of a quality system requires constant maintenance.
Management reviews, systematic internal audits and preventive and corrective actions reinforce the habits and actions of the employees. These key elements form corrective and preventive loops that are essential for the implementation and maintenance of a quality system. Management reviews and internal audits ensure that the systems are working well. Corrective actions allow the elimination of root causes of, which is the basis for continuing improvement. Preventive actions, for their part, anticipate potential problems and initiate business process redesign.
Together they avoid repetition of, prevent occurrence of potential, decrease costs of non quality, and make companies more competitive. The fact that employees have organizational freedom, responsibility, adequate training, power to resolve problems and propose corrective and preventive actions, and support from executive management, constitutes real empowerment. External follow-up External audits can be conducted by customers on a regular basis. One of the goals of certification is to decrease the number of audits, which are costly to both supplier and customers. However, certification is only the first step in the implementation of a quality system, not an end in itself. External follow-up activities begin after certification.
For example, QMI, a North American registrar, conducts an annual surveillance audit to make sure that a company's quality system is maintained adequately. QMI audits approximately 50% of the quality system. Recertification audit after three years In third year, at the end of the certificate's validity, QMI performs a re certification audit to renew the company's registration. This audit covers between 50% and 100% of the quality system and takes into account results of the previous audits. If the quality system is found compliant, the company receives a new three-year registration.
In the US, registration is in effect for either one or three years, depending on the complexity of the quality system. Post-registration assessments are performed every year in accordance with agreements between the registrar and the company. 4. Software The software programs available in the market offer a comprehensive and integrated solution that manages all major functions necessary to implement and maintain ISO 9000 certification. They provide facilities to schedule reviews, audit the system, manage documents, control problems and take corrective action. They also helps review and approve suppliers, control and maintain records, monitor quality costs, record equipment calibration history and review training records.
Putting the Quality System online empowers the information in terms of currency, accessibility, maintenance and analysis. It takes the quality manuals out of the office and makes them available on every company PC. And it gives Managers the reports when they request them and how they request them, from their own desks. The software that are available in the market are as follows: SoftwarePurposePriceAction Track Stores, tracks, and reports on corrective and preventive actions. Pin points the status of any corrective / preventive action at any point in time.
Generates memos for department managers regarding late corrective / preventive actions. Create timely status reports for management review. Graph corrective / preventive actions and more. $99.95 Training Doc Stores / relates training requirements, qualifications, and document master lists.
Indicates who must be retrained when a document is revised. Also tracks controlled document locations and reminds you replace old revisions with new ones. Reports on employees who need additional training when a position requirement is added. $299.95 Audit Planner A key audit preparation tool.
Generates professionally formatted checklists of questions for use during an audit. Contains over 1000 questions to get you started. Ability to customize questions, add questions of our own and save complete question lists$99.95 Cal Master Stores an instrument inventory, calibration schedule, and calibration records. Alerts user to instruments coming due and past due for calibration. Prints calibration data collection worksheets, instrument calibration histories, and more$199.95 Vendor Watch Stores approved supplier list and vendor monitoring data. Ability to graphically analyze vendor problems for adverse trends, and generate 'corrective action packages' for the vendor, including memos, corrective action form detailing problems found, and a graph demonstrating the trend.
Templates can be saved for memos and select fields of the corrective action form. Also, alarms can be set to sound when a particular problem occurs over a predetermined frequency, so a corrective action package can be generated. $199.95 PM Master Stores an equipment inventory, maintenance schedule, and maintenance records. Alerts user to equipment coming due and past due for maintenance.
Prints maintenance checklists, and equipment maintenance histories. Ability to store replacement part information and relate to equipment using each part. Ability to store Supplier information and relate to parts available from each supplier. Ability to maintain a replacement part inventory$199.95 web Conclusion The ISO 9000 series is becoming increasingly interesting to enterprises, companies and organizations throughout the world. In this transformed business world, the ISO 9000 family of internal standards for quality management has become a must for some companies and a guideline for others in the quest for better quality and better business results. Questions on ISO 9000 and QS 9000: 1.
Companies usually initiate an ISO 9000 project due to which of the following reasons: A. customer demand B. to get European business C. for the purpose of advertising D. All of the above 2. If you were to do a business with General Motors, your company has to be A. ISO 9000 certified B. QS 9000 certified. ISO 9004 certified D. ISO 9001 certified 3. ISO 9001 A. is a quality systems model for quality assurance in design and development, production, installation and servicing; B. is a quality systems model for quality assurance in production and installation. C. is a quality systems model for quality assurance in final inspection and test. D. Is a quality management and quality system elements guidelines. 4. ISO 9002 A. is a quality systems model for quality assurance in design and development, production, installation and servicing; B. is a quality systems model for quality assurance in production and installation. C. is a quality systems model for quality assurance in final inspection and test. D. is a quality management and quality system element guidelines.
5. ISO 9003 A. is a quality systems model for quality assurance in design and development, production, installation and servicing; B. is a quality systems model for quality assurance in production and installation. C. is a quality systems model for quality assurance in final inspection and test. D. is a quality management and quality system elements 6. To assess the organization's present level of quality with respect to the chosen standard's requirements, a preliminary audit must be conducted by which of the following? A. External Auditor B. In-house Quality Conductor C. Yourself. Both A and B 7. The foundation of a quality system is its A. Quality documentation B. Quality Planning. Quality discussion D. None of the above 8.
The ISO 9000 standards require that all work affecting quality be documented. A. True B. False 9. Certification of quality systems is carried out by which of the following. ISO B. Registrars C. Auditors D. Company CEO 10. To renew the company's registration, re certification audit is performed at the end ofA. 2nd year B. 3rd year C. 4th year D. 10th year Answers.
1. D 2. B 3. A 4. B 5.
C 6. D 7. A 8. A 9. B 10. B.