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Iso 9001 Quality Management System

EME2036 – MANUFACTURING AND OPERATIONS MANAGEMENT Lecturer: MR JAMIL BIN HASHIM Title: 17. ISO 9001 Quality Management System Trimester 3 2010/11 No| Name| Id| 1| CHUAH KIM SAN| | 2| SOON JAN FEI| | 3| CHAN JUN YU| | 4| KOK ZIH FONG| | 5| TAN WEN JUN| | | | | | | | Title: ISO 9001 Quality Management System Acknowledgements We would like to thank our Manufacturing and Operations Management lecturers, Mr Jamil bin Hasim and Ms How Heoy Geok for all the patience and guidance given to us throughout our research.

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Besides that, thanks to each group members for their precious time and fantastic team work. They were present in every meeting, dedicated in gathering information, and diligent in writing the report. Last but not least, thanks our parents for having faith in us as well as friends who supported us all the way. Thank you from the bottom of our heart. Abstract Our group consists of 5 members and we choose to study and analyze ISO 9001 Quality Management System.

The purpose of this research is to learn more about ISO 9001 Quality Management System. First, we introduce what is ISO 9001 Quality Management System. Next, we expound the concept of the topic. Then, we discuss the implementation issues and its applicability thoroughly. In addition, the benefits are included in this report. Finally, we conclude what do we learned from this research assignment. We obtained information mainly from International Standard Organization (ISO) main website.

Besides that, we searched related journals from MMU Library Website data base. We also included the citations from various related journals. Introduction ISO 9001 is an international quality certification that defines minimum requirements for a company’s Quality Management System (QMS). A company’s QMS comprises the organization’s policies, procedures and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction.

Some of the areas of the company within the scope of ISO 9001 include: * Customer contracts * Hiring and employee training * Design and development of products and services * Production and delivery of products and services * Selection and managing of suppliers| * Management responsibility * Internal quality audits * Monitoring and measuring * Continual improvement * Corrective and preventive action| To receive an ISO 9001 certification a company must put the required QMS processes and controls in place, monitor performance of its processes and demonstrate continual improvement.

Most companies hire an experienced consulting firm to assist with these preparations. Once the QMS is in place, a registrar (or certification body) is hired to audit the company’s compliance with ISO 9001 requirements. If discrepancies are found during the audit, they must be corrected before the ISO 9001 certificate is issued. The ISO 9001 certification must be maintained through regular audits (bi-annual or annual) conducted by the selected registrar. Why seek certification to ISO 9001? Registration to ISO 9001 by an accredited certification body shows committed to quality, customers, and a willingness to work towards improving efficiency. * It demonstrates the existence of an effective quality management system that satisfies the rigors of an independent, external audit. * An ISO 9001 certificate enhances company image in the eyes of customers, employees and shareholders alike. * It also gives a competitive edge to an organization’s marketing. Concept of the topic Why an organization should implement ISO 9001:2008?

To keep customers satisfied, the organization needs to meet their requirements. This is because without satisfied customers, an organization will be in peril. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization’s processes so that they consistently turn out product that satisfies customers’ expectations. Quality management principles There are eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based.

These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards. The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.

The eight quality management principles are: * Principle 1: Customer focus * Principle 2: Leadership * Principle 3: Involvement of people * Principle 4: Process approach * Principle 5: System approach to management * Principle 6: Continual improvement * Principle 7: Factual approach to decision making * Principle 8: Mutually beneficial supplier relationships Applicability ISO 9001:2008 ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004.

ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. No new requirements were introduced in ISO 9001:2008 edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS. ISO 9001:2008 is intended to be generic and applicable to all organizations, regardless of type, size and product category.

It is recognized, however, that not all the requirements of this standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may consider the exclusion of the application of some requirements of ISO 9001:2008 from its QMS. ISO 9001:2008 makes allowance for such situations, through sub-clause 1. 2 Application. How the ISO 9001:2008 model works? The requirements for a quality system have been standardized – but many organizations like to think of themselves as unique.

So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a “Mr. and Mrs. ” enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration? The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures. Checking that it works 1.

The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively – or, to put it another way, to check that it is fully in control of its activities. 2. In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements. 3. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity.

This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment. The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context. How is the Certification Achieved? There are basically four steps to get certified: Step 1: Plan

The starting point for a company pursuing ISO certification is the planning and preparation of the required processes and documentation specified in the ISO 9001 standard. While these requirements are comprehensive in scope, meaning they apply to most areas of your business, they are also very general in their descriptions, meaning they can be adapted to any type of business. Because of this non-specific language, the ISO standard is extremely flexible and may be implemented in a variety of ways to suit your specific way of doing business. Step 2: Implement

The starting point for any ISO implementation is to identify and define your key business processes; that is, how you produce and deliver your products and services to your customers. For each process, measurable performance measures and objectives (called “quality objectives”) must be developed and implemented to serve as the basis for continual improvement. In addition to defined processes and objectives, certain formal documents must be developed and implemented to provide “control” of your processes. The first is a quality manual that defines policies your company follows based on the ISO requirements.

Additionally, six administrative procedures must be documented and implemented which include: control of documents, control of records, internal auditing, control of nonconforming products, corrective action, and preventive action. Beyond these basic six procedures, your company must determine any additional procedures, work instructions, forms or other formal documents needed to effectively implement your QMS. In prior editions of ISO 9001 (prior to 2000), there were numerous “required” procedures. More recent versions of the tandard have reduced the focus on required documentation and increased focus on control and improvement of your key business processes. Once your processes and documents are developed and implemented, train your employees. Once your QMS is implemented, it is required that you maintain your system for a minimum of 60 – 90 days before your certification. This “waiting period” is necessary to generate sufficient records of your QMS to be auditable. Newly developed processes and documents cannot be demonstrated effectively without some auditable history for the auditor to review.

This timeframe should be factored into your overall project plan for certification. Step 3: Review During the Review Stage you will conduct your internal audit and management review. Once these are completed, your QMS is considered implemented and your company is “ISO Compliant”, though not yet certified. Step 4: Certify The ISO 9001 certification is granted by a third-party auditing firm called a Registrar who specializes in quality system auditing. There are a wide variety of Registrars located in every ISO participating country. Some firms have offices internationally; others have a more regional focus.

The selection of your Registrar is one of the more important decisions you will make to ensure the best alignment with your type of business, your location(s) and overall cost of maintaining the certification. Auditing Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment, to verify that the system is working as it’s supposed to, find out where it can improve and to correct or prevent problems identified.

It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. The initial certification audit is conducted in two parts. The Stage 1 audit is a general review of your QMS documentation to ensure you have addressed all of the requirements of the standard. Depending upon the size of your business, this can be conducted in a one to two day visit to your facility or virtually via phone. Any discrepancies noted during the Stage 1 audit will be documented in a formal report and must be corrected before the Stage 2 audit.

The main part of the ISO audit is the Stage 2 audit which is always conducted onsite at your location(s) and will be focused on the implementation and effectiveness of your QMS. During this audit which can take 1 day (for very small companies) to several days, the auditor(s) will tour your company, speak to managers and employees, and review documentation and records (along with any Stage 1 discrepancies) to ensure that your system is fully implemented. If nonconformances are found, they will be documented in a formal report for correction.

Following the Stage 2 audit, you are generally given thirty (30) days to submit corrective action plans for all audit nonconformances. Once corrective actions are received, your certification is complete and your certificate is issued. In order to maintain the certification, you will participate in an annual surveillance audit from your Registrar where they confirm that you are maintaining your QMS. Every third year, a more comprehensive re-certification audit is conducted, similar to the initial certification audit. The Process Approach The process approach means that you improve your business by managing and improving certain key business processes that directly impact your ability to serve your customer. ” Since the year 2000 release of ISO 9001, all ISO certified companies have wrestled with the practical application of the “Process Approach” that was introduced in the current version of the standard. In fact, other than the reduction of the number of “required” (i. e. prescribed) documents, the shift to the Process Approach was the most significant change from older editions of ISO 9001.

The “process approach” is described as: The application of a system of processes within an organization, together with the identification and interaction of these processes, and their management” (ref. section 0. 2). The process approach means that you improve your business by managing and improving certain key business processes that directly impact your ability to serve your customer. Since your business processes are basically “how you get things done”, by improving these processes you improve your company’s ability to meet customer requirements.

Gains made by improving your key processes pay dividends today and in the future as your QMS drives meaningful improvement in your business. So, that takes the focus of your ISO efforts off of “getting ready for the next audit. ” While a necessary part of ISO, passing the audit will only maintain your certification. This is the minimum benefit you should receive from your efforts. The real opportunity for measurable business benefit from ISO 9001 is for better efficiency, reduced failures and higher levels of performance for your customers.

The most effective ISO “lever” to achieve these results is the management and improvement of key business processes. Often, the most critical processes in your business are cross-functional, cutting across boundaries within you organizational structure. Improvements in these processes have an ongoing payback if such improvements are sustainable and sustained. The process approach, when correctly applied to your QMS, is the way this gets done. What’s involved in managing processes?

The management of key business processes basically involves the following: 1. Identifying the processes that most directly impact your customer and overall business performance. 2. Establishing reliable measures of performance for those processes. 3. Assigning responsibility for monitoring and improving each process. 4. Proper procedural documentation to control each process. 5. Effective action to root out obstacles in the process and to resolve root causes to performance gaps. 6. Integrating the process with the requirements of other business processes.

The management of your key processes should serve as the “top level” of your QMS – that is, it should provide the overall purpose and structure to your procedures, work instructions, training, etc. In addition, the selection of processes and establishment of process measures should be derived from your overall business and quality objectives. When reading the ISO 9001:2008 standard, it’s easy to miss this central emphasis on managing key processes. This is in part because the requirements for managing processes are sprinkled throughout the standard under various headings. Piecing together a complete understanding involves pulling a umber of requirements together. Implementation Issues A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. According to Barnes, “Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed. ” ISO 9001 is not in any way an indication that products produced using its certified systems are any good. A company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it.

According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard “helps to mislead companies into thinking that certification means better quality, … [undermining] the need for an organization to set its own quality standards. ” Paraphrased, Wade’s argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

While internationally recognized, most US consumers are not aware of ISO 9000 and it holds no relevance to them. The added cost to certify and then maintain certification may not be justified if product end users do not require ISO 9000. The cost can actually put a company at a competitive disadvantage when competing against a non ISO 9000 certified company. The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. If you just want the certificate on the wall, chances are, you will create a paper system that doesn’t have much to do with the way you actually run your business,” said ISO’s Roger Frost. Certification by an independent auditor is often seen as the problem area, and according to Barnes, “has become a vehicle to increase consulting services. ” In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation f the Quality System of a firm. Effectiveness Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which is the commitment of Senior Management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment, often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits. Besides that, how well the ISO system integrates into their business practices.

Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual rather than create a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary. Next factor is how well the ISO system focuses on improving the customer experience. The broadest definition of quality is “Whatever the customer perceives good quality to be”. This means that you don’t necessarily have to make a product that never fails, some customers will have a higher tolerance for product failures if they always receive shipments on-time, or some other dimension of customer service.

Your ISO system should take into account all areas of the customer experience, the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (your customers, your suppliers, and your organization), only then will you be able to sustain improvements in your customer experience. The following factor is how well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement.

Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard, however, to most executives; this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands allows the companies they audit to act on improvement initiatives. When management doesn’t understand why they were non-compliant and the business implications, they simply ignore the reports and focus on what they do understand. Moreover, the standard also strongly promotes a methodology, amely the plan-do-check-act (PDCA) cycle originally proposed by Deming in the 1950s. The PDCA cycle, incorporates a continuous feedback loop, allowing organizations to achieve benefits, such as reducing variation between the desired goals and realized performances and creating process-oriented thinking and perspective [Gupta, 2006] through continuous feedback. In addition, the standard provides a process-based model that describes processes that are necessary components of a quality management system such identifying customer’s requirements and measuring outcomes.

The model includes the specification of activities which address the following areas of concern: management responsibility, resource management, product realization, and measurement, analysis, and improvement. The model essentially considers that the areas of concern are address sequentially. Therefore, initially top management commits to the adoption of ISO 9001 standard by allocating resources and establishing strategies. Using the resources and strategies, employees produce products or services. The products or services are measured and analyzed through the enactment of appropriate activities or sets of activities.

Benefits The main objective of the standard is to state requirements for a quality management system for organizations that want to demonstrate their ability to offer high-quality products consistently and increase customer satisfaction. Through the standard, certified companies can enjoy numerous benefits. These include: improved internal communication and performance; improved quality perception; a disciplined work environment; improved documentation; continual improvement of operations; consistency in procedures and practices; fewer supplier quality assurance audits; and improved customer satisfaction [Casadesus et al. 2001; Dissanayaka et al. , 2001; Dowlatshahi and Urias, 2004; Bhuiyan and Alam, 2005]. ISO 9001 certification benefits can be classified into external and internal categories. The former are related to improvements in terms of marketing and promotional aspects, customer satisfaction and market share, while internal benefits are related with organizational improvements, the reward system, team work, measurement of performance and communication, and continuous improvement [Coleman and Douglas, 2003; Gotzamani and Tsiotras, 2002]. As an xternal motivation factor, ISO 9001 certification is frequently used mostly as a marketing tool [Poksinska et al. , 2006]. Some companies admit that without ISO 9000 certification they would not have achieved a significant number of contracts [Douglas et al. , 2003]. One of the benefits is to create a more efficient, effective and consistent in operations. With ISO 9001 certification, your operation will run more smoothly, as the QMS promotes consistency in how work is performed and recorded. This helps new employees learn processes more quickly and reduces misunderstandings with customers.

If a problem does occur, it is traced to its root cause and fixed, saving the organization from “re-correcting” it every time it happens. Moreover, it can improve employee motivation, awareness, and morale. During implementation, quality awareness will increase, since all staff must be trained on ISO 9001. Staff will be required to take “ownership” of processes that they are involved in developing and improving. The QMS will also have built-in systems to report on key quality indicators, which will significantly reduce the reoccurrence of problems.

This helps develop a strong quality culture, where the staff recognizes problems such as systems or process issues and works on fixing them, rather than placing blame with an individual. The result is increased confidence in workmanship and a more confident staff. The next benefit is process improvements. As you implement your QMS, you have the opportunity to improve your processes. You will outline the current process, add the requirements of the standard and then optimize the process with input from the process users. After achieving certification, you will likely see continual process improvements.

A recent survey of 100 registered firms reported the average improvement in operating margin at 5% of sales. These firms also reported faster turnaround times, and a reduction in scrap and overtime. In addition, ISO 9001 certification is becoming a must to do business in many markets. A recent survey of ISO 9001 certified companies shows that 41% were asked to achieve certification by a client. Considering that it can take 6 months or longer for some organizations to accomplish certification, already having a compliant QMS in place can be a distinct advantage.

Other benefits include increase customer satisfaction and retention, reduce audits, promote international trade, increases profit, reduce waste, and increases productivity. Conclusion ISO 9001 is an international quality certification that defines minimum requirements for a company’s Quality Management System (QMS), illustrating company’s competence to design, produce and deliver products or services with a consistent and coherent level of quality. It doesn’t matter what size they are or what they do. ISO 9001 is an excellent tool for developing a strong foundation of good processes and systems.

Processes and systems are essential for ensuring performance and growth in any enterprise. Furthermore, ISO 9001 certification can be effectively used in marketing, as it is a well-recognized standard for quality. It demonstrates to customers that the entity takes quality seriously and considers customers’ satisfaction to be a top priority. It is wise to conclude that ISO 9001: 2000 is viewed as an opportunity to develop an effective total quality management and quality assurance system that can contribute to the achievement of a total quality management and organizational performance.

Moreover, most certified organizations use ISO 9001: 2000 certification to meet or exceed the quality levels of competition, as they are faced with powerful international competitors from the industrialized world in its domestic market as well as in foreign markets. In addition, proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of legal action. References 1. ISO 9001- Quality Management Standard, Quality Standards from Approachable Auditors, from http://www. isoqar. com/iso9001/qualintro. tm/ 2. Scott Dawson. ISO 9001:2008 Articles: Enhance your ISO Knowledge Base, ISO 9001:2008 Certification Solutions, from http://www. 9000world. com/ 3. Hesham Magd. Quality Management Standards (QMS) Implementation in Egypt: ISO 9000 Perspectives. Global Business and Management Research(GBMR): An International Journal. Vol. 2, No. 1, 2010. pp. 57-68 4. Jelena Jovanovic, Aleksandar Vujovic ; Zdravko Krivokapi. Between Balanced Scorecard and Quality Management System. International Journal for Quality research. UDK- 005. 21 / 006. 35 (100) ISO. Scientiic Review Paper (1. 02). Vol. 2, No. 3, 2008 5.

Roslina Ab Wahid and James Corner. Critical success factors and problems in ISO 9000 maintenance. International Journal of Quality ; Reliability Management Vol. 26 No. 9, 2009 pp. 881-893 Emerald Group Publishing Limited 6. Adolfas Kaziliunas. Impacts of different factors on the implementation of quality management systems and performance outcomes. Current Issues of Business and Law, 2010, Vol. 5 75 ISSN 1822-9530 7. Gilles Lambert and Noufou Ouedraogo. Empirical investigation of ISO 9001 quality management systems’ impact on organisational learning and process performances. Total Quality Management Vol. 9, No. 10, October 2008, 1071–1085 8. Dong-young Kim, Vinod Kumar and Uma Kumar. A Framework of Intellectual Capital Management Based on ISO 9001 Quality Management System: The Case Study of ISO 9001 Certified Public R;D Institute. Knowledge and Process Management Vol 16 Number 4 pp 162–173 (2009). 2009 John Wiley ; Sons, Ltd. 9. Sousa-Poza, Mert Altinkilinc ; Cory Searcy. Implementing a Functional ISO 9001 Quality Management System in Small and Medium-Sized Enterprises. International Journal of Engineering (IJE), Volume (3) : Issue (3) 220 10. Ray Tricker. ISO 9001:2000—The Quality Management Process.

Information Systems Control Journal. Volume 6, 2007 11. ISO 9001:2008, International Standards for Business, Government and Society, from http://www. iso. org/iso/iso_catalogue/management_and_leadership_standards/quality_management/iso_9001_2008. htm 12. D. Tzelepis, K. Tsekouras, D. Skuras and E. Dimara. The effects of ISO 9001 on firms’ productive efficiency. International Journal of Operations ; Production Management Vol. 26 No. 10, 2006 pp. 1146-1165 Emerald Group Publishing Limited 13. ISO 9001 2008 Translated to Plain English. Praxiom Research Group Limited. ,from http://www. praxiom. com/iso-9001. htm


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