Iso 9001:2000
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Quality Management System
A report submitted to the faculty of Business Administration in part fulfillment of requirement of final examination in Business Communication
Prepared and submitted by(ASSURANCE)
NameID Name ID Name ID Name ID
Khan, Md. Saquib 07-07642-1 Siddique, Barkat Mashroor 05-0548-1 Chowdhury, Mohd. Imran Hossain 07-07729-1 Mohammed, Fahad Sikdar 07-08214-1
Course Instructor: Rezaur, Mohammad Razzak
American International University-Bangladesh
A I
U 1
B
ACKNOWLEDGEMENT: We would like to express our gratitude to our course teacher Mr Rezaur, Mohammad Razzak, Assistant Professor, American International University – Bangladesh for his kind, continous guidance and relentless efforts to make our Group Project report a worth one. We would also like to mention AIUB library for allowing us to use valuable references.
2
Table of Contents:
Contents:
Page
1.
Introduction to Quality Management System.................................................1 Benefits of ISO registration…………………………………………………2 ISO 9000 series of standards………………...………………………………3
2.
ISO 9001 Requirements………………………………………………………3 Scope…………………………………………………………………………4 Normative References……………….……………………………………….4 Definition …………………………..……….………………………………...4 Quality management System……….……….………………………………..4 Management Responsibility…………….……………………………………5 Resource Management ……………………………………………………...7 Product or Service Realization and management……………………………8 Analysis and Improvement………………………………………………….11
3.
ISO certified Companies…………………………………………………….12 Ambee Pharmaceuticals LTD………………………………………………..12 Northern Corporation LTD………………………………………………….13 Bangladesh Internet Press LTD…………………………………………….13
4.
Conclusion………………………………………………………………...…13 Debates on the effectiveness on the ISO 9000 standards…………………....13
5.
Bibliography………………………………………………………………..15
3
1: Introduction to Quality management system. Introduction: The international organization for standardization (ISO) was founded in 1946 in Geneva, Switzerland, were it is still based. Its mandate is to promote the development of international standards to facilitate exchange of goods and services worldwide. ISO is composed of more than 90 member countries. The United States representative is the American National Standards Institute (ANSI). The ISO technical committee (TC) 176 developed a series of international standards for quality systems, which were first published in 1987. The standards (ISO 9000.9001, and 9004) were intended to be advisory and were developed for use in two-party contractual situation and internal auditing. However with their adoption by the European community (EC) and a worldwide emphasis on quality and economic competitiveness, the standards have become universally accepted. Most countries have adopted the ISO-9000 series as their national standards. Likewise, thousands of organizations throughout the world have quality systems registered to the standard. In the United States, the national standards are published by the American national institute/American society for Quality (ANSI/ASQ) as the ANSI/ASQQ9000 series. Government bodies throughout the world, including the united states, are also using the standards. U.S. Govt agencies using the series are the department of defense (DOD) and the food & drug administration (FDA). In a two-party system, supplier of a product or service wood develop a quality system that conformed to the standards. The customers would then audit the system for acceptability. This two party system results in both the supplier and customer having to participate in multiple audits, which can be extremely costly. This practice is replaced by a third party registration system. A quality system registration involves the assessment and periodic surveillance audit of the adequacy of a supplier ’s quality system by a third party, who is a registrar. When a system conforms to the registrar ’s interpretation of the standard, the registrar issues a certificate of registration to the supplier. This registration ensures customers or potential customers that a supplier has a quality system un place and it is being monitored. [1]
(1. B esterfield D. H. Total Quality Managem ent.)
4
1.1 Benefits of ISO Registration: There are various reasons for implementing a quality system that conforms to an ISO standard. The primary reason is that customers or marketing are suggesting or demanding compliance to a quality system. Other reasons are needed improvement in a process or systems and a desire for goal deployment of product and services. As more and more organization become registered, their requiring their subcontractors or supplier to be register, creating a snowball effect. Consequently, In order to maintain or increase market share, many organizations are finding they must be in conformance with ISO standard. Internal benefits that can be received from developing and implementing a well documented quality system can far outweigh the external pressures. A study of 100 Italian firms was undertaken to determine if there was any improvements in performance after registration. Significant improvement was noted in: • • • • •
Internal quality as measured by the percent of scrap, rework, and nonconformity at final inspection. Production reliability as measured by the numbers of breakdowns per month, percent of time dedicated to emergencies, and percent of downtime per shift. External quality as measured by product accepted by customers without inspection, claims of nonconforming product, and returned product. Time performance as measured by time to market, on time delivery, and throughput time. Cost of poor quality as measured by external nonconformities, scrap, and rework.
On the negative side, prevention and appraisal cost increased. Additional examples of benefits after registration are: •
• • •
The American Institute of certified public accountant (AICPA) now has a quality system at works, and there was a 4% improvement in gross margin, which was the largest improvement in their history. North town ford automobile dealership in Toronto, Ontario raise customer satisfaction and loyalty by 20%, and it had a 55% increase in customer who would recommend the dealership. United reduced the average engine overhaul cycle , time from 120 days to 60 days. Cleveland center for joint registration has experienced lower costs and more control and consistency in the care it provides.
5
1.2 ISO 9000 Series of standards The ISO 9000 series of standard is generic in scope. By design, the series can be tailored to feet any organizations needs, whether it is a large or small, a manufacturer or a service organization. It can be applied to construction, engineering, health care, legal, and other professional services as well as the manufacturing of anything from nuts and bolts to spacecraft. Its purpose is to unify quality terms and definitions used by industrialized nations and use those terms to demonstrate a supplier ’s capability of controlling its processes. In very simplified terms, the standards require and Organization to say what it is doing to ensure quality, then do what it says, and, finally, document or prove that it has done what it said. The three standards of the series are described briefly in the following paragraphs: • •
•
ISO 9000:2000-Quality management systems (QMS)-fundamentals and vocabulary discusses the fundamental concepts related to the QMS and provides the terminology used in the order two standards. ISO 9001:2000 – Quality management systems (QMS)- requirements in the standard used for registration by demonstrating conformity of the QMS to customers, regulatory, and the organization’s own requirements. ISO 9004-2000- Quality management Systems (QMS)- guidelines for performance improvement provides guidelines that an organization can use to establish a QMS focused on improving performance.
2. ISO 9001 Requirement: The standard has clauses: • Scope. • Normative references. • Definition. • Quality management system. • Management responsibility. • Resource management. • Product or service realization. • Measurement. • Analysis. • Improvement.
6
The first three clauses are for information. While last five are requirements that an organization must meet. The numbering system used in standard. The application of a system of processes within organization, together with identification and interactions and the managing of these processes, is referred to as the PROCESS APPROACH. This approach emphasizes the importance of: • • • •
Understanding and fulfilling the requirement. Add values. Obtaining results of process performance and effectiveness. Continuous improvement process based on objective measure.
1) Scope: the purpose of the organization is to demonstrate its ability to provide a product that meets customer requirements and achieve customer satisfaction. This purpose is accomplished by evaluating and continually improving the system. 2) Normative reference: fundamentals and vocabulary are a normative reference that provides applicable concept and definition. 3) Terms and definition: supplier
organization
customer.
4) Quality management system: 4.1 General requirement: organization shall establish, document, implement, and maintain a quality management system and continually improve its effectives. Organization shalla) Identify need processes such as management activities, provision of resources, product realization and measurement. b) Determine sequence and interaction. c) Determine method of effective operation. d) Ensure the availability of resources and information necessary to support and monitor these processes. e) Monitor measure and analyze the processes. f) Implement action to achieve planned results and continual improvement of processes.
7
4.2 Documentation: 4.2.1 a) b) c) d)
General documentation shall include Statement of quality policy and quality objective. A quality manual. Required documented procedures. Needed documents to ensure effective planning, operation and control of processes. e) Required record
4.2.2 Quality Manual: a) The scope of the quality management system with justification for any exclusion. b) The procedures. c) A description of the interaction among the quality measurement procedures. 4.2.3 Control of document: a) Approve document prior to use. b) Review, update and re approve. c) Identify the revision status. d) Ensure the current revision. e) Ensure that documents are legible. f) Identify and distribute document. Control of document is established, maintained. 4.2.4
documented,
implemented,
and
Control of records: record should legible, ready, identifiable, retrievable: Controls of records define the control needs for identification, storage, protection, retrievals, time and disposition of records. Record can be used to traceability, and to provide evidence of verification, preventive action, and corrective action.
5) Management responsibility: 5.1 Management commitment: a) Communicating the need to meet customer. b) Establishing a quality policy. c) Ensure the quality objectives are established. d) Conducting management review. e) Ensure the resources.
8
5.2 customer focus: ensure the customer requirement. 5.3 Quality policy: a) Organization mission is linked with quality policy. b) Frame work for establishing quality objective. c) Understood the objectives and communicate with the organization. d) Continuing stability. 5.4 planning: 5.4.1
Quality objectives: top management set the organization objective and quality maintaining policy which is linked up with quality management system. And top management should establish the system that quality implements in system and it can satisfy customers need. 5.4.2 Quality management system planning: top management shall ensure that the planning of the quality management system. Is accomplished in order to me T the requirement of the QMC as stated in the genral requirements as well as quality objectives. 5.5 responsibility, authority and communication: Define job descriptions, procedures and work instructions. Ensuring processes needed for the QMS system are established. Implemented and maintained. Reporting to top management and ensure the promotion of awareness of customer requirement through out the organization. Ensuring the better chain of command. 5.5 Management review: 5.6.1 General: top management has to review and monitor all the processes and make sure the process effectiveness. 5.6.2 Review input: result of audit, customer feed back, product conformity, corrective and preventive actions and performance, follow up actions from past management review, change and recommendation for better improvement. 5.6.3 Review output: improvement, improvement in customer need and requirement, resource effectiveness.
9
5.6: Management review General Top management shall review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the QMS including the quality policy and quality objectives. Records from the reviews shall be maintained. Review input: The input to the review shall include information on (a) results of audits. (b) customer feedback. (c) Process performance and product conformity, (d) status of corrective and preventative performance, (e) follow-up actions from previous management reviews, (f) changes that could affect the QMS, and (g) recommendations for improvement. Review output: The output from the review shall include any decisions and actions related to (a) improvement of the effectiveness of the QMS and its processes, (b) improvement of the product related to customer requirement, and (c) resource needs. Top management can use the outputs as inputs to improvement opportunities. 6. Resource Management 6.1: Provision of Resources The organization shall determine and provide the resources needed (a) to implement and maintain the QMS and continually improve its effectiveness, and (b) to enhance customer satisfaction by meeting customer requirements. Resources may be people, infrastructure, work environment, information, suppliers, natural resources and financial resources. Resources can be aligned with quality objectives. 6.2: Human Resources 6.2.1 General: Personnel performing work that affects product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, Awareness and Training: The organization shall (a) determine the necessary competence for personnel performing work affecting product quality, (b) provide training or take other actions to satisfy these needs. (c) evaluate the effectiveness of the action taken, (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and (e) maintain appropriate records of education, training, skills, and experience. Competency is defined as the demonstrated ability to apply knowledge and skills. It can be contained in the job description by function, group or specific position. Training effectiveness can be determined by before and after tests, performance, or turnover. ISO 10015 Guidelines for Training will help organization comply with this standard.
10
6.3: Infrastructure The organization shall determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable (a) buildings, workspace and associated utilities, (b) process equipment (both hardware and software), and (c) supporting services (such as transport or communication). 6.3.1: Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. Creation of a suitable work environment can have a positive influence on employee motivation, satisfaction and performance. 7. Product Realization 7.1: Planning of Product realization: The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirement of the other processes of QMS. In planning product realization, the organization shall determine the following, as appropriate, documents, and provide resources specific to the product,(c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance, and (d) records needed to provide evidence that the realization processes and resulting product or service meet requirement s. The output of this planning shall be in a form suitable for the organization’s method of operation. A document specifying the processes of the QMS (including the product realization processes) and the resources to be applied to a specific product, project or contact, can be referred to as a quality plan. The organization may also apply the requirements given in 7.3 to the development of the product realization processes. 7.2: Customer- Related Processes: 7.2.1: Determination of Requirements Related to the Product: The organization shall determine (a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, (b) requirements not stated by the customer but necessary for specified or intended use, where known, (c) statutory and regulatory requirements related to the product, and (d) any additional requirements determined by the organization.
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7.2.2: Review of Requirements Related to the Product: The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (for example, submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that (a) product requirements are defined. (b) Contract or order requirements differing from those previously expressed are resolved, and (c)the organization has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. In some situations, such as Internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material. 7.3: Design and development: 7.3.1 Design and Development Planning: The organization shall plan and control the design and development of the product. During the design and development planning, the organization shall determine (a)the design and development stages, (b) the review, verification and validation that are appropriate to each design and development stage, and (c) the responsibilities and authorities for design and development stage, and (c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. 7.3.2: Design and development Inputs: Inputs relating to product requirements shall be determined and records maintained. These shall include (a) functional and performance requirements, (b) applicable statutory and regulatory requirements, (c) where applicable, information derived from previous similar designs, and (d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3: Design and Development Outputs: The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall (a) meet the input requirements for design and development; (b) provide appropriate information for purchasing, production
12
and for service provision. (c) Contain or reference product acceptance criteria, and (d) specify the characteristics of the product that are essential for its safe and proper use. 7.3.4:Design and Development Review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (a) to evaluate the ability of the results of design and development to meet requirements and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed. Records of the results of the reviews and any necessary actions shall be maintained. Risk assessment such as FMEA, reliability prediction, and simulation techniques can be undertaken to determine potential failures in products or processes. 7.3.5: Design and Development Verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained. Verification confirms, through objective evidence, that the specified requirements have been fulfilled. Confirmation can comprise activities such as performing alternate calculations, comparing the new design specification to a similar proven design specification, undertaking tests and demonstrations, and reviewing documents prior to issue. 7.3.6: Design and Development Validation: 7.3.7 Control of Design and development changes: 7.4 Purchasing: Purchasing covers three steps (a)Purchasing process: Purchasing Information: (b) Purchasing Information (c)Verification of Purchased Product: 7.5: Production and service provision: a) Control of production and service provision: b) Validation of Processes for production and service provision: c) Identification and Traceability: d) Customer Property: e) Preservation of Product: The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging storage, and protection. Preservation shall also apply to the constituent parts of a product.
13
7.6: Control of monitoring and measuring devices: The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. 8. Measurement, Analysis, and Improvement: 8.1 General: the organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed (a) to demonstrate conformity of the product, (b)to ensure conformity of the QMS and (c) to continually improve the effectiveness of the QMS, and (c) to continually improve the effectiveness of the QMS. This shall include determination of applicable method, including statistical techniques, and the extent of their use. 8.2Monitoring and Measurement: Customer satisfaction: As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. 8.2.2Internal Audit: The organization shall conduct internal audits at planned intervals to determine whether the QMS (a) conforms to the planned arrangements (b) is effectively implemented and maintained 8.2.3Monitoring and Measurement of process: The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. 8.2.4: Monitoring and Measurement of Product and service: The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the Persons authorizing release of product. Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
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8.3: Control of Nonconforming Product: 8.4: Analysis of DATA: The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to (a) customer satisfaction, (b) conformity to product requirements, (c) Characteristics and trends of processes and products, including opportunities for preventive action, and (d) suppliers. 8.5: Improvement: 8.5.1: Continual Improvement: The organization shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. 8.5.2: Corrective Action: The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. 8.5.3: Preventive Action: The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. (Bester field.D.H. Total Quality Management)
3. ISO Certified Companies: 3.1: AMBEE PHARMACEUTICALS LTD., a fast growing company was established in 1976 in Bangladesh. This public limited company was registered under the companies Act, 1913 and was incorporated in Bangladesh on 4th February 1976. Ambee has a joint venture with a famous multinational company Medimpex of Hungary. Ambee started its operation with modest 17 joint ventured products and is now running in full swing with 76 products. We have Tablets, Capsules, Liquids, Gel in tubes and Injectables. Its operational area covers all over Bangladesh with a large number of field forces who strive hard to establish the demand of products of the company in every corner of the country. The company maintains four out side Depots located at Khulna, Bogra, Chittagong and Sylhet besides its National Distribution Cell in Dhaka. In 2001 Ambee Pharmaceuticals Ltd. became ISO 9001 certified company. ISO 9001 certificate is the international recognition of the quality management system of this organization that complies with the standard of ISO 9001 system. This certificate was awarded by United Registrar of Systems Ltd.(URS) of UK. In Bangladesh among 250 pharmaceutical companies only few have become ISO 9001 certified and Ambee is one of them. 15
3.2: Northern Corporation Ltd. was founded and established in the year of 1987. The company started with the knitting and dyeing unit and later on start producing knit garment for the export market. The capacity has grown from 3000 pcs of garment per day to 25000 pcs of garment per day at the present. This company is now one of the few companies in Bangladesh, which ensures high end dyeing, and finishing of knitted fabrics facilitated by the state of the art dyeing and finishing machineries. NCL is ISO certified and OKO-tex certified company. This provides a leading edge to the foreign buyers while it comes to marketing. The well-educated group of work-study and production engineering team, which makes NCL a modern company of its kind, runs the garment unit. The company’s yearly turnover stood at 16.5 million US in the financial year of 2005-2006. The production unit for knitting, Dyeing and Garment is situated nearby Dhaka at Tongi, BSCIC, and Gazipur, Bangladesh. 3.3: Bangladesh Internet Press Limited (BIPL) is the first CMMI Maturity Level 3 company in Bangladesh. The company has reached maturity Level 3 after working for several years on combining its own vast experience and accumulating best practices in implementing software engineering processes with SEI CMMI recommendations. BIPL is also a Microsoft Gold and ISO 9001:2000 certified global IT enterprise with key focus on client-server technology, open source platforms & e-business solutions.
4: Conclusion: Debate on the effectiveness of ISO 9000: Advantages: It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.[2][3] The quality principles in ISO 9000:2000 are also sound, according to Wade,[4] and Barnes, [3] who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by DeloitteTouche which reported that the costs of registration were recovered in three years. According to the Providence Business News [5], implementing ISO often gives the following advantages: 1. 2. 3. 4. 5. 6. 7. 8.
Create a more efficient, effective operation Increase customer satisfaction and retention Reduce audits Enhance marketing Improve employee motivation, awareness, and morale Promote international trade Increases profit Reduce waste and increases productivity
16
However, a broad statistical study of 800 Spanish companies found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration. In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability. Problems: A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration.[7] 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."[3] According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. [8] [9] 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, Wada’s argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. 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." [3] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. (http:// Wikipedia – the free encyclopedia. htm)
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5. Bibliography
I. Besterfield, D. H. (2007). Total Quality Management. New Delhi: Prentice Hall of India. II. ISO 9000. Wikipedia- The free Encyclopedia. Retrived in April 11, 2009, from http://en.wikipedia.org/wiki/ISO_9000#ISO_9000_series_of_standards.
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A report submitted to the faculty of Business Administration in part fulfillment of requirement of final examination in Business Communication
Prepared and submitted by(ASSURANCE)
NameID Name ID Name ID Name ID
Khan, Md. Saquib 07-07642-1 Siddique, Barkat Mashroor 05-0548-1 Chowdhury, Mohd. Imran Hossain 07-07729-1 Mohammed, Fahad Sikdar 07-08214-1
Course Instructor: Rezaur, Mohammad Razzak
American International University-Bangladesh
A I
U 1
B
ACKNOWLEDGEMENT: We would like to express our gratitude to our course teacher Mr Rezaur, Mohammad Razzak, Assistant Professor, American International University – Bangladesh for his kind, continous guidance and relentless efforts to make our Group Project report a worth one. We would also like to mention AIUB library for allowing us to use valuable references.
2
Table of Contents:
Contents:
Page
1.
Introduction to Quality Management System.................................................1 Benefits of ISO registration…………………………………………………2 ISO 9000 series of standards………………...………………………………3
2.
ISO 9001 Requirements………………………………………………………3 Scope…………………………………………………………………………4 Normative References……………….……………………………………….4 Definition …………………………..……….………………………………...4 Quality management System……….……….………………………………..4 Management Responsibility…………….……………………………………5 Resource Management ……………………………………………………...7 Product or Service Realization and management……………………………8 Analysis and Improvement………………………………………………….11
3.
ISO certified Companies…………………………………………………….12 Ambee Pharmaceuticals LTD………………………………………………..12 Northern Corporation LTD………………………………………………….13 Bangladesh Internet Press LTD…………………………………………….13
4.
Conclusion………………………………………………………………...…13 Debates on the effectiveness on the ISO 9000 standards…………………....13
5.
Bibliography………………………………………………………………..15
3
1: Introduction to Quality management system. Introduction: The international organization for standardization (ISO) was founded in 1946 in Geneva, Switzerland, were it is still based. Its mandate is to promote the development of international standards to facilitate exchange of goods and services worldwide. ISO is composed of more than 90 member countries. The United States representative is the American National Standards Institute (ANSI). The ISO technical committee (TC) 176 developed a series of international standards for quality systems, which were first published in 1987. The standards (ISO 9000.9001, and 9004) were intended to be advisory and were developed for use in two-party contractual situation and internal auditing. However with their adoption by the European community (EC) and a worldwide emphasis on quality and economic competitiveness, the standards have become universally accepted. Most countries have adopted the ISO-9000 series as their national standards. Likewise, thousands of organizations throughout the world have quality systems registered to the standard. In the United States, the national standards are published by the American national institute/American society for Quality (ANSI/ASQ) as the ANSI/ASQQ9000 series. Government bodies throughout the world, including the united states, are also using the standards. U.S. Govt agencies using the series are the department of defense (DOD) and the food & drug administration (FDA). In a two-party system, supplier of a product or service wood develop a quality system that conformed to the standards. The customers would then audit the system for acceptability. This two party system results in both the supplier and customer having to participate in multiple audits, which can be extremely costly. This practice is replaced by a third party registration system. A quality system registration involves the assessment and periodic surveillance audit of the adequacy of a supplier ’s quality system by a third party, who is a registrar. When a system conforms to the registrar ’s interpretation of the standard, the registrar issues a certificate of registration to the supplier. This registration ensures customers or potential customers that a supplier has a quality system un place and it is being monitored. [1]
(1. B esterfield D. H. Total Quality Managem ent.)
4
1.1 Benefits of ISO Registration: There are various reasons for implementing a quality system that conforms to an ISO standard. The primary reason is that customers or marketing are suggesting or demanding compliance to a quality system. Other reasons are needed improvement in a process or systems and a desire for goal deployment of product and services. As more and more organization become registered, their requiring their subcontractors or supplier to be register, creating a snowball effect. Consequently, In order to maintain or increase market share, many organizations are finding they must be in conformance with ISO standard. Internal benefits that can be received from developing and implementing a well documented quality system can far outweigh the external pressures. A study of 100 Italian firms was undertaken to determine if there was any improvements in performance after registration. Significant improvement was noted in: • • • • •
Internal quality as measured by the percent of scrap, rework, and nonconformity at final inspection. Production reliability as measured by the numbers of breakdowns per month, percent of time dedicated to emergencies, and percent of downtime per shift. External quality as measured by product accepted by customers without inspection, claims of nonconforming product, and returned product. Time performance as measured by time to market, on time delivery, and throughput time. Cost of poor quality as measured by external nonconformities, scrap, and rework.
On the negative side, prevention and appraisal cost increased. Additional examples of benefits after registration are: •
• • •
The American Institute of certified public accountant (AICPA) now has a quality system at works, and there was a 4% improvement in gross margin, which was the largest improvement in their history. North town ford automobile dealership in Toronto, Ontario raise customer satisfaction and loyalty by 20%, and it had a 55% increase in customer who would recommend the dealership. United reduced the average engine overhaul cycle , time from 120 days to 60 days. Cleveland center for joint registration has experienced lower costs and more control and consistency in the care it provides.
5
1.2 ISO 9000 Series of standards The ISO 9000 series of standard is generic in scope. By design, the series can be tailored to feet any organizations needs, whether it is a large or small, a manufacturer or a service organization. It can be applied to construction, engineering, health care, legal, and other professional services as well as the manufacturing of anything from nuts and bolts to spacecraft. Its purpose is to unify quality terms and definitions used by industrialized nations and use those terms to demonstrate a supplier ’s capability of controlling its processes. In very simplified terms, the standards require and Organization to say what it is doing to ensure quality, then do what it says, and, finally, document or prove that it has done what it said. The three standards of the series are described briefly in the following paragraphs: • •
•
ISO 9000:2000-Quality management systems (QMS)-fundamentals and vocabulary discusses the fundamental concepts related to the QMS and provides the terminology used in the order two standards. ISO 9001:2000 – Quality management systems (QMS)- requirements in the standard used for registration by demonstrating conformity of the QMS to customers, regulatory, and the organization’s own requirements. ISO 9004-2000- Quality management Systems (QMS)- guidelines for performance improvement provides guidelines that an organization can use to establish a QMS focused on improving performance.
2. ISO 9001 Requirement: The standard has clauses: • Scope. • Normative references. • Definition. • Quality management system. • Management responsibility. • Resource management. • Product or service realization. • Measurement. • Analysis. • Improvement.
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The first three clauses are for information. While last five are requirements that an organization must meet. The numbering system used in standard. The application of a system of processes within organization, together with identification and interactions and the managing of these processes, is referred to as the PROCESS APPROACH. This approach emphasizes the importance of: • • • •
Understanding and fulfilling the requirement. Add values. Obtaining results of process performance and effectiveness. Continuous improvement process based on objective measure.
1) Scope: the purpose of the organization is to demonstrate its ability to provide a product that meets customer requirements and achieve customer satisfaction. This purpose is accomplished by evaluating and continually improving the system. 2) Normative reference: fundamentals and vocabulary are a normative reference that provides applicable concept and definition. 3) Terms and definition: supplier
organization
customer.
4) Quality management system: 4.1 General requirement: organization shall establish, document, implement, and maintain a quality management system and continually improve its effectives. Organization shalla) Identify need processes such as management activities, provision of resources, product realization and measurement. b) Determine sequence and interaction. c) Determine method of effective operation. d) Ensure the availability of resources and information necessary to support and monitor these processes. e) Monitor measure and analyze the processes. f) Implement action to achieve planned results and continual improvement of processes.
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4.2 Documentation: 4.2.1 a) b) c) d)
General documentation shall include Statement of quality policy and quality objective. A quality manual. Required documented procedures. Needed documents to ensure effective planning, operation and control of processes. e) Required record
4.2.2 Quality Manual: a) The scope of the quality management system with justification for any exclusion. b) The procedures. c) A description of the interaction among the quality measurement procedures. 4.2.3 Control of document: a) Approve document prior to use. b) Review, update and re approve. c) Identify the revision status. d) Ensure the current revision. e) Ensure that documents are legible. f) Identify and distribute document. Control of document is established, maintained. 4.2.4
documented,
implemented,
and
Control of records: record should legible, ready, identifiable, retrievable: Controls of records define the control needs for identification, storage, protection, retrievals, time and disposition of records. Record can be used to traceability, and to provide evidence of verification, preventive action, and corrective action.
5) Management responsibility: 5.1 Management commitment: a) Communicating the need to meet customer. b) Establishing a quality policy. c) Ensure the quality objectives are established. d) Conducting management review. e) Ensure the resources.
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5.2 customer focus: ensure the customer requirement. 5.3 Quality policy: a) Organization mission is linked with quality policy. b) Frame work for establishing quality objective. c) Understood the objectives and communicate with the organization. d) Continuing stability. 5.4 planning: 5.4.1
Quality objectives: top management set the organization objective and quality maintaining policy which is linked up with quality management system. And top management should establish the system that quality implements in system and it can satisfy customers need. 5.4.2 Quality management system planning: top management shall ensure that the planning of the quality management system. Is accomplished in order to me T the requirement of the QMC as stated in the genral requirements as well as quality objectives. 5.5 responsibility, authority and communication: Define job descriptions, procedures and work instructions. Ensuring processes needed for the QMS system are established. Implemented and maintained. Reporting to top management and ensure the promotion of awareness of customer requirement through out the organization. Ensuring the better chain of command. 5.5 Management review: 5.6.1 General: top management has to review and monitor all the processes and make sure the process effectiveness. 5.6.2 Review input: result of audit, customer feed back, product conformity, corrective and preventive actions and performance, follow up actions from past management review, change and recommendation for better improvement. 5.6.3 Review output: improvement, improvement in customer need and requirement, resource effectiveness.
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5.6: Management review General Top management shall review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the QMS including the quality policy and quality objectives. Records from the reviews shall be maintained. Review input: The input to the review shall include information on (a) results of audits. (b) customer feedback. (c) Process performance and product conformity, (d) status of corrective and preventative performance, (e) follow-up actions from previous management reviews, (f) changes that could affect the QMS, and (g) recommendations for improvement. Review output: The output from the review shall include any decisions and actions related to (a) improvement of the effectiveness of the QMS and its processes, (b) improvement of the product related to customer requirement, and (c) resource needs. Top management can use the outputs as inputs to improvement opportunities. 6. Resource Management 6.1: Provision of Resources The organization shall determine and provide the resources needed (a) to implement and maintain the QMS and continually improve its effectiveness, and (b) to enhance customer satisfaction by meeting customer requirements. Resources may be people, infrastructure, work environment, information, suppliers, natural resources and financial resources. Resources can be aligned with quality objectives. 6.2: Human Resources 6.2.1 General: Personnel performing work that affects product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, Awareness and Training: The organization shall (a) determine the necessary competence for personnel performing work affecting product quality, (b) provide training or take other actions to satisfy these needs. (c) evaluate the effectiveness of the action taken, (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and (e) maintain appropriate records of education, training, skills, and experience. Competency is defined as the demonstrated ability to apply knowledge and skills. It can be contained in the job description by function, group or specific position. Training effectiveness can be determined by before and after tests, performance, or turnover. ISO 10015 Guidelines for Training will help organization comply with this standard.
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6.3: Infrastructure The organization shall determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable (a) buildings, workspace and associated utilities, (b) process equipment (both hardware and software), and (c) supporting services (such as transport or communication). 6.3.1: Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. Creation of a suitable work environment can have a positive influence on employee motivation, satisfaction and performance. 7. Product Realization 7.1: Planning of Product realization: The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirement of the other processes of QMS. In planning product realization, the organization shall determine the following, as appropriate, documents, and provide resources specific to the product,(c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance, and (d) records needed to provide evidence that the realization processes and resulting product or service meet requirement s. The output of this planning shall be in a form suitable for the organization’s method of operation. A document specifying the processes of the QMS (including the product realization processes) and the resources to be applied to a specific product, project or contact, can be referred to as a quality plan. The organization may also apply the requirements given in 7.3 to the development of the product realization processes. 7.2: Customer- Related Processes: 7.2.1: Determination of Requirements Related to the Product: The organization shall determine (a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, (b) requirements not stated by the customer but necessary for specified or intended use, where known, (c) statutory and regulatory requirements related to the product, and (d) any additional requirements determined by the organization.
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7.2.2: Review of Requirements Related to the Product: The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (for example, submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that (a) product requirements are defined. (b) Contract or order requirements differing from those previously expressed are resolved, and (c)the organization has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. In some situations, such as Internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material. 7.3: Design and development: 7.3.1 Design and Development Planning: The organization shall plan and control the design and development of the product. During the design and development planning, the organization shall determine (a)the design and development stages, (b) the review, verification and validation that are appropriate to each design and development stage, and (c) the responsibilities and authorities for design and development stage, and (c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. 7.3.2: Design and development Inputs: Inputs relating to product requirements shall be determined and records maintained. These shall include (a) functional and performance requirements, (b) applicable statutory and regulatory requirements, (c) where applicable, information derived from previous similar designs, and (d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3: Design and Development Outputs: The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall (a) meet the input requirements for design and development; (b) provide appropriate information for purchasing, production
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and for service provision. (c) Contain or reference product acceptance criteria, and (d) specify the characteristics of the product that are essential for its safe and proper use. 7.3.4:Design and Development Review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (a) to evaluate the ability of the results of design and development to meet requirements and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed. Records of the results of the reviews and any necessary actions shall be maintained. Risk assessment such as FMEA, reliability prediction, and simulation techniques can be undertaken to determine potential failures in products or processes. 7.3.5: Design and Development Verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained. Verification confirms, through objective evidence, that the specified requirements have been fulfilled. Confirmation can comprise activities such as performing alternate calculations, comparing the new design specification to a similar proven design specification, undertaking tests and demonstrations, and reviewing documents prior to issue. 7.3.6: Design and Development Validation: 7.3.7 Control of Design and development changes: 7.4 Purchasing: Purchasing covers three steps (a)Purchasing process: Purchasing Information: (b) Purchasing Information (c)Verification of Purchased Product: 7.5: Production and service provision: a) Control of production and service provision: b) Validation of Processes for production and service provision: c) Identification and Traceability: d) Customer Property: e) Preservation of Product: The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging storage, and protection. Preservation shall also apply to the constituent parts of a product.
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7.6: Control of monitoring and measuring devices: The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. 8. Measurement, Analysis, and Improvement: 8.1 General: the organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed (a) to demonstrate conformity of the product, (b)to ensure conformity of the QMS and (c) to continually improve the effectiveness of the QMS, and (c) to continually improve the effectiveness of the QMS. This shall include determination of applicable method, including statistical techniques, and the extent of their use. 8.2Monitoring and Measurement: Customer satisfaction: As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. 8.2.2Internal Audit: The organization shall conduct internal audits at planned intervals to determine whether the QMS (a) conforms to the planned arrangements (b) is effectively implemented and maintained 8.2.3Monitoring and Measurement of process: The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. 8.2.4: Monitoring and Measurement of Product and service: The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the Persons authorizing release of product. Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
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8.3: Control of Nonconforming Product: 8.4: Analysis of DATA: The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to (a) customer satisfaction, (b) conformity to product requirements, (c) Characteristics and trends of processes and products, including opportunities for preventive action, and (d) suppliers. 8.5: Improvement: 8.5.1: Continual Improvement: The organization shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. 8.5.2: Corrective Action: The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. 8.5.3: Preventive Action: The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. (Bester field.D.H. Total Quality Management)
3. ISO Certified Companies: 3.1: AMBEE PHARMACEUTICALS LTD., a fast growing company was established in 1976 in Bangladesh. This public limited company was registered under the companies Act, 1913 and was incorporated in Bangladesh on 4th February 1976. Ambee has a joint venture with a famous multinational company Medimpex of Hungary. Ambee started its operation with modest 17 joint ventured products and is now running in full swing with 76 products. We have Tablets, Capsules, Liquids, Gel in tubes and Injectables. Its operational area covers all over Bangladesh with a large number of field forces who strive hard to establish the demand of products of the company in every corner of the country. The company maintains four out side Depots located at Khulna, Bogra, Chittagong and Sylhet besides its National Distribution Cell in Dhaka. In 2001 Ambee Pharmaceuticals Ltd. became ISO 9001 certified company. ISO 9001 certificate is the international recognition of the quality management system of this organization that complies with the standard of ISO 9001 system. This certificate was awarded by United Registrar of Systems Ltd.(URS) of UK. In Bangladesh among 250 pharmaceutical companies only few have become ISO 9001 certified and Ambee is one of them. 15
3.2: Northern Corporation Ltd. was founded and established in the year of 1987. The company started with the knitting and dyeing unit and later on start producing knit garment for the export market. The capacity has grown from 3000 pcs of garment per day to 25000 pcs of garment per day at the present. This company is now one of the few companies in Bangladesh, which ensures high end dyeing, and finishing of knitted fabrics facilitated by the state of the art dyeing and finishing machineries. NCL is ISO certified and OKO-tex certified company. This provides a leading edge to the foreign buyers while it comes to marketing. The well-educated group of work-study and production engineering team, which makes NCL a modern company of its kind, runs the garment unit. The company’s yearly turnover stood at 16.5 million US in the financial year of 2005-2006. The production unit for knitting, Dyeing and Garment is situated nearby Dhaka at Tongi, BSCIC, and Gazipur, Bangladesh. 3.3: Bangladesh Internet Press Limited (BIPL) is the first CMMI Maturity Level 3 company in Bangladesh. The company has reached maturity Level 3 after working for several years on combining its own vast experience and accumulating best practices in implementing software engineering processes with SEI CMMI recommendations. BIPL is also a Microsoft Gold and ISO 9001:2000 certified global IT enterprise with key focus on client-server technology, open source platforms & e-business solutions.
4: Conclusion: Debate on the effectiveness of ISO 9000: Advantages: It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.[2][3] The quality principles in ISO 9000:2000 are also sound, according to Wade,[4] and Barnes, [3] who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by DeloitteTouche which reported that the costs of registration were recovered in three years. According to the Providence Business News [5], implementing ISO often gives the following advantages: 1. 2. 3. 4. 5. 6. 7. 8.
Create a more efficient, effective operation Increase customer satisfaction and retention Reduce audits Enhance marketing Improve employee motivation, awareness, and morale Promote international trade Increases profit Reduce waste and increases productivity
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However, a broad statistical study of 800 Spanish companies found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration. In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability. Problems: A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration.[7] 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."[3] According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. [8] [9] 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, Wada’s argument is that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. 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." [3] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. (http:// Wikipedia – the free encyclopedia. htm)
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5. Bibliography
I. Besterfield, D. H. (2007). Total Quality Management. New Delhi: Prentice Hall of India. II. ISO 9000. Wikipedia- The free Encyclopedia. Retrived in April 11, 2009, from http://en.wikipedia.org/wiki/ISO_9000#ISO_9000_series_of_standards.
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