THEORETICAL FOUNDATION … 8 1.1 What is ISO 9001:2000
The Standards ISO 9001:2000 analysis …
ISO 9001:2000 is the latest version of a quality management standard which has been in existence for many years and which has been applied by more than 300,000 organizations world-wide It specifies minimum requirements for a quality management system where an organization needs to:
• Demonstrate its ability to provide consistently a product that meets customer and applicable regulatory requirements and to:
• Address/enhance customer satisfaction through the effective application of the system, developing processes for continual improvement and the prevention of errors and mistakes
The ISO 9001: 2000 contains five requirements sections, each dealing with one of the fundamental building blocks required by any process These are:
This section details the general requirement for QUALITY MANAGEMENT SYSTEM and documentation requirements that are the foundation of the management system The general requirements ask the organizations to look at the processes of the management system, how they interact with each other, and what resources are needed to run the processes; and how the processes will be measured and monitored and action plan will be implemented The second part of the section then sets out the requirements for the documentation needed to operate the system effectively, including quality manuals, procedures, records and how the documentation should be controlled
The management of the systems is the responsibility of the "top management" at a strategic level in the organization The "top management" must know it‘s commitment to develop QUALITY MANAGEMENT SYSTEM , make the staffs awareness of customers' requirements at a strategic level and make a commitment to meeting these as well as statutory and regulatory requirements Set up quality policy, objectives, "Top management" must set policies; and to achieve these policies set objectives through planning how the objectives will be met "Top management" should also ensure that there are clear internal communications and that the management system is regularly reviewed
This covers the people and physical resources needed to carry out the process
People should be competent to carry out their tasks and the physical resources and work environment need to be capable of ensuring that the customers' requirements are met
These are the processes necessary to produce the product or to provide the service Determine the quality & objectives for the products, requirements of customers
; monitor ,validate the product, communicate with customers This is the act of converting the input of the process to the output For a service organization, this may be the process of take tourists on tour throughout the country
These are the measurements to enable the systems to be monitored to provide information on how the systems are performing with respect to the customer, the management systems themselves through internal audits, the processes and the product
Analyzing these, including any defect or shortfall in performance, will provide valuable information for use in improving the systems and products where this is required
Each of these five fundamental building blocks is required for any process because, if one is missing, a controlled process does not occur This is recognized in the new standard and represents a shift to viewing the quality system as a series of processes
In order to carry out a "process analysis" the inputs will be started, then followed by the process through its various stages to examine how it is controlled and verify that the output meet what is required
Such a process may be, for example, the actions required by the organization on receipt of a customer order, and the steps taken to convert that order into something that will allow a reservation to be provided The input here would be the customer order, and the output, the organization‘s internal documents, resources and services that allow the provision of the service
Thus the process will need be looked, the inputs be determined, examined how it is controlled, and look at the outputs The way the process is controlled may require an examination of mechanisms other than documented procedures
Such control mechanisms could be by, for example, control charts, process flow diagrams or by training of operatives to ensure they are competent Whatever the means by which the organization decides to control the process, evidence will be sought that the control mechanism is indeed effective The ultimate test of effectiveness is an examination of whether the end result of the process is in accordance with the inputs
Thus, during research of the process, process output would be determined if it met the requirements of the organization and the process for obtaining them was operating under the controlled conditions that the organization had defined
Research of processes should result in a logical research of the activities in carrying out the various functions required to supply customers with a product or service which meets their needs
In order that each organization may have the opportunity of demonstrating the conformity of its quality management system with ISO 9001:2000, exception are permitted in clause7 According to ISO 9001:2000, clause 1.2 only those requirement may be excluded ―where exclusions are limited to requirements within clause7, and such exclusions do not affect the organization‘s ability, or responsibility to provide product that meets customer and applicable regulatory requirements‖[ISO]
Such exclusion may find their justification in:
The character of the organization
The character of the product
If more exceptions are made than are permitted, conformity with ISO 9001:2000 may not be claimed This includes situations where the fulfillment of regulatory requirements allows exceptions, which go beyond the exceptions permitted by ISO 9001:2000
1.5.1 Introduction The ISO 9000 Family of standards will be based on these Quality Management Principles With growing global competition, quality management is becoming increasingly important to the leadership and management of all organizations
The Quality Management Principles apply universally to all user groups This document focuses on the needs of executive managers The Quality Management Principles may be incorporated into new or existing documents to satisfy the needs of other user groups
By applying the following eight Quality Management Principles, organizations will produce benefits for customers, owners, people, suppliers, local communities and society at large
Figure 1.3: Concept relating to quality management [sources ISO 9000:2000]
Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.[ISO 9001:2000]
For an organization to function effectively, it has to identify and manage numerous linked activities An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process Often the output from one process directly forms the input to the next The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the
"process approach" An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.[ISO 9001:2000]
When used within a quality management system, such an approach emphasizes the importance of a) Understanding and meeting requirements, b) The need to consider processes in terms of added value, c) Obtaining results of process performance and effectiveness, and d) Continual improvement of processes based on objective measurement
The model of "a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8 This illustration shows that customers play a significant role in defining requirements as inputs Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.[ISO 9001:2000] In addition, the methodology known as "Plan-Do-Check-Act" (PDCA) can be applied to all processes.[ISO9001:2000] PDCA can be briefly described as follows Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies Do: implement the processes Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results Act: take actions to continually improve process performance
Figure 1.5: Model of process–based quality management system
EXPERIMENTAL RESEARCH
Research report
The responses made by senior manager were categorized and organized into data Documents related to its performance are also reviewed for this study Documents included policy, manuals, and records of operation, web site information, and memos… Finally, this allowed making a report with evidence throughout the study Information from the data collected and document review were used to develop findings which later will be formed the foundation for the conclusions of this study
The research report is built up on the guide of the research questions
Consequently, it reveal‘s the company quality management system, management responsibility, resources management, product/service realization, measurment analysis and improvement
Clauses Interview questions Yes No Comment
4 Quality management system 4.1 General requirements
4.1-1 Has the organization built up and documented a QM system which corresponds to the requirements of ISO 9001?
4.1-2 Does the organization implement this
QM system, maintain it and continually improve its effectiveness ? v Shall be created
4.1-3 Does identify the processes needed for the quality management system and their application throughout the organization ? v
4.1-4 Does the organization determine the sequence and interaction of these processes? v
4.1-5 Does the organization determine criteria and methods needed to ensure that both the operation and control of these processes are effective?? v Shall be modified
4.1-6 Does the organization ensure the availability of resources and information necessary to support the operation and monitoring of these processes?? v Shall be modified
4.1-7 Are these processes monitored, measured and analyzed ?? v Shall be modified 4.1-8 Are the necessary actions implemented to achieve planned?
Results and continual improvement of these processes ? v
4.1-9 Does the organization manage these processes in accordance with the requirements of ISO 9001 ? v Shall be modified
4.1-10 Does the organization ensure the control over such processes which it outsources, if they affect product conformity with requirements? v Shall be documented
4.1-11 Can the control of such outsourced processes be recognized within the QM system? v Shall be document
Clauses Interview questions Yes No Comment
4.2 Documentation requirements 4.2.1 General: does the QM system documentation include
4.2-1 a) documented statements of a quality policy and quality objectives ? v Shall be created
4.2-2 b) a quality manual ? v Shall be created
ISO 9001‖2000? v Shall be redesign 4.2-4 d) documents needed by the organization to ensure the effective planning, operation and control of its processes? v
4.2-5 e) records required by ISO 9001-2000? v Shall be modified
4.2-6 Has the organization established quality manual and is it maintained ? v Shall be modified Does the manual quality include
4.2-7 a) the scope of the quality management system, including details of and justification for any exclusions ? v Shall be redesign
4.2-8 b) the documented procedures established for the quality management system, or reference to them? v Shall be documented
4.2-9 c) a description of the interaction between the processes of the quality management system? v
4.2-10 Are the documents required by the quality management system be controlled
4.2-11 Are the document controlled according to the requirements given in 4.2.4.‖ Control of document‖?? Is a documented procedure established to v Shall be redesign define the controls needed?
4.2-12 a) to approve documents for adequacy prior to issue? v
Clauses Interview questions Yes No Comment
4.2-13 b) to review and update as necessary and re-approve documents ? v
4.2-14 c) to ensure that changes and the current revision status of documents are identified? v Shall be documented
4.2-15 d) to ensure that relevant versions of applicable documents are available at points of use? v
4.2-16 e) to ensure that documents remain legible and readily identifiable? v
4.2-17 f) to ensure that documents of external origin are identified and their distribution controlled? v
4.2-18 g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? v
4.2-19 Are these records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system? v Shall be redesign
4.2-20 Are these records legible, readily identifiable and retrievable? v Shall be modified
4.2-21 Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? v
Does top management provide evidence of its commitment to the development and Implementation of the quality management system and continually improving its effectiveness by…
5.1-1 a) communicating to the organization v as statutory and regulatory requirements?
5.1-2 b) establishing the quality policy? v Shall be created
Clauses Interview questions Yes No Comment
5.1-3 c) ensuring that quality objectives are established? v Shall be documented 5.1-4 d) conducting management reviews? v
5.1-5 e) ensuring the availability of resources? v
5.2-1 Does the top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction ? v
Does the top management ensure that the quality policy
5.3-1 a) is appropriate to the purpose of the organization? v Shall be documented 5.3-2 b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system? v Shall be modified
5.3-3 c) provides a framework for establishing and reviewing quality objectives? v
5.3-4 d) is communicated and understood within the organization? v
5.3-5e) is reviewed for continuing suitability? v
5.4-1 Does the top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization? v
5.4-2 Are the quality objectives measurable and consistent with the quality policy? v Shall be modified
5.4.2 Quality management system planning: Does the top management ensure that
5.4-3 a) the planning of the quality v Shall be management system is carried out in order to meet the requirements given in 4.1,
―general requirements‖ as well as the quality objectives? modified
Clauses Interview questions Yes No Comment
5.4-4 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?
5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority
5.5-1 Does the top management ensure that responsibilities and authorities are defined and communicated within the organization?
5.5.2 Management representative: Has the top management appointed a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes…
5.5-2 a) ensuring that processes needed for the quality management system are established, implemented and maintained? v Shall be documented
5.5-3 b) reporting to top management on the performance of the quality management system and any need for improvement? v Shall be documented
5.5-4 c) ensuring the promotion of awareness of customer requirements throughout the organization? v Shall be documented
5.5-5 Does the top management ensure that appropriate communication processes are established within the organization? v
5.5-6 Does the top management that communication takes place regarding the effectiveness of the quality management system? v
5.6-1 Does the top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? v
Clauses Interview questions Yes No Comment
5.6-2 Does this review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives? v
5.6-3 Are records from management reviews maintained ? v
5.6.2 Review Input: Does the input to management review include information on
5.6-4 a) results of audits? v Shall be modified
5.6-6 c) process performance and product conformity? v
5.6-7 d) status of preventive and corrective actions? v Shall be documented 5.6-8 e) follow-up actions from previous management reviews? v
5.6-9 f) changes that could affect the quality management system? v
5.6.3 Review output: Does the output from the management review include any decisions and actions related to…
5.6-11 a) improvement of the effectiveness of the quality management system and its processes? v Shall be modified
5.6-12 b) improvement of product related to customer requirements? v
6 Resource management 6.1 Provision of resources : Does the organization determine and provide the resources needed…
6.1-1 a) to implement and maintain the quality management system and continually improve its effectiveness? v
6.1-2 b) to enhance customer satisfaction by meeting customer requirements v
Clauses Interview questions Yes No Comment
6.2-1 Is the personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience? v
6.2-2 a) Does the organizations determine the necessary competence for personnel performing works affecting product quality? v
6.2-3 b) Does the organization provide training or take other actions to satisfy these needs? v
6.2-4 c) Does the organization evaluate the effectiveness of the actions taken? v
6.2-5 d) Does the organization 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? v
6.2-6 e) Does the organization maintain appropriate records of education, training, skills and experience? v
6.3-1 Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements? v
Does the Infrastructure include, as v
6.3-2 a) buildings, workspace and associated utilities?
6.3-3 b) process equipment (both hardware and software)? v
6.3-4 c) supporting services (such as transport or communication)? v
Clauses Interview questions Yes No Comment
6.4-1 Does the organization determine and manage the work environment needed to achieve conformity to product requirements? v
7 Product realization 7.1 Planning of product realization
7.1-1 Does the organization plan and develop the processes needed for product realization? v
7.1-2 Is planning of product realization consistent with the requirements of the other processes of the quality management system? v
In planning product realization, Does the organization determine the following, as appropriate:…
7.1-3 a) quality objectives and requirements for the product? v
7.1-4 b) the need to establish processes, documents, and provide resources specific to the product? v
7.1-5 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? v
7.1-6 d) records needed to provide evidence that the realization processes and resulting product meet requirements? v Shall be documented
7.1-7 Is the output of this planning in a form suitable for the organization's method of operations? v
7.2 Customer-related processes 7.2.1 Determination of requirements related to the
7.2-1 a) requirements specified by the customer, including the requirements for delivery and post-delivery activities? v
7.2-2 b) requirements not stated by the customer but necessary for specified or intended use, where known? v
7.2-3 c) statutory and regulatory requirements related to the product? v
Clauses Interview questions Yes No Comment
7.2-4 d) any additional requirements determined by the organization? v
7.2.2 Review of requirements related to the product
7.2-5 Does the organization review the requirements related to the product? v
7.2-6 Is this review conducted prior to the organization's commitment to supply a product to the customer (e.g submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) ? v
Does this review ensure that…
7.2-8 b) contract or order requirements differing from those previously expressed are resolved? v
7.2-9 c) the organization has the ability to meet the defined requirements? v
7.2-10 Are records of the results of the review and actions arising from the review maintained v
7.2-11 Where the customer provides no documented statement of requirement, the customer requirements confirmed by the organization before acceptance? v
7.2-12 Where product requirements are changed, does the organization ensure that relevant documents are amended? v Shall be modified
7.2-13 Does the organization ensure that relevant personnel are aware of the changed requirements? v
7.2.3 Customer communication arrangements for communicating with customers in relation to…
7.2-15 b) enquiries, contracts or order handling, including amendments? v
7.2-16 c) customer feedback, including customer complaints? v
Clauses Interview questions Yes No Comment
7.3 Design and development 7.3.1 Design and development planning
7.3-1 Does the organization plan and control the design and development of product? v
During the design and development planning, does the organization determine…
7.3-2 a) the design and development stages? v
7.3-3 b) the review, verification and validation that are appropriate to each design and development stage? v
7.3-4 c) the responsibilities and authorities for design and development? v Shall be documented
7.3-5 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility? v Shall be designed
7.3-6 Is planning output updated, as appropriate, as the design and development progresses? v
7.3-7 Are the inputs relating to product requirements determined and records maintained ? v
7.3-9 b) applicable statutory and regulatory requirements? v
7.3-10 c) where applicable, information derived from previous similar designs? v
7.3-11 d) other requirements essential for design and development? v
7.3-12 Are these inputs reviewed for adequacy? v
Clauses Interview questions Yes No Comment
7.3-14 Are the outputs of design and development provided in a form that enables verification against the design and development input? v
7.3-15 are the design and development inputs approved prior to release? v
7.3-16 a) Do the outputs meet the input requirements for design and development? v
7.3-17 b) Do the outputs provide appropriate information for purchasing, production and for service provision? v
7.3-18 c) Do the outputs contain or reference product acceptance criteria? v
7.3-19 d) Do the outputs specify the characteristics of the product that is essential for its safe and proper use? v
7.3.4 Design and development review At suitable stages, systematic reviews of design and development is performed in accordance with planned arrangements…
7.3-20 a) to evaluate the ability of the results of design and development to meet requirements? v
7.3-21 b) to identify any problems and propose necessary actions? v
7.3-22 Do Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed? v reviews and any necessary actions maintained? documented
7.3-24 Is verification performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements? v
Clauses Interview questions Yes No Comment
7.3-25 Are records of the results of the verification and, any necessary actions maintained? v Shall be documented
7.3-26 IS design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known ? v
7.3-27 Wherever practicable, is validation completed prior to the delivery or implementation of the product? v
7.3-28 Are records of the results of validation and any necessary actions maintained? v
7.3.7 Control of design and development changes
7.3-29Are design and development changes identified and records maintained? v Shall be modified
7.3-30Are the changes reviewed, verified and validated, as appropriate? v
7.3-31Are the changes approved before implementation? v
7.3-32Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product already delivered? v
7.3-33Are records of the results of the review of changes and any necessary v Shall be documented actions maintained?
7.4-1 Does the organization ensure that purchased product conforms to specified purchase requirements? v
7.4-2 Are the type and extent of control applied to the supplier and the purchased product where known dependent upon the effect of the purchased product on subsequent product realization or the final product? v
Clauses Interview questions Yes No Comment
7.4-3 Are suppliers evaluated and selected based on their ability to supply product in accordance with the organization's requirements? v
7.4-4 Have criteria for selection, evaluation and re-evaluation been established? v Shall be documented
7.4-5 Are records of the results of evaluations and any necessary actions arising from the evaluation maintained? v
7.4-6 Does the purchasing information describe the product to be purchased? v
Does this including where appropriate…
7.4-7 a) requirements for approval of product, procedures, processes and equipment? v
7.4-8 b) requirements for qualification of personnel? v
7.4-9 c) quality management system requirements? v Shall be modified
7.4-10 Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier? v
7.4-11 Does the organization establish and v implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
7.4-12 Where the organization or its customer intends to perform verification at the supplier's premises, does the organization state the intended verification arrangements and method of product release in the purchasing information? v
7.5.1 Control of production and service provision
7.5-1 Is production and service provision planned and carried out under controlled conditions? v
Clauses Interview questions Yes No Comment
Do the Controlled conditions include, as applicable…
7.5-2 a) the availability of information that describes the characteristics of the product? v
7.5-3 b) the availability of work instructions, as necessary? v
7.5-4 c) the use of suitable equipment? v
7.5-5 d) the availability and use of monitoring and measuring devices? v Shall be redesign 7.5-6 e) the implementation of monitoring and measurement?
Shall be modified 7.5-7 f) the implementation of release, delivery and post-delivery activities? v
7.5.2 Validation of processes for production and service provision
7.5-8 Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement? v
7.5-9 Does this includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered? v
7.5-10 Does Validation demonstrate the v ability of these processes to achieve planned results?
Does the organization establish arrangements for these processes including, as applicable
7.5-11 a) defined criteria for review and approval of the processes? v
7.5-12 b) approval of equipment and qualification of personnel? v
7.5-13 c) use of specific methods and procedures? v
7.5-16 Where appropriate, does the organization identify the product by suitable means throughout product realization? v
Clauses Interview questions Yes No Comment
7.5-17 Does the organization identify the product status with respect to monitoring and measurement requirements? v
7.5-18 Where traceability is a requirement, does the organization control and record the unique identification of the product? v
7.5-19 Does the organization exercise care with customer property while it is under the organization's control or being used by the organization? v
7.5-20 Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? v
7.5-21 If any customer property is lost, damaged or otherwise found to be unsuitable for use, is this reported to the customer and records maintained? v
7.5-22 Does the organization preserve the v processing and delivery to the intended destination?
7.5-23 Does this preservation include identification, handling, packaging, storage and protection? v
7.5-24 Does preservation also apply to the constituent parts of a product? v
7.6 Control of monitoring and measuring devices
7.6-1 Does the organization 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? v Shall be modified
7.6-2 Has the organization established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements? v Shall be modified
Clauses Interview questions Yes No Comment
Where necessary to ensure valid results, is measuring equipment …
7.6-3 a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? v
7.6-4 where no such standards exist, is the basis used for calibration or verification recorded? v
7.6-5 b) is adjusted or re-adjusted as necessary? v
7.6-6 c) Is the equipment identified to enable the calibration status to be determined? v
7.6-7 d) Is the equipment safeguarded from adjustments that would invalidate the measurement result? v
7.6-8 e) Is the equipment protected from damage and deterioration during handling, maintenance and storage? v
7.6-9 Are the validity of the previous measuring results assessed and recorded when the equipment is found not to conform to requirements ? v
7.6-10 Does the organization take appropriate action on the equipment and any product affected? v
7.6-11 Are records of the results of calibration and verification shall be maintained ? v
7.6-12 When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed? v
7.6-13 Is this undertaken prior to initial use and reconfirmed as necessary? v
8 Measurement, analysis and improvement 8.1 General Does the organization plan and implement the monitoring, measurement, analysis and improvement processes needed……
8.1-1a) to demonstrate conformity of the product? v Shall be documented
Clauses Interview questions Yes No Comment
8.1-2 b) to ensure conformity of the quality management system? v Shall be documented
8.1-3 c) to continually improve the effectiveness of the quality management system? v Shall be documented
8.1-4 Does this include determination of applicable methods, including statistical techniques, and the extent of their use? v
8.2 Monitoring and measurement 8.2.1 Customer satisfaction
8.2-1 As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements? v
8.2-2.Are the methods for obtaining and v
8.2.2 Internal audit Does the organization conduct internal audits at planned intervals to determine whether the quality management system…
8.2-3 a) conforms to the planned arrangements to the requirements of this International Standard and to the quality management system requirements established by the organization? v Shall be redesign
8.2-4 b) is effectively implemented and maintained? v
8.2-5 Is an audit program planned? v Shall be modified 8.2-6 Are the status and importance of the processes and areas to be audited taken into consideration? v
8.2-7 Are the results of previous audits taken into consideration? v
8.2-8 Are the audit criteria, scope, frequency and methods defined? v
8.2-9 Does the Selection of auditors ensure objectivity and impartiality of the audit process? v
8.2-10 Does conduct of audits ensure objectivity and impartiality of the audit process? v
Clauses Interview questions Yes No Comment
8.2-11 Are the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records defined in a documented procedure? v
8.2-12 Does the management responsible for the areas being audited ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes? v
8.2-13 Do follow-up activities include the verification of the actions taken and the reporting of verification results ? v
8.2.3 Monitoring and measurement of processes
8.2-14 Does the organization apply suitable methods for monitoring and, where v applicable, measurement of the quality management system processes?
8.2-15 Does these methods demonstrate the ability of the processes to achieve planned results? v
8.2-16 When planned results are not achieved, is correction and corrective action taken, as appropriate, to ensure conformity of the product? v
8.2.4 Monitoring and measurement of product
8.2-17 Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met? v Shall be documented
8.2-18 Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements
8.2-19 Is evidence of conformity with the acceptance criteria maintained? v Shall be documented 8.2-20 Do records indicate the person(s) authorizing release of product? v
8.2-21 Do 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? v
Clauses Interview questions Yes No Comment
8.3-1 Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery? v Shall be redesigned
8.3-2 Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure? v
Does the organization deal with nonconforming product by one or more of the following ways:…… v
8.3-3 a) by taking action to eliminate the detected nonconformity?
8.3-4 b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer? v
8.3-5 c) by taking action to preclude its original intended use or application? v
8.3-6 Are records maintained of the nature of nonconformities and any subsequent actions taken including concessions obtained? v
8.3-7 When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements? v
8.3-8 When nonconforming product is detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity? v
8.4-1 Does the organization determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made? v
Clauses Interview questions Yes No Comment
8.4-2 Does this include data generated as a result of monitoring and measurement and from other relevant sources? v
8.4-3 Does the analyses of data provide information relating to…… a) customer satisfaction ? v
8.4-4b) conformity to product requirements v 8.4-5c) characteristics and trends of processes and products including opportunities for preventive action? v
Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review? v Shall be redesigned
8.5-2 Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? v
8.5-3 Are the corrective actions appropriate to the effects of the nonconformities encountered?
Is a documented procedure shall be established to define requirements for…… v
8.5-4 a) reviewing nonconformities (including customer complaints)?
8.5-5 b) determining the causes of nonconformities? v
8.5-6 c) evaluating the need for action to ensure that nonconformities do not recur? v
8.5-7 d) determining and implementing action needed? v
8.5-8 e) records of the results of action taken ? v
Clauses Interview questions Yes No Comment
8.5-10 Has the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence? v
8.5-11 Are preventive actions appropriate to the effects of the potential problems? v Shall be documented
Is a documented procedure established to v define requirements for……
8.5-12 a) determining potential nonconformities and their causes?
8.5-13 b) evaluating the need for action to prevent occurrence of nonconformities? v
8.5-14 c) determining and implementing action needed? v
8.5-15 d) records of results of action taken
AND
Research findings
The findings in this study represent only a sample of the actual management system in place at the Ben Thanh Tourist and do not exclude any further deviations that may still be present
The practical implementation of the standard was evaluated and compare with the company‘s management system manual and supporting documents The evaluation was conducted through discussion and interview with the senior manager of the company
The research covered relevant process/ areas of tour operation in order to obtain an overall picture of the degree of management system implementation Although performed to reasonable depth, not every detail of the complete management system could be checked
The company management system‘s conformity and nonconformity derived from data describe extent that Ben Thanh tourist complies with the standard requirement
Data are reported through general and particular description, as well as interpretive commentary It prove that the management system of the Ben thanh Tourist do not comply with the requirements of the ISO 9001:2000
There are 34 points of nonconformity found in its system
Figure 3.1: Concept relating to conformity [sources 9000:2000]
Data and evidence indicate that quality management systems at Ben Thanh Tourist are not compliant with ISO requirements The standard requires Ben thanh tourist to document, implement and maintain the quality management system and continually improve its effectiveness Particular, its require Ben thanh tourist to write quality objective, quality policy, quality manual and procedures Once these documents are written, standards requires Ben thanh tourist to control them, making sure that the current, correct copy is available to employees and old copies are removed from use right away All above requirements are failed to follow at Ben thanh Tourist
Although Ben Thanh has established the organization policy, it does not include a commitment to comply requirements and continually improve the effectiveness of quality managements system Moreover, that policy is not public communicated and understood within the company
The parent company set objectives for Ben thanh tourist to achieve It is therefore the objective is far from being consistent with quality policy However the objective is measurable and plays as a motivator for staffs to strive for it
It does not comply with the standards
The data indicate that the management responsibilities at Ben thanh tourist are not compliant with ISO 9001:2000 The standard requires Ben thanh tourist‘s management to develop and implement a quality management system and continually improve its effectiveness by :
communicating to the all employees the importance of meeting customer as well as statutory and regulatory requirements,
ensuring that quality objectives are established,
ensuring the availability of resources
The evidence shows that these requirements are partly met by Ben thanh tourist‘s management However it does not comply with ISO Quality objective and policy shall be created In addition, the management review shall be documented properly, showing the attention paid by the management to the quality
Figure 3.2: Concept relating to documentation [sources ISO 9000:2000]
The data shows that Ben thanh tourist had determined and provided the resources needed to implement and maintain the quality management system and to enhance customer satisfaction by meeting customer requirements However the evidences also show that it determined the necessary competence for personnel performing work affecting product quality, additionally, it provided training then evaluating the effectiveness of the actions taken in order to 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
The data also indicates that Ben thanh had determined provided and maintained the working infrastructure needed to achieve conformity to product requirements
Working Infrastructure includes buildings, workspace and associated utilities, process equipment
The data prove that these requirements are met, however it must be documented properly according to ISO 9001:2000
The data indicate that Ben thanh Tourist had planned and developed the processes needed for product realization In planning product realization, the Ben thanh Tourist had determined the following quality objectives and requirements for the product; and the need to establish processes, documents, and provide resources specific to the product;
Aiming at providing services to its customers, Data and evident indicate that Ben Thanh determines the needs and expectations of customers mainly by :
in writing( email, fax, letter:
Most customers are foreign tour wholesalers and Retail travel agents Small percentages of customers are direct enquiries which are individuals
All these enquiries are handled promptly and with correct responses All information is recorded It enables Ben Thanh tourist to prepare an accurate written quotation and offers,
The information is written on a check list as follows:
Contact reference for reply (email, fax, phone
Any specials handling requirements (aged, handicapped )
Accommodation standards preferred ( specific hotel may be requested)
Any self –drive rental requirement
Tour guide and interpreter requirements
Essential itinerary inclusions( cultural, entertainments, other
Any special interest/ activities Service inclusion) The evident proves that Ben thanh determine the needs and expectation of customers in accordance with standard requirements
Aiming to provide better services to customers, Ben thanh determined necessary processes and responsibilities such as:
Making reservation process o Handling enquiry and prepare quotations o Taking reservations, creating customers files, defining payment terms o Making booking all products and services o Correspondence with customer and supplier o Coordinating customers files o Handling documents o Creating records
Operation process: o Monitor schedule of forward booked customers o Allocate transport, accommodation and other components for each group or individual booking o Allocate driver and tour guide o Names list to hotels and transportation o Double check of booking of tour arrangements o Follow up and problem solving during the tour
Planning and costing tour itinerary process o Itinerary planning o Costing itinerary o Booking all components of itinerary o Deposit and full payments o Handling cancelation and refund o Maintain complete record
Customer care process o Customer enquiries o Customer follow-up
Promoting and selling travel service/ tour process o Determining the needs, interests and preferences of customer o Recommendation of product o Obtaining customer agreement to buy and book
The data show that Ben thanh tourist has determined the process and responsibility to attain customer satisfaction It is quite compliant with standards requirements However Ben thanh tourist must set up preventive action to eliminate the cause of a potential problem raising or other undesirable potential situation happens
The date shows that the Ben Thanh applied some method to monitor and measure the characteristics of the product to verify that product requirements have been met Such as
The statistics Observation Survey, interview, questioners
This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements
However the evidence of conformity with the acceptance criteria is not maintained Some record does not include the person who designed the tour or mended
This indicates that this should be documented properly In addition, the data indicate that Ben thanh has not determined the means of preventing nonconformities and eliminating their causes
The company does not identify what are nonconformities It is rather reactive than proactive It is therefore there is not preventive action in the company All staff do base on their experiences This make Ben thanh tourist not compliant with standard requirement
Figure 3.3 Concept relating to measurment management system
Recommendations
Numerous implications and recommendations for developing a quality management system that may be valuable to Ben Thanh Tourist can be drawn from this study‘s findings These are as follows:
The implementation of a formal management system is best handled as a specific project with a Project Manager, who should be a key member of the organization‘s management team and appointed at the outset of the project
The existing system of management and working practices must be known in some detail before the framework of the formal management system documentation can be designed The system is best designed based on existing processes as the development of new systems that require additional resources may simply delay the implementation process
Ben Thanh Tourist is likely to need to appoint a full-time Quality Manager This person can be generally assigned as part of their overall duties This will help to ensure that the system does not become the property of a Quality Department rather than remaining the tool of the organization‘s management It should also ensure that the system does not become too demanding for the organization in terms of additional expenses
Ben Thanh tourist can provide training in system requirements through a series of induction or training workshops for the people who have not been involved in the writing of procedures and who will be required to work to them In addition to developing a full understanding of the system requirements, the training will extend ownership of the procedures to those who work to them New employees will also require induction or training in the quality management system
3.2.3 Step 3 Set up quality policy and objectives:
Then Ben Thanh tourist‘ Top management provides evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by establishing the quality policy which is as follows: a) is appropriate to the purpose of the Ben Thanh Tourist b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability
3.2.4 Step 4: Designing the System Framework
The first task is to develop the initial framework of the quality management system, identifying the various processes that are used to deliver services to the customer, [either an external or internal customer] From the framework of the management system the project team will identify the required supporting documentation, firstly in terms of defined processes and then in terms of the supporting competencies and procedures that will underpin these processes
Once the full framework of the quality management system has been designed and the supporting documentation identified, it is important to prepare a plan for implementation so that all participants understand their responsibilities The plan will detail the authors of the various documents, the personnel responsible for the later stages of implementation and will include the associated deadlines for completion
3.2.5 Step 5: Developing the System of Documentation
To ensure that procedures are maintained as current documents and to reinforce the concept of ownership, it should be assigned to all system documentation
The easiest way to prepare process definitions and procedures is during a series of cross –team work supervised by the Management representative and attended by the people who are stakeholders in the process or procedure under development The team work will generally take the form of a 'brain-storming' session and during or following the team work the management representative will prepare the draft process definitions and/or procedures and competencies
System process and procedures should reflect, as far as possible, existing working practices and identify the interfaces with the function's internal and/or external customers and suppliers
The draft processes and procedures are then circulated to interested parties, i.e customer/supplier interfaces They are invited to submit comment within a given time and/or attend a finalization meeting at which the process or procedure is approved for issue
The processes are essentially shown what needs to be done, who needs to do it and what is the result or evidence that it has been done Either procedures and/or competencies will support processes Procedures and other instructional documents [work/operating instructions, etc.] will define how an activity is required to be done
The Most important document for demonstrating and describing a documented quality management system is typically a quality manual The prime purpose of this manual is to establish a rough structure for the quality management system and at the same time serves as reference for the development and maintenance of this system
The quality management manual is an abbreviated representation of the quality management system of the company, including its quality policy It contains structural and, in particular, process organizational information and reference to future documents for instance, process instructions
Ben Thanh Tourist will usually work to the system documentation for three to six months During this time Ben Thanh Tourist will generate the required evidence of execution Following this, Ben Thanh Tourist can undertake the first series of internal audits
Selecting and training internal auditors are important aspects of the process of implementation It is essential that Ben Thanh Tourist select internal auditors carefully
It is recommended that Management reprehensive choose people to train in auditing from a variety session of the company, rather than employing a specific internal audit department This helps to create a good understanding of formal systems management throughout the company, avoids the impression that internal auditing is a policing activity and provides the opportunity for suppliers to audit customers and vice versa
Additionally, it is best that, if possible, Ben Thanh Tourist do not select auditors from management This will ensure that internal audit is perceived as a system evaluation rather than an appraisal of personnel The training of internal auditors will focus on conveying the message that the aim of internal audit is to add value rather than to find fault with the function being audited
3.2.8 Step 8: Performance Improvement and Learning