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ISO 9000

ISO 9000

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ISO 9000 The International Organisation for Standardisation (ISO) is an international federation of national standards involving more than

140 countries. ISO 9000 is a well-known family of guidelines and standards developed by the ISO. It has become popular worldwide for its role in setting up quality management systems within organisations.
Understanding > Introduction to ISO What are Standards? Today great emphasis is being laid on organisations following predefined levels of standards in their processes and operation. But what are standards? How are they useful to an organisations business performance? Standards are documented technical specifications and other defined benchmarks. These specifications are applied as a set of regulations and procedures to ensure that the materials, products, operations and services conform to predefined requirements. Standards contribute to the enhancement of the product parameters such as quality, safety, reliability, effectiveness and interchangeability at an optimum cost. The ISO: The International Organisation for Standardisation (ISO) is an international federation of national standards involving more than 140 countries. A non-governmental organisation it was set up in 1947. The motto of ISO is to endorse the growth of standardisation worldwide to promote international trade and services. ISO promotes mutual collaboration between various organisations in the scientific, technology and economic related activities. Advantages of ISO standards: ISO sets up technical standards (that are voluntary) that help in enhancing various types of organisational processes. They aid in the development, production and delivery of products and services in a more effective, secure and cleaner way. ISO standards also seek to safeguard customer interests. ISO Standards are acknowledged worldwide as the means for manufacturers and service providers to bring about utmost ease and effectiveness in trading their products and services. These International Standards provide a benchmark to make the transfer of technology between suppliers and their customers possible. The evolution of ISO: International standardisation was first initiated in the electro technical area. The International Electro Technical Commission (IEC) was established in 1906. The International Federation of the National Standardising Associations (ISA), established in 1926, put in groundbreaking efforts in other areas. ISA focused mainly on mechanical engineering. Its activities came to an end in 1942. In 1946, representatives from 25 countries convened in London and decided to form a new international organisation, in order to “make possible the international coordination and integration of organisational standards". The new organisation, ISO, formally became operative on 23 February 1947. ISO standards -The process: ISO has a well-defined process for incorporating standards. First phase: In any country a business segment puts forward the need for a standard before its national standards institute. The latter suggests this to the ISO. Once the necessity for an International standard has been acknowledged and officially approved, the technological feasibility of the standard is defined. This stage is usually performed in teams consisting of professionals from those countries that are interested in the particular standard. Second phase: Once the experts reach a conclusion on the technical parameters to be covered in the standard, the participating countries discuss in detail the specifics pertaining to the standard. This is the consensus-building phase. Final phase: The final phase comprises of the endorsement of the final draft of the International Standard. This report is subsequently made available in print as an ISO International Standard. Many of the standards need regular reviews. Various factors contribute to make a standard obsolete: scientific advancement, new techniques and equipment, changing trends in quality and safety procedures. To consider these issues, ISO has stipulated that all ISO standards should be evaluated every five years. Continue the tour: The ISO 9000 Understanding > The ISO 9000 The ISO 9000: The goal of any organisation is to constantly accrue benefits through product innovation and efficiency in the use of resources. The critical aspect to achieve this is to attain all round quality performance. Quality is a basic consumer requirement. A customer prefers organisations reliable as far as its quality performance is concerned. Consistently

manufacturing products and offering services of superior quality is the need of the hour worldwide. This is a critical aspect in sustaining customer loyalty and retaining the market base. In order to attain this, organisations have to comply with a set of procedures that are not only acknowledged and accepted within a country but also internationally. ISO 9000 standards serve this purpose. ISO 9000 is a well-known family of guidelines and standards developed by the ISO. ISO 9000 standards for a Quality Management System handles the processes concerned with the design, development and delivery of a product or service. The standard stipulates specifications for the control and assessment of a process for attaining quality performance. The 1987 version of ISO 9000 standard, (originally published as BS5750 by the British Standards Institute) emphasised on quality control by means of effective checking and corrective actions. Quality control (QC) is a management function that controls the quality of raw materials, products, components, and services concerned with production and inspection activities. It aims to prevent defects in the products or services. The 1994 version of the ISO 9000 standard focused on quality assurance via preventive actions, and stipulated the need for documented procedures. Quality assurance (QA) comprises all measures taken to ascertain that the standards and procedures are in conformity and that the products or services meet the performance requirements. An ISO 9000 certification indicates that the management is effectively controlling the processes that are ‘critical to quality’ with respect to the customer. ISO 9000 is not just about service or product quality; it's about quality in management. These standards address aspects related to process management. This requires organisations to identify, document and control processes ranging from executive management to the production of different items. An organisation could be successfully certified to ISO 9000 if it adhered to the specifications of the standard. In order to be certified, an organisation must submit to an accredited assessor’s examination. The assessor interviews staff members to ensure that they are aware of their roles and responsibilities in complying with the ISO 9000 standard. The assessor also examines the organisation's paperwork to check on ISO 9000 compliance. When all issues are addressed, the organisation is deemed for certification. Continue the tour: The ISO 9000:94 Family Understanding > The ISO 9000:94 family ISO 9000:94 family is a set of international quality standards and guidelines that have become popular worldwide for their role in setting up quality management systems within organisations. In the past, organisations preferred to implement any of the three ISO 9000:94 requirement standards i.e. the ISO 9001, ISO 9002 and ISO 9003. Moreover, there was a notion that ISO standards are applicable only in the manufacturing sector. ISO in a move to change this perception drafted some more guidelines that cater to the requirements of the service sector, small and medium scale industries and software companies. Given below is a list of ISO 9000:94 guidelines and standards. ISO 8402, Quality management and quality assurance – Vocabulary. Defines the essential terms used in the ISO 9000 family, which is necessary for avoiding misinterpretations. ISO 9000-1, Quality management and quality assurance standards – Part 1: Sets the guidelines for selection and use of specific standards. Provides the scope for understanding and selecting the appropriate standards. ISO 9000-2, Quality management and quality assurance standards –Part 2: Provides basic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. Helps in interpreting ISO 9001, ISO 9002 and ISO 9003. ISO 9000-3, Quality management and quality assurance standards –Part 3: Sets guidelines for the application of ISO 9001 1994 in the development, delivery, installation, and maintenance of computer software. Also provides a specific interpretation of the requirements of ISO 9001 for computer software development applications. ISO 9000-4, Quality management and quality assurance standards –Part 4: Provides guidance on how to plan, organise and control resources to produce reliable and sustainable products. ISO 9001, Quality systems – Model for quality assurance in design, development, production, installation and servicing. This is a requirement standard used to ascertain the process capabilities for the design and development of the product or service, as well as for installation and servicing. ISO 9002, Quality systems – Model for quality assurance in production, installation and servicing. This standard is used to ascertain process capabilities for production, installation and servicing (identical to ISO 9001except for design control requirement). ISO 9003, Quality systems – Model for quality assurance in final inspection and testing. This is a requirement standard used to control product or service through final inspection and testing. ISO 9004-1, Quality management and quality system elements –Part 1: Guidelines for implementation. This optional standard provides guidelines to implement a quality system to satisfy the customers’ and organisational requirements. ISO 9004-2, Quality management and quality system elements –Part 2: Sets guidelines for services. This standard is analogous to ISO 9004-1, but the guidelines are designed specifically to suit the requirements of the service sector. ISO 9004-3, Quality management and quality system elements –Part 3: Sets guidelines for processed materials.

ISO 9004-4, Quality management and quality system elements –Part 4: Sets guidelines for quality improvement. Provides guidelines for implementing continual quality improvement within the organisation using tools and techniques based on information compilation and evaluation. ISO 10005, Quality management –Sets guidelines for quality plans. This standard provides guidance on how to prepare quality plans for the control of specific products, and projects. ISO 10006, Sets guidelines to quality in project management ISO 10007, Quality management –Sets guidelines for configuration management. Provides guidelines to ensure that a complex product continues to work in the desired manner even when certain parts are modified. ISO 10011-1, Sets guidelines for auditing quality systems – Part 1: Provides guidelines for auditing a quality system, and verifying the system’s capability to achieve set quality goals. It can be used within the organisation or for auditing the suppliers. ISO 10011-2, Sets guidelines for auditing quality systems – Part 2: Qualification criteria for quality systems: auditors. Provides guidance on the education, training, know-how, personal traits and management capabilities needed to carry out an audit. ISO 10011-3, Sets guidelines for auditing quality systems – Part 3: Management of audit programmes. Provides basic guidelines for managing quality system audit programmes. ISO 10012-1, Quality assurance requirements for measuring equipment – Part 1: It is a metrological confirmation system for measuring equipment. Provides guidelines on the key characteristics of a calibration system to ensure that measurements are done with the projected accuracy. ISO 10012-2, Quality assurance for measuring equipment – Part 2: Sets guidelines for control of measurement processes. Provides additional guidance on the application of statistical process control whenever it is apt for achieving the objectives of Part 1. ISO 10013, Sets guidelines for developing quality manuals. Provides guidelines for the setting up, organising and controlling quality manuals customised to specific needs. Continue the tour: The ISO 9000:94 Quality System Elements Understanding > The ISO 9000:94 Quality System Elements The ISO 9000 Quality system elements: An ISO 9000 compliant quality assurance system includes 20 system elements. Of the three system models (ISO 9001, 9002, and ISO 9003), ISO 9001 requires all 20-system elements whereas certain sub clauses have been omitted in ISO 9002 and 9003. The 20 system elements that ISO 9001 requires are listed below: 4.1 Management Responsibility. 4.2 Quality System. 4.3 Contract Review. 4.4 Design Control. 4.5 Document and Data Control. 4.6 Purchasing. 4.7 Control of Customer – Supplied Product. 4.8 Product Identification and Traceability. 4.9 Process Control. 4.10 Inspection and Testing 4.11 Control of Inspection, Measuring and Test Equipment. 4.12 Inspection and Test status. 4.13 Control of Non-Conforming Product. 4.14 Corrective and Preventive Action. 4.15 Handling Storage, Packaging, Preservation, and Delivery. 4.16 Control of Quality Records. 4.17 Internal Quality Audits. 4.18 Training. 4.19 Servicing. 4.20 Statistical Techniques. The ISO 9002 standard comprises of all the twenty clauses except Design control (clause 4.4) The ISO 9003 standard comprises all the twenty clauses as in ISO 9000 barring Design control (4.4), Process control (4.9), Preventive action (4.14) and Servicing (4. 19) The ISO 9000 Standard’s twenty system elements are explained in detail below. 4.1. Management Responsibility: 4.1.1. Quality policy:

The organisation should establish a quality policy and properly document it.

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The goals set to achieve quality performance must be in line with the overall organisational objectives. The quality policy should be communicated to all the departments of the organisation.

4.1.2. Organisation: An organisation should have a clear structure, in which individuals join together and play clearly defined roles, acting in co-ordination to further the aims of the organisation. Responsibility and authority:

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An authorised official who is competent to examine and control the procedures that have an influence on the quality system should be selected. This person should be given the liberty to take necessary steps to ensure that the organisation controls quality related processes in an effective manner. Resources:

The organisation should identify resources required for achieving the specifications of the quality policy. These resources should include trained employees. Management representative:

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The organisation should appoint a management representative (on behalf of the organisation’s management). This representative is responsible for the proper deployment of the quality system. He should convey the status of the quality system to the top management.

4.1.3. Management review: • The management should regularly assess the quality system in order to ascertain its consistency and efficiency.

4.2. Quality System: 4.2.1. General:

Organisations should have a quality manual consisting of the functional aspects of this standard. The quality manual should comprise of the information pertaining to the work to be done in the quality system. It should also explain how it should be done, who should do it, and under what circumstances.

4.2.2. Quality system procedures: • • The quality system procedures should be in line with the standard and quality policy. These procedures should be efficiently applied. The information pertaining to the procedures should be within the scope of the organisational activities.

4.3. Contract Review: 4.3.1. General:

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The organisation must take steps to ensure that it identifies with the customer requirements. If the essential technical requirements for the items, materials, or services vary from that of the customer needs, a systematic procedure for resolving the matter should be put in place. The ISO 9000 standard also recommends that mutual interactions be kept up with the customer during the entire transaction. Organisations should lay down procedures for the assessment of the customer invoice.

4.3.2. Review: The organisations must conduct a thorough assessment of the customer orders before taking them up.Therefore, the management should ensure that: • The customers' order is well interpreted (if it is orally conveyed) before taking up the order. The organisation has sufficient resources to fulfil the requirements of the customer.

4.3.3. Amendment to contract: Sometimes, the consumer might go for a replacement of the order or the organisation itself could fall short of the specifications. The standard states that:

Organisations must possess a documented system that specifies the modification procedure and the techniques being implemented so that the relevant information is conveyed to the concerned people.

4.3.4. Records: Upon the assessment of the customer order, the organisation should document the information pertaining to the order and the subsequent assessment incorporated in it. This is to be preserved for a specific duration. 4.4. Design Control: 4.4.1. General: The organisation needs to lay down procedures to ensure that the design of the product suits the customer requirements. 4.4.2. Design and development planning: The design plan must describe how the design process will be executed. It covers the employees in various hierarchies, their interactions and design procedures. Experts must regularly evaluate the design processes. 4.4.3. Organisational and technical interfaces: All interfaces between the design of a product and other organisations that design it have to be identified, communicated, and assessed periodically. The information required for carrying out a design process within the organisation must be gathered and incorporated within the documents. 4.4.4. Design input: The organisation must put in place procedures to ensure that the design team obtains the crucial information pertaining to the design parameters. The design team must promptly explain, convey and solve discrepancies in the product specifications. 4.4.5. Design review: The organisation must carry out design reviews at various phases of product evolution in order to control the design process. 4.4.6. Design output: The output of the design process consists of documented drawings, and tolerance specifications, materials requirements, and assembly guidelines. 4.4.7. Design verification: Design verification states that: • • As the designs develop, the design must be evaluated to ensure that the inputs are conformed to. Designs are verified by means of tests, displays, and contrasting with previous designs.

4.4.8. Design validation: The organisation must make sure that the final product conforms to the design parameters, which in turn suit the customer’s needs. To attain design validation, the product must be tested in the environment it is going to be used. This is done to ensure that the product conforms to customer's requirements. 4.4.9. Design changes: The course of action for making modifications in design should be documented. 4.5. Document and Data Control: 4.5.1. General: All documents relevant to the ISO 9000 standard should be managed by a system with relevant procedures laid down for document assessment, improvement, approval and disposition. This also includes verifying documents used in design and testing. The documents must be easily accessible. 4.5.2. Documentation approval and issue: To meet the terms of this clause:

• • •

The concerned officials should assess, endorse review and approve all the documents that are utilised. The organisation must maintain a record of all the documents in use. The organisation must ensure that employees can easily access documents pertaining to them. Obsolete or incorrect documents must be removed from locations where there are chances of their inadvertent usage.

4.5.3. Document changes:

Documented modifications must be assessed and authorised by those who conduct the initial assessment, or by an official who has the freedom to use the relevant and crucial information to enable a good evaluation.

New modifications from the previous documents should be charted, when required.

4.6. Purchasing: 4.6.1. General:

• •

The organisation should have well laid down procedures to perform its purchasing activities. Only then can the materials being supplied to the organisation suit the specific needs of the product. The organisation must evolve an effective purchasing system with complete documentation and records that make sure that the purchased goods conform to the requirements.

4.6.2. Evaluation of subcontractors: Assessment of a supplier must include an official documented assessment procedure. Review of subcontractors stipulates that:

• • •

The organisation must choose a contractor on the basis of his capacity to conform to quality requirements. An assessment of the quality system set up in the supplier’s organisation must be performed. The organisation must maintain accessible records of those vendors who conform to the standards.

4.6.3. Purchasing data: Goods being purchased should be clearly specified. This consists of pinpointing critical components and high lighting process capabilities, guidelines for inspection and other relevant data. The purchase record must contain details of conformity to a relevant standard. 4.6.4. Verification of purchased product: It is the purchaser's choice to carry out a check of the product at the supplier’s place or within the purchaser’s organisation. Product verification proves that the information pertaining to the inspection of the product is incorporated in the purchase record. 4.7. Control of Customer Supplied Product: The organisation should lay down procedures to assess, stock up, utilise and maintain the goods made available by the customer to be integrated into the final product. Materials that are not viable should be identified, separated and intimated to the concerned customer. 4.8. Product Identification and Traceability: To maintain product identification and traceability:

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The organisation should lay down procedures so that the materials are individually traced from the time they are supplied to the organisation till the customer accepts them. Depending on the customer needs, organisations may even require to provide component identification. The organisation should have official documents and records in place to cater to the customers’ requirements.

4.9. Process Control: Process control can be defined as the means by which the process is designed to be in line with the standards or specifications.

The organisation should execute operations under a controlled work environment that ensure that the quality of the product is sufficient and in line with the documented specifications of ISO 9000 standard. The documents should stipulate the requirements for the machinery, location, reference standards, and quality plans. They must also include the procedure for routine inspection during the production process. The equipment utilised by the employees must have proper operational guidelines. The instructions should be evaluated regularly to see that they are in line with the other procedures.

4.10. Inspection and Testing: 4.10.1. General: • • There should be a detailed inspection and testing system to check whether customer needs are conformed to. This should be promptly incorporated in the documents and records that are accessible to the employees. Attribute acceptance sampling plans should have zero defects as the benchmark. Certified laboratories should be utilised on consumer request.

4.10.2. Receiving inspection and testing:

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The organisation should lay down procedures that ascertain use of material in the processes till they suit the predetermined quality aspects. During emergencies where the material is utilised before inspection, it should be positively pinpointed and documented in order to facilitate instant recall and replacement (if the set standards are not met).

4.10.3. In-Process Inspection and Testing:

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• •

The organisations should inspect and test the product as required by the documented procedures. Utilisation of positive recall method in cases of emergency. Emphasis should be laid on defect minimisation techniques such as SPC, visual management, mistake proofing.

4.10.4 Final Inspection and Testing: The organisation should perform final inspection and testing in accordance with the documented procedures. This will help to establish the conformance of the finished product to the specified requirements. The Quality Plan for final inspection and testing stipulates that all specified inspection and tests have been accomplished. The results should satisfy the specifications. No product should be shipped until all the procedures specified in the documented procedures have been accomplished and the related information is approved officially.

4.10.4 Inspection and Test Records:

The organisations should put in place records to ascertain whether a product has been tested or not. These records will show clearly whether the product has passed or failed the inspections conducted in accordance to the requirements. If a product fails any inspection or test, the procedure for control of nonconforming product should be utilised. Records should clearly identify the officials who are in-charge of the despatching of the product.

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4.11. Control of Inspection, Measuring, and Test Equipment : This clause defines the system established to ensure that the products meet the quality requirements through effective inspection and testing. 4.11.1. General:

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The organisation should have a system in place to ensure that the devices used for inspection and testing are appropriately calibrated and managed. When using software to check the product’s conformance to the requirements, they should be periodically reexamined for consistency. Records of calibration, authentication, and precision need to be easily accessible to the customers.

4.11.2. Control procedure: • • • • • • • Choose the pertinent device for testing. Pinpoint those devices that can positively influence product quality. Calibrate such devices at regular intervals. Designate the current state of calibration. Put in place records providing the information for calibration. Make sure that the devices used for testing and inspection are properly maintained and regularly checked for defects. Protect the equipment from modifications that could have a negative effect on calibration.

4.12. Inspection and Test Status:

The organisation should designate the current state of inspection and testing of the products during the various stages of the production process. This can be done using stamps, labels, tags, records, or diskettes.

4.13. Control of Nonconforming Product: This clause defines the system to manage nonconforming product.

4.13.1. General: • Products that do not meet the requirements should be restricted from inadvertent usage or installation. The organisation should lay down procedures to tackle product failures for e.g. preventing the product from being delivered to the customer. These procedures should specify isolation of such products and the subsequent corrective actions.

4.13.2 Nonconforming product review and disposition: The defective product should be assessed in compliance with the procedures laid down. This product may be: • • • • • Modified to meet the specified requirements. Taken up again. Reassigned as a substitute for other purposes. Discarded. Returned to the supplier.

The products that are fixed and modified are re-examined in compliance with the procedures laid down. 4.14: Corrective and Preventive Action: 4.14.1General: The organisation should implement corrective and preventive actions taking into consideration consumer grievances, service faults, audit results and quality documents. These measures should identify the causes of nonconformity and establish remedial procedures to eliminate potential non-conformities. The organisation should take measures to ascertain that all activities are executed with efficiency. 4.14.2. Corrective Action: The corrective action procedure must involve: • • • • Compilation of customer grievances and defects (in product) in records. An analysis of the failure of a product to meet a specified requirement and its subsequent recording. Establishing the steps to be taken to mend the defect i.e. determining the procedure for corrective action. Establishing methods for monitoring the effective implementation of the corrective action.

4.14.3. Preventive Action: The preventive action procedure must involve:

• • • •

Compilation of data relating to the products (that fail to meet a specified requirements) mentioned in the records. Some of the means to source this information are consumer grievances, internal audits, quality documents and service feedbacks. The purpose is to utilise the records to eliminate the causes of product failure. An analysis of the failure and its recording should be done. Establishing the steps to be taken to mend the defect i.e. efficiently carrying out the corrective action plan. Outlining a corrective action plan to deal with the root cause of product failure. Ensuring that the top management revaluates the preventive and corrective actions.

4.15. Handling, Storage, Packaging, Preservation, and Delivery: 4.15.1. General: The organisation should lay down procedures to process, stock, pack and deliver products. 4.15.2. Handling: • • The handling of products should be such that the product is safe and uncontaminated. Training should be given to the employees in issues relating to the safe handling of products.

4.15.3. Storage:

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The organisation should define locations for stocking the materials in order to safeguard them from damage, corrosion, accidental usage, or unintentional delivery to a customer. The organisation should set controls for receiving or delivering goods from the warehouse. Thorough assessment should be done to ensure degradable materials (items that deteriorate by exposure to air, sunlight, heat, moisture and similar factors) are despatched before the expiry date.

4.15.4. Packaging: • • The packaging guidelines must be properly documented and protection techniques high- lighted. Also the material used for packing should be appropriate. Employees must be provided adequate training in packaging techniques and in the use of packaging devices.

4.15.5. Preservation: • Preservation includes activities taken to repair or treat damaged materials (retrospective) and prevent or delay material becoming damaged (preventive preservation). The preservation procedure should be properly documented. The material must be confined in a restricted area until they have been shipped to the customers.

4.15.6. Delivery: • • • Delivery of the product is made in conformance to the prior agreement with the customers. Proper measures should be taken to facilitate undamaged shipment to the customer. The delivery procedure must be documented and the personnel should be adequately trained for the job.

4.16. Control of Quality Records: The organisation should • • • • • Preserve records that establish product conformity to the specifications. Define the warranty period i.e. the duration for the preservation of a record. Ensure that the records are easily accessible by the employees. Check whether the quality records provide information regarding the quality status of an item, process, operation, or research activity. Quality records should be preserved in locations that are safe and easily accessible.

4.17. Internal Quality Audits:

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The quality audits within the organisations should be scheduled appropriately. Trained employees unrelated to an activity should preferably conduct its audit. The outcome of the auditing process should be recorded and judicious corrective action taken.

4.18: Training:

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A training programme necessitates the systematic collection of information pertaining to the employee skills and the requirements of the organisation. Organisations must encourage the workforce to accept training in relevant areas. The organisation must provide ample resources to facilitate training so that the employees can upgrade their skills. Procedures for the training activities should be in place.

4.19. Servicing:

On the basis of the conditions set by the organisation and the agreement between customers and the management the organisation should draft its service procedures. All these activities should conform to the ISO 9000 standard. The organisation should document procedures required to confirm compliance of the services to the set standards.

4.20. Statistical Techniques: 4.20.1. Identification of need:

The organisation should evaluate the application of statistical tools and techniques in its QMS. The use of statistical tools enables the organisation to effectively manage its process and product parameters.

4.20.2. Procedures:

Once the organisation starts utilising statistical tools, it should simultaneously lay down procedures to ascertain their proper application.

Implementation > Establishing ISO 9000 Quality Management System

Establishing ISO 9000 Quality Management System: ISO 9000 family provides a basic structure to analyse and enhance organisations key activities - that are particularly involved in establishing and maintaining quality. The best known of the ISO 9000 family are the ISO 9001, ISO 9002 and ISO 9003 standards - each defining standards for different aspects of an organisation. For instance, while ISO 9001 specifies the model for quality assurance in design, development, production, installation and servicing, ISO 9002 specifies standards for production, installation and servicing, and ISO 9003 is applicable for final inspection and testing. Thus, before embarking on implementation every organisation should consider factors like • The services and products it offers. Size of the organisation.

Regardless of the kind of standard adopted, organisations can go about their quality system implementation through the following steps: Step 1: Top management commitment: The first step towards establishing a QMS in accordance with ISO 9000 series of standards is the commitment of the topmanagement. Any measure taken towards the development of a QMS will be productive only when the top- management is committed towards it. The top-management must be convinced of the benefits of certification. They should realise how certification will help them improve their systems and demonstrate a visible commitment to quality to customers. The top management can demonstrate their commitment to the implementation and enhancement of the QMS by several methods, some of which include: • Developing effective strategies to communicate to their employees the importance of implementing the ISO 9000 QMS. Developing the organisation's quality policy and communicating it to all the employees. Establishing quality targets at all levels and functions of the organisation. Providing necessary resources to implement the QMS. Appointing a management representative drive the implementation of the QMS. Conducting management reviews.

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Step 2: Establish an implementation team and allocate responsibilities: The next step is to form an implementation team and appoint a management representative to streamline the organisation¡¦s planning and manage the implementation program. Care should be taken that the team members are from all the functions in the organisation. A management representative, is a person within the organisation who acts as an interface between organisation¡¦s management, it's employees and the ISO 9000 registrar. He should be the organisation's "quality management system champion," and should: • • • • Be committed to quality and particularly to implementing ISO 9000 standards. Demand the respect of managers and other levels of employees. Have knowledge of quality systems and ISO 9000 in particular. Have complete backing from the management.

Step 3: Start ISO 9000 awareness programs: Enhancement of quality performance in an organisation does not occur by itself. The top-management should motivate and support the work force in their efforts to achieve quality improvement. An organisation-wide awareness program should be conducted on ISO 9000 QMS. This will help employees gain adequate knowledge of ISO 9000 quality system. They should be able to understand:

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Why the organisation is opting for certification? What is the current status of the organisation when compared to the required standards? What is the desired objective of the management? What are the benefits of implementing quality system based on ISO 9000 standards?

Step 4: Provide training: Once the above activities are performed, necessary training should be provided for different categories of employees - senior managers, middle-level managers, supervisors and workers. The duration may vary depending on the need but training is a must for all. This training needs to be comprehensive enough to include all the basic concepts of the QMS, the standards and their influence on the planned targets of the organisation.

The management representative along with the members of the implementation team, who conduct internal audits, would need an internal auditor-training course. Training may also be necessary on writing quality manuals, procedures and work instruction, auditing principles, techniques of laboratory management, calibration, and testing procedures. If expertise is not available to conduct the training, it may be necessary to participate in external training courses that professional training organisations conduct. Alternatively, an external training consultant could be invited to conduct inhouse training courses. Step 5: Conduct Gap analysis: Gap analysis is an evaluation of the organisation's current policies and procedures to identify those that fall short of what is required by ISO 9000. Gap analysis enables the organisation to analyse its business plan, policies and strategies and their suitability. Many organisations have the necessary procedures in place for a QMS but the question is whether they are in accordance with the required standards. Gap analysis assists in identifying such procedures. It also helps in identifying the need for new procedures. A gap analysis generally uses a standard template of questions (questionnaire) on the current status of the organisation's processes. The analysis can be conducted internally i.e. by an in-house team, provided the required knowledge is available. Otherwise the services of an external consultant should be availed. Step 6: Create a documented implementation plan (Action plan): Once the organisation gets a clear picture of the status of its existing quality initiatives, all non-conformances should be managed with a documented implementation plan (action plan). This requires identifying the non-conformance process and modifying them to make the QMS compliant to the required standard. Gap analysis helps to obtain information pertaining to all the activities that an organisation practices. This information should be used to develop a new implementation plan. This implementation plan should define: • • • • • • The documentation that needs to be developed. Vision and targets of the system. Relevant ISO 9000 section. Person or team responsible. Required resources, approval and training. Clear deadlines.

These elements need to be arranged in the form of a chart, to enable periodic reviews. This plan should define the roles and responsibilities of employees in different departments and specify the time limits for the completion of the activities. The implementation team should approve the action plan that is developed. While a quick action is essential it should not be the only norm. The management representative should control, review and update the plan as the implementation process proceeds. Step 7: Develop QMS documentation: Once the action plan is ready, the next step is documentation. Documentation is a common area of non-conformance in organisations willing to implement quality systems. In most organisations the documentation is either insufficient or absent in some areas. Areas like inspection and measurement are generally performed in every organisation, but very few document them. Documentation of the QMS should include all the activities that have their profound impact on quality. This generally should include: • • • • Documented statements of quality policy and quality objectives. A quality manual. Documented work instructions and quality records. Documented quality plans and those that are required for operation and control of quality processes.

Step 8: Document control: Once the necessary documentation is developed, a documentation system should be developed to control it. These control systems need to be simple and easy to operate. Document control should include: • • Approval for adequacy by responsible persons before issue. Effective means for employees to access the documents. Revision, updating and re-approval of documents by authorised persons. Prevention of unintended use of obsolete documents.

Step 9: Implementation: After developing the necessary documentation and systems for their control, the management representative (quality cocoordinator) needs to validate them. Then the actual QMS implementation can be initiated. Implementation is putting down the written systems into practice. Care should be taken that the all activities in the organisation are in accordance to the documented standards. It would be a good idea to initially evaluate areas where the chances of a positive evaluation are high. This helps to maintain the confidence of both management and staff in the merits of implementing the QMS. Step 10: Internal quality audit (Phase-1 audit): Internal quality audit can help identify the gaps in the quality system implementation that are not yet compliant to the ISO standards. Internal audit process should be conducted properly and thoroughly. It helps to verify that the QMS is in accordance with the: • • Planned arrangements. Requirements of the standard. The organisation's requirements .

This may require modification of a particular system or procedure. Even after the system stabilises and starts functioning, internal audits should be planned and performed as part of an ongoing strategy. Step 11: Pre-assessment audit (Phase-2 audit): When system errors are no longer observed, it is normally time to apply for certification. However, before doing so, arranging a pre-assessment audit though not mandatory is advisable. Phase - 2 audit generally conducted by an external agency could help organisations re-evaluate their QMS. This may help them identify defects that were not visible previously. Thus the organisation gets a certain a degree of confidence before going through the formal process of certification. Generally, an independent and qualified auditor conducts the pre-assessment. In certain cases certifying agencies provide this service. Step 12: Selecting a certifying agency: Some criteria that organizations can consider while evaluating a certifying agency are: • Background of certifying agency. Kind of organisations and industries audited by them previously. Number of organisations audited by them. Expertise in the implementation of ISO 9000 standards. Market feedback. Audit fees. The audit team deployed. Compatibility of audit firm's working with organisational culture.

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Step 13: Certification and registration: The next step is the certification. The certifying agency first conducts a document review to check for the adequacy of available documentation. Once the documentation is found adequate, a conformity audit or a compliance audit is conducted. Such an audit is performed in accordance with the ISO 10011 auditing standard. On satisfying the conformance audit, the certifying agency grants certification. Step 14: Surveillance and re-certification audits: Establishment of a QMS in accordance with the ISO 9000 series of standards is not a one-time effort. ISO 9000 standards need to be adhered to by the QMS once it is implemented in the organisation. Hence, organisations need to ensure that the systems implemented are also established. Regular surveillance audits are necessary for this. They help to ensure that the organisation continuously adheres to the required quality standard. In general, the certifying agency conduct these surveillance audits. The certification issued is valid for a period of 3 years. After which a re-certification audit is conducted. Gap Analysis > The ‘What’ and the ‘How’ Of Gap Analysis Gap Analysis: Gap analysis is an evaluation of the organisation’s Quality Management System.

Purpose: Gap analysis assists in identifying the organisation’s functions that conform to the ISO 9000:1994 standard and the “gap” between the non-conforming functions to the requirements of the ISO 9000 standards. Gap analysis also provides the organisation with some suggestions to fill the identified “gaps”. Indeed such proposals guide the implementation process. Every organisation requires effective and efficient systems to remain competitive. Gap analysis helps to identify the range and depth of the conformance of its systems to the standards. Most organisations find documentation falling short of the standards. Similarly, internal audits (conducted by in-house employees), corrective and preventive actions and management reviews are some of the other areas that often fail to meet the standards. Conducting the gap analysis: The organisation can use the services of either trained internal personnel or external consultants to conduct the gap analysis. The gap analysis will evaluate the system in terms of adequacy of documentation and compliance of working system to the ISO 9000 standard requirements. Tools: A standard questionnaire is used to collect information regarding the existing QMS. Based on the gap analysis and report generated, the organisation can work out an appropriate implementation plan and time schedule to meet the ISO 9000 requirements. Continue the tour: Questionnaire Gap Analysis > Questionnaire Questions 4.1 Management responsibility: • • Does the top-management have a defined plan for maintaining quality? Is it consistently implemented? Is the top-management committed to maintain quality? Yes No Comments

4.1.1 Quality policy: • Is the quality policy clearly defined and well documented? Does it act as a clear guideline for establishing and evaluating the organisations quality objectives and targets and the customer requirements? How well is it communicated to the organisation’s employees?

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4.1.2 Organisation: Does the organisation have a defined structure to explain the roles and responsibilities of personnel in the organisation? Responsibility and authority:

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Does the organisation have an established practice to define the responsibility and authority of various employees? Is it well documented? Is there a practice that defines the various interactions between the personnel? Are there personnel responsible for managing non-conformance products and implementing corrective actions? Resources: • Is there a defined practice to identify and provide the resources required? Do they include trained personnel as an important resource? Management representative: • Is a management representative assigned to drive the QMS implementation and to update the top management on its progress? Is the management representative a member of organisation’s own management?

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4.1.3 Management review: Does the organisation conduct reviews on a periodic basis to inspect the sufficiency and effectiveness of the QMS?

4.2 Quality system: 4.2.1 General:

Does the organisation have a quality manual encompassing all the essentials of the ISO 9000:1994 standard? Does the quality manual define the system for documentation?

4.2.1 Quality system procedures: • • Are the defined quality system procedures, in line with the standard and the quality policy? Are the quality procedures regularly inspected for their compliance? Do the quality system procedures reflect the scope and depth of the activities of the organisation?

4.3 Contract review: 4.3.1 General: • Is the tender evaluated prior to the submission of tender?

4.3.2 Review:

Does the contract review ensure that: 1. Needs are clearly defined and documented? 2. Disparities among tender and order are rectified? 3.The organisation has all the required elements in place to satisfy its needs?

4.3.3 Amendment to a contract:

Does the organisation have in place procedures for amending a contract and are those procedures clearly conveyed to the functions that need them?

4.3.4 Records: • Are the changes made to the contract recorded? Are these records maintained?

4.4 Design control:

4.4.1 General:
• Does the organisation have procedures laid out for managing the design and for testing the ability of design to satisfy the customer needs?

4.4.2 Design and development planning:

Does the design and development planning include: 1. Identifying the responsibility of all those involved in the design and development phase? 2. Allocating adequate resources?

4.4.3 Organisational and technical interfaces:
• Is there a defined practice to identify the organisational and technical interfaces among the various groups? Is the nature of information that streams between those groups identified?Is this information flow evaluated periodically?

4.4.4 Design input:
• • Is there a defined practice n the organisation to identify the employees accountable for inspecting, documenting and solving complex design input needs? Does this design input incorporate the changes made in the contract during evaluation?

4.4.5 Design review:
• • Is the mode of performing review (stages of review) pre-defined? Is it efficiently conducted according to the plan? Is it documented?

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Does the review include personnel from all the necessary functions? Are the results of the review recorded and preserved?

4.4.6 Design verification:
• • • Is verification performed at the appropriate stages? Does this include integration of alternate measurements? Are these verification initiatives recorded and evaluated before realisation of products?

4.4.7 Design validation:
• Do appropriate personnel identify, document, evaluate and approve the changes made in the design before implementation?

4.5 Document and data control: 4.5.1 General:

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Does the organisation ensure the accessibility of the information such as standards, procedures, material for reference and other documents? Are the various roles and responsibilities in document and data control effectively entrusted? Is the mode of documentation (paper or electronic) decided upon?

4.5.2 Document and data approval and issue:
• • Is the responsibility of evaluating the “sufficiency and authorisation “entrusted to qualified employees? Is there a defined practice to pinpoint the status of the review? Is there a defined procedure for control to assist in: 1. Preserving the correct documents at the correct place? 2. Preventing the use of outdated documents? Can preserved documents be easily located?

4.5.3 Document and data changes:
• Are changes reviewed and approved by the appropriate authorities? 4.6 Purchasing: 4.6.1 General: • Is it ensured that the purchased product conforms to the listed requirement?

4.6.2 Evaluation of sub-contractor:

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Are the sub-contractors assessed and chosen based on their capability to conform to requirements? Is the scope and depth of control exercised over the sub-contractor effectively defined? Is this information recorded and preserved?

4.6.3 Purchasing data: • Are the documents prepared for a product purchase adequate for describing the product?

4.6.4 Verification of product purchased: Supplier verification at subcontractor’s premise: • Does the organisation provide the details of verification that will be undertaken before acceptance of a product from the supplier? Customer verification of subcontractors product:
• Is the customer provided with the facility of conducting verification of product conformance at the organisations premises as well as the supplier’s premises?

4.7 Control of customer-supplied product: Does it include:

Inspection, storage and maintenance of customer-supplied product? Informing the failure or denial to the customer and preservation of records?

4.8 Product identification and traceability:

Is there a defined practice to trace the product through out its process cycle (receipt, production, delivery and installation)?

4.9 Process control: Does the organisation:

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Plan and implement various processes required for production, installation and servicing? Are processes conducted in controlled environments? Conduct regular maintenance of machinery to ensure break down free production? Specify qualifying requirements of equipment, processes, and personnel.

4.10 Inspection and testing: 4.10.1 General: • • Are the necessary inspections and testing procedures adequately described in the quality plan or procedures? Does the organisation utilise the services of certified laboratories when required by the customers?

4.10.2 Receiving inspection and testing:
• • Is the inspection procedure for inspecting incoming material carried out in line with the quality plan? Are products released for urgent production are identified and recorded?

4.10.3 In-process inspection and testing:
• Are methods used for avoiding errors like SPC, error proofing and visual control adequately applied?

4.10.4 Final inspection and testing:

• • Is the final inspection and testing performed in accordance with the quality plan?

4.10.5 Inspection and test records:
Does the organisation have adequate records to assist in identifying the activities/personnel accountable for product release? Are the records of inspection and testing sufficiently maintained?

4.11 Control of inspection, measuring, and test equipment: 4.11.1 General: • Does the organisation employ documented procedures to manage, calibrate and maintain inspection, measurement and testing equipment?

4.11.2 Control procedures:

Does the organisation have control procedures for: a) Choosing the right equipment? b) Identifying the equipment that can have maximum impact on the overall quality of product? c) Calibration?

d) Efficient handling, storage and preservation of equipment? 4.12 Inspection and test status: • Does the organisation’s quality plan and procedures specify the stages at which inspection and test needs to be conducted?

4.13 Control of non-conforming product:

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Is the control executed over the non-conforming product sufficient to stall the unintentional use of the product? Does the organisation have defined processes to manage and examine the nonconformance relative to the requirements? Does the organisation have established procedures for managing a non-conforming product? Do these procedures for managing non conforming product include: a) Rework? b) Alternative actions?

4.14 Corrective and preventive action: 4.14.1 General: • Does the organisation have defined procedures for corrective and preventive actions?

4.14.2 Corrective action:

Do the corrective actions include: a) Evaluation of quality records? b) Inspection and recording information pertaining to the main causes of nonconformance? c) Initiatives to eradicate the chief causes identified? Are the corrective actions being implemented efficiently and regularly?

4.14.3 Preventive action:

• Do the preventive actions include evaluation of quality records, audit reports, concessions and customer requirements?Identification and evaluation of the root causes of nonconformance? Do they include techniques to enhance their effectiveness?

4.15 Handling, storage, packaging, preservation and delivery: 4.15.1 General: • Does the organisation have established procedures for safe handling, storage, packaging and delivery of products?

4.15.2 Handling: • Are necessary safeguards in place to protect product from damage while handling?

4.15.3 Storage:
• • • • Are appropriate storage areas provided? Are these locations safe such that they prevent damage or deterioration? Are there appropriate methods to deliver and despatch unused products from the storage locations? Are the products examined at periodic intervals to identify deterioration?

4.15.4 Packaging:

Is there a defined practice to effectively manage the activities involved in packing, packaging and labelling?

4.15.5 Preservation:
• Are suitable methods used for preservation?

4.15.6 Delivery:
• • Is product quality ensured even after final inspection and testing? Is there a provision for making delivery to customer destination if necessary?

4.16 Control of quality records:

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Does the organisation have a system for filing, storing and retrieving records? Are the records well maintained and preserved from damage? Do the records have predefined periods set for preservation before disposal?

4.17 Internal quality records:

Does the organisation have established procedures for planning and conducting audits? Are the results of the audits recorded and reported for taking appropriate and adequate action?

4.18 Training: • • • Is there a process in place to analyse and identify training needs? Is relevant training provided to all the employees? Are records maintained of training provided?

4.19 Servicing: • Is support for the product provided after it has been sold?

4.20 Statistical techniques:

Are suitable statistical techniques necessary for investigating process control and other procedures identified? Are there documented instructions for applying these statistical techniques?

Documentation > Documentation of ISO 9000:1994 Documentation: Documentation can help an organisation to

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Provide a road map to the organisations quality activities. Allow large and complex tasks to be easily comprehended. Save the time new employees spend to learn tasks. Provide the basis for internal audits.

Documentation is the most common area of non-conformance within organisations implementing ISO 9000:1994 quality management systems. In most organisations the documentation is either insufficient or absent in many areas. ISO 9000:1994 standards necessitate an organisation’s quality management system to be documented and controlled. But most organisations fall short of their defined goals and objectives due to improper planning i.e. lack of an organised approach. The 1994 version of ISO 9000 unlike the 1987 version included a new clause-Quality planning. This requires preparation of quality plans showing how the requirements of quality are going to be met. Thus, before embarking on documentation an organisation should first analyse what to document and what is already documented. Mere documentation is not sufficient. Documentation will be effective only if it is properly planned and managed in stages. Common problems: • • Employees prepare the documents unaware of the difference between a procedure and a work instruction. The terminology is not clearly defined and used consistently.

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Obsolete documents often still in use. Absence of a process for tracking changes.

Given below are some guidelines for developing the documentation for a QMS 1. Provide a structure for documentation: ISO 9000:1994 standards do not address the details of the quality system. Instead, they specify that an organisation must have defined processes for areas such as quality, process documentation, and verification. Therefore, organisations need to first identify the processes that impact the quality of their products or services. Then, a basic approach is to be developed involving all these processes and their interrelationship. These processes generally include • • Material, equipment and the resources that need to be obtained. Production and administration processes and their conformance with the design norms of product or service. Targets of the organisation’s QMS. Training, purchasing and material checking/testing procedures. Inspection, validation and control procedures.

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Once the processes are identified, a model, which acts as the base for the documentation is to be outlined. ISO 9000:1994 follows a three-tier model - quality manual, process guides and work instruction respectively.

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The quality manual explains the quality policy, quality goals and targets. The organisational structure needed to fulfil the ISO 9000 requirement. Process guides are documents that describe how an process is to be carried out. Work instructions are documents that specify how a job or activity is to be done.

2. Check the clauses of ISO 9000: After outlining the model for documentation, organisations need to check all the clauses of ISO 9000:1994 standards. The family of ISO 9000:1994 series specify three different standards, namely ISO 9001, ISO 9002 and ISO 9003- each specifying standards for different aspects of the business. Hence, organisations (before preparing the quality manual or process guides) initially need to verify the standard appropriate to them. This requires an extensive clause-by-clause inspection of the elements in the organisation. Check lists are used for this purpose. These checklists present a clear picture of the organisation’s existing quality system and ensure that there is nothing overlooked. 3. Review the process map: This forms the most crucial stage of the entire documentation process. Many organisations view the quality system as the responsibility of the quality manager alone. However, the quality system is the responsibility of the entire organisation. Thus, top-management needs to first evaluate their process map and analyse existing systems and those planned for the future. Employees’ viewpoints need to be considered to make the documentation more effective. 4. Write Quality manual: Once the inadequate processes are identified, they need to be rectified and new documents prepared. There is no standard format for writing a quality manual but it is essential to keep it simple. If the organisation consist of complex processes, it may even be necessary to create functional manuals (defining every function). The criteria should not be the style and size but the needs of the users of the manual. Document control: Some tips to maintain an effective document control system are explained below: Keep It Simple: Documentation should be comprehensive, short and user-friendly. It should be simple so that everyone can comprehend it easily. It should be precise and adequate enough to cover all the necessary activities. Have the right amount of documentation: Too much documentation may prove burdensome while too little could prove insufficient and ineffective. Other tips: • • • Document only relevant and important activities. Retain the old documents unless they are no longer useful. Keep it simple and easily comprehendible. Describe the process route for every activity. Avoid following ISO 9000 clause by clause if it is inappropriate to the organisations business.

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Integrate the quality manuals of other companies if found beneficial. Never start documentation without a plan.

Measurement, Analysis and Improvement > Elements Included Quality of products or service is the major factor that determines the success or failure of any organisation. Therefore, organisations must assure customers of their high standards in product quality. For this organisations need to initially implement strong and effective techniques for measurement, analysis and improvement of the quality related activities. ISO 9000 series of standards defines certain specifications for this purpose. Measurement, analysis and improvement are an important part of both quality control and quality assurance systems. These initiatives are directly related to product quality, where they take the form of testing or inspection measurements (ISO 9001 requirement 4.10), or relate indirectly to initiatives that affect product quality, taking the form of process control measurements. (ISO 9000 requirement 4.9). How can quality be measured and improved? ISO 9000:1994 has some defined clauses to measure, analyse and improve the quality related activities in an organisation. In most organisations, it is the quality manager who evaluates these measurement, analysis and improvement techniques. The various clauses defined in ISO 9000:1994 for measurement, analysis and improvement are: • • • • • • 4.9 4.10 4.13 4.14 4.17 4.20 Process control. Inspection and testing. Control of non-conformity. Corrective and preventive action. Internal quality audits. Statistical techniques.

The above clauses and the processes relevant to these clauses are explained below. 4.9 Process Control: The purpose of process control is to ensure that all the processes in the organisation that directly impact quality are identified, planned and carried out under controlled conditions. This identification requires organisation’s to measure and analyse their quality related activities. Some of the activities defined in this clause that involve measurement and analysis directly or indirectly are: • • • • • Carry out quality related activities under controlled conditions. Identify the processes that could have their impact on quality. Verify that the procedures conform to the required reference standards. Monitor and control processes and product characteristics. Approve processes and equipment.

“In the 2000 version, process control is integrated along with the statistical techniques in the measurement and monitoring of processes(Clause 8.2.3).The additional requirement in the 2000 version is continuous improvement of these processes.” 4.10 Inspection and testing: “Inspection and testing” necessitates organisations to have a detailed inspection and testing system to ensure that the processes conform to the required standard. In order to ensure this conformance, organisations need to continuously measure and analyse their existing processes. The clause “Inspection and testing” requires organisations to carry out inspection and testing at three different stages of the production process as below: • Inspection and testing at the stage of receipt (Raw materials and components).

This specifies that the inputs received are not used or processed until they have been verified and conformance to the necessary requirements certified. • Inspection and testing at the stage of processing (Continuously fine tuning the manufacturing process).

Inspection at this stage is carried out on steps that are involved in the production of output. It is aimed at preventing the production of defective output. • Inspection and final testing (final product).

This requires organisations to conduct inspection and testing on output that has been produced. This is to prevent output that does not meet the quality specifications from reaching customers. “In the 2000 version, there was no significant change in this, but monitoring, analysis and improvement, and the use of appropriate statistical techniques were introduced.”

4.13 Control of non-conforming products: The purpose of this element is to ensure that products that do not conform to required standards are prevented from unintended use. This prevention, initially, requires organisations to identify the non-conforming product, which requires measurement and analysis. Control of non-conformance product thus directly or indirectly requires organisations to maintain defined procedures for measurement and evaluation of the non-conforming products. Some aspects in this clause that relate to measurement and analysis are: Clause 4.13.1 specifies that the organisation need to identify and evaluate the non-conforming product. Clause 4.13.2 specifies that the defective product should be assessed in compliance with the procedures laid down. These products may be: • • • • Modified to meet the specified requirements. Taken up again. Reassigned as a substitute for other purposes. Discarded.

It also specifies that the products fixed and modified are re-examined in compliance with the laid down procedures. Measurement, analysis and improvement are the basic functions involved in this. “2000 version has no major change from this except that the production terms such as rework or repair are removed.” 4.14 Corrective and preventive action: Corrective action refers to the initiatives taken to identify the causes of non-conforming products or services and establishing necessary measures to reduce these occurrences. Preventive action refers to the precautionary measures taken to prevent the occurrence of a problem or to reduce its effect. Both corrective and preventive actions are intended to improve the existing organisations quality processes. Some of the aspects in this clause that relate to measurement, analysis or improvement are: Clause 4.14.2 Corrective action requires that the organisation

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Analyse its quality records. Analyse the cause of a non-conforming product. Establish necessary methods to effectively monitor the actions taken (Analysis and improvement).

Clause 4.14.3 Preventive action involves • • • • Analysis of the quality records and their recording. Establishing the steps to be taken to mend the defect i.e. efficiently carrying out the corrective action plan (improvement). Setting a corrective action plan to deal with the root cause of product failure (measurement). Ensuring that the top management revaluates the preventive and corrective actions. (Measurement, analysis and improvement).

“2000 version has focussed much more on “improvement” and has made it a continual process. Additional clauses such as planning for continual improvement were added”. 4.17 Internal quality audits: The purpose of this element is to help management determine if the implemented quality system is effective in achieving required quality objectives. This is an evaluation technique organisations use to verify processes. They collect the data from a variety of sources and crosscheck them for the purpose of Internal quality audits. This data is analysed and loopholes identified. Management is required to take the necessary action on the loop holes discovered and implement the suggestions of the audit team. Some aspects of this clause that relate to measurement, analysis and improvement are: • • Planning and scheduling of audits (measurement and analysis). Recording results of audits to take up timely corrective action (Improvement).

“The 2000 version of this clause is similar to 1994 version, but it allows employees who have the responsibility and who actually carry out the activity to conduct auditing. It necessitated that the procedure included the requirements for ensuring the autonomy of the audit.” 4.20 Statistical techniques:

Statistical techniques involve measurement, analysis and improvement techniques. They ensure that systematic approaches are used in quality improvement and control. These techniques range from analysis of the markets to the measurement of the level of the follow-up service. The analysis techniques must be appropriate to the situation and the data collected effectively utilised. Aspects defined in this clause that relate to measurement, analysis or improvement are Clause 4.20.1 Identification of need requires organisations to evaluate their systems to verify their appropriateness (measurement and analysis). Clause 4.20.2 Procedures are essential for ascertaining the proper application of the tools (improvement). “In the 2000 version, statistical techniques are included in the measurement and monitoring of processes (Clause 8.2.3) that require the processes to be continually improving”. Tools Deployed > ISO 9000:1994 Tools The tools applicable in the various stages of the ISO 9000:94 implementation process are : Gap Analysis:

Comprehensive questionnaire on gap analysis in QMS, management responsibility, resource management, product realisation, corrective actions.

Quality policy establishment:

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Brainstorming Technique.

Document control: Fagan Document Inspection. Document Management System.

Planning: PERT. Critical Path Analysis. Gantt Charts.

Awareness and Training: Skills Gap-Analysis Technique.

Process Control: Process Analysis. Process Capability Analysis. FMEA. Reliability Technique.

Problem identification and rectification: Cause and Affect Diagram. Problem Analysis. Solution Effect Analysis.

Design and development of a product: CAD software. Design for Manufacturability. Simulation. Design of Experiment.

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Poka Yoke. Loss Function Analysis.

Delegation of responsibilities: Arrow Diagrams. Flowcharts.

Monitoring and Measurement: Control Charts. Pareto Charts. Histograms. Check Sheets. Scatter Diagrams.

Corrective and Preventive action: Potential Problem Analysis. Problem Prevention plan.

Quality Tools > Brainstorming Brainstorming is a process wherein a group of people focus on an issue/ problem and then come up with several radical solutions. They bring out ideas as they think of them, regardless of the content of the ideas, such that each of the participants has the opportunity to build on the ideas of others. No discussion, evaluation, or criticism of ideas is allowed until the brainstorming session is complete. Every brainstorming session should have a facilitator assigned to record all ideas. An American advertising executive Alex Osborn developed this technique in the 1940s. Types of Brainstorming:

Individual Brainstorming: When you brainstorm on your own you do not have to worry about other people's egos or opinions, and can therefore be creative and generate more ideas. However, the ideas you develop individually may not be as effective since you do not have the experience of a group to help you. Group brainstorming: Group brainstorming can be very effective as it uses the experience and creativity of all participants. The advantage here is that when an individual participant is saturated, another participant's creativity and experience can take the idea to the next stage. Group brainstorming, therefore, tends to develop ideas more in depth than individual brainstorming.

For effective brainstorming: • • • • Clearly define the problem to be solved, and lay out any conditions to be met. Encourage everyone to contribute and develop ideas, including the seemingly reserved members of the group. A single train of thought should not be followed for too long during a brainstorming. Ensure that one person documents all ideas generated during the session.

Quality Tools > Fagan Document Inspection What is it? Fagan Inspection is a well-defined procedure for thoroughly evaluating documents (especially those pertaining to designing and implementing projects). This evaluation is done by a team that includes the person who has designed the project/programme and, if possible, the customer. Fagan Inspection helps eliminate conceptual errors in the early stages of the documentation. Implementation Process: • • • Select the inspections team i.e. the team leader, author, people who conduct the inspection, and a data analyst. The author gives a general idea of the information in the document to the members. The other members in the team gain an insight into the details of the project and identify errors in the

document on their own.

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The entire team conducts the inspection collectively. Any errors identified are listed and categorised. The team leader presents a textual document of the inspection conducted and evaluates the list of errors and defects. The errors and defects are then rectified.

Advantages: Early defect detection in a document through inspection enhances its quality and reduces subsequent modifications. Back | Top Quality Tools > Document Management System What is it? Document Management System (DMS) is a software solution that enables organisations to better manage their documents that are in electronic or digital format. The objective of a DMS is to manage documents from their conception to the phase out. It includes storing documents at identifiable locations and to be able to recover them swiftly and easily. Implementation process:

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Initially, the organisation must assess the need for DMS in certain specific areas of the organisation such as library service, storage facilities, the basic infrastructure and the work processes. The DMS should be assessed for the following criteria: 1. Efficiently handles the need for storage and recovery of data. 2. Keeps track of modifications in the documents. 3. Makes sure that the documents are filed in the appropriate locations. 4. Ensures security and provides variable access rights to documents to different job profiles. 5. Ensures proper evaluation and assessment of the documents.

The accumulation of unnecessary and irrelevant documents may negatively affect the working of the DMS. Identifying and separating the documents pertinent to the organisational requirements is an important step towards the setting up of an efficient document management system. Scanning and OCR (Optical Character Recognition) technology is required to transform and integrate the paper document into the organisation’s document management system. The organisation must make sure that the OCR device has fine accuracy and identification rate. it must also monitor the indexing and searching abilities of the product closely. Advantages: DMS can simplify the organisation’s need for managing documents. The system is especially useful in managing management systems such as EMS Review. Quality Tools > Activity Network Diagram/ PERT/CPM What is it? Activity Network Diagram is the graphical display of the sequence in which actions have to be performed to complete a project. Activity Network Diagram is applicable to those projects where the tasks (actions to be performed) are known in advance. It enables the team to implement the most efficient path/sequence. Some of the other versions of this method are Arrow diagram, PERT Chart, CPM chart. Programme Evaluation Review Technique (PERT): What is it? Program Evaluation Review Technique is an organised network based method used for planning complex processes. Network diagram is the essential element of network based planning approach. Network diagram is an outline drawing that indicates all the activities in a sequence (i.e. the order in which they need to be accomplished to finish the project) signifying their correlation. PERT is an effective tool in the area of Project Management. This technique helps planning the duration of the project and the various resources required. Implementation Process:

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Complex processes are divided into job operations in an organised way. The job operations are sequenced in a manner pertinent to the order in which they need to be performed. The network diagram is laid out. Numbers represent the events and activities. An event is a particular time that signifies the beginning and completion of an activity.

An activity can be a critical activity or a non-critical activity. A critical activity is one that if delayed can delay the project. The delay of a non-critical activity does not affect the project’s deadlines/completion.

Utilising the three time estimates, the expected/estimated time for each individual activity is determined. 1. Optimistic time (ot): It is the minimum possible time taken to accomplish an activity. 2. Most likely time (ml): It is the duration in which an activity can be performed taking into consideration various likely problems. 3. Pessimistic time (pt): It is the maximum possible time in which an activity can be performed.

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The expected time is denoted by: (ot + (ml * 4) + pt) /6. The earliest starting times and latest finishing times are computed. Expected times, earliest starting times and latest finishing times are depicted on the network diagram. The Slack is computed. Slack is the additional time taken by a non-critical activity. Critical paths are pinpointed and noted on the network diagram. Joining the critical activities forms a critical path. It is the longest path and takes the most amount of time. If the critical path specifies that the project cannot be accomplished in the estimated time the finish date will have to be postponed. The optimum total project time-span is calculated.

Advantages: PERT is an effective technique to determine where interruptions (that lead to increase in project duration) in the project implementation are likely to take place and the resulting consequences on the entire project. Quality Tools > Critical Path Analysis What is it? Critical path analysis is an effective tool to plan the most optimum and cost effective sequence of activities to complete a project. Critical path analysis is a deterministic model with familiar operation times taken into consideration through past experience. Implementation Process:

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The complex process is divided into job operations in an organised way. The job operations are sequenced in a manner pertinent to the order in which they need to be performed. The network diagram is laid out. Numbers represent the nodes (events) and activities. A node is a particular time that signifies the beginning and completion of an activity. Compute the duration of each activity. Indicate the activity times on the network diagram. Compute the earliest starting times and latest finishing times. The earliest starting times and latest finishing times are depicted on the network diagram. Compute the total float for each activity. It is the extra time a non-critical activity can take without delaying the project. Critical paths are identified and are noted on the network diagram. Joining the critical activities forms a critical path. It is the longest path and takes the maximum time. If the critical path specifies that the project cannot be accomplished in the estimated time the finish date will have to be postponed. The optimum total project time-span is calculated.

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Advantages: Critical path analysis is best applied for recurring projects wherein cost effectiveness is given priority. This ensures efficient use of resources. Quality Tools > Gantt Charts

What is it? A Gantt chart is an effective tool used for planning and implementing complex projects. It enables the project team to evaluate the total time needed to accomplish a project, estimate the resources required and outline the sequence in which activities will have to be accomplished. Implementation Process: A complex project can be broken down into its individual activities. Some of these activities can be started only when certain other activities are completed first. These activities contingent on one another should be carried out emphasising the need to complete a task before starting the next one. These activities are called sequential activities. Some activities can be carried out at any time during the implementation of the project. They do not rely on the completion of other activities and can be performed independent of other project activities. These activities are called parallel activities. Calculate approximately the time required to accomplish each activity and the dates indicating its beginning and its completion. Drawing a Gantt chart: The Gantt chart is created with the horizontal axis indicating the total duration of the project, broken down into increments (days, weeks, or months) and the vertical axis representing the various activities that constitute the project. Each activity in the Gantt chart is signified using horizontal bars connecting the starting date and the date of completion of each activity. These bars are also known as activity bars. Above the activity bars, specify the time taken to complete them. Parallel horizontal bars should represent the parallel activities and horizontal bars in sequence indicating the sequential activities. Schedule the sequential activities. The path traced by each set of sequential activities is called a critical path. Schedule the parallel activities such that they do not disturb the way of the critical path. Determine the optimum amount of resources to be allocated for each activity. Carefully assess the project advancement making use of the Gantt chart. Advantages: The Gantt chart has certain options that assist the project team such that: • • • The names of the personnel who are in charge of each activity are included. Milestones and intermediary objectives of the project can be indicated. Filling the activity bar to the amount of work completed can indicate the status of the project.

Additional reading: 1. This article explains how to create a Gantt chart using MS Excel. http://www.me.umn.edu/courses/me4054/assignments/gantt.html 2. This article presents the application of Gantt charts in daily life. http://www.smartdraw.com/resources/examples/business/gantt.htm Quality Tools > Skills Gap Analysis Technique What is it? The skills gap-analysis is a valuable technique to evaluate training requirements. It helps to provide personalised training. Implementation process: An in-depth analysis of the job of each employee is conducted to identify the variety of skills set needed to accomplish the task successfully. The employees’ individual skills have to be compared against the skills required to perform the individual jobs. Training has to be imparted wherever the skills of the employees fall short. In this context it is important to understand the various skills that are involved. These skills can be classified into two broad categories. Technical skills: These include requisite knowledge to perform the tasks/jobs, occupational knowledge i.e. skills to operate various equipments, familiarity of various processes etc. Personal skills: The soft skills and personal skills such as communication skills or teamwork that improve the capability to perform or accomplish the required job. The people with identical roles or responsibilities or those needing similar skill sets in their job, have to be grouped together. Key training objectives for each group has to then be identified and common training modules developed. Advantages: The technique enables the organisation to methodically assess the training requirements of its employees and develop effective training strategies.

Quality Tools > Process Analysis What is it? The process analysis technique is used to assess processes or operations in order to make improvements. Processes can be assessed for their effectiveness, efficiency or impact on external environment. Implementation:

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Identify the process to be analysed/evaluated. Create a Block Diagram, with each block representing a stage of the process. Create a flowchart of all activities carried out in each stage. For each activity develop the list of inputs, outputs, and impacts along with relevant metrics. Evaluate each activity and identify areas of improvement. Generate an action plan to implement improvements.

Advantages: Process analysis helps understand a process and develop ways to improve those activities that fall short of the set requirements. Best Practices > Constructing on a Good Foundation ABC Ltd. is one of the first building contractors in Singapore to be registered to the ISO 9002 standards. From the time of its registering to the standards in 1994, ABC had been committed to providing superior quality services while constantly enhancing its quality system. Introduction: ISO 9000:1994 has defined quality as ``totality of characteristics of a product, process, organisation, person, activity or system that influence them to satisfy stated or implied needs’’. In this context quality in construction can be defined as conformity to the needs of all the people involved in construction, satisfying the needs of the client, legal and regulatory compliances and needs of the society. ISO 9000 in construction was the key: to attaining reliable performance levels, enhanced effectiveness and output, and gaining a competitive advantage. ISO 9000 compliance was a prerequisite for companies in search of international construction contracts. Case study: The present study explains how ABC Ltd. applied ISO 9000 QA standards aptly and minimised the generic human related defects classified in three sub systems. These sub systems can be classified as Technical, Human Resource, and Management sub systems. ABC Ltd. is one of the first building contractors in Singapore to be registered to the ISO 9002 standards. From the time of its registering to the standards in 1994, ABC had been committed to providing superior quality services while constantly enhancing its quality system. Quality system: The organisation’s quality system stipulated responsibilities for each organisational unit and employee, in order to attain quality within the scope of the organisation. It also controlled the operations among various departments to make sure that the construction and civil engineering activities were carried out efficiently. Even before the organisation got certified to ISO 9002 in 1994, the organisation established a quality improvement programme called the ‘quality recipe’. It was a set of values and viewpoints that focus on modifying and enhancing the mind-set of the workforce towards quality. ABC also emphasised on the PDCA (Plan-Do-Check-Act) cycle. Along with it is the Methods-Materials-Steps-Sequence programme that was personally created by the Managing Director to remind his employees to get involved in planning, monitoring and assessment so that a most favourable means to achieve quality was put in place. Soon after the ISO 9002 registration, all the quality management programmes initiated by ABC were amalgamated into a single action plan towards quality improvement, structured in line with the ISO 9000 QMS. External quality management experts guided the initial phase of the ISO 9000 implementation process. For the other phases i.e. planning and documentation the top management delegated the responsibilities to its employees. Employees involved in the implementation of the quality system were allowed to undergo training in this aspect. This would enable them to educate the remaining staff on the quality system. The half yearly assessment of the documents on quality management enabled ABC to identify defects in its operations. Certain innovative features in the newly taken up projects were promptly incorporated. The organisation had established comprehensive procedures to efficiently carry out the various aspects relating to the three sub systems within the scope of ISO 9000 QMS. This was primarily done to minimise the defects in the construction. Some of these are presented in detail.

Technical sub-system analysis: This sub system consists of those elements that are concerned with procurement of projects and the ensuing implementation process. Procurement: The top management made the choice of clients. This was complemented with the suggestions of the contract’s manager. To ensure that building being constructed was of high quality and that the project was completed within the scheduled duration and costs, the management utilised the documented procedures at each crucial phase of the project. It was the motto of the organisation, to be dedicated to satisfying the client’s requirements for a venture and construct a structure of high quality. In order to accomplish this, ABC introduced new techniques, novel practices and sophisticated design features into building construction. ABC also had in place additional design options within the scope of each project. Though it did not have the resources for designing the buildings it managed to form business related associations with architectural and design experts to establish alternative designs. Procedures for these were documented and incorporated into the quality system maintained as per the requirements of the ISO 9002 standards. Project planning: Planning for all construction projects the organisation had taken up, was an elaborate procedure. Often the project director and the managing director personally participated. The key employees of the organisation visited the location where the building was to be constructed to evaluate the necessity of additional machinery, and workforce. The duration required to carry out the project was determined taking into consideration the assessment at the site. Problems identified were brainstormed. If the employees were not able to come up with effective remedial measures, experts’ opinion was solicited. Viable options for carrying out the project were put forward in order to consider the opinion of the client. Any inconsistencies in the contract documents were communicated to the clients. The complete construction procedure was established and the ease of use of the resources was established. The project manager devised a quality plan with the help of his employees who were responsible for the on site operations. Pertinent data for any new procedure or machinery to be used was collected and incorporated into the document for future reference. Execution and control of works: Once a contract was authorised, the preparatory work done was assessed and modified as required. The resources were assembled and organised with the help of a checklist to ensure every aspect is taken into consideration. If a group of contractors had to carry out the project then care was taken to assign the phases of the project to individual contractors appropriately. Moreover, emphasis was laid on harmonising the activities of various contractors. The entire process from placing the order to buying raw materials and storing them was executed in agreement with the set procedures. Key staff members directed their entire operation to ensure the material was not damaged. The sites wherein the material was to be stocked were identified keeping in view how tasks were done, by whom, in what order and how quickly. The possible impacts of the current processes were also used to determine the storage sites. The organisation did not encourage overstocking of materials and made use of the JIT concept for the purpose. This minimised the threat of damage to the materials. JIT (Just in time) is a concept in inventory management that ensure raw materials are supplied to an organisation precisely when needed. This implies that the fresh stock must reach the site just before the process actually starts. The purpose of JIT is to drastically reduce the storage of raw materials thus avoiding the accumulation of the stock. Once the building was completed, safety measures were implemented until the client took over the building. A team proficient in more than one technique carried out the project. This was a consequence of the organisation’s principle to consistently upgrade its employees’ abilities. With a view to generate an output high in quality ABC shuns contracting out a part of its responsibilities to an external entity except when inevitable. ABC shoulders the responsibility for the results of the projects it handles. Supervisors and engineers were required to put in place a set of measurements within a process so the outcome of the process adhered to the relevant specifications. This was especially done for the ‘critical to quality’ components of the building ABC had identified through the evaluation of the projects it had executed previously. Checklists for various phases of the project were utilised for evaluation during internal site quality audits. Procedures for identifying the tasks that were not meeting the requirements, the subsequent correction done, re assessment, and the analysis of the causes of non conformance were structured in the form of flowcharts for better know-how. The management of the organisation extensively encourages the application of Value Engineering methodology. Value Engineering in the context of construction was the assessment of construction procedures and/or materials to identify those processes that can be performed by reducing unnecessary costs while conforming to the specifications, the design features, the performance standards and safety criteria. Human resource sub-system analysis: In ABC this sub-system covers aspects such as the enhancement of the knowledge levels of the staff, and providing constant encouragement and support to the staff. Employing the staff: The guidelines for recruitment were based on in -sourcing before out-sourcing. Every time there was a requirement of staff

internal candidates were considered first. The organisation’s policy was to make every employee proficient in various skills. In addition to monetarily benefiting the organisation enhances the employee know-how thus enhancing his worth in the organisation. The management resorted to out-sourcing as a last resort. The recruitment of prospective employees was done on the basis of pre-determined criteria. The interview procedure consists of filling up of forms to evaluate in detail the competency of each candidate for the post. These evaluation sheets were integrated into the documented procedures on quality and enable the personnel to execute the interviews efficiently. Training and Development: The managing director personally focused on the training aspect of the employees. It was the policy of the organisation to constantly impart training in order to upgrade employees’ skills. This also helps the employees to attain job competencies. The training programme necessitates a systematic collection of information pertaining to the employees or the requirements of the organisation. A good appraisal by the top management included a study of the extent to which the organisation was able to meet certain specific requirements; the skill set the employees must possess to achieve these requirements and the manner in which the training was to be imparted. Senior employees and sometimes outside agencies conducted the training classes. The training emphasised on imparting the knowledge of the three ISO management systems implemented. So that employees could go for training without any difficulty the classes were held at the place where the project was being carried out. Technical skills training was imparted by allowing the employees to get trained in certified training institutions. ABC sponsors employees in the executive category aspiring to continue their higher studies. Provisions were set up to enable them to handle their job and learning responsibilities. These employees are even sent for short-term courses to develop specific skills as and when the need arose. This includes attending international symposiums on the innovative practices in the area of construction engineering and management. Trips abroad to gain knowledge and expertise from world-renowned contractors had been arranged earlier. The employees who had attended these programmes were needed to present their learning to the top management. They were also required to convey their opinions on the effectiveness of these programmes. This enabled the organisation to assess the efficiency of the training programmes and implement improvements in its procedures wherever necessary. Encouragement and support Motivating the employees was a high priority in ABC. Events such as get-together of employees and their families were held regularly to foster better relations between the employees. Employees were encouraged to express any problems they encountered in their work by utilising the forms allocated for this purpose. Management sub-system analysis The important aspects covered in this sub-system are documentation management and generating awareness of crucial information in the employees. Comprehensive documented procedures ABC’s policy to cope with ineffective communication across various departments was to prepare comprehensive documents for all relevant procedures. The details of the employee performing the documentation and the location of the document were incorporated within. Sets of flowcharts were drawn to describe the relevant procedures for various processes. The employees who personally perform a process indicated the process flow in a flow chart, providing information critical to the quality wherever necessary. Checklists were used to identify the defects in the documents. The QES department of the organisation routinely checks those procedures and checklists that were widely used in the entire organisation. A few modifications that may result from the suggestions put forward by the clients are promptly noted, rectifications made and sent to the concerned clients. To generate knowledge The organisation regularly updated its employees on the accessibility to the information that was relevant and critical for performing their jobs. A chart that contained crucial information on individual projects was put up in the premises of the main office and at strategic places where projects were being executed. Also each division of the organisation and every location where a project was being carried out possessed the latest copy of the organisation’s quality system documents. These included the quality manual, procedures and work instructions. A quick recourse to the documents as and when required was thus possible. Conclusion: It is thus obvious that the ISO 9002 QMS ABC had implemented was successful. It ensured that quality was sustained in the construction. A holistic approach had been adopted towards the understanding and accomplishment of the needs of the ISO 9000 standards to incorporate the other quality programmes. This had resulted in the development of a wide range of policies, programs and procedures to ascertain the effectiveness and efficiency of all its operations. Continue: Moving Up The Ranks

Best practices > Moving Up The Ranks Asset Recovery Business (ARB) of Dell is a model for this approach of process innovation to make the utmost use of the ISO 9000:1994 QMS. In this modern world, initiatives specifying the steps for controlling quality or inspection are inadequate for organisations to remain competitive. Business Success largely depends on the entrepreneurs who have the ability and vision to

implement and enhance their processes. This case study highlights the method of using the ISO 9000:1994 quality management system, as a tool for developing a culture for constant improvement. Dell Computers: “Dell” is the world number-1 PC manufacturer and seller. It is known for its direct selling and build-to-order business model. Dell’s understanding of its customers and the strategies it tailors for them are the key factors for its success. Dell is an example of how effective leadership can bring about changes in an organisation. Dell has a unique business culture that helps it to be the No 1 in the computer industry. Special features of Dell’s business culture: • • • • A strong vision of the future. A new marketing strategy. Constant innovation. Product development driven by constant improvement.

Employee performance assessment is conducted in Dell only if it reflects in the enhancement of the business performance. Training is deemed as a day- to day activity but not as one that interrupts work. Risk is encouraged at every stage of the process because of the shared vision of the organisation. Roadblocks are viewed as opportunities and coped with bold and systematic effort. With all such existing initiatives, in 1995 Dell accomplished ISO 9002 certification. However, the “ISO process” was not looked as a performance enhancement tool. Most of its business units viewed it as a structure to evaluate and enhance their existing processes and ensuring conformance to international standards. Case under study: The Asset Recovery Business (ARB) of Dell computers at AUSTIN, USA is an internal division of Dell computers and sells renovated computers at a nominal price. Background: Dell computers has a unique system in place under which any Dell product can be returned for repayment or substitution within a month. Earlier these returned products were used to inspect faults, renovated and sold to retail customers at the Factory Outlet Store. Although the errors were minimised to the maximum possible extent, due to consistent growth in sales the number of units returned each month seemed enough to keep 450 people busy everyday. Thus they developed an e-commerce site for selling the renovated computers. However, the organisation’s main focus was not just gaining by selling these renovated products but on making this particular unit also a recognised profit centre. Asset Recovery Business (ARB) is a model for this approach of process innovation to make the utmost use of the ISO 9000:1994 QMS. ARB does not have defined production lines nor does it demand specialisation in its cycle. Almost every employee is made responsible for all the products that the group has to deal with. Even the issues they deal with are quite different from the issues in the typical Dell manufacturing units. They have to find out what the customer returned and why did he do so. Then the best solution for each unit is determined. Planning used to be done in real time instead of estimates since ARB has no defined practice to predict the number of units that will be received. Even ARB’s customers were very distinct from the customers of the other Dell manufacturing units. They were more price-sensitive and precisely consistent hunters for broader technical requirements. ARB employees work on the challenges thrown at them to improve throughput, curtail cost and essentially make this recovery unit a profit centre. When all other plants of the organisation were trying to sustain their reputation, ARB was working towards becoming the standard of productivity, novelty and business process enhancement for all of Dell. Despite meeting such diversified requirements, instead of being recognised as the most talented and innovative division, they were perceived as the operators at the bottom line of the chain. Blessing in disguise: As a part of the certification process of the Dell manufacturing units, ARB was scheduled to go through an inspection by their registrar (NSAI) That was a time when they had the obsolete documentation of their earlier business unit. ARB does not have the required documentation to prove their continuous enhancement process. Thus with two months to go before the audit they choose to implement ISO9000: 1994 not only for preparing the essential documentation but also for using it as a tool for enhancing their business of selling renovated computers. A “Business Management System (BMS)” was developed on a six-week basis to help in the documentation of existing processes and assisting for transition to continuous business process enhancement. The steps taken to ensure this include:


Identifying the crucial areas of the plant totalled to 49 that need to be summarised and documented. Identifying the experts in each of these functional areas and assigning the responsibility of drafting a procedure

encompassing activities like the method of conducting each process. 3. 4. 5. 6. Developing a Business Management Systems Manual (BMSM) after interviewing each of the experts by the BMSM representative and outlining an agenda for ARB to perform its daily activities. Inspection and review of the drafts prepared for approval by the respective managers. Preparing a “Roles and Responsibilities” Manual. Placing the manual, roles and responsibilities and 49 identified procedures on website named BMIS (Business Management Information System).

Audit: External auditors (NSAI) were astonished to see the ARB’s drive for continuous enhancement. Very few areas were noticed for possible improvement contrasting the expectation of large number of non-conformities. Thus the audit resulted in a series of reforms and revisions instead of disciplinary remedial actions focussed at individual performance as expected. Contradicting to the view of ARB as the bottom line of the business chain, the unit was cited as the “Most improved” business unit. Conclusion: There were no supernatural activities involved in the two-month reformation process of the business. The success is attributed to the visionary leaders in the plant always seeking internal and external channels to build solutions for different business issues. Using the concept of continuous process improvement and implementing ISO 9000:1994 as a value adding activity rather than as a non-conformance inspection tool, helped the plant in acquiring certification. BMS (Business Management System) developed in ARB was thus included in every sector of the organisation as in finance, sales and marketing, and the organisation’s operations. Dell ARB has moved from being under the eye of suspicion to the spotlight of success. It proved that ISO 9000:1994 can in fact be a system of business enhancement and not just a tool for traditional quality management. Continue: Aiming for Consistency in Practices Best Practices >Aiming For Consistency In Practices An insight into the efforts of a steel maker to improve consistency of practices through ISO 9002 implementation. Advanced technology has helped steel makers to develop the best operating processes to melt, roll and ship steel. The full impact of these processes can be realised, only if they are performed on a daily basis without any irregularities. Companies today are working towards ensuring consistency in practices, with the aim of improving quality, productivity, customer services and profitability. Structural Metals Inc., (SMI) is the steel-making venture of Commercial Metals Co., (CMC) of Dallas. It accounts for 53% of CMC’s annual sales of $2.25 billion. The annual production for the year 1999 was 7,50,000 tons. In order to ensure consistency in its practices, SMI’s plant at Texas decided to work for the ISO 9002 quality management certification. SMI’s employees were initially reluctant to accept its ISO programme, since it involved changes in procedures. Quality meetings were conducted every week. The employees slowly but surely began to involve themselves in the company’s programmes. Department managers and other employees also attended the weekly meetings. Production statistics, quality issues, customer complaints and internal problems were discussed during these meetings. Mistakes commonly committed by the employees were also discussed in a constructive manner. The main aim of these meetings was to identify problems, and solve them before customers spotted them. At first, the mill’s quality-systems manager attended a one- week ISO introduction class. A steering committee comprising of eight department managers was formed to discuss the ISO process. In turn, these managers, along with their key employees imparted ISO training to their department workers. One of the important requirements of the ISO process was documentation of the work instructions, procedures and practices. The main cause of concern of the department managers was the allocation of resources and time for documenting procedures. The shop-floor workers and operators helped by documenting all the work instructions, which were later compiled and stored on a computer. Documentation helped to develop consistency in practices. Earlier, it was observed that there were slight differences in processes due to variations in operating procedures among workers. For example, each of the four members of the rolling-mill department had different methods for redirecting “red tag” or non-conforming materials. After discussing the procedures with the four workers, a standard method was evolved and documented. Similarly, in the melt shop, during the melting process, different workers added alloys at different times. ISO helped to evolve a standardised procedure, by eliminating variations from worker to worker. Although procedures were standardised, ISO gave workers the flexibility to incorporate changes when required. Also, they had to record the diversions from standard procedures in their shift notes. The results of the ISO programme were seen in the first year itself. In the first fiscal year after starting the programme, SMI noticed that customer complaints had reduced by 23.5% and the final-chemistry non-conformance of its steel dipped by 14%. This was a remarkable achievement, considering the fact that the company was still in the process of ISO certification. Auditing process:

SMI appointed teams to undertake the internal auditing programme. These teams, comprising three members had to conduct audits of different departments, and evaluate the workers with regard to their responsibilities and functions. The leader of the audit team then wrote a summary, which included strengths and opportunities for improvements. If the auditors recorded any non-conformance or deviation, the concerned departments had to take up corrective actions and document the same. The results of the internal audits were then submitted to Steel Related Industries (SRI), which was the external auditor. SRI also conducted surveillance audits of SMI every six months. The auditors were allowed to evaluate people from other departments, and this gave scope to cross-functional learning. The internal audits helped team members to learn about procedures and functions of other departments. This enhanced communication between departments. The 17-member in-house team, which undertook the ISO 9002 Internal Auditing task for SMI, received the first “Steelworkers of the Year” award from New Steel. This award honours the services of a team of plant floor steelworkers whose quality, productivity, safety, profitability and problem-solving skills are a model for the entire steel industry. Within two years of starting the ISO process, SMI found that external customer complaints had dropped by an amazing 74%, and the final-chemistry non-conformance of its steel had reduced by 80%. The ISO programme has also helped SMI in providing enhanced training to new employees. During the training process, new employees study the ISO procedures stored on the computer and understand their job responsibilities. They also gain a good understanding about the functions and procedures in individual departments. ISO also brought about functional improvements in SMI’s sales department. Earlier, the sales department would communicate only with a few departments to check if new customer requirements could be fulfilled. The introduction of ISO brought in a stringent rule, that all department managers must be consulted while considering a new customer’s request. Being a paperless system, ISO enabled SMI’s workers to become more computer-literate. All the instructions, work rules and procedures are now maintained on Lotus Notes software. This eliminated paper work. SMI not only used ISO to improve consistency of its processes, but also for improving safety at the workplace. The analyses of job safety, along with instructions to perform jobs safely are also documented and stored on the Lotus software. In consequence, the number of shop-floor accidents at SMI has dipped to almost zero. Thus, ISO served as a platform for developing consistency, improving quality, productivity and safety. Case Studies > A Healthy QMS The present case study outlines the implementation of ISO 9001 standards in a healthcare centre highlighting the need for it. It thereby establishes that ISO 9001 can be implemented in any organisation irrespective of the services it caters to. Introduction: Many organisations have got the ISO 9001 registration, which is a quality system standard implemented by organisations worldwide. It is considered a good alternative to the other quality management systems. ISO 9001standard is broad and flexible making it possible for each certificant to customise and adopt these standards according to his requirements. Even health care institutes can register for ISO 9001 standards. They can thereby generate effective practices in the design and health care services they provide. ISO 9000:1994 standards emphasis on documenting the critical to quality procedures. This implies that hospitals can establish and document innovative procedures to guarantee quality in their services. CCJR (Cleveland Centre for Joint Reconstruction): CCJR (Cleveland Centre for Joint Reconstruction) is one of the seven units in the Cleveland Orthopaedic and Spine department that provides treatment for bone and joint problems. This department is a part of Lutheran hospital in Cleveland, Ohio. In May 1995, CCJR achieved ISO 9001certification. This initiative helped CCJR to effectively manage its operations and to provide enhanced services to its customers. CCJR (Cleveland Centre for Joint Reconstruction) is the first medical entity in United States to achieve ISO 9001 registration. CCJR earns $2 million every year to the hospital and employs only 10 personnel. Need for QMS: Between 1992-1994 (From identifying the need for certification to accomplishing it) there was no formal quality management system in CCJR. Hence, the centre had to begin the process of developing the quality management system from the scratch. This did not mean that the centre was providing ineffective service to its customers. The unit had some effective practices in place to ensure efficient service. The only drawback was that the maintenance of these procedures was not systematic. For instance, there were no set practices to record the results of the routine activities conducted in the centre. This prevented the unit from using documented information in order to train other employees in specific areas or hold anyone responsible for not following procedures. Procedures were planned and sometimes even modified by inadequately trained employees. This led to utilising the services of more number of employees for a work that a few could do.

Thus CCJR found the need for a suitable documentation method that would assist them in regularly reviewing and revising their quality practices. Establishing a QMS was the need of the hour. Pre-registration CCJR emerged a pioneer when it registered its centre for ISO 9001 certification in 1995. Few organisations had adopted ISO 9001 at that time and it was still in the initial stages, especially in the health care industry. Stulberg (A renowned surgeon in CCJR) initially heard of ISO 9001 system and the benefits it could bring to an organisation from his acquaintances in the manufacturing sector. Believing that it would be worthwhile to further investigate the process, he performed an extensive research and found that ISO 9001 QMS does not have any specific standards for the medical industry. Even then, Stulberg and his colleagues in CCJR decided to adopt ISO 9001 since they were aware of the numerous benefits that could be accrued. As the employees did not have adequate exposure to ISO certification, CCJR hired a consultant (Tim Weber, who was at that time president of ICON consultants) to assist them in planning the organisations approach to certification. Care was taken such that the consultant hired, had adequate experience in implementing ISO 9000 QMS and was significantly interested in conducting in-depth study on the registration process and in assessing its effects for a health care practice. Steps followed: The initial priority of CCJR on its path to certification was on conducting an in-depth study of the ISO 9001 QMS and setting the standards for a health care centre. ISO 9001 in general, is a quality system for areas likely design/development, production, installation, and servicing that are common to the manufacturing sector. Hence CCJR felt the necessity of setting the quality standards in its health care centre structured in line with that of a manufacturing sector. They realised that their QMS needed to focus on defining and executing health care plans for its customers (patients) with arthritic hips and knees. Thus every clause in the ISO 9001 QMS (like management responsibility, document control, control of customer-supplied product, inspection and handling, storage, packaging, preservation delivery) was evaluated and structured to make it relevant for health care practice. For instance, what is viewed as delivery in the manufacturing sector is the final contentment of the patient in CCJR. Care was thus taken to structure every stage of the health care service within the scope of ISO 9001 standard. This took a lot of time and effort. The following two activities proved to be the most significant ones among all the activities performed. 1.Developing the documentation system: Developing the document system proved to be a complex process. Tools like flow charts were used to simplify the task. Since CCJR already had a defined process to evaluate its client satisfaction after surgery, assimilating them into the system was taken care of. In addition, the need to develop documents for the following processes was identified and successfully implemented. • • • • Patient’s progress. Training of employees. Purchasing of medical equipment. Calibrating equipment.

2. Training: Training the employees was the next major task. Efficient training was provided to the employees to speed up the process of implementation of ISO 9001QMS. Care was taken to ensure that the training offered enabled the employees to understand what ISO 9001 actually is and the benefits that would accrue to CCJR and its employees. This enhanced the involvement of the employees in the ISO 9001 QMS implementation. They started using the process as an aid for tackling complaints and documenting the remedial actions. As stated by an employee in the centre, “ISO 9001 system ensures sure the staff addresses a problem and works together to find a solution”. Checklists were maintained to ensure that the activities relating to ISO 9001 were consistently maintained. Employees were entrusted the responsibility of documenting these necessary activities. Effective communication system was developed to ensure better interaction among the employees. Registration procedure: BSI Inc. was selected as the ISO 9001 registrar. Phase-1 audit was conducted in March 1995 for four days. BSI inspected for the conformance of the activities in CCJR to ISO 9001 standards. No major non-conformities were found. However some minor ones in document control were identified for correction. These include: • • Undocumented evaluation and approval techniques used in the design process. Undocumented references to external standards.

• • •

Inadequate explanation of why a specific supplier was being used. Inaccurate and a complex method of maintaining records. Ineffective documentation for internal audits and procedures.

BSI reported that on the whole, CCJR satisfied all the necessary requirements to accomplish ISO 9001 certification save a few non-conformities. These minor ones were immediately focussed upon and corrected successfully. Thus CCJR received ISO 9001 certification in May 1995. Results: The certification enabled CCJR to develop a comprehensive and a detailed documentation plan for each and every aspect in its centre. This included action plans to tackle every specific disorder their clients complained of. All the stages of the health care service were continuously improved. Certification also provided for a system to evaluate the satisfaction of the patient. Allocation of crucial responsibilities to the employees made them work with enhanced dedication and motivation. Benefits: CCJR has been putting together the benefits of ISO 9001 certification. Price-sensitive techniques were developed and its health care service properly managed and made more reliable. Considerable reduction in complaints from the customers (post surgery) was observed. CCJR observed that it could identify problems the moment they started. Problems were solved quickly and effectively. Above all, patients were satisfied with the services of CCJR. Conclusion: Thus CCJR found ISO 9001 a useful approach to successfully accomplish the following:: • • Customer contentment. Simple and price-sensitive operations. Optimum utilisation of resources.

Continue: ISO 9000 - The Other Point Of View Case Studies > ISO 9000- the other point of view Introduction: The 1990’s witnessed a flurry of ISO certifications. However the question that arises is have these certifications been useful in improving the quality performance of organisations or have they just been an exercise in futility. At least some seem to think so. Due to the increased awareness of ISO 9000 and its benefits, more and more customers are requiring organisations to become certified. Certifying to ISO 9000 is voluntary under ISO rules, but has become necessary for many organisations in order to retain their customers. The certification process to ISO 9000 standards however is a costly and timeconsuming affair, especially for small organisations. A perceived drawback of the ISO 9000:1994 standards was that while ISO 9000 registered companies are certified to have standardised quality procedures, that in no way ensured that the organisation produced quality products or services. ISO 9000:94 registration ensured that a quality system is in place but provided no guarantee of customer satisfaction or results. It did not address a company’s need for continuous improvement, evaluation, or performance planning. Given below is a study conducted on two organisations Tech Co, Systems Co, and System Co to study the impact ISO 9000:94 QMS implementation had on their organisational performance. The issues that were common to the two organisations are discussed in detail. Tech.Co: 'Tech. Co.' is a retailing and distribution organisation located in the UK. The organisation sells high technology products. Tech. Co. decided to certify itself to ISO 9000. The registration process was completed in three years. The main motive behind registration was that its customers (especially the government agencies) were insisting on the certification. Tech.Co felt that not getting certified to the ISO standards might cause it to lose customers. The organisation had seven product divisions and each unit had its own order processing function. After ISO 9000 certification Tech.Co standardised it’s the order processing procedures. Each division however continued to process its own sales orders. Registration to ISO 9000 led to the development of nine procedure manuals. It had one manual for each type of product, one manual for quality and another for the warehouse. The manuals documented what should be done at each stage of an order, and ensured that every thing had been taken care of.

Has ISO 9000 contributed to performance? A tussle between Sales and Administration: The sales administration manager felt that sales personnel considered themselves special. He was of the view that the sales personnel displayed a careless attitude towards filling the forms with the required information. He therefore felt that ISO 9000 would help control their activities. He was of the opinion that strict adherence to the procedures would automatically make the sales personnel fall in line. As a result, the sales personnel were asked to perform their jobs in strict accordance with the laid down procedures. However, the way the sales personnel operated did not change. The differences between the sales people and the administration remained the same and in fact got worse. This was because the former felt that the administration was imposing restrictions on them in the name of procedures. Complexity in pricing: The next issue was that of pricing. The pricing of the products was a complex process. The sales personnel encountered customers with different requirements. Thus they wanted the administration to be more flexible in pricing products based on the customer requirements and circumstances. The administrative staff on the other hand was asked to work in compliance with the new procedures. They therefore adhered only to those prices and procedures that were recorded in the manual. Some of the requirements were not available in the sales manual and therefore had to be constantly updated. Everyone’s energy was being spent on documenting information but the real issue was being overlooked. The administration failed to realise that it was losing customers due to its rigid pricing. Customer Orders: One of the ISO 9000 conditions was to record the customer orders. Management used these recorded manuals as evidence, in case of differences between the customers and the organisation. This was however a wrong way to approach a difference with the customer. Take for instance a case when the customer wants to change his order. In such instances, customers expect their suppliers to be kind, polite and accomodating. They do not expect the supplier to show them a paper document and contest their request for a change in order. If they ask for a change in the order, it is the responsibility of the supplier as far as possible, to make the change swiftly. However, the management at Tech Co. seemed to think otherwise. This indifferent attitude of the organisation towards its customers led to a decline in its customer base. Quarantine Procedure: One of the ISO 9000 conditions was the handling of goods returned by the customers. As per ISO 9000 these goods were to be quarantined till the official paperwork permitted reuse. The organisation found that the goods sent back in less than fifteen days were not damaged even if subjected to unfavourable conditions. As per ISO 9000, the storehouse in charge should verify the date on which the goods had been returned against the date on which it was shipped to the customer. Those products that were found to be in condition (that were sent back in less than fifteen days) were sent to the concerned authority for signature, as per the procedure. These authorities were hardly found and when present did not consider signing the forms from the storehouse as priority. Since Tech.Co’s goods were heat and light sensitive, the quarantine only delayed its reuse. Moreover, any re-testing done at this stage further damaged the goods. Actually there was no need to implement the 'quarantine' procedure. Except for some rare occasions, the organisation had not faced any major issue with the goods returned prior to the registration. The organisation could in most occasions reuse the product immediately after its return. If the organisation had worked as an integrated system, it would have realised that customers often returned good products because it did not meet their specifications, rather than it being defective. Tech. Co. had established a documented procedure on the basis of a rare occurrence, giving rise to new problems. The consequence was losses to the organisation. Conclusion: ISO 9000 implementation had not improved the overall performance of Tech Co. Tech Co. was of the wrong notion that implementing a quality system would automatically improve the organisation’s quality performance. The focus lay on documenting each and every procedure, which was a time consuming, costly and tedious affair. The drawback of the system was that the thinking level of the employees was confined to the scope of the written procedures. The result was that ISO 9000 registration did more harm than good to Tech Co. Systems Co: 'Systems Co' produces handling systems that are used in packaging and manufacturing operations and sets them up on customer sites. Systems Co got registered to ISO 9000 QMS standards. In order to get the certification, Systems Co took the assistance of a consultant agency. After many deliberations, it finally selected a consultant who seemed to display an attitude that was practical and accommodating. The case study focuses on the auditor’s (the consultant employed) perception of ISO 9000 quality standard and also

whether the action plans initiated by him, really enhanced the quality performance of the organisation. The organisation management considered the auditor a capable person and the entire auditing procedure as a sort of backing for the various processes. The auditor as a part of his routine activity scrutinised several key matters of concern and then chose to focus on the engineering and customer service areas of the business. The auditor intended to identify the elements that did not meet the set standards and then set a deadline for corrective action. Engineering: In engineering, the auditor thoroughly examined the enquiry document. The document consisted of the information pertaining to consumers. The auditor wanted to investigate: • • • How Systems Co was ensuring that its customers were getting products that met their requirements? The procedures followed by Systems Co to properly channel the information. How any modifications were being incorporated.

All the time the auditor was referring to the set of manuals and procedures laid down in the document. He was blindly adhering to the clauses laid down in the ISO 9000 quality standards. The auditor felt that controlling the process by means of a set of procedures would prevent the employees from committing errors. He was not interested in finding ways to actually improve the various activities in the department. This was contrary to the ‘quality thinking’ approach. Quality thinking emphasises on continual enhancement that in turn necessitates initiation of certain action plans. ISO 9000 standard, on the other hand emphaised that a system would be in line with the requirements, if all the employees worked in adherence to the procedures. These procedures sometimes may not highlight issues that are critical to quality (such as customer related issues and certain innovative techniques etc). The major drawback of this standard is that it doesn’t emphasise on exploring the elements that appropriately fit into the quality model. Blindly adhering to ISO 9000 resulted in the organisation relying on the auditor for implementing corrective action. The auditor in turn strictly adhered to documentation, thus relegating the very thought of quality to the backburner. The quality approach requires that actions are associated to the intent. If the intent of the present organisation was quality, the procedures put in place to monitor and check this intent should have been enough to update the management about the status of the quality performance. Customer service: It was a positive turn when the auditor emphasised on the significance of customer requirements to the organisation. This was something novel. The auditor wanted to know the importance the organisation gave to customer service. This implied:

• • •

How frequently the organisation implemented customer surveys? How effectively was the organisation utilising the results of the survey?. What were the means by which the organisation was trying to ascertain the needs of the customers?

The auditor emphasised on linking the customer survey information to the quality management system. This helped the organisation to implement corrective actions so that the improved processes would be in line with the customer requirements. It would have been more helpful to the organisation if the auditor suggested better techniques to gather customer related information. However his focus was only on the existing procedures and identifying loopholes, rather than improving the system . Had ISO 9000 been beneficial? According to the quality manager, the ISO 9000 implementation was the point for the initiating other quality performance activities. There is no doubt that ISO 9000:94 standard bring clarity of procedures, which in turn improves performance. But if this required superfluous documentation and out of place controls, would it be of much use? The organisation had spent a large amount of valuable time dismantling those elements of ISO 9000 that failed to serve the purpose. Was it imperative to incur those extra costs and time? The answer would be no. Systems Co claimed that the ISO 9000 registration was the driving force for the initiation of other quality related activities. Instead of this, had Systems Co focussed on its customers as an inspiration it would have improved performance in a shorter time. Systems Co. was gradually transforming to being a customer-focused organisation. This commitment to customers would have been thwarted by the ISO 9000 registration with its focus on documentation and compliance to procedures, had the organisation not smartly evaded certain dysfunctional constraints of ISO 9000 standard. Conclusion:

In each of the two cases we find proof of ISO 9000 registration being detrimental to the organisation’s quality performance. In the first case, the harm done was obvious. In the second case it is relevant to make a note of how they overlooked the dysfunctional aspects of the Standard. The blind adherence to ISO 9000 quality standards had caused sub-optimisation in these organisations. More badly, maximum efforts were diverted into setting up the ISO 9000 Standard, which could have been utilised to explore more feasible ways of enhancing the quality and efficiency. It was observed that external agencies (auditors) were instrumental in inciting the organisations to perform activities that damaged the quality performance. Moreover, the registration to ISO 9000 involved both time and capital. The philosophy of ISO 9000 is one of control. “Control” of processes or activities is done by compliance to procedures i.e. the setting up of procedures that are presumed to influence the quality of the product. Many organisations assume that documentation and control of procedures will 'avert' problems. There is however no proof to support this opinion. Such a mindset results in people giving preference to procedures rather than intent. Thus, the certification to ISO 9000 quality standard can result in zero knowledge. Zero knowledge resulting from the tendency to stop thinking and follow procedures. Online Navigators > Concept and Implementation Given below are some online links that detail the different aspects related to ISO 9000:1994 1. ISO Online: ISO (International Organisation For Standardisation) is a federation of several national standards bodies working together to facilitate international trade. This link is to the official website of ISO. It clearly explains what ISO is, the technical committees involved in developing the different ISO standards, duties performed by ISO, the benefits it brings to society and the various standards it developed. http://www.iso.ch/iso/en/ISOOnline.frontpage 2. ISO 9000 - An introduction: ISO 9000 is a series of standards and guidelines for establishing a QMS in any kind of organisation. This document gives a brief insight of what ISO is, guidelines for selection and use of ISO 9000, what ISO 9000 consists of, how it can be useful for organisations in different businesses and the flow chart for implementing ISO 9000. http://www.isoeasy.org/selusee.pdf 3. ISO 9000 Documentation: One of the most intimidating aspects of ISO 9000 is the documentation. Documentation was often found inadequate or ineffective or even absent in many organisations. This page gives a detailed explanation of the five areas that need to be addressed by organisations in order to develop an effective quality system, with less paper work. The five areas included are process definition, structure, tools, format/grammar, and flexibility. http://www.cavendishscott.com/articles/Documentation.htm 4. ISO 9000 Process Documents: This document is a collection of ISO 9000 process documents. Also downloads for the documentation of the various aspects involved in ISO 9000:1994 QMS are provided. http://www.isoeasy.org/iso_9000_process_documents.htm 5. Implementation: This PDF provides an elaborate explanation of the various steps involved in the certification process of ISO 9000:1994 standards. http://www.dkminc.com/documents/pway_iso.pdf 6. Gap analysis: Gap analysis is a tool used for evaluation of the organisation’s existing quality management system. This tool is a template of questions that help organisations identify those organisational functions that fall short of the required standards. This document provides links to two questionnaires used for the gap analysis. The first is for a mini gap analysis while the other assists in-depth review of the organisations systems. http://www.realquality.com/gap.htm 7. Elements of ISO 9000:1994: Successful implementation of any standard depends on the way it is understood. This site gives a clear explanation of ISO 9000 series, elements in it, the meaning, purpose and elaboration of all the 20 clauses in the series.The explanation is comprehensive and extremely informative. http://www.realquality.com/elements.htm 8. Benefits of implementation of ISO 9000: This document outlines the benefits that companies large, medium, and small enterprises could accrue by implementing ISO 9000. This document is prepared based on an in-depth study of a number of Spanish organisations. http://www.sii.org.il/WebFiles/topicsQW/m10.pdf 9. ISO 9000 Advice: This document is a guide to ISO 9000. Questions such as what is quality, what is quality assurance, why is it necessary? This document is an arsenal of advice and guidance on ISO9000 and associated registration. http://www.quality.co.uk/isoadvic.htm

10. Choosing a trainer: Successful organisations have well-trained and skilled employees. However, there are many a cases where employees do not have the required knowledge and skills for new assignments. Thus choosing a trainer could be a daunting task. This document could help to make a more knowledgeable decision when trying to select the best training solution for an organisation. http://asia.bsi-global.com/Quality/BSI_Practical_Guide_for_Choosing_a_Trainer.pdf 11. ISO 9000 differences for businesses in the service industry: ISO 9000 is in general, considered applicable only to manufacturing industries. But it can be applied to the same level of efficiency in the service industry as in the manufacturing industry. This document explains the differences in implementation in the service industry compared to the manufacturing industries. http://www.dardenneassociates.com/iso9000/index.htm 12. Purchasing ISO standards and documents: All ISO standards and documents are copyrighted by the International ISO organisation and must be purchased from one of the local ISO member bodies in your country. The sale of these documents provides part of the ISO organisation's funding. This document provides the list of all such ISO members who sell the standards and documents. http://www.iso.org/iso/en/aboutiso/isomembers/MemberDetailPage.MemberDetail?MEMBER=address Continue the tour: Online links for Additional Reading Online Navigator > Additional Reading Following are some online links that could help for Additional Reading in ISO 9000:1994. 1. ISO 9000:1994 Guidelines: This website gives details about the various guidelines in the ISO 9000:1994 series. http://praxiom.com/iso-9000-1994.htm 2. ISO 9000:1994 Sample Pages: This website provides free downloads useful in implementing the different clauses of ISO 1994 version. It helps in the preparation of quality manual. http://www.iso9000commerce.com/htm/sample1994.htm 3. ISO 9000 consultants: This page symbolises a directory of consultants experienced in assisting organisations to develop ISO 9000 quality management systems, and achieve ISO 9000 Registration. http://www.isoeasy.org/Referral%20Network.htm 4. FAQ’s: This document provides answers to the frequently asked questions and thereby gives a clear picture of ISO 9000 series and the certification process of various standards involved in it. http://honeywellaircraftlandingsystems.com/working_at_als/new_hire_orientation/nhorientation/policies/ISO 9000.pdf 5. Sample quality manual: This document provides a sample quality manual of an organisation that has implemented ISO 9000. http://www.quality.co.uk/example/manual.htm 6. Sample Design procedure: The document explains at length the various activities involved in the system design procedure of ISO 9000. A flow chart to explain the same is also given in the document. http://www.quality.co.uk/example/op10ades.htm 7. A model ISO 9001/ 9002/ 9002 certificate http://www.okonite.com/certificate.html 8. Case studies This link provides downloads for case studies relating to different industries for various standards in the ISO 9000:1994 series. http://www.powerwayinc.com/about/resources.asp 9. Anglia Telephones and Data Communicators: This document provides a case study of “Anglia telephones and data communicators” . http://www.angliatelephones.co.uk/iso9002_approved.htm Online Navigators > Concept and Implementation Given below are some online links that detail the different aspects related to ISO 9000:1994

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