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(A unit of Sri Sringeri Sharada Peetham, Sringeri) Approved by AICTE Plot No. 7, Phase-II, Institutional Area, Behind the Grand Hotel, Vasant Kunj, New Delhi 110070 Tel.: 2612409090 / 91; Fax: 26124092 E-mail:; Website:


IMPLEMENTATION FOR 2 DAYS SUBMITTED TO Prof. Smiriti Dua SUBMITTED BY Deepanshu Chamoli (20100131) Saptarshi Roy (20100122) PGDM-2nd YEAR


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I hereby declare that the project on DESIGN A TRAINING PROGRAM FOR ISO IMPLEMENTATION FOR 2 DAYS of Training and Development of PGDM to Sri Sharada Institutes of Indian Management Research is my own original work for the fulfillment of the requirement for nay course of the study. I also declare that no chapter of the manuscript in whole or part is lifted and incorporated in this report from any other work done by me or others.

Place: Date:



It is said, the most important single word is WE and the zero important single word is I. This true even in todays modern era .It is absolutely impossible for a single individual to complete the assigned job without help and assistance from others.

I would like to acknowledge to my sincere gratitude to our CMT& MD Rev. Swami ji (Dr.) Parthasarathy and my project guide Prof. Smiriti Dua for helping me in this project work. I am thankful to all my friends and batch metes for their help in completing this project work. Finally, I am thankful to my entire family members for their great support and encouragement. Deepanshu Chamoli (20100131) Saptarshi Roy (20100122) PGDM (2010-2012) Sri Sharada Institute Of Indian Management- Research


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The term training refers to the acquisition of knowledge, skills, and competencies as a result of the teaching of vocational or practical skills and knowledge that relate to specific useful competencies. It forms the core of apprenticeships and provides the backbone of content at institutes of technology (also known as technical colleges or polytechnics). In addition to the basic training required for a trade, occupation or profession, observers of the labor-market recognize as of 2008 the need to continue training beyond initial qualifications: to maintain, upgrade and update skills throughout working life. People within many professions and occupations may refer to this sort of training as professional development.

The overall aim of the Interact Networks training program is to create the foundation of a network of individuals who can contribute to improving the quality of consultative, participative and partnership working in their area. This is to be achieved through: enabling participants to develop genuinely usable skills and experience in the challenging arenas of process management and facilitation, and bringing together a set of people who will learn and then practice together in a way that ensures they are able to apply their learning and make real progress in their skills development.

The field of participation and engagement is very large; including specific subsets such as consultation, collaborative working, partnership working, stakeholder dialogue and consensus building. These topics cannot all be covered in a three day training course and we do not attempt to do so. We also believe that some of the topics need to be well understood before attempting to tackle others; in other words, there is a natural progression of complexity and difficulty. This course therefore aims to: help people understand the full range of different levels and approaches to engagement and their respective purposes, and Focus detailed attention on the essential building blocks of collaborative approaches to process management and the use of facilitation as a specific skill within these.



Participants will be introduced to key drivers and elements which currently influence the field in the UK, such as: Key concepts and theories: This includes the benefits, pitfalls and principles of participative approaches, the different types of engagement, the basics of consensus building, different forms of third party intervention (chair, arbitration, facilitation, mediation etc), facilitation roles, process design and stakeholder analysis. Personal skills: This includes opportunities to practice and advance personal skills, such as listening, questioning, reframing, planning, using flip charts and recording are covered. Practical facilitation experience: participants will have an opportunity to practise facilitation, with supportive feedback. Basic techniques: Participants will be introduced to a range of simple practical techniques, with opportunities to observe them being used and practice them during the course. This includes various ways of gathering and grouping information and of collecting information; the use of different seating arrangements; prioritization; different forms of recording/reporting. Practicalities of process: Participative meetings or workshops require a great deal of practical preparation and planning. Participants will have an opportunity to consider the numerous logistical issues which need to be covered when organising an event. This includes dealing with speakers, presentation materials, catering, venues, props, materials needed on the day and so on. Setting up a successful Network: Together, participants will have an opportunity to identify some of the key issues arising from the development and operation of a Network and to consider ways forward.


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This course provides opportunities for participants to learn in a number of ways, particularly: Participating in training sessions or role -plays etc Practicing facilitation skills and techniques in learning by doing sessions. Taking part in facilitated discussions run by co-participants. Participating in feedback discussions, involving both trainers and co-participants. Observing facilitation practice by the trainer(s). Discussing facilitation and process management concepts, challenges and issues. Reading the course notes and any other suggested reading material


An analysis of training need is an essential requirement to the design of effective training. The purpose of training need analysis is to determine whether there is a gap between what is required for effective performance and present level of performance.

Analysis Phase


The Organization Analysis contain

determine the necessary competence for personnel performing work affecting product quality, provide training or take other actions to satisfy these needs, evaluate the effectiveness of the actions taken, ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriated records of education, training, skills and experience


Operational Analysis
Management must know why they are implementing the ISO standard. The initial reasons may be market pressures, or requests from clients. This may not be enough for all managers to buy into and support the project. Educating management on what the system is, what it is not, and what it will do for your company is the best way to gain the commitment you need from management. Two of the books listed on our resource page specifically address this issue. Group training sessions are also an effective way to educate management.

Manpower Analysis

The Task Teams that are set up will each look at the requirements for their process and procedure. They will be responsible for comparing the requirements of the standard to the current process used at your company. They will design a new process, or modify the current process so the company will be meeting ISO requirements. They will write a procedure for the new process, and give it to the management Team to review. Once the procedure is approved, training is needed. The company will then start using the new process/procedure.

Gap Analysis
The first step in planning your implementation is to perform a Gap Analysis, a comparison of your current management system to the requirements of the ISO standard. Quest Analytical can perform a Gap Analysis and then provide a Gap Report. The Gap Report explains what you will need to add to your current management system to meet the requirements, and what you have in place that already meets the standard.


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Project Plan
Using the Gap Report, develop an implementation approach, project plan, and timeline. Identify the staff members who will be leading and coordinating the project. Determine your approach to the project. Team-based projects are most effective. Establish your timeline for implementation. Plan a project "kick-off" to educate and inform everyone in the facility about your ISO implementation project.

ISO 9000
ISO (the International Standard Organization) head-quartered in Geneva, is a worldwide federation of national standard bodies (ISO member bodies, such as SIRIM, SISIR, etc) which is responsible for creating standard for each member country. The objective of setting up of this body is to encourage the formulation and practice of international standard. The creation of ISO 9000 standard is to assure the products and services offered by the member countries are globally recognized and accepted 10. ISO 9000 was initially published in 1979, and from a slow start it is now being implemented by a very large number of commercial organizations. The ISO 9000 deals with quality system requirements that can be used for external quality assurance purposes. The quality assurance models set out in this International Standards represent three distinct forms of quality system requirements suitable for the purpose of a supplier demonstrating its capability, and for the assessment of the capability of a supplier by external parties. Before any organization achieved ISO recognition, it has to establish a quality system and procedure outlined in the models set out in the standard. ISO 9000 is divided into three basic sections: ISO 9001, for quality assurance system which includes design, development, production, installation and servicing, ISO 9002, for quality assurance system in production, installation and servicing, and ISO 9003, for quality assurance in final inspection and testing. For the case of engineering programs, to achieved ISO recognition each department responsible for each program have to establish a quality management system and procedure that conformed to the standard, which is the ISO 9001. The ISO 9001 Quality Systems give guideline how to establish, document and maintain an effective quality system and demonstrate to the customer that the organization emphasized the importance of quality.


Benefits of Implementing ISO 9000

SIRIM carried out a survey on 536 companies which have attained ISO 9000 certification and received 500 respondents. From the survey it is found that the two major advantages are improved in quality (76.5%) and increased customer perception or improved advertising campaign (72.9%). Other than that, increased productivity (42.3%), reduced cost (36.7%), better staff morals (29.6%) and improved market shares (28.6%) are also gained when ISO 9000 is implemented.


Enhance organization image with internationally accepted quality standard Demonstrate documented quality management system. Foundation for a total quality management program Reduction in customer complaints. Increase quality awareness, motivation, co-operation, workmanship and consciousness Focuses training and professional development Improved communication internally

Recognized globally as a centre of engineering education where quality is assured. Satisfy customers and current market environment Sets a baseline for continuous improvement Improve productivity and efficiency. Reduces time consuming audits by customers and regulators Reduces time consuming audits by customers and regulators Prepare for future market requirement

If ISO 9000 is implemented for the engineering program and organization that offers it, the benefits listed in Table can be achieved. These can be achieved by having international accreditation through ISO 9000 and then only can we compete with the developed countries of the West having equal standing. Observing these virtues, it is an advantage for any educational institution to implement ISO 9001 to enhance its ability to serve the world and future generations.


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Requirements of ISO 9001:1994

There are 20 requirements for the quality system which have to be observed as listed in Table. These requirements form the basis of the two manuals that must be prepared which are Quality Policy Manual and Operational Procedures Manual. These are the Assurance and the implementation methods used. The following requirements on documentation are clearly stated in the ISO 9001; documentation on Quality Policies and Objectives, documentation of responsibilities and authorities which include organization structure, documented Quality Manual, documented Quality System Procedures, and documented Quality Planning documentary proof of an organization's dedication to the implementation of Quality

4.1 Management responsibility

4.11 Control of inspection, measuring and test equipment

4.2 Quality system

4.12 Inspection and test status

4.3 Contract review

4.13 Control of nonconforming product

4.4 Design control

4.14 Corrective and preventive action

4.4 Design control

4.15 Handling, storage, packaging and delivery


4.6 Purchasing

4.16 Control of quality records

4.7 Control of customer supplied product

4.17 Internal quality audit

4.8 Product identification

4.18 Training

4.9 Process control

4.19 Servicing

4.10 Inspection and testing

4.20 Statistical techniques


How We Meet ISO Requirements forms so important?

Many people cannot make the transition from the requirements to how the organization meets the requirements. This is why the Trainer must identify and review the document, form, software, or other method that the organization uses to meet the ISO requirements

Implementing ISO 9000 Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in 'cultural transition' to an atmosphere of continuous improvement. The process of implementing ISO 9000 depends on: The sophistication of your existing quality program, The size of your organization, and The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully. Step 1: Top management commitment Step 2: Establish implementation team Step 3. Start ISO 9000 awareness programs Step 4: Provide Training Step 5. Conduct initial status survey Step 6: Create a documented implementation plan Step 7. Develop quality management system documentation Step 8: Document control Step 9. Implementation Step 10. Internal quality audit Step 11. Management review Step 12. Pre-assessment audit Step 13. Certification and registration Step 14: Continual Improvement

Step 1: Top Management Commitment

The top management (managing director or chief executive) should demonstrate a commitment and a determination to implement an ISO 9000 quality management system in the organization. Without top management commitment, no quality initiative can succeed. Top management must be convinced that registration and certification will enable the organization to demonstrate to its customers a visible commitment to quality. It should realize that a quality management system would improve overall business efficiency by elimination of wasteful duplication in management system.


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The top management should provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by: Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, Defining the organization's quality policy and make this known to every employee, Ensuring that quality objectives are established at all levels and functions, Ensuring the availability of resources required for the development and implementation of the quality management system, Appointing a management representative to coordinate quality management system activities, and Conducting management review.

The top management should also consider actions such as:

Leading the organization by example, Participating in improvement projects, Creating an environment that encourages the involvement of people.
This type of top management commitment may be driven by:

Direct marketplace pressure: requirements of crucial customers or parent conglomerates. Indirect marketplace pressure: increased quality levels and visibility among competitors. Growth ambitions: desire to exploit market opportunities. Personal belief in the value of quality as a goal and quality management systems as a means of reaching that goal.
The top management should identify the goals to be achieved through the quality management system. Typical goals may be:

Be more efficient and profitable Produce products and services that consistently meet customers' needs and expectations Achieve customers satisfaction Increase market share Improve communications and morale in the organization Reduce costs and liabilities Increase confidence in the production system


Step 2: Establish Implementation Team
ISO 9000 is implemented by people. The first phase of implementation calls for the commitment of top management - the CEO and perhaps a handful of other key people. The next step is to establish implementation team and appoint a Management Representative (MR) as its coordinator to plan and oversee implementation. Its members should include representatives of all functions of the organization - Marketing, Design and development, Planning, Production, Quality control, etc. In the context of the standard, the MR is the person within the Organization who acts as interface between organization management and the ISO 9000 registrar. His role is, in fact, much broader than that. The MR should also act as the organizations "quality management system champion," and must be a person with: Total backing from the CEO, Genuine and passionate commitment to quality in general and the ISO 9000 quality management system in particular, The dignity - resulting from rank, seniority, or both - to influence managers and others of all levels and functions, Detailed knowledge of quality methods in general and ISO 9000 in particular.
The members of the implementation team should also be trained on ISO 9000 quality management systems by a professional training organization.

Step 3: Start ISO 9000 Awareness Programs

ISO 9000 awareness programs should be conducted to communicate to the employees the aim of the ISO 9000 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. Suppliers of materials and components should also participate in these programs. The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. The program should also stress the higher levels of participation and self-direction that the quality management system renders to employees. Such a focus will go far to enlist employee support and commitment. The programs could be run either by the implementation team or by experts hired to talk to different levels of employees.


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Step 4: Provide Training For two days i.e. Wednesday & Thursday by the Companys training department
Step 1: Define purpose of the training and target audience Step 2: Determine participants needs Step 3: Define training goals and objectives Step 4: Outline training content Step 5: Prepare the written training design Step 6: Prepare participant evaluation form(s) Step 7: Determine follow-up activities for the event


10.00-10.15 am: Welcome delegates to the course, refer to pre-course workbooks or handouts, intro to the presentation

10:15-10:45am Step 1- Define Purpose of the Training and Target Audience i.e. Middle level Managers
The ISO 9000 implementation plan should make provision for this training. The training should cover the basic concepts of quality management systems and the standard and their overall impact on the strategic goals of the organization, the changed processes, and the likely work culture implications of the system.

10:50-11:30 am Step 2: Determine participants Need Some of the ways to find out about the needs A brief, written survey as part of their registration packet all participants to collect general information from all participants, pre-training assessment form Survey a random sample of registrants by phone. This will allow you to collect detailed information from a few participants. Review evaluation and feedback forms from past-related training events.
So by this we can able to determine the participants needs.

11:30-11:45am- Tea break 11:45-12:30 pm Step 3: Define Training Goals and Objectives


Goals and Objectives of ISO Implementation
Goal: To increase knowledge of ISO and their benefits among the managers of the organization Objective: By the end of the training, participants will be able to identify three ways that how we can increase the standards using ISO. Objective: By the end of the training, participants will be able to writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc.

12:15-12:45 pm Step 4: Outline Training Content While objectives are defined, the features of each session are:
How to create a more efficient, effective operation Increases customer satisfaction and retention Enhances marketing Reduces waste and increases productivity. Writing quality manuals Procedures and work instruction Auditing principles Techniques of laboratory management Calibration Testing procedures

12:45-5:00 pm
Step 6: Prepare the Written Training Design
12:45-1:15 pm Topic 1: Details of how to create a more efficient, effective operation and increases customer satisfaction and retention Include the Brainstorming and Group Discussion 1:15-2:00 pm Working lunch


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2:00-3:00 pm Topic 2: Enhances marketing and reduces waste and increases productivity. 3:00-3:45 pm

Topic 3: Writing quality manuals during implementation

3:45-4:00 pm
Tea break

4:00-4:30 pm

Topic 4: link of procedures and work instruction and ISO implementation.

4:30-5:00 pm
Group exercise & information sharing


10:00-10:15 am Welcome delegates to the course 10:15-11:00 am Topic 4: link between the Auditing principles and the ISO implementation 11:00-11:30 am Topic 5: Techniques of laboratory management 11:30-11:45 am Tea break 11:45-12:30 pm Topic 6: Calibration in ISO implementation 12:30-1:00 pm Topic 7: Testing procedures 1:00-2:00 pm Working lunch


2:00-2:30 pm Group exercise & information sharing

2:30-3:30 pm

Step 7: Prepare Participant Evaluation Forms

Some issues to address through the evaluation form: Did the participants acquire the knowledge and skills that the training was supposed to provide? Were the trainers knowledgeable about training content? Were the activities interesting and effective? Was the training format appropriate? Is more training on this or related topics needed to support participants in their work? 3:30-4:00 pm Tea break

4:00-5:00 pm Step 8.Determine Follow-up Activities for the Event or training methods TRAINING METHODS
Some of the training methods used are:

Classroom Method

All instruction takes place in the classroom. The Trainer tells Trainees to read about 1/3 of a page of text at a time and the content is reviewed. Much of this course is interactive i.e. Trainees are asked to look at documents, make observations and answer questions. Users report that classroom training takes 3 days. The Trainer reviews the written explanation of the standard during classroom time. Trainees place a check mark in the margin of the text next to items that are new to them. A check mark means review this later.


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The Trainer identifies how your organization meets the ISO requirements Trainees record how the organization meets ISO requirements using the forms titled How We Meet ISO Requirements

Fast MethodThe course is divided into 5 Sections. Trainees are given a reading assignment and told to underline important statements in the text. If something is not totally clear, the Trainee should put a question mark (?) in the margin. Marked items are discussed during a Review Session with the Trainer. Most organizations use the FAST Method. This method is faster because it takes less time on the part of the Trainer. A Review Session that takes place after a reading assignment can range from 1 to 2 hours. Trainees are given 3 reading assignments. Each is followed by a Review Session. Trainees place a question mark (?) in the text margin when they want to discuss an item during the Review Session The Trainer identifies how your organization meets the ISO requirements Trainees record how the organization meets ISO requirements using the forms titled How We Meet ISO Requirements
Review This Clause?

How We Meet ISO Requirements Quality Management System

Quality Manual /Type of Document?

Software Driven

Instructions: Your Trainer will identify how your organization meets the requirements in each ISO clause. This information is in the Quality Manual, your documents, or is accomplished with a computer program. Use this document to write a note about how your organization meets the ISO clause requirements. Place a check mark in the "Review This Clause?" column when you want to review this clause.

Self-Learning Method
These materials were designed so a person can just read the material to learn the ISO requirements and how to conduct process audits. One or more Review Sessions with the person who is most familiar with the organizations quality system is suggested when this method is used. Why? Trainees should have a review of how the organization meets the ISO requirements and an opportunity to ask questions about the course content. The SelfLearning Method also works well when you need to add one or two new auditors to your audit team. The new auditor(s) observe an experienced auditor conduct several audits. The new auditor then conducts an audit that is supervised by the Lead Auditor.


The Self Learning Method is most effective in these situations: The person has no prior knowledge or experience and really wants to learn this information The person will write a list of all the questions he/she has related to the course content. These Items are discussed during a materials review with the Trainer. The person has been at the company for more than one year and has some knowledge of how the company works Some of the active learning follow strategies are: Brainstorming Games Mini-lectures Small group work Cooperative group work Role-playing Case Simulations

Step 5: Conduct Initial Status Survey

ISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organizations existing quality management system, if there is one -- with the requirements of the standard (ISO 9001:2000). For this purpose, an organization flow chart showing how information actually flows (Not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared. With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place. Unless they are very much out of date, these documents should not be discarded. Rather, they should be incorporated into the new quality management system.


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Documents requiring modification or elaboration should be identified and listed. This exercise is sometimes referred to as gap analysis''. During these review processes, wide consultation with executives and representatives of various unions and associations within the organization is required to enlist their active cooperation. In the review process, documents should be collected, studied and registered for further use, possibly after they have been revised. Before developing new quality management system documentation, you need to consider with which quality requirements or department you should start. The best is to select an area where processes are fairly well organized, running effectively and functioning satisfactorily. The basic approach is to determine and record how a process is currently carried out. We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times. Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2000). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g. inspection/test reports, inspection/test certificates). In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes. In general, the steps to follow are the following: Ascertain and establish the following: What is the present operation/process? What already exists? Analyze the relevant sections of the quality standard - ISO 9001:2000: What is actually required? If necessary, supplement and change operational arrangements in accordance with the standard, develop documents and records, and describe operations/ processes: What is the desired operation/process?

Step 6: Create a Documented Implementation Plan

Once the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2000 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organizations quality management system fully in compliance with the standard.


The implementation plan should be thorough and specific, detailing: Quality documentation to be developed Objective of the system Pertinent ISO 9001:2000 section Person or team responsible Approval required Training required Resources required Estimated completion date

These elements should be organized into a detailed chart, to be reviewed and approved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds. Typical implementation action plan is shown in Figure. Use ISO 10005:1995 for guidance in quality planning.


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Typical Action Plan

Appoint MR + establish Implementation team ISO 9000 awareness campaign

Initial status survey + planning Appoint MR + establish implementation team W w r i W Write Level C documents t r e i Monitor implementation process t L e e Firstvinternal audit L e e l v Clear nonconformities e B l d o c Quality training u m e n t s Pre-registration audit C d o c u Compliance audit m e Compliance n discrepancies t s Registration

Write Level B document


Step 7: Develop Quality Management System Documentation
Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out:"When we started our implementation, we found that documentation was inadequate . Even absent, in some areas. Take calibration. Obviously it's necessary, and obviously we do it, but it wasn't being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate". Documentation of the quality management system should include: Documented statements of a quality policy and quality objectives, A quality manual, Documented procedures and records required by the standard ISO 9001:2000, and Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Step 8: Document Control

Once the necessary quality management system documentation has been generated, a documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control systems should be as simple and as easy to operate as possible -- sufficient to meet ISO 9001:2000 requirements and that is all. Document control should include: Approval for adequacy by authorized person (s) before issue, Review, updating and re-approval of documents by authorized person (s), Identification of changes and of the revision status of documents, Availability of relevant versions of documents at points of use, Identification and control of documents of external origin, Assurance of legibility and identifability of documents, and Prevention of unintended use of obsolete documents. The principle of ISO 9000 document control is that employees should have access to the documentation and records needed to fulfill their responsibilities.

Step 9: Implementation
It is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented at once throughout the organization. Where phased implementation takes place, the effectiveness of the system in selected areas can be evaluated.


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It would be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system. The implementation progress should be monitored to ensure that the quality management system is effective and conforms to the standard. These activities include internal quality audit, formal corrective action and management review.

Step 10: Internal Quality Audit

As the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system:
Conform to the planned arrangements, to the requirements of the standard (ISO 9001:2000) and to the quality management system requirements established by your organization, and Is effectively implemented and maintained.

Even after the system stabilizes and starts functioning, internal audits should be planned and performed as part of an ongoing strategy. A few staff members should be trained to carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and programs

Step 11: Management Review

When the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system. The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. The input to management review should include information on: Results of audits, Customer feedback, Process performance and product conformity, Status of preventive and corrective actions, Follow-up actions from previous management reviews, Changes that could affect the quality management system, and Recommendations for improvements. Management reviews should also address the pitfalls to effective implementation including lack of CEO commitment, failure to involve everyone in the process, and failure to monitor progress and enforce deadlines.


Step 12: Pre-assessment Audit
When system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Sometimes certification bodies provide this service for a nominal charge. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for certification.

Step 13: Certification and Registration

Once the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency. The certification agency first carries out an audit of the documents (referred to as an "adequacy audit"). If the documents conform to the requirements of the quality standard, then on-site audit is carried out. If the certification body finds the system to be working satisfactorily, it awards the organization a certificate, generally for a period of three years. During this three-year period, it will carry out periodic surveillance audits to ensure that the system is continuing to operate satisfactorily.

Step 14: Continual Improvement

Certification to ISO 9000 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of:

Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management review


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