Syllabus

ISO 9000 and 9002 documentation: Introduction and Support package: Guidance on the terminology used in ISO 9001:2000 and ISO 9004:2000.

ISO - International Organization for Standardization set up in 1947 located in Geneva, Switzerland Purpose - to facilitate and support international trade by developing standards that people

everywhere would recognize and respect Achieves this purpose through the participation and support of its members Members come from 158 national standards

organizations

Who develops the ISO Standards?

Technical committees Member of TC - from many national standards organizations Hence, ISO standards have worldwide support Currently, ISO has 193 technical committees 540 subcommittees 2244 working groups Developed 16,455 international standards

Why acronym ISO not IOS?

the word ISO also means equal or equivalent in Greek

The making.. of ISO

Pre ISO 9000

During WWII, in many British high-tech industries such as ammunitions bombs were exploding in factories during assembly So, factories to document their mfg. process and to prove by record keeping it did not specify what to manufacture, but how to manage the manufacturing process The standard was called BS 5750 In 1987 it was adopted and called ISO 9000

1987 version
Called as ISO 9000:1987 BS 5750 + 3 models for QMS ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products. ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

1994 version
Called as ISO 9000:1994 Emphasize on quality assurance via

preventive actions require evidence of compliance with

documented procedures

2000 version
Called as ISO 9001:2000 or ISO 9001 9001 + 9002 + 9003 place the concept of process management front and centre "Process management" is the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product. demands involvement by upper executives to improve effectiveness via process performance metrics (numerical measurement of the effectiveness
of tasks and activities)

Expectations of continual process improvement and tracking customer satisfaction were made explicit

2008 Version:

TC 176 has reviewed It is called - ISO 9001:2008 standard No substantial changes

ISO family
ISO 9000:2005- Quality management systems Fundamentals and vocabulary ISO 9001:2000- Quality management systems Requirements ISO 9004:2000- Quality management systems Guidelines for performance improvements ISO 10006- Quality management - Guidelines to quality management in projects ISO 14000 - Environmental management standards ISO 19011 - Guidelines for quality management systems auditing and environmental management systems auditing ISO/TS 16949 - Quality management system requirements for automotive-related products suppliers

Why quality system is required?

Quality system ensures the quality of the products or services is always maintained towards the satisfaction of the costumer and benefit of the organization. Aims at: To ensure that everybody in the organization is involved and understands their responsibility to achieve and maintain the quality. Quality product at competitive price. Expanding the costumer base world over. Effective internal mean of communication for better understanding. To achieve costumer satisfaction so that costumer returns for the business.

What is Quality?
 Meeting defined product specification  Timely delivery of product  Cost effectiveness  Complete testing and verification activities as defined  Always follow process parameters  Always analyzing and solving problems by cross functional meetings

Myths about quality

Myths Quality improvement increases cost. Deviation in quality increases production. Quality is responsibility of Quality assurance dept. Quality improvement is workers responsibility. Customer pays emphasis on prices than quality. Truth If quality is not improved product cost is increased many fold. Deviation in quality causes low production and rejection. Every body is responsible for quality. Quality improvement can be done through effective management. Customer can pay better prices for good quality products

Quality can be achieved by many means One of those is ISO

Few benefits of ISO

Customer expresses more satisfied Defining quality plan Operating cost drop Increased productivity Reducing rework and rejection Opening avenues of export Improvement by statistical analysis Employee motivation Creating brand image of organization Toll to surface all hidden problems and provide solution by team members Effective training processes improves the necessary skills Procedures are developed to get jobs done properly

ISO Principles
Objective evidence Do and write Write and do Corrective and Preventive actions Auditing Reviewing

What's the difference between being certified and being registered?

None. There is no difference. In some countries companies say they're certified, and in others they say they're registered. It's the same thing.

What's the difference between being certified and being complaint?

When a company claims that they are ISO 9000 certified or registered, they mean that an independent registrar has audited their quality system and certified that it meets the ISO 9001:2000 requirements (or the old ISO 9001:1994, 9002:1994, or 9003:1994 requirements). It means that a registrar has given a written assurance that ISO's quality management system standard has been met. However, when a company says that they are ISO 9000 compliant, they usually mean that they have met ISO's quality system requirements but have NOT been formally certified by an independent registrar. In effect, they are selfcertified. This is perfectly acceptable for many companies, especially small ones. Of course, an official Certificate does tend to carry more weight in the market place. When a company says they're certified or compliant, they're NOT saying that their products and services meet the ISO 9000 requirements. The ISO 9000 standards are process standards, not product standards.

What's the difference between being certified and being accredited?

 Registrars audit and certify organizations who wish to become ISO 9000 registered or certified.  Accreditation Bodies, on the other hand, evaluate and accredit registrars.   In effect, accreditation bodies audit the auditors. Accreditation competent bodies certify that to registrars ISO are 9000

and

authorized

issue

certificates in specified business sectors.

TERMINOLOGY
Conformity is all about meeting requirements. ISO 9001 2000 lists many quality system requirements. If your organization meets these requirements, you can say that it conforms to these requirements. Continual improvement is a set of activities that an organization routinely carries out in order to enhance its ability to meet requirements. Continual improvement can be achieved by carrying out internal audits, performing management reviews, analyzing data, and implementing corrective and preventive actions. Contract review is a set of activities that an organization carries out in order to make sure that customer orders and contracts specify all the requirements that must be met, and in order to establish that the organization can actually meet these requirements.

Corrective actions are steps that are taken to remove the causes of an existing nonconformity or to make quality improvements. Corrective actions address actual problems. In general, the corrective action process can be thought of as a problem solving process. A customer is anyone who receives products or services from a supplier. A customer can be either external or internal to the supplier organization. Customer satisfaction is a perception. It is also a question of degree. It can vary from high satisfaction to low satisfaction. If customers believe that you've met their requirements, they experience high satisfaction. If they believe that you've not met their requirements, they experience low satisfaction. A design review is a set of activities whose purpose is to evaluate how well a potential product (a design) meets all quality requirements. During the course of this review, problems must be identified and solutions must be developed.

The term document refers to information and the medium that is used to bring it into existence. A document can be digital or physical.
 ISO identifies five types of documents: specifications, quality manuals, quality plans, records, and procedure documents.

An entity could be a product, process, person, activity, machine, service, system, department, company, institution, or organization. The term infrastructure includes buildings, workspaces, equipment, hardware, software, utilities, and support services such as transportation and communication.

Internal audits are carried out by organization personnel. Internal quality audits examine the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements. Management review: The purpose of a management review is to evaluate the overall performance of an organization's quality management system and to identify improvement opportunities. These reviews are carried out by the organization's top managers and are done on a regular basis. Nonconforming product: When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from quality requirements, it fails to conform. Nonconformity: ISO 9001: 2000 lists quality management system requirements. When your organization deviates from these requirements, nonconformity occurs. When a product, process, procedure, system, or structure deviates from ISO requirements, a formal nonconformity exists.

Product nonconformities: When one or more characteristics of a product fail to meet specified requirements, they are referred to as product nonconformities. Organization: An organization is a company, corporation, firm, or institution that has its own functions and administration. It can be either incorporated or unincorporated, privately or publicly owned. Organizational structure: The structure of an organization is the pattern of responsibilities, authorities, and relationships that control how people perform their functions and govern how they interact with one another. Preventive actions are steps that are taken to remove the causes of potential nonconformities or to make quality improvements. Preventive actions address potential problems, ones that haven't yet occurred. In general, the preventive action process can be thought of as a risk analysis process.

Procedures: Quality procedures control processes or activities.

 Procedures can be very general or very detailed  A detailed procedure defines the work that should be done, and explains how it should be done, who should do it, and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which supplies and materials should be used, and which documents and records must be used to carry out the work.

Process: In general, a process uses resources to transform inputs into outputs.  In every case, inputs are turned into outputs because some kind of work, activity, or function is carried out.  Processes can be administrative, industrial, agricultural, governmental, chemical, mechanical, electrical, and so on.  Types of process as per QMS of ISO 9001:
Purchasing process. Production process Record keeping process. Internal audit process. Planning process. Training process.

Product: A product is an output that results from a process. Products can be tangible or intangible, a thing or an idea, hardware or software, information or knowledge, a process or procedure, a service or function, or a concept or creation.
 Product also mean services

Product inspection: an activity that compares one or more characteristics of a product with specified requirements in order to determine if the product meets these requirements. Product realization: A product starts out as an idea. The idea is realized or actualized by following a set of product realization processes. So product realization refers to all the processes that are used to bring products into being. Quality: A quality is a characteristic that a product or service must have

Quality assurance (QA): A set of activities whose purpose is to demonstrate that an entity meets all quality requirements. QA activities are carried out in order to inspire the confidence of both customers and managers, confidence that all quality requirements are being met. Quality audits: Examining the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements. Quality control: A set of activities or techniques whose purpose is to ensure that all quality requirements are being met. In order to achieve this purpose, processes are monitored and performance problems are solved.

Quality improvement: Refers to anything that enhances an organization's ability to meet quality requirements. Quality management: It includes all the activities that managers carry out in an effort to implement their quality policy. These activities include quality planning, quality control, quality assurance, and quality improvement. Quality policy: A quality policy statement defines or describes an organization's commitment to quality. Quality planning: A set of activities whose purpose is to define quality system policies, objectives, and requirements, and to explain how these policies will be applied, how these objectives will be achieved, and how these requirements will be met. It is always future oriented.

Quality management system (QMS): A web of interconnected processes. Each process uses resources to turn inputs into outputs. And all of these processes are interconnected by means of many input-output relationships. Every process generates at least one output, and this output becomes an input for another process. These input-output relationships glue all of these processes together - that's what makes it a system. Quality manual: A quality manual documents an organization's Quality Management System. Quality record: A quality record contains objective evidence which shows how well a quality requirement is being met or how well a quality process is performing. It always documents what has happened in the past. Quality surveillance: A set of activities whose purpose is to monitor an entity and review its records to prove that quality requirements are being met.

Resources: Include people, money, information, knowledge, skill, energy, facilities, machines, tools, equipment, technologies, and techniques. Service: A customer-oriented result. This result is produced when an organization performs activities that are oriented towards meeting customer needs and expectations. Standard: A standard is a document. It is a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems.
 ISO's standards are agreements. ISO refers to them as agreements because its members must agree on content and give formal approval before they are published.

Total quality management(TQM): Defined as a management approach that tries to achieve and sustain long-term organizational success by encouraging employee feedback and participation, satisfying customer needs and expectations, respecting societal values and beliefs, and obeying governmental statutes and regulations. Work environment: Refers to all the factors that influence work. In general, these include social, cultural, psychological, physical, and environmental conditions.

What's the difference between a Quality Manual and a Quality System?

A quality manual is a document A quality system is a network of processes. Quality manual is supposed to document your

quality system; it's not supposed to BE your system Quality manual is all about paperwork, while your quality system is a web of REAL processes. Paper system Vs Real system

What's the difference between a procedure and a work instruction?

A procedure describes how a process is performed A work instruction describes how a task is

performed  Work instructions tend to be more detailed than procedures

What's the difference between a work instruction and a record?

Work instructions describe how tasks should be done Records document how tasks were actually done Work instructions are used before the task is performed, while records are used after the task has been performed Work instructions come before the fact, while records come after the fact.

What's the difference between corrective and preventive action?

Corrective actions are steps that are taken to remove the causes of existing nonconformities, while preventive actions are steps that are taken to remove the causes of potential nonconformities Corrective actions address actual problems, ones that have already occurred, while preventive actions address potential problems, ones that haven't yet occurred Corrective action process is a problem solving process, while the preventive action process is a risk analysis process.

ISO 9004:2000

Quality Management Systems - Guidelines for Performance Improvement

ISO 9000 group system of standards that establishes is intended a to

management

model

continually improve customer satisfaction and the effectiveness of the management system ISO 9004 provides guidance on the overall aspect of a quality management system to improve the organizations quality performance The ISO 9004:2000 manual serves as a link between the ISO 9001:2000 standard and TQM ISO 9004 should not be viewed as a requirements document, but rather companies a guidance document for

The ISO 9004:2000 manual consists of guidance and recommendations, which are not intended for certification, regulatory or contractual use Covers continual improvement This gives you advice on what you could do to enhance a mature system This standard very specifically states that it is not intended as a guide to implementation.

The eight Quality Management Principles stated in ISO 9000: 9000:2000 and ISO 9004:2000 provide the basis for the 9004: performance improvement outlined in ISO 9004:2000, 9004:2000, and reflect best the most effective management practices to-date. They are: to-date. are:  Customer focus  Leadership  Involvement of people  Process approach  System approach to management  Continual improvement  Factual approach to decision making  Mutually beneficial supplier relationships

ISO 9000 Vs ISO 9004:2000

Summary of ISO 9001:2000

The plan Each quality and to manual customer needs is a formal The statement quality from is management, closely linked to the business and marketing needs. manual to understood and followed at all levels and by all employees. employee measurable objectives work towards. Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness. You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.

To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions. You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you cant monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs. For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required.
 (Note: a product is hardware, software, services, processed materials, or a combination of these.)

You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated. You need to have clear requirements for purchased product. You need to determine customer requirements and create systems for communicating with customers about product information, complaints. When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs. inquiries, contracts, orders, feedback and

You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential

problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness.  (Note: you need a documented procedure for internal audits.) You need documented procedures for dealing with actual and potential nonconformances (problems involving

suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.

DOCUMENTATIONS

Quality Manual Quality Procedures Formats

Quality Manual
The M.R. is responsible for preparation and issue. One copy of each shall be made available with different heads. It includes  Quality policy  Quality objective  QMS planning  Responsibility, authority and communication  Organization chart  Management review

Quality Procedure
It records Procedure for  Quality policy deployment  QMS planning  Management review  Customer communication  Internal audits  PAR and CAR

Formats
It includes the documents required to perform the procedures, like  List of copy holders  Employee suggestion scheme  Customer suggestion scheme  Management review  Training needs and training records  Verification of purchase product  Calibration record  Schedule for internal audit and audit report  PAR and CAR  Cross functional meetings