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What is ISO?
ISO is the international organization for standardization based in Geneva, Switzerland. It is the largest standards organization in the world and it develops standards for use of companies and organizations worldwide.

Continued.

What is ISO ?
ISO is a non governmental organization and its membership comprises of standardization bodies of the major countries of the world including India.
Bureau of Indian Standards represents India in ISO.

STANDARDIZATION

STANDARDS

SPECIFICATION

Standardization Standardization is the process through which we arrive at an agreed and common performance parameters or specification for a product, process or a system Standard A standard documents the specification or the requirements for a product, process or a system arrived through the standardization process. It defines the requirements in measurable terms.

Specification: Requirements for a product, service or system in terms of dimension, tolerances, functions and performance.

Quality management system is a set of policies, procedures and processes required for planning and execution of the business activities of an organization.
The activities of the quality management system is designed to drive the organization to continually improve the effectiveness and efficiency of its performance.
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Policy An organizations business goals and objectives

Policy Procedure Process

Procedure Specifies how a job has to be done

Process A series of interlinked activities aimed to produce a planned result

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SYSTEM

Driving system Computer operating system Management system Design system

Can you name some other systems?

WHY QMS IS REQUIRED

Customer requirements QMS Regulatory & Legal requirements Process & procedure management

Continual improvement

Customer satisfaction

QMS is the framework for development of a quality policy that drives the organization to continual improvement and customer satisfaction, and also ensure compliance to legal and regulatory requirements
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Quality management systems consist of,

quality planning, quality assurance, quality control, and quality improvement.

All these activities are directed towards implementation of the quality policy of the organization. A set of procedures and processes are required to direct and control the activities of the organization and improve its effectiveness.

Quality plan is a framework of procedures and processes that establish the objectives for quality, and application of quality system elements. It translates quality policy into measurable objectives and requirements and lays down a sequence of steps for realizing them within a specified timeframe. It documents activity plans , resources required , responsibilities and all other requirements required for the relevant project.
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Quality assurance is a management function; it deals with setting policy and running an administrative system of management controls that cover planning, implementation, and review of data collection activities and the use of data in decision making. Quality control is a technical function that includes all the scientific precautions, such as calibrations and duplications, that are needed to acquire data of known and adequate quality.
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Quality improvement is a planned and structured approach to improve performance through,

1. systematic analysis of the activities,
2. measurement of performance, 3. prevention of errors,

4. setting targets, and

5. identifying and applying improved methods to

achieve the targetted improvements.

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Quality

HIGH QUALITY STATED REQUIREMENT

LOW QUALITY

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ISO 9001 is a quality management system standard

ISO 9001:2008

The standard was issued in 1987, revised in 1994, 2000 & 2008.

The standard ensures that quality products are produced consistently.

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ISO 9001:2008
ISO 9001:2008 is the current version of the quality management system standard issued by ISO. It provides a set of generic requirements for all type of business activities. The requirements
Apply to the processes that create and control the products and services of an organization. Prescribes systematic control of activities to ensure that the needs and expectations of customers are met. Is designed and intended to apply to virtually any product or service, made by any process anywhere in the world.

It is a standard against which an organization can be certified.

Certification
1. Certification is the formal recognition that an organization has the proficiency to meet the specified requirements of a recognized quality system standard. 2. Certification is given by an accredited body such as DNV, Bureau Veritas, BIS etc. after assessment of the organization through audits, and then issuing a certificate to show that the organization abides by the principles set out in the standard (viz.ISO 9001),following industry best practices 3. Certification communicates to the world that the company has established a recognized quality system. 4. Certification provides evidence that the organization has implemented an effective business management system, and that they are serious about quality and ensuring that the customer's expectations are met. 5. It gives buyers confidence that the organization would be able to supply quality products consistently.

Why an organization should implement ISO 9001: 2008?

An organization to survive and grow must satisfy its customers.

Customers are satisfied when products and services meet their expectations. ISO 9001: 2008 provides the framework of process models that turn out products

to satisfy customer expectations.

ISO 9001:2008 being a QMS standard, its implementation enables an organization to ensure that its business processes interact efficiently and effectively to produce quality goods and services.

ISO 9001:2008 requires a documented quality management system.

The standard allows flexibility to an organization to decide as to what documentation they will include in their quality management system. The objective of the quality management system is to support development and implementation of effective business processes. As such, documents not required for the business should not be included in the quality system.
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Documented statements of a quality policy and quality objectives. A quality manual. Documented procedures required by the standard. Documents needed by the organization to ensure the effective planning, operation and control of its processes. Records required by the standard. All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

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Quality policy
An organizations policy is a statement that enunciates the organizations business goals and objectives and broadly outlines the means to achieve them. It may also include a plan of action to gain competitive advantage.
A quality policy related to the overall corporate policy, defines the organizations commitment to quality. It sets up quality plans through which it aspires to achieve business leadership. A quality policy is a framework of quality objectives and action plans to drive continual performance improvement throughout the organization.

The quality policy should be aligned to the organizations business needs. The quality policy should include a commitment to comply to the requirements of the quality management system requirements. The effectiveness of the quality management system shall be continually improved. Quality policy should provide a framework for establishing and reviewing of quality objectives. The quality policy shall be communicated at all levels within the organization and it shall be reviewed for continuing suitability.
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ISO 9000:2005 defines quality objective as a quality oriented goal - something to aim for or try to achieve. To understand quality objective we must understand the difference between a Goal and Objective. A goal generally implies an intention, something that we would like to achieve.

Objective goes a step further. It is a goal with measurable target, that is achievable within a specified timeframe. Quality objective converts a goal to an effective action plan.
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Quality objectives to be measurable and consistent with the quality policy. The clause also requires quality objectives to be established at all relevant functions and levels.

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Quality Objectives
1. In practice quality objectives are selected from the day to day work functions of an organization with the intention of carrying out a specific targeted improvement which is measurable. 2. Quality objectives must be reviewed and tracked to ensure that there is progress towards the targeted improvement. 3. While quality objectives should be consistent with the quality policy, from the business perspective they can relate to the strategic business needs of the organization. 4. Since quality policy itself relates to the strategic business objectives of an organization, there is unlikely to be any conflict with quality policy when quality objectives are derived from the strategic needs.

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Strategy guides the nature and direction of an organization. It is about gaining business advantage over the competitors by differentiating and increasing the value of its products and services in the eyes of the customer. Strategy can be expressed in three different forms, 1. General Strategy 2. Corporate Strategy, and 3. Competitive Strategy
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Strategy

1. 2. 3.

General strategy is concerned with courses of action, the relationship between ends and means. Corporate strategy is concerned with choices and commitments regarding markets, business and the very nature of the company itself. Competitive strategy is concerned with competitors and competition Cost, Differentiaton and Focus, as also Operating excellence, Customer intimacy and Product leadership.
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An organization having a well defined strategy, the salient points of which has been communicated to its employees will be in an advantageous position in terms of competition in the market place. Think of a business as a collection of 1000 iron filings, each filing representing an employee. If you pick up the filings and drop them onto a piece of paper, they will lie spread out all pointing in different directions. This will be something like 1000 employees working hard with different objectives in mind. If you now bring a magnet over the filings, they change their positions and line up in the same direction

A well understood statement of the company strategy aligns employee behaviour with the business requirements.
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The concept of strategy has been borrowed from the military and adapted for use in business. In the military, troops are maneuvered into positions before the actual engagement takes place.

How the troops have to be deployed prior to engagement with the enemy is a matter strategy.
During actual battle various type of actions are involved depending on the progress and situation of the battle. These actions which could keep on changing are termed tactics. Together, strategy and tactics bridge the gap between ends and means. Many businesses have adopted the techniques of strategy and tactics to gain competitive advantage in the market place.
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As a competitive strategy an organization can think of three core values that it can deliver.
They are, Operational excellence (the lowest price), Product leadership (the best product), or Customer intimacy (the best solution & service). Of the three above the organization may have to decide which value proposition they are best equipped to offer.
Mission & Strategy Business Objectives Quality Policy Quality Objectives

Quality objectives are part of the continual improvement activities within the organization.
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A quality manual documents an organization's quality management system . Clause 4.2.2 of ISO 9001:2008 defines the minimum content of the quality manual as follows, Scope of the QMS Exclusions with their justifications Interaction of the QMS processes Quality procedures or reference to them The format and structure of the manual is a decision for each organization, and will depend on the organizations size, culture and complexity. The quality manual has to be controlled in accordance with the requirements of clause 4.2.3.
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Establish, document, implement and maintain a quality management system and continually improve its effectiveness. a. b. c. d. e. f. Identify the processes required for the quality management system Determine and document the sequence and interaction between the processes Identify and establish appropriate criteria and methods needed to operate and control them. Ensure that resources and supporting information are provided for process operation Monitor, measure where applicable, and analyze the processes Implement actions to achieve planned results and continual process improvement

These processes shall be managed by the organization in accordance with ISO 9001 . Organization should control outsourced processed. Type and extent control on outsourced processes should be defined.
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A series of
interlinked activities

that use resources to transform

inputs into outputs.
INPUT ACTIVITY 1 ACTIVITY 2 ACTIVITY 3 OUTPUT

Processes must be planned and controlled to achieve the desired results. Process planning requires control of inputs, resources and activities, and ensuring that the activities are arranged in the right sequence. Since the activities are also processes, they must also be controlled.
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PROCESS

EACH PROCESS HAS A SPECIFIC PURPOSE

INPUT
A1

ACTIVITIES A2 A3

RESOURCE

PROCESS

PROCESS CONTROL

OUTPUT

A process requires certain resources to be able to function.

A process has to be controlled to ensure that the output achieved is the desired one
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As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

Continuous

Continual

Continual improvement is a set of activities that an organization routinely carries out in order to improve its ability to meet requirements.
Continual improvement is achieved by carrying out internal audits, performing management reviews, analyzing data, and implementing corrective and preventive actions. Continual Improvement is a process of incremental improvement (step by step improvement) and is applied company wide so that both managers and workmen are involved in this process of improvement.

Breakthrough improvement is a major improvement that is achieved all at once. Such improvements can be achieved through innovative changes of the process or technology, new advanced equipment or complete overhaul of the working methods to achieve a large jump in improvement.

As opposed to continual improvement in which both managers and workmen are involved and work together,
Breakthrough improvement is in the preserve of managers alone as this require technical knowledge and out of the box thinking (innovation).

To conduct internal audits at planned intervals to verify, conformance of the quality management system to the planned arrangements, and its effective implementation and maintenance. The organization must: a. Plan audit programs taking into consideration the status and importance of the processes, areas and results of previous audits. b. Define the audit criteria, scope, frequency, and methods c. Select and use impartial and objective auditors, and d. Ensure that auditors do not audit areas of their own work, and establish a documented procedure to define the responsibilities and requirements for, I. Planning and conducting audits. II. Recording, reporting and maintenance of audit results. III. Ensuring that corrective actions are taken without delay to eliminate detected nonconformities and their causes. IV. Following up of implementation of the correwctive actions and reporting on the results of the corrective actions taken.
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An Audit is a fact finding mission. The purpose is verification of compliance to specified requirements. Internal audits are self auditing. Organizations audit themselves to verify that operations, activities and processes are being carried out as per planned requirements.

Internal audits must be conducted at planned intervals to ensure compliance to requirements.

A documented procedure should define, 1. How audits are to be planned including its frequency. 2. How they are to be recorded,and reported. 3. For what periods audit records shall be maintained. 4. Ensuring timely corrective actions, and 5. Verification of the results of corrective actions.

Internal audits verify, the effectiveness of the quality management system and its implementation Implementation and communicationof quality policy. Establishment, review and follow up of quality objectives. Implementation of continual improvement targets. Identification, implementation and improvements of processes and procedures. Achievement of customer satisfaction. Implementation of training requirements. Implementation of corrective anf preventive actions.

The organization shall take corrective actions to eliminate non conformities and their root causes to prevent their recurrence. A documented procedure shall define requirements for:

a) b) c) d) e) f)

reviewing non conformities and customer complaints, determining the causes of such nonconformities and complaints, evaluating the need for action to ensure that non conformities and complaints do not recur; determining and implementing action needed; records of the results of action taken (see 4.2.4), and reviewing the effectiveness of the corrective action taken.

A correction is an action taken to rectify a defective material through re-working, reprocessing, assigning the defectives to some other use where they are acceptable; or totally destroying the defectives.

Corrections may not address the root cause of the problem.

Corrective actions address the root cause of the problem so that the possibility of recurrence of the problem is eliminated.

Corrective action is a problem solving process, where the problem is analyzed to identify the causes and then eliminate them.

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Determine the actions to eliminate the causes of potential nonconformities in order to prevent their occurrence. Ensure that preventive actions are appropriate to the anticipated effects of the potential problem.
Establish a documented procedure to define the requirements for preventive action to:
Determine the potential nonconformities and their causes.

Evaluate the need for actions to prevent occurrence.

Determine and implement the needed actions . Maintain records of the results of the actions taken., and Review the effectiveness of preventive actions taken.

Preventive actions are steps that are taken to remove the causes of potential nonconformities something that hasnt as yet occurred. Preventive action is a risk analysis process. While corrective actions prevent recurrence, preventive actions try to prevent future occurrences.

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CUSTOMER SATISFACTION (8.2.1)

VERIFICATION OF SYSTEM

CONTINUAL IMPROVEMENT (8.5.1)

QUALITY OBJECTIVES (5.4.1)

INTERNAL AUDIT (8.2.2)

QUALITY MANAGEMENT SYSTEM (ISO 9001)

QUALITY POLICY (5.3)

STARTING POINT

 Creation of an efficient and effective organization. Consistent product quality. Retention of customers.

Well defined documented procedures and processes. Increased customer satisfaction. Improved quality image, increased marketshare and profits. Improved employee motivation, and awareness.

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1959 1972 1979 1987 1994 2000 2008

MIL-Q-9858: US defence qlty system standard

BS 4891: Quality Assurance Standard

BS 5750: Quality System Standard MIL-Q9858 ISO 9001: International Quality System Standard First revision: ISO 9001 Second revision: ISO 9001 Current Version Of ISO 9001

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