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ISO’s means "International Organization for Standardization“

Central Secretariat in Geneva, Switzerland International federation of over more than 176 countries

Non-governmental organization founded in 1947 on the basis of one member per country “ISO”, derived from the Greek word isos, meaning ‘equal”

Published more than 17500 International Standards

ISO 9001 is the internationally recognized standard for the quality management of businesses.

It prescribes systematic control of activities to ensure that the needs and expectations of customers are met. It is designed and intended to apply to virtually any product or service, made by any process anywhere in the world.

It applies to the processes that create and control the products and services an organization supplies.

It certifies that formalized business processes are being applied.

It is a quality system.

It is a standard in which to conduct business.

It is a set of rules which should be followed in order to meet the needs.

Registration to ISO 9001 by an accredited certification body shows committed to

- quality, - customers and - a willingness to work towards improving efficiency.

Demonstrates the existence of an effective quality management system

Satisfies the rigor of an independent, external audit.

An ISO 9001 certificate enhances company image in the eyes of customers, employees and shareholders alike.

It also gives a competitive edge to an organization's marketing.

The records must show that the company “Says what it does and does what it says”

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Definition :"A quality management principle is a comprehensive and fundamental rule / belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stake holders".

These Eight dynamic Quality Management System Principles are:

1. Customer Focus2. Leadership3. Involvement Of People4. Process Approach5. System Approach6. Continual Improvement7. Factual Approach To Decision Making8. Mutually Beneficial Supplier Relationships

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Meaning : "Organizations depend on their customers and therefore should understand

current and future customer needs, meet customer requirements and strive to exceed customer expectations.”

Customer is a only Profit If you don't care of your customers somebody else

Without customers businesses do not survive

Which Qualities Required for Customer Focus ? Who is your customers? How many types of customers? How you communicate with your customers? What your customers want/requirements? How much you concentrate on customer focus activities?

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Meaning : “Leaders establish unity of purpose and direction of the organization. They should create

and maintain the internal environment in which people can become fully involved in achieving the organization's objectives."

Which Qualities Required for Leadership ? Are people motivated through your leadership? Does your leadership quality set goals and targets for the organization? How you inspired, encourage and recognize people’s contribution? What actions you take to avoid miscommunication?

Taking initiative and being accountable Leader says "Let's Go“ Leadership is essential for any business to meet

customer requirement, and to continuously improve as a business

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Meaning : People at all levels are the essence of an organization and their full involvement

enables their abilities to be used for the organization's benefit".

"WE CAN" Team work build great business People at all levels are the essence of an organization

and their full involvement enables their abilities to be used for the organization's benefit.

Which Qualities Required for Involvement of people?1) How people are involved in the organization?2) Are people accountable for their own performance? How?3) Are people participate in and contribute to continual improvement? How?4) What you do for increasing the opportunity for innovation and creativity?

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Meaning : "A desired result is achieved more efficiently when related resources and

activities are managed as a process."

Its a management strategy Defines the efficiency and effectiveness of any business

operation If there is no process approach in your organization, how

would you manage the activities and related resources?

Input Process Output

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Meaning : “Identifying, understanding and managing a system of interrelated processes for a

given objective improves the organisation's effectiveness and efficiency."

Synergy of interrelated process of organisation

Identifying, understanding and managing interrelated processes

Regarded as a "system"

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Meaning :

“Continual improvement should be a permanent objective of the organization."

Developing and maintaining systems An ongoing need to improve the effectiveness

of a management system Continuous improvement through the

establishment of goals and targets

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Meaning :

"Effective decisions are based on the analysis of data and information."

Accurate data for decision making Effective decisions are based on the

analysis of data and information.

1) Which method is been adopted for collecting data and relevant information?2) How you analyze the collected data?3) Data and information collected by you are matching as per your requirement?

How?4) Decisions taken by you are as per the data and information collected? How?

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Meaning :

“An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.”

Your supplier is your partner in Business

1) How you recognized your supplier?2) What are the key elements you take into consideration while dealing with the supplier?3) How you communicate with your customer/supplier to improve relations?4) How Business if beneficial with the help of improved relationships with the supplier?

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Some of the requirements in ISO 9001:2008 include

A set of procedures that cover all key processes in the business

Monitoring processes to ensure they are effective;Keeping adequate records;Checking output for defects, with appropriate and

corrective action where necessary;Regularly reviewing individual processes and the quality

system itself for effectiveness; andFacilitating continual improvement

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Development, manufacturing and supply of products and services more efficient, safer and cleaner Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment

WHAT STANDARDS DO

STANDARDS COVERS Risks Costs and benefits Management responsibility Quality system principles Other building blocks

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“Say what is to be done

Do the work

Prove that it has been done”

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ISO 9001:2008, the requirement standard, includes the following main sections which deals with clauses of ISO i.e.

Quality Management System Clause No.4 Management Responsibility Clause No.5 Resource Management Clause No.6 Product Realization Clause No.7 Measurement, Analysis Clause No.8 And

Improvement

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This clause tells about: 4.1 - General Requirements 4.2 - Documentation Requirements

4.1 - General Requirements The quality management system should:

Identify all processes involved

Ensure that the processes are effective

monitor measure and

improve these processes

And finally have sufficient resources

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4.2 – Documentation Requirements

4.2.1 General Statements of quality policy and quality objectives A Quality Manual documented procedures and records required by

this International Standard, and documents, including records, determined by the

organization to be necessary to ensure the effective planning, operation and control of its processes.

4.2.2 Quality Manual Quality Manual must include to document The scope of the quality management system

including any relevant exclusions Procedures or references to them Description of the interaction between then

processes

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4.2.3 Control of Documents HOW a practice is carried out? A real corner stone requirement

4.2.4 Control of Records Records shall be established and

maintained Quality records are suitably

controlled with regard to• defining what records are

required, • how & where they are stored,• ensuring that they can be

retrieved, • describing their retention time

and subsequent disposal

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This clause tells about:5.1 - Management Commitment5.2 - Customer Focus5.3 - Quality Policy5.4 - Planning 5.5 - Responsibility, Authority & Communication 5.6 - Management Review

5.1 – Management Commitment The top most management grouping within the company responsible for its running and operation

5.2 – Customer Focus It recognizes the importance of defining customer requirements in providing overall customer satisfaction

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5.3 – Quality Policy It should define: What you provide Your commitment to your quality system Your commitment to key role players necessary for a successful system

5.4 – Planning5.4.1 Quality Objectives SMART S-Specific

M-MeasurableA-Attainable R-Realistic

T-Time-bound

5.4.2 Quality Management System Planning Identifying activities, verified activities and the records to be established in the process.

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5.5 - Responsibility, Authority & Communication To plan organize and control the quality management system Define and communicate authorities and responsibilities

5.5.1 - Responsibility & Authority Everyone should know what they are expected to do (responsibilities) and what they are allowed to do (authorities)

5.5.2 – Management Representative Person must have the necessary authority within the organization

5.5.3 – Internal Communication Management should ensure that people have the information necessary in order to be able to do their work

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5.6 – Management Review5.6.1 – General Regular management reviews ensure that the quality management system is still suitable, adequate, and effective in a changed environment

5.6.2 – Review InputThe management should consider appropriate inputs for review of QMS. These inputs may include:

Audit results customer feedback process & product (or service) conformity status of preventive/corrective actions follow-up actions from previous reviews changes that could affect the system recommendations for improvement

5.6.3 – Review OutputThe output of review must be recorded. The decisions and actions may be related to:

improvement of QMS and its processes improvement of productresource needs

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Review and provide the resources needed to implement and improve the systemIt includes the following:

6.1 - Provision of Resources6.2 - Human Resources6.3 - Infrastructure6.4 - Work Environment

6.1 – Provision of Resources The organization must determine and provide resources needed to

* Implement and maintain the quality management system and continually improve its effectiveness * Enhance customer satisfaction by meeting customer requirements.

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6.2 – Human Resources

6.2.1 - GeneralProduct requirements shall be competent on the basis of:

1. Appropriate education 2. Training 3. Skills 4. Experience

6.2.2 - Competence, Awareness & TrainingYou must :

Determine the competency for personnel performing work affecting conformity to product requirements.

Provide training to address identified needs. Evaluate the effectiveness of training.

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6.3 – Infrastructure Involves the facilities and equipment that need to perform effectively

6.4 – Work Environment

The right physical factors (space, temperature, noise, etc) Social factors (individual and corporate value system) Psychological factors (satisfying the needs of the individual) are addressed.

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Start with planning. Plan the journey from the point where the customer asks for something, right through to deliveryIt includes the following:7.1 - Planning of Product Realization7.2 – Customer Related Processes7.3 - Design and Development7.4 - Purchasing7.5 - Production & Service Provision7.6 - Control of Monitoring & Measuring Devices

7.1 – Planning of Product Realization The key word here is “consistency” It implies that an organization is consistently providing products that meet customer's expectations.

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7.2 – Customer Related Process7.2.1 - Determination of Requirements Related to the ProductFor each product, an organization needs to consider:

The requirements are specified by the customer The requirements are not specified by the customer Statutory and regulatory requirements Other requirements considered necessary by the organization

7.2.2 - Review of Requirements Related to the ProductEnsure that organization understand and can meet customer requirements

7.2.3 - Customer CommunicationAimed at ensuring good communication between yourselves and your customer with regard to:

product information order/enquiry handling and changes customer feedback Customer complaints

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7.3 – Design & Development7.3.1 – Design PlanningIdentify responsibilities/ authorities and specific timelines

7.3.2 – Design InputIt should be clear how the final product is going to look, and which conditions must be fulfilled.

7.3.3 – Design OutputSpecify the design outputs required form the design or development proposed

7.3.4 – Design ReviewEnsure that the process is regularly reviewed and recorded

7.3.5 – Design VerificationVerify the design to check they comply with the input requirements

7.3.6 – Design ValidationThe actual physical product meets the original input requirements7.3.7 – Design ChangesIf changes are necessary through out and post the design process ensure that it is controlled

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7.4 - Purchasing7.4.1 – Purchasing Control The objective is to ensure that the requirements for the procured goods/services are properly defined and communicated to the supplier

7.4.2 – Purchasing Information This relates to the specification or requirement for the purchased goods / services How is this communicated to the supplier7.4.3 – Verification of Purchased Product An organization needs to ensure that the product or service from the supplier meets its requirements

7.5 – Production & Service Provision7.5.1 - Control of Production & Service Provision This requirement addresses The process of producing the product or delivering the services; and How is it controlled?

7.5.2 - Validation of Processes for Production & Service ProvisionThe product or service produced cannot be tested directly

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7.5.3 - Identification and Traceability Identifications take the form of labeling, colour coding, marking, etc. When it is a requirement the extent of traceability must be defined

7.5.4 - Customer PropertyDefines:- If there are any products, materials, or tools on an organization's premises that are owned by a customer. Examples of customer property are: motor vehicles left for service or repair, clothing that a customer left at a laundry or customer-owned material in a warehouse.

7.5.5 - Preservation of ProductIdentification, handling, packaging, storage and protection.

7.6 - Control of Monitoring & Measuring DevicesVerifications, inspections and tests are important ways to ensure that the product meets the customer's expectations.

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It includes the following:

8.1-General8.2-Monitoring & Measurement8.3-Control of Nonconformity8.4-Analysis of Data8.5-Improvement

8.1 – General Organizations should define: what is the crucial information that they need?8.2 – Monitoring & Measurement

8.2.1-Customer Satisfaction Organizations had to go to the customer and ask "how am I performing"?

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8.2.2 - Internal Audit Allows an organization to determine the strengths and weaknesses of the quality system in place

8.2.3 - Measuring & Monitoring of Processes Organizations need to determine how they are going to measure whether activities are being adequately carried out.

8.2.4 - Measuring & Monitoring of Product It covers any activity that determines whether something is acceptable Like verification of quality, dimensions, weight, thickness, hardness, etc. 8.3 - Control of NonconformityIt is important that inspections are carried out, it is equally important that people know what to do with the nonconforming

8.4 - Analysis of DataThe sources of information can provide organizations with valuable data, but this data is only valuable if it is analyzed

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8.5 - Improvement

8.5.1 - Continual ImprovementEach organization should continually seek to improve, rather than waiting for a problem to reveal opportunities for improvement

8.5.2 - Corrective ActionTo ensure that actions are identified, taken and verified for implementation/ effectiveness

8.5.3 - Preventive ActionIt is better to prevent a problem than to correct a problem

Documented procedures are now required in only six areas:

Control of documents (4.2.3) Control of quality records (4.2.4) Internal audits (8.2.2) Control of nonconforming product (8.3) Corrective action (8.5.2) Preventive action (8.5.3)

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“WHY ISO?”

It controls quality

Saves money

Customers expect it

Competitors use it

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1) For Employees They get a better understanding of their work. There is a reduced stress level because of an efficient management system. New staff learns their job quickly because it's written down Increased morale of the workforce through registration to ISO 9000

BENEFITS OF ISO

2) For the Organization Products are consistent quality with fewer rejects Production is more efficient with less reworks Export marketing is easier Increased market share Customer confidence is enhanced as they

expect products of consistent quality

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3) Financial benefits

Profits are enhanced because of low rejections

More work is done in less time thus increasing production rate

Cost of quality comes down as a whole

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wecare

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INTELLECT STRATEGIC CONSULTANTS PVT. LTD. UNIVERSAL B2B SERVICE PROVIDER

UAE Office :

Al Sadafa General ContractingP.O. Box 63939 Al Ain United Arab Emirates

Tel. No. +971 3 7666067 Fax No. +971 3 7666034

Contact Person:Engr. Abdallah Mohammad

Ms. Dona BorjaMobile No. +97 1 559767485

Branch Office:

205-206, Atmiya Complex, Maneja Crossing

Vadodara – 390 013Gujarat, India.

Head Office:

B-62, Pariseema Complex, Opp. Swagat Complex,

Above Jade Blue,C.G.Road,

Ahmedabad – 380009,Gujarat, India.

+91 079 26462201+91 9825800332

1, Ajinkya Tara Society, CST Road, Chembur,

Mumbai – 400071Maharastra, India.

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