Welcome to Shahi Enterprises Ltd. An ISO 9001:2008 Services Provider Company India Office: 205-206, Atmiya Complex, Maneja Crossing Vadodara – 390 013 Gujarat, India. Tel: 9601349008 Email: [email protected] Website: www.shahienterprises.com UAE.

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Transcript Welcome to Shahi Enterprises Ltd. An ISO 9001:2008 Services Provider Company India Office: 205-206, Atmiya Complex, Maneja Crossing Vadodara – 390 013 Gujarat, India. Tel: 9601349008 Email: [email protected] Website: www.shahienterprises.com UAE.

Welcome to

Shahi Enterprises Ltd.

An ISO 9001:2008 Services Provider Company

India Office: 205-206, Atmiya Complex, Maneja Crossing Vadodara – 390 013 Gujarat, India.

Tel: 9601349008 Email: [email protected]

Website: www.shahienterprises.com

UAE Office : Shahi Enterprises FZE P.O. Box 31291 Al-Jazeera Al Hamra, Ras Al Khaimah United Arab Emirates Lead Auditor Shiv Shankar Mobile No. +971 562646057 Email: [email protected]

Website: www.shahifze.com

************************** Our Branches ***************************

Lucknow, Gorakhpur, Raipur, Kolkatta, New Delhi, Mumbai, Rajkot,Mehsana, Jamnagar,Ranchi,Dehradoon, Guhawati Bangalore, Patna, Valsad.

Shahi Enterprises has been established in 2004 as a Quality Consulting firm in India at Baroda (Vadodara). Shahi Enterprises has grown from a Quality Consulting firm now become a limited company providing its quality management consulting services to various parts of India (Gujarat, Maharashtra, Uttar Pradesh, Uttarakhand, and Chhattisgarh) and started its quality consultancy services at UAE. We have our offices at Baroda, Lucknow, Mumbai, Guwahati.

Shahi Enterprises is serving over more than two thousand certified clients providing them whole range of ISO Certification Consulting Services for ISO 9001, ISO14001, ISO 18001, ISO 22000, ISO 27001, HACCP, BRC, PED, UL/CE Marking, API Monogram, Trade Mark, GMP- WHO & Product Up gradation.

Shahi Enterprises Ltd. train and utilize highly capable staff to provide valuable service to assist our clients to achieve the international recognition and acceptance through the standard of the quality management system, it would cover systematic approach through format for:

Purchase order/-monitoring Storage.

Process control/production planning.

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Inventory management. Machine breakdown monitoring.

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Neat working place. Training management staff.

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We help for subsides for different quality standards from STATE & CENTRAL GOVT.

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Quality Up gradation System Subsidy 5% Interest Subsidy

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R&D Subsidy ETP (Environment Treatment Plan)

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Foreign Exhibition Subsidy IT Subsidy GEB Subsidy Our Associations have been rewarding in the following areas of activities.

Quality Standard Developments

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ISO 14001-2004 Environment Management System ISO 18001-2007 Occupational Health & Safety Management System ISO 22000-2005 Food Safety Management System ISO 27001-2005 Information Security Management System HACCP – Hazard Analysis and Critical Control Points BRC - British Retail Consortium PED - Pressure Equipment Derivative QUALITY & HR- TRAINING Product Certification

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UL/CE Marking API Monogram GMP- WHO & Product Up gradation Business Development

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Franchise and Dealer Management Project Finance Liaison and Representation

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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

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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

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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 rigour 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.

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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.

2.

3.

4.

5.

6.

7.

8.

Customer Focus Leadership Involvement Of People Process Approach System Approach Continual Improvement Factual Approach To Decision Making 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.

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Customer is a only Profit If you don't care of your customers somebody else will Without customers businesses do not survive Which Qualities Required for Customer Focus ?

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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."

      

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

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?

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Meaning :

People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation'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) 2) 3) 4) How people are involved in the organization?

Are people accountable for their own performance? How?

Are people participate in and contribute to continual improvement? How?

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, and managing understanding interrelated processes

Regarded as a "system"

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Meaning :

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

Developing systems

An ongoing need to improve effectiveness system and of a maintaining the management

Continuous the establishment targets improvement of through goals and

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Meaning : 1)

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

 

Accurate making data for decision Effective decisions are based on the analysis of data and information.

Which method is been adopted for collecting data and relevant information?

2) 3) 4) How you analyze the collected data?

Data and information collected by you are matching as per your requirement? How?

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) 2) 3) 4) How you recognized your supplier?

What are the key elements you take into consideration while dealing with the supplier?

How you communicate with your customer/supplier to improve relations?

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 effective; processes to

Keeping adequate records; ensure they are

Checking output for defects, with appropriate and corrective action where necessary;

Regularly reviewing individual processes and the quality system itself for effectiveness; and

Facilitating continual improvement

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WHAT STANDARDS DO

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

STANDARDS COVERS

    

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

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

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Quality Management System Management Responsibility Resource Management

Product Realization

Measurement, Analysis And Improvement

Clause No.4

Clause No.5

Clause No.6

Clause No.7

Clause No.8

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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

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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

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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

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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 Commitment 5.2 - Customer Focus 5.3 - Quality Policy 5.4 - 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 – Planning

5.4.1 Quality Objectives

SMART

S -Specific M -Measurable A -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 Review

5.6.1 – General

Regular management reviews ensure that the quality management system is still suitable, adequate, and effective in a changed environment 5.6.2 – Review Input The 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 Output The output of review must be recorded. The decisions and actions may be related to:

improvement of QMS and its processes

improvement of product

resource needs

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Review and provide the resources needed to implement and improve the system It includes the following: 6.1 - Provision of Resources 6.2 - Human Resources 6.3 - Infrastructure 6.4 - 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 - General Product requirements shall be competent on the basis of: 1. Appropriate education 2. Training 3. Skills 4. Experience 6.2.2 - Competence, Awareness & Training You must :

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

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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

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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 delivery It includes the following: 7.1 - Planning of Product Realization 7.2 – Customer Related Processes 7.3 - Design and Development 7.4 - Purchasing 7.5 - Production & Service Provision 7.6 - 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 Process

7.2.1 - Determination of Requirements Related to the Product For 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 Product Ensure that organization understand and can meet customer requirements 7.2.3 - Customer Communication Aimed 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 & Development

7.3.1 – Design Planning Identify responsibilities/ authorities and specific timelines 7.3.2 – Design Input It should be clear how the final product is going to look, and which conditions must be fulfilled.

7.3.3 – Design Output Specify the design outputs required form the design or development proposed 7.3.4 – Design Review Ensure that the process is regularly reviewed and recorded 7.3.5 – Design Verification Verify the design to check they comply with the input requirements 7.3.6 – Design Validation The actual physical product meets the original input requirements 7.3.7 – Design Changes If changes are necessary through out and post the design process ensure that it is controlled

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7.4 - Purchasing

7.4.1 – 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 supplier 7.4.3 – Verification of Purchased Product

An organization needs to ensure that the product or service from the supplier meets its requirements

7.5 – Production & Service Provision

7.5.1 - 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 Provision The 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 Property

Defines:- 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 Product Identification, handling, packaging, storage and protection.

7.6 - Control of Monitoring & Measuring Devices

Verifications, 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-General 8.2-Monitoring & Measurement 8.3-Control of Nonconformity 8.4-Analysis of Data 8.5-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 Nonconformity

It is important that inspections are carried out, it is equally important that people know what to do with the nonconforming

8.4 - Analysis of Data

The 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 Improvement Each organization should continually seek to improve, rather than waiting for a problem to reveal opportunities for improvement 8.5.2 - Corrective Action To ensure that actions are identified, taken and verified for implementation/ effectiveness 8.5.3 - Preventive Action It 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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BENEFITS OF ISO

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

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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we care with quality

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For More

Detail Visit our website www. shahifze.com

www.shahienterprises.com

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