Shahi Enterprises Ltd. An ISO 9001:2008 Services Provider Company UAE Office : Shahi Enterprises FZE...
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Transcript of Shahi Enterprises Ltd. An ISO 9001:2008 Services Provider Company UAE Office : Shahi Enterprises FZE...
Shahi Enterprises Ltd. An ISO 9001:2008 Services Provider Company
UAE Office :Shahi Enterprises FZE
P.O. Box 31291 Al-JazeeraAl Hamra, Ras Al Khaimah
United Arab Emirates
Lead Auditor Shiv Shankar Mobile No. +971 562646057Email: [email protected]: www.shahifze.com
India Office:
205-206, Atmiya Complex, Maneja Crossing
Vadodara – 390 013Gujarat, India.
Tel: 9601349008 Email: [email protected]: www.shahienterprises.com
**************************Our Branches
***************************
Lucknow, Gorakhpur, Raipur, Kolkatta, New Delhi, Mumbai, Rajkot,Mehsana, Jamnagar,Ranchi,Dehradoon,
Guhawati Bangalore, Patna, Valsad.
Welcome to
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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. Inventory management. Machine breakdown monitoring. Neat working place. Training management staff.
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.
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We help for subsides for different quality standards from STATE & CENTRAL GOVT. Quality Up gradation System Subsidy 5% Interest Subsidy R&D Subsidy ETP (Environment Treatment Plan) Foreign Exhibition Subsidy IT Subsidy GEB Subsidy
Our Associations have been rewarding in the following areas of activities. Quality Standard Developments
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 UL/CE Marking API Monogram GMP- WHO & Product Up gradation
Business Development Franchise and Dealer Management Project Finance Liaison and Representation A Unit of Shahi Group
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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. Customer Focus
2. Leadership
3. Involvement Of People
4. Process Approach
5. System Approach
6. Continual Improvement
7. Factual Approach To Decision Making
8. 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 will 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 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) 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; and Facilitating 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 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 & 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 requirements
7.3.7 – 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 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 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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we
care
with
quality
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For
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Detail
Visit our website
www. shahifze.com
www.shahienterprises.com
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