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ISO 9001:2000
Quality management System
Introduction to
ISO 9001:2000
What is Quality ?
Quality is customer satisfaction Quality means conformance to specified requirements Quality means fitness for use
Latest definition
Quality
Degree to which a set of inherent characteristics (of a product, system or process) fulfills requirements (of customers and other interested parties).
(ISO 9000:2000)
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 organizations objectives.
Principle 2 Leadership
Principle 8
Mutually beneficial supplier relationships An organization and
its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
CHECK
Management Responsibility
Customer
Customer
Resource Management
Measurement Analysis and Improvement
Satisfaction
Requirements
Product Realization
Product
4.2.1 General
4.2.2 Quality manual 4.2.3 Control of Documents
5 Management Responsibility.
5.1 5.2 5.3 5.4 5.5 5.6 Management commitment Customer focus Quality Policy Planning (QMS and Q. Objectives) Responsibility, authority and communication Management Review
The organization shall determine and provide resources needed to implement and improve the Quality Management System.
and to enhance
Customer satisfaction
The organization will need to plan and develop processes required for Product realization.
7. Product Realization
7.1 Planning of Product Realization
To plan and develop the processes needed for Product Realization Planning to be consistent with the requirements of other processes of QMS (see 4.1) During planning, determine the following, as appropriate:
Quality Objectives and requirements for product; Need to establish processes & documents and provide resources; Required verification, validation, monitoring, inspection and test activities and criteria for product acceptance; Records to provide evidence that realization processes and resulting products fulfill requirements
Output of planning in a form suitable for organizations method of operations (It may be referred as Quality Plan)
Perform verification to ensure that D/D outputs have satisfied D/D input requirements Records of results of verification & necessary actions to be maintained
Wherever practicable, validation to be completed prior to delivery or implementation of the product Records of results of validation and necessary actions to be maintained
Any customer property lost, damaged or found unsuitable to be reported to customer and records maintained
Section 8 - Measurement, analysis & improvement 8.1 8.2 8.3 8.4 8.5 General Monitoring and measurement Control of nonconforming product Analysis of data Improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes: Conformity of product, of the QMS and achieve improvement
Quality Policy and Objectives A quality manual Documented Procedure required by the Standard Other documents required to monitor, control and improve the processes Records
NOTE 2:-
NOTE 3:-
(Level A)
QMS Procedures
A: Describe the QMS in accordance with the stated Quality Policy and Objectives
B: Describe the Interrelated Process and activities required to implement the QMS C: Consist of detailed work documents
(Level B)
Work Instructions and Other Documents (Level C)
b)
Documented procedures of the QMS or reference to them Description of the interaction between the QMS processes - Example
SPECIMENS\Justification for exclusions.pdf
c)
QUALITY POLICY
Example 1 XYZ Limited will continuously improve its products and services to satisfy the needs to its customers better and will deliver to them, on time and every time, defect-free products and services. Example 2 It is the companys policy to manufacture and market goods which comply with the customers needs and the designers specifications. The quality system is designed to ensure the maintenance of the product quality standard through the evaluation, inspection and verification of processes at all stages of manufacture. Compliance with the provisions and objectives of this manual are mandatory for all employees of the company.
QUALITY POLICY
Example 3 Quality means fitness for the intended purpose in all aspects of the companys activities. The company will strive to meet the needs of its customers through a continuous process of quality improvement. All employees are responsible for quality improvement. Education and training are vital to the quality improvement process. Measurable annual objectives for quality improvement will be set. Emphasis must be on prevention rather than detection. The company will involve its suppliers in the process of quality improvement.
Example 4 It is the policy of the company to continually meet and exceed customers' needs. This is the only way to ensure the companys future prosperity. To this end, the company has instituted a quality system which complies with ISO 9001. All staff shall be familiar with the quality procedures that are relevant to their work and shall use them.
QUALITY POLICY
Example 5 XYZ Ltd produces (state name of product) for both domestic and export markets. As a supplier, it is our policy to ensure that supplies adhere to contractual specifications and satisfy the customer in terms of consistent quality and timely delivery. We are committed to maintaining an effective quality management system through the active involvement of all employees. We will comply with all statutory safety and environmental regulations to ensure the safety of our employees and to discharge our responsibility to society.
QUALITY POLICY
Quality Policy of the Sri Lanka Standards Institution, Standardization Division is To enhance industrial development and economic growth of the country, we are committed to provide our technical services to exceed customer expectation every time, with high standards of professionalism, updated knowhow and through co-operate effort of all stakeholders
Aim to reduce
Errors:variations,defects,failure,repair, damages,rework,reject,complaints,warranties, claims,accident,idle time, non-conformity, etc. Breakdown of : equipment, process, machine, instrument, software, etc. Delays of : internal schedules, delivery schedules, promised services, benefits, awards, payment to suppliers, etc.
Aim to reduce
Inventories : raw, process, semi-finished & finished product; spares, consumables, etc.. Paper Work : Excessive procedures, recording/approvals, etc. Emissions : To air, to water, to ground, noise, vibrations, spillages, leakages, odour, etc
Aim to improve
Customer satisfaction : Increased turnover, customer retention, compliments, timely payment, etc. Yield : Production efficiency, throughput per unit of inputs/per hour/per unit of space etc. Employee Satisfaction : Competency, career advancements, involvement etc. Profits : Per unit of sale, per unit of input, per employee, per machine, ROI, etc.
QUALITY OBJECTIVES To improve average customer satisfaction level by 3% from last year. To improve sale by 30% from that of last year. To maintain or reduce manufacturing and marketing cost by 5% through effective development of personnel and processes. To increase production by 30% from last year. To reduce the rejection and product non conformities by 5% from last year average. To improve scheduled delivery by 5% over last year average To meet and maintain statutory/regulatory requirements.
Lalit Mahajan Managing Director
Reference:
Reference:
I N T
6.2,
6.3,
6.4 Q M S D O C U M E N T A T I O N
E R N A L C U S T O M E R
Sales & Marketing 7.2 R&D 7.3
Supplier
7.5.3 Procurement 7.4 Stores 7.5.5 7.5.3 Production 7.5.1 7.6 Customer Property 7.5.4
Verification. 7.4.3 After Sales
A U D I T
8.2.2
NCPs 8.3
Product MM 8.2.4 7.6
C U S T O M E R
Data Analysis