WHAT IS ISO 9000

WHAT IS ISO 9000 ISO is a ‘nickname’ to “International Organization for Standardization”. An international standard more than 100 countries ISO is a non-governmental organization established in 1947 by International Standard Agency headquartered in Geneva. Principles are applicable to all organizations

WHAT IS ISO 9000 ISO 9000 is a written set of standard which describe and define the basic elements/clauses of the quality system needed to ensure that an organization’s products/or services meet or exceed customer needs and expectations

Principles of ISO 9000 ISO 9000 is a standard for a quality system, not product. ISO 9000 is based on documentation and is premised on the following:- - Document what you do; - Do what your document; - Prove it and improve it ISO 9000 emphasizes prevention. ISO 9000 is a universal standard; the focus is on what needs to be done and not on how it is to be carried out

WHY QUALITY SYSTEM - ISO 9000 to satisfy customers through a quality product to gain self confidence – we get what we planned to achieve competitiveness in both the local and overseas markets. as a blueprint for efforts to improve the quality system of the organization.

QUALITY SYSTEM = VEHICLE QUALITY MANAGEMENT = DRIVER QUALITY POLICY = ROAD MAP

ADVANTAGES OF ISO 9000 IMPLEMENTATION

WHAT IS IT INTENDED FOR? This International Standard specifies quality system requirements for use where organization’s capability to design and supply conforming product needs to be demonstrated. The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing

BENEFITS OF ISO 9000 IMPLEMENTATION For the company:- - Well defined organization and responsibilities, i.e., minimize grey areas and possible resources wastage. - Standardize practice and establishment of proper communication channel, i.e. maximize productivity and communication efficiency.

BENEFITS OF ISO 9000 IMPLEMENTATION For the company:- - A greater degree of internal control. - Ultimately, increase profitability and market share, improve competitive position. For the customer:- - Increase satisfaction and growth in confidence.

QUALITY MANAGEMENT SYSTEM – ISO 9001:2000 Set of comprehensive and fundamentals rules or beliefs for leading and operating an organization. The aim is to improve performance continually , by focusing on customers while addressing the needs of all stakeholders.

ISO 9000-2000 QMS- |Fundamentals and vocabulary Provides fundamentals of QMS and specifies QM terms and definitions ISO 9001-2000 QMS- Requirements Specifies requirements for a QMS where an organization needs to demonstrate its capability to meet customer requirement for product/service and its assessment ISO 9004-2000 QMS- Guidance for performance improvements Provides guidance on QMS as a mean of continual improvement of processes that contribute to the satisfaction of customers

Eight Quality Management Principles which can facilitate any organization in creating quality work culture Customer - focused organization Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship

Customer focused organization Identify customer needs Design a product that respond to customer needs Produce and deliver the product as per the design Enhance after sales service Measure customer satisfaction Improve quality to delight the customer

Leadership Senior leaders set directions and create customer orientation. Values, directions and expectations must address all stakeholders. Leaders needs to ensure the creation of strategies, systems and methods for achieving excellence. Should encourage participation, learning innovation and creativity. Serve as role models who reinforce values and expectations.

Involvement of people Involvement of all people is one way of improving quality and productivity. Involvement of people at all levels by providing a good corporate culture providing an interesting environment, and building the capability to perform tasks in the organization

Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process.

System approach to Management Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization

Continuous Improvement Continually improve the performance by addressing the needs of all the interested parties is the permanent objective of the organization

Factual approach to Decision-making Effective decisions are based on the logical or intuitive analysis of data and information

Mutually Beneficial Supplier Relationship To create value mutual beneficial relationship between the organization and supplier in necessary

Structure of the ISO 9001:2000 standard 20 elements of ISO 9001:1994 still there but in the context of a model based on organizational processes Core organizational processes covered under: Clause 4. QUALITY MANAGEMENT SYSTEM Clause 5. MANAGEMENT RESPONSIBILITY Clause 6. RESOURCE MANAGEMENT Clause 7. PRODUCT REALISATION Clause 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT

Structure of the new ISO 9001:2000 standard - Process-oriented structure and a more logical sequence of contents - Allows for more flexibility on amount of documentation - Changes in terminology for easier interpretation by all sectors.

QUALITY MANAGEMENT SYSTEM Continual improvement of the Quality management system Management responsibility Customers Customers Measurement, analysis and improvement Resource management Satisfaction Requirements The ISO 9001:2000 Requirements: Scope General Application Normative reference Terms and definitions Quality management system General requirements Documentation requirements Quality manual Control of documents Control of records Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Output Input Product realization Product Information flow Value-adding activities Reference: ISO 9001:2000

The ISO 9001:2000 standard has new more clearly defined requirements relating to : Continual improvement; Increased emphasis on the role of top management; Consideration of legal and regulatory requirements; Establishment of measurable objectives at relevant functions and levels; Monitoring of information of customer satisfaction as a measure of system performance;

The ISO 9001:2000 standard has new more clearly defined requirements relating to : (contd.) Increased attention to resource availability; Determination of training effectiveness; Measurements extended to systems, process and product; Analysis of collected data on the performance of the QMS; Control of outsourced processes .

ISO 9001: 2001 1. Scope 2. Normative reference 3. Definitions 4. Quality system requirements 4.1 General requirements Organization shall establish document implement and maintain a QMS and continually improve 4.2 Documentation Requirement It includes Quality policy Quality objectives Quality manual Documented procedures Documents to ensure effective planning Operation and control of processes and records required by the international standard

5. Management Responsibility 5.1 Management Commitment development and implementation of QMS Continuous Improvement in its effectiveness 5.2 Customer Focus Constantly endeavor to enhance customer satisfaction 5.3 Quality Policy The quality policy is appropriate to the purpose of the organization includes the commitment to comply with requiremtns and continually improve QMS framework for reviewing quality objectives understood in the organization reviewed for continuing stability 5.4 Planning Quality Objectives QMS Planning

5.5 Responsibility, Authority and Communication define the responsibilities and authority of the key personnel and ensure they are known throughout the organization. 5.6 Management Review Review of the QMS at regular intervals 6. Resource Management 6.1 Organization shall determine and provide needed resources 6.2 Workers will be provided necessary education, training skills and experience 6.3 organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirement 7. Product or Service Realization 7.1 Planning of processes needed for Product/Service realization 7.2 Customer Related Processes

7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices 8. Measurement, analysis and improvement (title only) 8.1 General 8.2 Monitoring and measurement (title only) 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement (title only) 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

DOCUMENTING THE SYSTEM BASED ON ISO 9001:2000 STANDARD

Quality Management System Documentation The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. (Clause 4.1, ISO 9001:2000) Documentation is a set of documents, for example specifications and records. Document is information (meaningful data) and its supporting medium. Quality management system is a management system to direct and control an organization with regard to quality. Quality manual is the document specifying the quality management system of an organization.

DOCUMENTATION PYRAMID LOW QUALITY/ POLICY MANUAL LEVEL 1 LEVEL 2 LEVEL 3 LEVEL 4 OPERATION PROCEDURES DETAIL WORK INSTRUCTIONS FORMS, LABEL, RECORDS, ETC. HIGH A Purchasing Department B Production Department C Personnel Department D Quality Control E Stores

LEVEL 1: QUALITY MANUAL The quality manual as a highest level document at the peak of a pyramid outlining the quality system and acting as a directory for the documents and procedures below. It will outline the company’s policy and commitment to quality.

WHY NEED QUALITY MANUAL? Communicating the organization’s quality policy, procedures and requirements; Describing and implementing an effective quality system; Providing improved control of practices and facilitating assurance activities; Providing the documented bases for auditing the quality system; Providing continuity of the quality system and its requirements during changing circumstances; Training personnel; Presenting quality system for external purposes; Demonstrating compliance of the quality system with quality requirements

Quality Policy Clause 5.3 The overall quality intentions and direction of an organization related to quality, as formally expressed by top management