ISO 9001 : 2000

Objective Introduce the concept of ISO 9001 Standard Highlight important areas of ISO 9001 Standard Briefly introduce the system requirements of ISO 9001 Standard

What is ISO 9001: 2000 Quality Management System Requirement Standard from International Organization for Standards Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994 Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements

Continual Improvement cycle ISO 9001:2000 QMS Management Responsibility General requirements Resource management Measurement, analysis & improvements Product Realization Continual Improvement cycle

CUSTOMERS CUSTOMERS ISO 9001 : 2000 – Model 5.Management Continual Improvement of the Quality Management System Quality Management System 5.Management Responsibility 8. Measurement Analysis and Improvement 6. Resource Management CUSTOMERS CUSTOMERS Satisfaction 7. Product Realization Requirements Product Consumption

Principles of ISO 9001:2000 Customer focus Leadership Mutual beneficial supplier relationship Involvement of people Based on eight quality management principles Factual approach to decision making Process approach System approach to Management Continual improvement

Principles of ISO 9001:2000 Customer focus Leadership Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations Leadership Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organization’s objectives Involvement of People People of all levels are essence of an organization Their full involvement for organization’s benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process

Principles of ISO 9001:2000 Continual improvements System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency Continual improvements Continual improvement of the organization’s overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships An organization & its suppliers are interdependent Mutually beneficial relationship enhances the ability of both to create value

Expectations of ISO 9001:2000 Avoid the application of systems that are separate from the organization’s business process Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business Enable Continual improvements of the system for enhanced customer satisfaction Enable compliance to statutory & regulatory requirements

Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs Identify the processes Identify the Inputs & outputs Identify the Interactions to other processes Establish measuring criteria Ensure continual improvements Do it for all value adding processes

Process approach – Continual improvements of Process Understandings & meeting requirements PLAN PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK

E.g. - Purchasing Process Procedure Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time Interactions to Storage Inspection and Testing Manufacturing Finance Performance Measurements Delivery status – On-time, On spec, NCP etc Supplier evaluation

System Requirements / Structure of the Standard 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement Management Commitment Customer focus Quality policy Planning Responsibility, authority & communication Management Reviews General requirements Documentation Requirements Provision of resources Human resources Infrastructures Work environment Planning Customer related processes Design & development Purchasing Production & service provision General Monitoring & measurement Control of NCP Analysis of data Improvements

4 - Quality management system Identification of processes required Continual improvements 4.1 General requirements Criteria and methods to ensure Operation & control Monitoring and Measuring of processes Availability of information & resources for operation & control

4 - Quality management system 4.2 Document requirements Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records

5 - Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility authority & communicate 5.6 Management Review Quality objectives QMS planning Internal communication Management representative Responsibility & authority General Review inputs Review outputs

5 - Management Responsibility Development, implementation and continually improvement of QMS Establishment of Quality Policy Quality Objectives Top Management’s commitment Identification of Customer requirements Appointment of Management Representative Conducting Management Reviews Providing required resources Communication of importance of Regulatory & statutory requirements Meeting customer requirements Quality Policy & Quality objectives Responsibilities & authorities

5 - Management Responsibility Evidence must be provided to show that the Management is committed to the above requirements Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system

6 - Resource Management 6.1 Provision of resources 6.2 Human Resources 6.3 Infrastructures 6.4 Work Environment General Competence, awareness & training

6 - Resource Management Resources required to Human Resources Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Human Resources Resource Management Infrastructures Infrastructures needed to achieve product conformity Work environment Work environment needed to achieve product conformity

6 - Human Resources 6.2 Human Resources Enhanced Competent on the basis of appropriate education, skill and experience Define competencies for people performing work affecting product quality 6.2 Human Resources Provide training or actions Evaluate effectiveness of the training / actions Employees should aware importance of the activity being performed

7 - Product Realization 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 Identification of customer requirement Review of customer requirement Customer communication Design planning Design inputs Design outputs Design review Design Changes Design validation Design verification Verification of purchased products Purchasing process Purchasing information Control Preservation of product Validation of processes Identification & traceability Customer property

7 - Product Realization 7.1 Planning of Product realization Quality objectives of Products – Specs 7.1 Planning of Product realization Processes, procedures to realize product Verification, validation, monitoring, inspection and testing of product Record to demonstrate conformance

7 - Product Realization 7.2 Customer related processes – (Sales) Identification of Customer / Market requirements Specified by customer Requirements taken for granted Statutory / Regulatory requirements 7.2 Customer related processes – (Sales) Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements Effective communication with customer in relation to Product information Sales order handling Customer feedback Customer complaints

Design and Development – (Product) 7 - Product Realization Planning Effective & efficient Expectations of interested parties EHS 7.3 Design and Development – (Product) Design inputs and outputs Review and verification, validation and control of changes Accuracy Potential hazards & faults Corrections Evaluations against lessons learned

Clause 7.3 Design Process Design plan 7.3.1 Design Review 7.3.4 C U U T O M E R U S E R Design Input 7.3.2 Design Output 7.3.3 Design Process Design verification 7.3.5 Design validation 7.3.6 Design changes 7.3.7

7 - Product Realization 7.4 Purchasing Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements Supplier evaluation Verification of purchased product – Inspection and testing

7 - Product Realization Product characteristics (Specs) Procedures and work instructions Suitable equipments to manufacture. Monitoring and inspection & testing 7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product Product release, delivery and post delivery Process validation Identification and traceability Customers property Material supplied by customers – e.g.. 3rd party blending

7 - Product Realization 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing

8 - Measurement, analysis and improvement 8.3 Control of non conforming product 8.1 General 8.2 Monitoring & measurements 8.4 Analysis of data 8.5 Improvement Measurement of product Internal audits Customer satisfaction Measurement of processes Corrective action Preventive action Continual improvements

8 - Measurement, analysis and improvement To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system 8.1 - To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system 8.2 - Monitoring and Measurements Customer satisfaction / perception Internal audits - conformity planned arrangements of QMS and ISO9001 Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results Monitoring and measurements of product – Conformity to product requirements 8.3 - Control of NCP To assure that NCP products are identified and controlled to prevent unintended use / delivery

8 - Measurement, analysis and improvement 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system Analysis shall provide information related to Customer satisfaction / perception Conformity to specs, requirements Trends of processes and products Opportunities for preventive actions Suppliers

8 - Measurement, analysis and improvement 8.5 - Improvements Continual Improvements QMS needed to be continually improved Corrective action Actions to prevent recurrence of NCP, NCR etc Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records Preventive action Actions against potential non conformities to avoid their occurrence Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records

Criteria for measurements Satisfaction surveys for customers and other interested parties Feedback on products Customer & market requirements Financial measurements Prevention cost Non conforming / failure cost Lifecycle cost System performance Self assessment Internal audits Effectiveness & efficiency of processes Opportunities for improvements Use of data / information Effective & efficient use of resources Adequacy, accuracy and performance of measurements Relationships with customers/ suppliers/ other interested parties

Criteria for measurements Process capability / process validation Reaction time Cycle time / throughput (Capacity) Utilization of technology Waste reduction Cost reduction Processes Products Inspection and testing of incoming, in process and final product Product verification Product validation

Pros and Cons More business oriented. Less procedure oriented Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Continual improvements Less emphasis on documentation More resource demanding ??

Challenges in implementing ISO 9001:2000 Management Support Encouragement ISO 9001:2000 Other employee Support Communication

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