ISO9000 Partha

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ISO M.PHARM QUALITY ASSURANCE

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ISO 9000:

ISO 9000 Parthasarathy G

What is ISO 9000?:

What is ISO 9000? ISO 9000 is a standard to conduct any business It is a set of rules which should be followed in order to meet the needs and understand the wants of customers

Objectives of ISO 9000 Standards:

Objectives of ISO 9000 Standards Achieve, maintain, and improve product quality Improve quality of operations to continually meet customers and needs Provide confidence to management, employees, customers, and stakeholders that quality requirements are fulfilled

ISO 9000 Key Characteristics:

ISO 9000 Key Characteristics Establishes a quality management system (QMS) to facilitates consistency It is not prescriptive; does not tell “how” to do anything; specifies “what” processes need to be in place It is not a product standard It is site specific

How is ISO 9000 Being Implemented Today?:

How is ISO 9000 Being Implemented Today? If an organization implements ISO 9000 in order to simply remain competitive and without mutually beneficial goals in mind, it will most likely fail in the long term

ISO Implementation:

ISO Implementation Implementing ISO 9000 in an organization can be very beneficial The goal of this implementation is to achieve customer satisfaction at its highest level

How can ISO 9000 be used in a business?:

How can ISO 9000 be used in a business? ISO 9000 can benefit many industries, such as: Banking Health Care Manufacturing, etc. ISO 9000 is generic , so it can be applied virtually anywhere! ISO 9000 is just one part of an entire system needed to create value for customers

ISO 9000: In Depth:

ISO 9000: In Depth ISO is not an acronym ISO is a name used for the International Organization for Standardization The ISO was formed in 1947 in Geneva, Switzerland

ISO 9000: In Depth:

ISO 9000: In Depth ISO counts 140 nations as member bodies (actively involved in the nearly 3,000 technical committees and other activities of the organization), correspondent members, and subscriber members.

ISO 9000:In Depth (cont):

ISO 9000:In Depth (cont) ISO 9000 is a European Standard The organization has two stated objectives: 1. To promote development of standardization to facilitate international exchange of goods and services. 2. To promote cooperation in intellectual, scientific, technological, and economic activity.

What is the role of BIS in ISO 9000? :

What is the role of BIS in ISO 9000? BIS is the National Standards Body of India and is a founder member of ISO.  BIS represents India, in ISO. Quality and industry experts from India including BIS officers nominated by BIS participate in the meetings of the Technical Committee of ISO and its Sub-committees.

What are the parts of ISO 9000?:

What are the parts of ISO 9000? ISO 9000 is composed of 5 different, but related parts: ISO 9000, 9001, 9002, 9003, and 9004 ISO 9000 and 9004 are guidelines, while ISO 9001, 9002, and 9003 are the categories in which a company may apply for certification

Part 1: ISO 9000:

Part 1: ISO 9000 ISO 9000: “Quality Management and Quality Assurance Standards – Guidelines for Selection and Use” Written in order to determine which category your organization should apply for

Part 2: ISO 9001:

Part 2: ISO 9001 ISO 9001: “Quality Systems – Model for Quality Assurance in Design/Development, Production, Installation, and Servicing” This is the category for companies which are involved in manufacturing or the creation and delivery of a service.

Part 3: ISO 9002:

Part 3: ISO 9002 ISO 9002: “Quality Systems – Model for Quality Assurance in Production and Installation” Companies who perform many functions, with the exception of design and development, may apply to this category

Part 4: ISO 9003:

Part 4: ISO 9003 ISO 9003: “Quality Systems – Model for Quality Assurance in Final Inspection and Test” This category is useful for outside of the manufacturing sector, such as in distributors ISO 9003 is being used less and may be dropped in the future

Part 5: ISO 9004:

Part 5: ISO 9004 ISO 9004: “Quality Management and Quality System Elements – Guidelines” Used in order to help interpret the categories included in ISO 9000 certification

Other ISO Programs:

Other ISO Programs ISO 9000:2000 ISO 9000 upgraded for 2000 ISO 14000 ISO 14000 is environmental certification for an organization Not as prominent, as environmental issues are more complex than ISO 9000 issues

ISO 9000:2000 Standards:

ISO 9000:2000 Standards ISO 9000:2000, Quality Management Systems – Fundamentals and Vocabulary ISO 9001:2000, Quality Management Systems - Requirements ISO 9004:2000, Quality Management Systems – Guidelines for Performance Improvement

ISO 9000:2000 Quality Management Principles:

ISO 9000:2000 Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships

Principles of new standard:

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

Structure of ISO 9000 Standards:

Structure of ISO 9000 Standards 21 elements organized into five major sections: System Requirements Management Responsibility Resource Management Product Realization Measurement, Analysis, and Improvement

Structure of ISO 9000 Standards:

Structure of ISO 9000 Standards QMS Resource management Measurement, analysis & improvements Product Realization Management Responsibility Continual Improvement cycle General requirements General requirements

ISO 9001:2000 – Model:

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

ISO 9001:2000 Requirements:

ISO 9001:2000 Requirements System Requirements Establish a quality management system Document the quality management system

ISO 9001:2000 Requirements:

ISO 9001:2000 Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Administration Management Review

ISO 9001:2000 Requirements:

ISO 9001:2000 Requirements Resource Management Provision of Resources Human Resources Facilities Work Environment

ISO 9001:2000 Requirements:

ISO 9001:2000 Requirements Product and/or Service Realization Planning of Realization Processes Customer-Related Processes Design and/or Development Purchasing Production and Service Operations Control of Measuring and Monitoring Devices

ISO 9001:2000 Requirements:

ISO 9001:2000 Requirements Measurement, Analysis, and Improvement Planning Measurement and Monitoring Control of Nonconformity Analysis of Data Improvement

System Requirements / Structure of the Standard:

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

4 - Quality management system:

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

4 - Quality management system:

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

5 - Management Responsibility :

5.6 Responsibility authority & communicate 5.4 Planning 5 - Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.7 Management Review 5.3 Quality policy Quality objectives QMS planning General Review inputs Review outputs Internal communication Management representative Responsibility & authority

5 - Management Responsibility:

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

5 - Management Responsibility:

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:

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

6 - Resource Management:

1/12/2013 6 - Resource Management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Human Resources Infrastructures Infrastructures needed to achieve product conformity Work environment Work environment needed to achieve product conformity Resource Management

6 - Human Resources:

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

7 - Product Realization :

7.6 Control of monitoring measuring devices Control Preservation of product Validation of processes Identification & traceability Customer property 7.5 Production & service provision Verification of purchased products Purchasing process Purchasing information 7.4 Purchasing Design planning Design inputs Design outputs Design review Design Changes Design validation Design verification 7.3 Design and development 7 - Product Realization 7.1 Planning of product realization Identification of customer requirement Review of customer requirement Customer communication 7.2 Customer related processes

7 - Product Realization :

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

7 - Product Realization :

7 - Product Realization 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 Identification of Customer / Market requirements Specified by customer Requirements taken for granted Statutory / Regulatory requirements 7.2 Customer related processes – (Sales)

7 - Product Realization :

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

7 - Product Realization :

7 - Product Realization Supplier evaluation Verification of purchased product – Inspection and testing 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

7 - Product Realization :

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

7 - Product Realization :

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

8 - Measurement, analysis and improvement:

8 - Measurement, analysis and improvement 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 T o assure that NCP products are identified and controlled to prevent unintended use / delivery 8.1 - To demonstrate Conformity of the product Conformity to QMS requirements Continually improvements and the effectiveness of the system

8 - Measurement, analysis and improvement:

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:

1/12/2013 http://www.kwaliteg.co.za - ISO 9000:2000 explained 49 8 - Measurement, analysis and improvement 8.5 - Improvements Continual Improvements QMS needed to be continually improved Corrective action 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:

1/12/2013 http://www.kwaliteg.co.za - ISO 9000:2000 explained 50 Criteria for measurements 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 Financial measurements Prevention cost Non conforming / failure cost Lifecycle cost Self assessment Satisfaction surveys for customers and other interested parties Feedback on products Customer & market requirements System performance

Criteria for measurements:

1/12/2013 http://www.kwaliteg.co.za - ISO 9000:2000 explained 51 Criteria for measurements Inspection and testing of incoming, in process and final product Product verification Product validation Process capability / process validation Reaction time Cycle time / throughput (Capacity) Utilization of technology Waste reduction Cost reduction Products Processes

Documentation Levels of 9001:2000:

Documentation Levels of 9001:2000 Manual (philosophy, policy, objectives, approach) Procedures Work instructions (department, product, process) Records (proof and objective evidence) Ad-hoc, temporary documents

ISO 9000 Certification Process:

ISO 9000 Certification Process 1. The company first implements the control and documentation procedures outlined in the series. 2. It then involves a thorough audit by an independent certification organization (i.e., a Registrar) that is licensed to register quality systems by an accreditation body (e.g., Registrar Accreditation Board in U.S.)

ISO 9000 Certification Process:

ISO 9000 Certification Process 3. Upon compliance, it receives a registration certificate and its name is included in a published directory of registered suppliers. 4. The systems will be continually verified by the registrar in periodic surveillance and full audits are conducted every few years.

Potential Benefits of Registration:

Potential Benefits of Registration Documentation of quality management system Reduction of variation Help develop and expand business Reduction or elimination of customer audit Increased profitability/reduced costs

Potential Benefits of Registration:

Potential Benefits of Registration Improved communication, both internal and external Greater awareness of quality by employees Provision of training to all employees Ability to remain or become competitive Elimination of duplication of quality systems

Problems with Certification:

Problems with Certification Costs - application & maintenance Time - application & maintenance Level of internal expertise Executive commitment Selection of registration

Summary: ISO 9000:

Summary: ISO 9000 ISO 9000 is a standard in which organizations conduct business ISO 9000 has 5 parts ISO 9000 is a generic standard There are currently over 70,000 organizations registered for ISO 9000 certification

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