International Systems and Standards. Discussion Topics. Introduction to Quality and Standardization Evolution of Quality Management System (ISO 9000) Quality Management System - Requirements (ISO 9001:2008). Introduction to Quality and Standardization. What is Quality after all?. Quality…!.
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Discussion Topics Introduction to Quality and Standardization Evolution of Quality Management System (ISO 9000) Quality Management System - Requirements (ISO 9001:2008)
Quality…! • ‘Fitness for use’ – Juran • ‘Conformance to requirements’ – Crosby • ‘Customer satisfaction/delight’ – Deming • ‘Degree to which a set of inherent characteristics fulfils requirements’ - ISO 9000:2000
Customer Satisfaction “ Degree to which the customer’s requirements have been fulfilled ” Performance < 1 - Dissatisfaction Satisfaction = = 1 - Satisfaction Expectation > 1 - Delight
Standardization The process of developing and agreeing upon Standards.
Aims of Standardization • Fitness for purpose • Interchangeability • Variety reduction • Compatibility • Guarding against factors that affect the health and safety of consumers • Environmental protection • Better utilization of resources • Better communication and understanding • Better communication and understanding • Removal of trade barriers
Standard? Standards are documented agreements containing technical specifications or precise criteria to be used consistently as a guideline of characteristics, to ensure that materials, products, processes and services are fit for their intended purpose.
TYPES OF STANDARDS Vocabulary standards: Glossaries, signs and symbols; A few examples are Paper Vocabulary, List of Equivalent Terms Used in the Plastic Industry, Vocabulary for the Refractory Industry and Vocabulary of Information Processing. Measurement standards: Material measure or physical property that defines or reproduces the unit of measurement of a base or derived quantity. Such as units of measures; The seven basic units of the SI system e.g. meter, Kg, Ampere etc. Product standards: Cover specifications for dimensions, performance, health, safety, environmental protection and documentation; Standards for inspection, test methods and analysis. Management Standards: Standards that focus on organization, such as for logistics, maintenance, inventory management, quality management, project management and production management such as ISO 9000, ISO 14000, ISO 17025, SA 8000, HACCP etc.
Attributes of a standard A standard generally has three attributes: Level: such as at the company, national or international level. Subject: such as engineering, food, textile or management. Aspect: such as specification, testing and analysis, packaging and labeling (more than one aspect may be covered in a single standard: a standard may include specification of items such as the product, its sampling and inspection, related tests and analysis, packaging and labeling). For example the term “Pakistan Standard Specification of Biscuits”, means that the standard is a national standard (level), in the food area (subject), and provides specifications (aspect) for the biscuits.
Infrastructure for Standardization in Pakistan ISO ILAC IAF Legal framework in Pakistan BIPM OIML Accreditation Board PNAC Standards Institute PSQCA An institution for training and monitoring Auditors System certifiers.. System auditors System consultants Laboratory accreditation ISO 17025 NPSL CALIBRATION HACCP ISO14000 ISO 9000 LABORATORIES Legal metrology CALIBRATION Microbe Chemical Textile TESTING SERVICES Factory metrology lab Trade transaction ENTERPRISES
Certification Means Compliance with a standard or specification (e.g. Systems or Product Standards). May be general in the scope of recognition Considers total business .
Accreditation It means recognition of competence in a specific area and scope. Its scope is highly specific. Evaluates people, skills and knowledge.
Evolution of Quality Management System – ISO 9001:2008 1987 First Published – ISO 9001, 9002 & 9003 1994 First revision – ISO 9001, 9002 & 9003 2000 Second revision - ISO 9001 2008 Third revision – ISO 9001
Quality Management System Management System to direct & control an organization with regard to quality.
Quality management Principles 1. Customer focus2. Leadership3. Involvement of people4. Process Approach5. System approach to management6. Continuous Improvement7. Factual approach to decision making8. Mutually beneficial supplier relationships
Quality Management Principle No.1Customer Focus Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.Application of this principle is reflected in ISO 9001:2008 clauses 5.2, 7.2.3 and 8.2.1
Customer Focus... Application of this principle involves : Researching and understanding customer needs and expectations. Ensuring that the objectives of the organization are linked to customer needs and expectations. Communicating customer needs and expectations throughout the organization. Measuring customer satisfaction and acting on the results Systematically managing customer relationships. Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local communities and society as a whole)
Quality Management Principle No.2Leadership 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.This principle is reflected in ISO 9001:2008 clauses 5.3, 5.4, 5.5, 6.1, 6.2
Leadership... Application of this principle involves: Considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole. Establishing a clear vision of the organization’s future. Setting challenging goals and targets. Creating and sustaining shared values, fairness and ethical role models at all levels of the organization. Establishing trust and eliminating fear. Providing people with the required resources, training and freedom to act with responsibility and accountability. Inspiring, encouraging and recognizing people’s contributions.
People at all levels are essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit. This principle is reflected in ISO 9001:2008 clauses 5.3(d) and 6.2. Quality Management Principle No.3 Involvement of people
Involvement of people... Application of this principle involves: People understanding the importance of their contribution and role in the organization. People identifying constraints to their performance. People accepting ownership of processes and problems and their responsibility for solving them.
Involvement of people... People evaluating their performance against their personal goals and objectives. People actively seeking opportunities to enhance their competence, knowledge and experience. People freely sharing knowledge and experience. People openly discussing problems and issues.
A desired result is achieved more efficiently when activities and related resources are managed as a process.This principle is reflected in almost all clauses of ISO 9001 Quality Management Principle No.4 Process Approach
Application of this principle involves: Systematically defining the activities necessary to obtain a desired result. Establishing clear responsibility and accountability for managing key activities. Analyzing and measuring of the capability of key activities. Process Approach...
Identifying the interfaces of key activities within and between the functions of the organization. Focusing on the factors - such as resources, methods, and materials - that will improve key activities of the organization. Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested parties. Process Approach...
Identifying, understanding and managing inter-related processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives. This principle is reflected in ISO 9001:2008clauses 4.1& 4.2. Quality Management Principle No.5System approach to management
System approach to management... Application of this principle involves: Structuring a system to achieve the organization’s objectives in the most effective and efficient way. Understanding the inter-dependencies between the processes of the system. Structured approaches that harmonize and integrate processes.
System approach to management... Proving a better understanding of the roles and responsibilities necessary for achieving common objectives and thereby reducing cross-functional barriers. Understanding organizational capabilities and establishing resource constraints prior to action. Targeting and defining how specific activities within a system should operate. Continually improving the system through measurement and evaluation.
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.This principle is reflected in ISO 9001 clause 8.5. Quality Management Principle No.6 Continual Improvement
Continual Improvement... Application of this principle involves: Employing a consistent organization-wide approach to continual improvement of the organization’s performance. Providing people with training in the methods and tools of continual improvement.
Making continual improvement of products, processes and systems an objective for every individual in the organization. Establishing goals to guide, and measures to track, continual improvement. Recognizing and acknowledging improvements. Continual Improvement...
Effective decisions are based on the analysis of data and information.This principle is reflected in ISO 9001:2008 clauses 5.4.1, 5.6.2, 7.3 and 8.4 Quality Management Principle No.7Factual approach to decision making
Factual approach to decision making Application of this principle involves: Ensuring that data and information are sufficiently accurate and reliable. Making data accessible to those who need it. Analyzing data and information using valid methods. Making decisions and taking action based on actual analysis, balanced with experience and intuition
An organization and its suppliers are inter-dependent and a mutually beneficial relationship enhances the ability of both to create value.This principle is reflected in ISO 9001:2008 clause 7.4 Quality Management Principle No.8Mutually beneficial supplier relationships
Application of this principle involves: Establishing relationships that balance short-term gains with long-term considerations. Pooling of expertise and resources with partners. Identifying and selecting key suppliers. Clear and open communication. Mutually beneficial supplier relationships
Sharing information and future plans. Establishing joint development and improvement activities. Inspiring, encouraging and recognizing improvements and achievements by suppliers. Mutually beneficial supplier relationships
ISO 9000 standards Three important standards in the family of ISO 9000 International Standard are: ISO 9000: Concepts, Principles, Fundamentals and Vocabulary ISO 9001: Sets the QMS Requirements to be met ISO 9004: Provides guidance for Continual improvement of organization’s overall performance
ISO 9001:2008 Internationally accepted management standard that has become a world benchmark for good management practice Generic standard i.e. any industry sector viz. manufacturing or service (education, hospitals, hotels, banks, transport, accountancy, etc.) can use it. Any type (private, public, government enterprise, etc) and any size of enterprise can use it (big, small or tiny)
PDCA Methodology Plan Act Do check
Model of Process based Quality Management System Continual Improvement of the quality management system R E Q U I R E M E N T S S A T I S F A C T I O N Management responsibility C U S T O M E R C U S T O M E R Measurement, analysis & improvement Resource management Product realization Product
ISO 9001:2008 Quality Management System - Requirements 1.0 Scope 2.0 Normative References 3.0 Terms and Definitions 4.0 Quality Management System Requirements 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, Analysis & Improvement
Quality Management System - 1 4.1 General Requirements Identification of the processes for the QMS Determine the sequence of these processes Determine criteria for effective operation & control of these processes Ensure the availability of resources Monitor, measure (where applicable) and analyze these processes Implement actions necessary for achieving planned results and continual improvement
Quality Management System - 2 4.2 Documentation Requirements - 1 4.2 Documentation Requirements - 1 4.2.1 General The QMS Documentation shall include: Quality Policy & Quality Objectives Quality Manual Documented procedures and records required by this Standard Documents needed for planning, operation and control of processes Records required by this Standard
Quality Management System - 3 4.2 Documentation Requirements - 2 4.2.2 Quality Manual Scope of QMS / Justification of the Exclusions Documented procedures or reference to them Description of interaction between the processes of the QMS
Quality Management System - 4 4.2 Documentation Requirements - 3 4.2.3 Control of documents Establish documented procedure to define method to: Approve documents Review, update and re-approve documents Identify the revision status / changes Ensure availability of relevant versions at point of use Ensure documents are legible and readily identifiable Identification and Control the external documents Identification and Control of obsolete documents
Quality Management System - 5 4.2 Documentation Requirements - 4 4.2.4 Control of records Establish / Maintain records to demonstrate conformity to this International Standard Keep records legible, readily identifiable and retrievable Establish documented procedure for identification, storage, protection, retrieval, specify retention time and their disposition
Documentation Requirements Clause 4 Documents Quality manual Flow chart of major processes and their interaction Document control procedure Record control procedure. Description of out sourced services and their control procedure. Records Document updating records Disposal of quality records