Purpose of Program Awareness of ISO 9001:2008. Self Improvement Improvements in routine working To improve the health of organization’s Quality Management System
FAQ? What is ISO? From where it comes? How it is helpful for us? How it works? What we have to do?
Contents Of Program Background of ISO ISO Family Quality Management Principle Process Approach ISO 9001:2008 Overview Detail Of Different Clauses Of ISO 9001:2008
What is ISO 9001:2008?ISO = International Organization forStandardizationISO has representation from 162 countriesand has issued many standardsISO 9001:2008 is a model for a qualitymanagement system.
Who created the standard? International Organization for Standardization - Geneva Standards created in 1987 To eliminate country to country differences To eliminate terminology confusion To increase quality awareness
ISO 9000:2005 Consists of 3 Areas ISO 9000:2005 Quality Management Systems: fundamentals and vocabulary ISO 9001:2008 Quality Management Systems – Requirements (required for certification) Management responsibility Resource management Product/service realization Measurement, analysis, improvement ISO 9004-2009 Quality Management Systems – Guidelines for performance improvement
Generic standardsISO 9001 is a generic standards.Generic means that the same standards can be applied: to any organization, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department.
Generic standards (cont.)Generic also signifies that no matter what the organizations scope of activity if it wants to establish a quality management system, ISO 9001 gives the essential features
Certification and registration Certification is known in some countries as registration. It means that an independent, external body has audited an organizations management system and verified that it conforms to the requirements specified in the standard (ISO 9001). ISO does not carry out certification and does not issue or approve certificates,
Accreditation Accreditation is like certification of the certification body. It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 certification in specified business sectors. Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility. ISO does not carry out or approve accreditation.
Certification not a requirement Certification is not a requirement of ISO 9001. The organization can implement and take benefit from an ISO 9001 system without having it certified. The organization can implement them for the internal benefits without spending money on a certification programme.
Certification is a businessdecision Certification is a decision to be taken for business reasons: if it is a contractual, regulatory, or market requirement, If it meets customer preferences if it will motivate staff by setting a clear goal.
Ten Steps to ISO Registration 10. Registration! 9. Final assessment by registrar 8. Take corrective actions 7. Pre-assessment by registrar 6. Submit quality manual for approval 5. Perform self-analysis audit 4. Select a third-party registrar and apply 3. Develop and implement the quality system 2. Select the appropriate standard 1. Set the registration objective
What is a Quality ManagementSystem? A Quality Management System is a web of interconnected processes that are used to manage a business.
Operating Cycle of ISO. The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISOs management system standards Plan – establish objectives and make plans (analyze your organizations situation, establish your overall objectives and set your interim targets, and develop plans to achieve them). Do – implement your plans (do what you planned to). Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives). Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).
ISO 9001:2008 CONTINUAL IMPROVEMENT OF THE QUALITY CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM MANAGEMENT SYSTEM Management Customers responsibilityCustomers Clause 6 Clause 5 Measurement, Resource Resource analysis and Satisfaction management management improvement Clause 8 Product Output InputRequirements Product Product realization Clause 7 Value adding activities Information flow
PROCESS REQUIREMENTS With What? WHO?(Materials / Equipment) Objectives Special Skills? / Competence? and Targets Process Inputs Outputs How? Measure Process(Methods / Procedure) Linkages
Management Principles A Quality Management Principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all stakeholders.
8 Management Principles Principle 1 : Customer Focus Principle 2 : Leadership Principle 3 : Involvement Of People Principle 4 : Process Approach Principle 5 : System approach to management Principle 6 : Continual Improvement Principle 7 : Factual approach to decision making Principle 8 : Mutually beneficial supplier relationships
Principle 1 : Customer Focus Organizations depend on their customers & therefore should understand current & future customer needs, should meet customer requirements & strive to exceed customer expectations
Principle 2 : Leadership Leaders establish unity & direction of the organization. They should create & maintain the internal environment in which people can become fully involved in achieving the organizations objectives.
Principle 3 : Involvement OfPeople People at all levels are the essence of an organization and their full involvement enables their abilities to be utilized for the organizations mutual benefit.
Principle 4 : Process Approach The application of a system of processes within an organization, together with the identification and interaction of these processes, and their management to produce the desired outcome, can be called “Process Approach”
Principle 5 : System approach tomanagement Identifying, understanding & managing interrelated processes as a system contributes to the organizations effectiveness & efficiency in achieving its objectives.
Principle 6 : ContinualImprovement Continual Improvement of the organizations overall performance should be the primary driver of the organization’s Quality Management System. Continuous Continual Improvement Improvement
Principle 7 : Factual approach todecision making Effective decisions are based on the analysis of data & information
Principle 8 : Mutually beneficialsupplier relationships An organization & its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
Clauses of ISO 9001-2008 1.Scope 2.Normative References 3.Term & Definitions 4.Quality Management System 5.Management Responsibility. 6.Resources Management 7.Product Realization 8.Measurment,Analysis and Improvement
SCOPE OF STANDARD1. Scope General Application2. Normative reference3. Terms and definition e.g., Supplier Organization Customer
QUALITY MANAGEMENT SYSTEMREQUIREMENTS4.1 General requirements Document, implement, maintain and continually improve Identify and determine sequence and interaction of processes Determine criteria and methods needed Ensure availability of resources Monitor, measure and analyze processes Implement actions to achieve planned results
QUALITY MANAGEMENT SYSTEMREQUIREMENTS4.2 Documentation requirements Management system documentation Quality Manual Control of documents Control of records
QUALITY SYSTEMDOCUMENTATION STRUCTURE 1st Level Policy and Objectives Quality Manual What the company wishes to achieve 2nd Level Procedures How the company implements its policy 3rd Level Structured to reflect Work Instructions process flow of events Machine instructions Computer inputs Detailed instructions Detailed work instructions How to complete a job or task 4th Level Technical Data International standards Computer operating manuals Detailed product specifications
MANAGEMENT RESPONSIBILITY5.1 Management commitment5.2 Customer focus5.3 Quality policy Must be documented Must be used for setting objectives5.4 Planning Document objectives- Must be Measurable Quality management system planning
MANAGEMENT RESPONSIBILITY5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication
MANAGEMENT RESPONSIBILITY5.6 Management Review General Review input Review output
RESOURCE MANAGEMENT6.1 Provision of resources6.2 Human resources General Competence, awareness and training6.3 Infrastructure6.4 Work environment
PRODUCT REALIZATION7.1 Planning of product realization7.2 Customer-related processes Determination of requirements related to the product Review of requirements related to the product Customer communication
PRODUCT REALIZATION7.3 Design and development Planning, inputs, outputs, systematic reviews, verification and validation, control of changes7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product - receiving, source
PRODUCT REALIZATION7.5 Production and service provision Controlled conditions including product characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activities Validation of processes when no other method Identification and traceability of product and it’s status Care of customer property Preservation of product Includes constituent parts
PRODUCT REALIZATION 7.6 Control of monitoring and measuring devices Calibrated or verified where necessary Adjusted and re-adjusted as necessary Identified to enable calibration status Safeguarded from invalid adjustment Protected from damage and deterioration
MEASUREMENT, ANALYSIS, ANDIMPROVEMENT8.1 General8.2 Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product
MEASUREMENT, ANALYSIS, ANDIMPROVEMENT8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement Continual improvement Corrective action Preventive action