ISO 9000 and TQM

ISO 9000 and TQMPresented By : Prasad KaduSections coveredWhat is ISO ?Genesis of ISOFamily of ISOWhat is ISO 9001 ?8 Quality Management Principles8 Clauses of ISO 9001Why is ISO required ?Advantages of ISO 9001Misconceptions of ISO 9001How to get ISO certification ?Documentation required for ISO 9001 certificationWhat is ISO ?It stands for international Organization for Standard.ISO story began in 1946 at an Institute of Civil Engineers , where 65 delegates from 25 countries met to form an international body.ISO 9000 was first published in 1987. It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.

However, its history can be traced back to 1959 for the publication of the United States Department of Defense MIL-Q-9858 standard .

MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which again were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979 before being submitted to ISO.

HQ at Geneva Switzerland and has members of 164 countries 3368 technical bodies as of today.What is ISO ?The name ISO came from isos in Greek meaning Equal (Standardization).It is the worlds largest developer of International Standards covering specifications for products , services and good practices (CGMP).Has helped in breaking barriers to international trade through global consensus.Bureau of Indian Standards (BIS)

Founders of the ISO at London 1946

Family of ISOMany standards of ISO are there like ISO 9000 : Quality Management ISO 14000 : Environmental ManagementISO 50001 : Energy ManagementISO 22000 : Food safety ManagementISO 26000 : Social ResponsibilityISO 27001 : Information SecurityISO 9000 familyISO 9001:2008 - sets out the requirements of a quality management systemISO 9000:2005 - covers the basic concepts and languageISO 9004:2009 - focuses on how to make a quality management system more efficient and effectiveISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

ISO 9001 Quality ManagementISO 9001 : 1988 Quality AssuranceISO 9001 : 1994 Quality AssuranceISO 9001 : 2000 Quality Assurance and Customer satisfactionISO 9001 : 2008 Quality Management SystemISO 9001 : 2015 Sustainable Development8ISO 9001. QMS Lays down the requirements for Quality Management Systems (QMS)Definition of QMS : The process of Management of the System of an organization , with regard to its Quality related activities, for meeting and enhancing customer satisfaction and also taking care of all other interested parties such as the legislative and regulatory bodies, shareholders, suppliers, and the employees.8 Quality Management Principles1. Customer focused organization Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations2. Leadership Leaders establish unity of purpose and direction. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives3. Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.4. Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process.

8 Quality Management Principles5. System approach to management Identifying, understanding and managing a system of interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.6. Continual improvement Continual improvement of the organization's overall performance should be a permanent objective of the organization.7. Factual approach to decision making Effective decisions are based on the analysis of data and information. 8. Mutually beneficial supplier relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Clauses of ISO 9001Clauses 1 , 2 and 3 : Tell us about the introduction , terms and definitions related to ISO. They also tell us about the concepts and principles used in the standards along with the guidance on the QMS scope.The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. Clauses of ISO 9001Clause 4 -Quality Management System- sets requirements to identify, plan, document, operate and controlQMS processesand to continually improve QMS effectiveness.

Clause 5 -Management Responsibility- sets requirements fortop managementto demonstrate its leadership and commitment to develop, implement and continually improve the QMS.

Clause 6 -Resource Management- sets requirements to determine, provide and control the variousresourcesneeded to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements.

Clauses of ISO 9001Clause 7 - Product Realization- sets requirements to plan, operate and control the specific QMS processes that determine, design, produceand deliveran organizations product and services.Clause 8- Measurement, Analysis and Improvement- sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.

The overall objective of your QMS must be to enhancecustomer satisfactionby meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness.

Why is ISO required ?Fulfill customer requirements.Keep up with the competition.Gain a market advantage.Provide a better framework for development and growth.Improve image.Gain publicity and build confidence.Comply with export market requirements.Create a system identifying and defining requirements.

Advantages of ISO 9000Improved their levels of customer satisfaction and loyalty.Boosted their operational performance.Acquired new customers and retained existing clients.Achieved cost savings.Improved communications, morale and job satisfaction of the employees.The certificate can be used as a marketing tool.

Misconceptions about ISO 9001Set poor standards and get certified.An already recognized organization does not need to prove its excellence in quality.An organization with a good existing QMS process does not need certification.Certification is expensive for small scale organizations.Results in a lot of unnecessary paperwork.All job descriptions must be documented and peoples competence must be evaluated for them.All outdated documents must be removed from the place of use.Everyone in the organization must be able to repeat the quality policy verbatim.How to get ISO certificationOrganizations willing to achieve ISO certification shall follow steps mentioned below

Step 1: Decide ISO certification to be obtained.

Step 2: Review advantages of ISO certification.

Step 3: Contact ISO certification consultants if requirements of ISO system is not known.

Step 4: Review existing work practices being followed in the company and identify gaps against requirements mentioned in ISO standards

Step 5: Prepare action plan describing work to be done to fulfill requirements of ISO standard

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Step 6: Give trainings to all employees of organization about ISO requirements.

Step 7: Complete necessary documentation like manual, procedures preparations.

Step 8: Follow defined ISO system in routine and overcome difficulties in following same.

Step 9: Conduct internal audit

Step 10: Contact ISO certification agencies and finalize 3 year contract with them.Cont..

Step 11: After ensuring adequate preparations for audit, call certification agency for stage 1 audit.

Step 12: Close non conformities given by certification agencies during stage 1 audit.

Step 13: Call certification agency for stage 2 ( final ) certification audit.

Step 14: Close non conformities given by certification agency during stage 2 certification audit.

Step 15: Receive ISO certificate after 4-6 weeks of successful completion of stage 2 certification audit

Step 16: Use ISO logo as per recommendation of certification agency. Documentation required for ISO 9001:2008 certificationDocumented statements of a quality policy and quality objectives.A quality manual .Documented procedures required by this International Standard Documents needed by the organization to ensure the effective planning, operation and control of its processes.The size of organization and type of activities.The complexity of processes and their interactions.The competence of personnel.

Documentation required for ISO 9001:2008 certificationCertificate of Incorporation.VAT , CST , TIN and Service certificates.Organizational Hierarchy information.Customer appraisal certificates.Information about the financial worth of the company.Information about the owners.Documents related to Safety precautions and measures observed by the organization.

ISO 9001:2008 implementation guidelines..2000 2008The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004. Certification to ISO 9001:2008 is not an upgrade, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements but users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS.Translation from 2000 2008 The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories: No changes or minimum changes on user documents, including records .No changes or minimum changes to existing processes of the organization. No additional training required or minimal training required .No effects on current certifications .

The benefits identified for the ISO 9001:2008 edition fall into the following categories: Provides clarity.Increases compatibility with ISO 14001.Maintains consistency with ISO 9000 family of standards.Improves translatability.

The next version of ISO 9001The ISO 9001:2015 A meeting in Bilbao, Spain, in June 2012, was held for the revision of ISO 9001 and a draft was developed, with a draft design specification and project plan.What is intended to achieve.

What the draft says..... According to the draft design specification, the revised standard should (among other things):Provide a stable core set of requirements for the next 10 years or more.Remain generic, and relevant to all sizes and types of organization operating in any sector.Maintain the current focus on effective process management to produce desired outcomes.Take account of changes in quality management systems practices and technology since the last major revision in 2000.Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate.Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards.Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties.Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements.Thankyou