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What is iso 9001 qms

Although it is difficult to define quality as every organization looks at it differently but the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs is most commonly considered as quality. If your organization is committed to ensure that its products and services are made as per customers’ requirements and intend to stay in the business by understanding and optimizing the whole system of value exchange; a quality management system can help you in fulfilling all these requirements.

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What is iso 9001 qms

  1. 1. What is ISO 9001 QMS?1 Business Beam (Pvt.) Limited
  2. 2. Contents  What is Quality  About Quality Management System  About ISO 9001  ISO 9001 Certification Process What is ISO 9001? 2 Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  3. 3. What is ISO 9001 QMS? What is Quality?3
  4. 4. What is Quality?  The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs 4 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  5. 5.  Internal perspective: Products or services made as per customers requirements  External perspective: Staying in business by understanding and optimizing the whole system of value exchange An Organization’s Perspective of Quality 5 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  6. 6. Can be summarized as Significance of Quality “Quality is the result of a carefully constructed cultural environment. It has to be the fabric of the organization, not part of the fabric”. Philip B. Crosby 6 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  7. 7. What is ISO 9001 QMS? About Quality Management System7
  8. 8. What is a Management System?  “A management system is a proven framework for managing and continually improving your organization's policies, procedures and processes.” BSI 8 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  9. 9. Management System 9 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  An effective management system defines an organization’s…  Goals,  Policies & procedures and…  The processes…  By which they are maintained and improved  It stipulates…  Documented processes, Clear-cut responsibilities, Ongoing training, Internal checks for compliance, A way to correct noncompliance, Management reviews and Continual improvement  The critical aspect of a management system is that…  All elements work cohesively toward the stated objectives
  10. 10. About Quality Management System 10 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  A set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance  Collective policies, plans, practices and supporting infrastructure by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards and customer expectations
  11. 11. Objectives of QMS  To satisfy customers through a quality product  To gain self confidence – we get what we planned  To achieve competitiveness in both the local and overseas markets  To use as a blueprint for efforts to improve the quality system of the organization What is ISO 9001? 11 Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.
  12. 12. Pillars of QMS 12 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  Management Support  Documented Procedures  Internal Audit  Corrective/Preventive action
  13. 13. Goals of QMS 13 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  To ensure compliance with company and industry standards  Defining the processes to result in the production of quality products and services, rather than in detecting defective products or services after they have been produced
  14. 14. Benefits of QMS What is ISO 9001? 14 Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  Provides a framework for…  Existing quality functions and processes  Consistency across the organization  Improved customer relations  Consistent approach to complying with customer & internal quality requirements  Accountability  Continual improvement  Operational effectiveness
  15. 15. Benefits of QMS 15 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved.  Provides a structured framework to all existing processes  Identifies the sequence of all processes  Documents all processes to avoid personal dependencies  Documented procedures help to perform consistent operational activities  Consistency in processes leads to quality product or services  Increased satisfaction level of internal & external customers
  16. 16. What is ISO 9001 QMS? About ISO 900116
  17. 17. ISO 9000 Family  The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product  The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 17 What is ISO 9001?
  18. 18. ISO 9000 Family  ISO 9000:2005 Fundamentals and vocabulary  ISO 9001:2008 Quality Management Systems requirements  ISO 9004:2009 Guidelines for performance improvements  ISO 19011:2002 Audit of management system Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 18 What is ISO 9001?
  19. 19. Some Facts about ISO 9001:2008  Originated in 1987  Certificates issued worldwide:  ‘03 – 497,919 companies in 149 countries  ’06 – 897,866 companies in 170 countries  ‘09 – Over 1.2 Million companies in 178 countries Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 19 What is ISO 9001?
  20. 20. ISO 9001:2008 is based on Eight Quality Management Principles  Customer focused organization  Understanding customer’s needs, striving to exceed their expectations  Leadership  Establishing direction, unity of purpose, and a supportive work environment  Involvement of people  Ensuring that all employees at all levels are able to fully use their abilities for the organization’s benefit  Process approach  Recognizing that all work is done through processes, and managing them accordingly Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 20 What is ISO 9001?
  21. 21. ISO 9001:2008 is based on Eight Quality Management Principles  System approach to management  Expands on the previous principle in that achieving any objective requires a system on interrelated processes  Continual Improvement  As a permanent organizational objective, recognizing and acting on the fact that no process is so good that further improvement is impossible  Factual approach to decision making  Acknowledging that sound decisions must be based on analysis of factual data and information  Mutually beneficial supplier relationship  To take advantage of the synergy that can be found in such relationships Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 21 What is ISO 9001?
  22. 22. QMS Process Model Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 22 What is ISO 9001?
  23. 23. Required Procedures in ISO9001:2008  Control of Documents  Control of Records  Internal Audit  Control of Non-conforming Product  Corrective Action  Preventive Action Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 23 What is ISO 9001?
  24. 24. Requirements of ISO 9001:2008  Requirements of the ISO9001:2008 are classified into the following five sections of the standard: 4 . Quality Management System 5 . Management Responsibility 6 . Resource Management 7 . Product Realization 8 . Measurement, Analysis and Improvement Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 24 What is ISO 9001?
  25. 25. Quality Management System  This section defines the overall requirements by the QMS  It has following sub sections 4.1 General Requirements 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 25
  26. 26. Management Responsibility  This section outlines the overall management commitment and its responsibilities in order to successfully implement the QMS.  This section has following sub-sections: 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority & Communication 5.6 Management Review Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 26 What is ISO 9001?
  27. 27. Resource Management  This section is about ensuring that the resources essential to the implementation of strategy and the achievement of the organization's objectives are identified and made available, by the Top Management.  This section has following sub-sections 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 27 What is ISO 9001?
  28. 28. Product Realization  This section is about effective and efficient operation of realization and support processes and the associated process network so that the organization has the capability of satisfying its interested parties.  This section has following sub-sections: 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 What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 28
  29. 29. Measurement, Analysis and Improvement  Measurement data are important for making fact-based decisions.  This section is about ensuring effective and efficient measurement, collection and validation of data to ensure the organization's performance and the satisfaction of interested parties.  This section has following sub-sections: 8.1 General 8.2 Monitoring & Measurement 8.3 Control of Nonconformity 8.4 Analysis of Data 8.5 Improvement What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 29
  30. 30. What is ISO 9001 QMS? ISO 9001 Certification Process30
  31. 31. Certification Process  The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:  Stage 1 - the purpose of this visit is to confirm the readiness of the organization for full assessment. The assessor will:  Confirm that the quality manual conforms to the requirements of ISO 9001:2008  Confirm its implementation status & the scope of certification  Check legislative compliance  Produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.  Develop an assessment plan and confirm a date for the Stage 2 assessment visit. What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 31
  32. 32. Certification Process  Stage 2 - the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 9001:2008 in practice. The assessor will:  Undertake sample audits of the processes and activities defined in the scope of assessment  Document how the system complies with the standard  Report any non-compliances or potential for non-compliance  Produce a surveillance plan and confirm a date for the first surveillance visit  If the assessor identifies any major non-conformance, the organization cannot be certified until corrective action is taken and verified. What is ISO 9001?Copyrights 2004-2013 Business Beam (Pvt.) Ltd. All rights reserved. 32
  33. 33. Thank you!33 contact@businessbeam.com

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