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ISO 90012015.pptx
- 2. Introduction to ISO ISO – International Organization for Standardization Develop and Publish International Standards A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose Practical Tool for tackling todays global challenge 21000 Internal standards QHSE Solutions
- 3. ISO Versions ISO 9001:1987 ISO 9001:1994 ISO 9001:2000 ISO 9001:2008 ISO 9001:2015 QHSE Solutions
- 4. Why ISO 9001:2015 The purpose of this standard is to help organizations to provide products and services that meet all relevant customer needs and expectations and comply with all relevant regulatory and statutory requirements. A quality management system (QMS) is a set of interrelated or interacting elements that organizations use to formulate quality policies and quality objectives and to establish the processes that are needed to ensure that these policies are followed and these objectives are achieved. QHSE Solutions
- 5. Benefits of ISO Business Cut costs Customer satisfaction Access new markets Environment Consumers Confidence Government Getting Expert Opinion Opening up world trade QHSE Solutions
- 6. Benefits of ISO Increased Efficiency Increased Revenue Employee Morale National / International Recognition Factual approach in Decision making Supplier Relationship Documentation Consistency Customer satisfaction Process improvement QHSE Solutions
- 7. Seven Principles of ISO 9001:2015 Customer Focus Leadership Engagement of people Process Approach Improvement Evidence based decision making Relationship Management QHSE Solutions
- 8. Customer Focus The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. QHSE Solutions
- 9. Leadership Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization. QHSE Solutions
- 10. Engagement of People It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value. QHSE Solutions
- 11. Process Approach Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. QHSE Solutions
- 12. Improvement Successful organizations have an ongoing focus on improvement. QHSE Solutions
- 13. Evidence based decision making Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. QHSE Solutions
- 14. Relationship Management For sustained success, organizations manage their relationships with interested parties, such as suppliers. QHSE Solutions
- 16. PDCA Cycle Plan Objectives Process Resources • Do Implement what planned • Check Monitor and measure Product and Service result • Act Action to improve Performance QHSE Solutions
- 17. 4.Context of the Organization Understanding the Organization and its context QHSE Solutions Determining Internal and external Issues and monitoring and reviewing information about these issues
- 18. 4.Context of the Organization Understanding the needs and expectation of Interested Parties QHSE Solutions Determining Interested parties and requirements of Interseted parties relevant to QMS and monitoring and reviewing information about these intersted parties
- 19. 4.Context of the Organization Determining the scope of the QMS QHSE Solutions Applying rerquirements of Internal standarad within scope Documented Information for developed sope Justification for requiremets that not applicable to the organization Determining scope by considering • External and Internal issues • Requirements of relevant interested parties • Product and service of the organization
- 20. 4.Context of the Organization QMS and its process QHSE Solutions Establish, Implement, maintain and continually improve the QMS including process and interection and shall • I/P required and Output Excepted from process • Sequences and Interection of process • Criteria and methods for operation of these process • Resurces needed for these process • Responsibilities and authorities for these process • Risk and opportunities on these process • Evaluation of process and implementing changes needed
- 21. 5.Leadership Leadership and Commitment- General QHSE Solutions • Accountability • Quality Policy and Objectives • Integration of QMS Process Approach and Risk based thinking • Resources • Communication • Results of QMS • Engaging, directing and supporting person • Promoting Improvement
- 22. 5.Leadership QHSE Solutions Leadership and Commitment- Customer Focus • Ensuring Requirements – customer, statutory and regulatory requirements • Risk and opportunities that effect conformity of products and services • ability to enchase customer satisfaction are determined • Maintaining customer satisfication.
- 23. 5.Leadership Quality Policy - Establishment QHSE Solutions
- 24. 5.Leadership Communicating Quality Policy QHSE Solutions • Documented information • Communicated, understood and applied within the organization • Be available to the interested parties
- 25. 5.3 Leadership - Organizational roles, Responsibilities and Authorities QHSE Solutions Responsibilities and authorities for relevant roles are assigned, communicated and understood • Conformation of QMS to International Standard • Deliverance of intended output • Performance reporting • Promoting customer focus • Integrity of QMS
- 26. 6.Planning Action to address risk and opportunities QHSE Solutions To • Assurance- to achieve intended result • Enchase desirable effect • Prevent or reduce, undesired effect • Achieve improvement • Action plan to address risk and opportunities
- 27. 6. Planning Quality Objectives and Planning QHSE Solutions SMART • Specific • Measurable • Achievable • Realistic • Time Bound
- 28. 6. Planning-Planning of changes QHSE Solutions • Potential consequences of changes • Integrity of QMS availability of resources • Allocation or reallocation of responsibilities and authorities
- 29. 7. Support Resources General People Infrastructure Environment for Operation of process Monitoring and Measuring Resources General Measurement and traceability Organizational Knowledge QHSE Solutions
- 30. Resources General QHSE Solutions Capabilities and constraints - Existing internal Resources Need from External Provider
- 31. People People QHSE Solutions People - Effective Implementation of QMS Operation and Control of Process
- 32. Infrastructure Infrastructure QHSE Solutions Building and its associated utilities Equipment's, transportation, information & communicating technology
- 33. Environment for the Operation of Process Environment for the Operation of Process QHSE Solutions Social Psychologic al Physical
- 34. Monitoring and Measuring Resources QHSE Solutions Resources for Monitoring and Measuring activities Fitness Maintaining Calibration Status Identification safeguarding
- 35. Organizational Knowledge QHSE Solutions Necessary knowledge for Process Operation Changing needs Organizational knowledge based on Internal sources, External sources
- 36. Competence QHSE Solutions Determination of competence level Skills Actions to increase the competence of persons Records
- 37. Awareness QHSE Solutions Awareness On • Policy • Objective • Contribution • Removing Implications
- 38. Communications QHSE Solutions Communication Methods Internally and externally • What • When • With whom • How • Who
- 39. Documented Information QHSE Solutions Documentation required by International Standard Documented information for Organization
- 40. Creating and Updating QHSE Solutions Identification &Description Format Review and approval
- 41. Control of Documented information QHSE Solutions Control of changes Distribution, access retrieval Storage, preservation Use • Availability and suitability • Protection
- 42. 8. Operation Operational Planning and Control QHSE Solutions Planning, implementing and controlling of process to meet product and service requirements and implement action on risk and opportunities identified The organization has to determine • Products and service requirements • Establishing criteria for process and acceptance of products and services • Resources • Implementing control as per criteria • And keep documented information • Control over outsourced process • Unintended changes
- 43. Requirements for Products and Services Customer Communication QHSE Solutions Communication to the customer regarding Products and Services
- 44. Requirements for Products and Services Determining Requirements related to products and services QHSE Solutions While determining requirements for products and services the organization shall consider • Applicable statutory and regulatory requirements • Requirements considered by the organization • Meeting of claims that offers
- 45. Requirements for Products and Services Review of requirements related to products and services QHSE Solutions Review before committing to supply products and services that include • Requirements specified by customer • Requirements not specified by customer, but necessary • Requirements specified by organization • Statutory and regulatory requirements • Contract or order requirements differing from those previously expressed • Conformation of customer requirements
- 46. Design and Development General QHSE Solutions Establishment, Implementation and maintain of Design and Development process
- 47. Design and Development Design and Development Planning QHSE Solutions Determination of design stages and controls for design and development by considering Nature, duration and complexity Required process stages and reviews Required Verification and validation Responsibilities and authorities
- 48. Design and Development Design and Development Planning QHSE Solutions Controlling of interface between person Internal and External resources Need for Involvement of customer and user Subsequent provision Documented Information Level of Control
- 49. Design and Development Design and Development Inputs QHSE Solutions Determining the requirements by considering Functional and Performance Req Information from previous similar design /statutory and regulatory req / standards and codes Potential consequences of failure
- 50. Design and Development Design and Development controls QHSE Solutions Applying Controls to design and Development process for ensuring • Results • Conducting of review to meet design and development requirements • Verification to meet input requirements • Validation meet the requirements for specified application or intended use • Any Necessary action taken • Documented information
- 51. Design and Development Design and Development Outputs QHSE Solutions Organization ensure design and development outputs • Meet input requirements • Are adequate for subsequent process • Include or reference monitoring and measuring requirements • Specify characteristics of the product
- 52. Design and Development Design and Development changes QHSE Solutions Organization identify, review and control changes made during or subsequent to , the design and Development and retain documented information
- 53. Control of externally provided processes, products and services General QHSE Solutions Ensuring externally provided process that conforms to the requirements Controls over externally provided process are applied to Incorporation of external provided products and process into org own products and services
- 54. Control of externally provided processes, products and services General QHSE Solutions Directly to customers Selection, evaluation performance monitoring, re- evaluation A process or part of a process
- 55. Control of externally provided processes, products and services Type and extent of control QHSE Solutions Do not adversely affect the delivery of products and service to its customer by Within the Control QMS Controls applied to the external provider and those it intends to apply to the resulting output
- 56. Control of externally provided processes, products and services Type and extent of control QHSE Solutions • Potential impact of externally provided process to meet customer and applicable statutory and regulatory requirements • Effectiveness of control • Verification and other activities
- 57. Control of externally provided processes, products and services Information for external providers QHSE Solutions Communication to external provider on Ensuring Adequacy of Requirements Required from external provider Competence Approva l Interaction Verification or validation Controls and Monitoring
- 58. Production and Service Provision Control of Production and Service Provision QHSE Solutions Production and Service Provision has to be performed Under Controlled Condition, that means inclusion of
- 59. Production and Service Provision QHSE Solutions Availability of Documented Information Monitoring and Measuring Resources Implementation of monitoring and measuring activities Use of suitable Infrastructure and environment for operation of Process Control of Production and Service Provision
- 60. Production and Service Provision Control of Production and Service Provision QHSE Solutions Validation and Periodic Validation Implementation of action to prevent human error Implementation of release, delivery and post-delivery activities
- 61. Production and Service Provision Identification and traceability QHSE Solutions • Suitable means to Identify Process Outputs • Suitable means to Identify Status of outputs • Unique Identification
- 62. Production and Service Provision Property Belonging to customers or external providers QHSE Solutions • Care for property belonging to customers or external providers • Identify, verify, protect and safeguarding of customer or external providers • Reporting
- 63. Production and Service Provision Preservation QHSE Solutions Preservation of outputs during production and service provision to ensure conformity
- 64. Production and Service Provision Post-delivery activities QHSE Solutions Meeting requirements of Post delivery activities Consideration of Post delivery activities • Statutory and regulatory requirements • potential undesired consequences • Nature, use and intended life time of products and services • Customer requirements • Customer feedback
- 65. Production and Service Provision Control of changes QHSE Solutions • Review and control of changes • Retention of documented information to describe • Review of changes • Person authorizing the change • Action arising form review
- 66. Release of Products and Services QHSE Solutions Performing Planned arrangements at appropriate stage to release products and service to ensure that the requirements have been met Retaining the documented information on the release of products and service • Evidence of conformity with acceptance criteria • Traceability to the person authorizing the release
- 67. Control of Non conforming Outputs Outputs that not conforming to the requirements Action – for non conforming products and service by QHSE Solutions Segregation, containment return Correction Informing to customer Obtaining authorization
- 68. Control of Non conforming Outputs Organization Retain the documented Information that describes QHSE Solutions Non conformity Action Taken Concession obtained Deciding authority
- 69. 9. Performance Evaluation Monitoring, Measurement, Analysis and Evaluation QHSE Solutions Methods to ensure valid result What to be monitored When to be Perform Result analysis and evaluation
- 70. Performance Evaluation Customer Satisfaction QHSE Solutions Monitoring customer perception by customer surveys, customer feedback, complements etc.
- 71. Performance Evaluation Analysis and Evaluation QHSE Solutions Conformity of product and services Degree of C.S Performance and Effectiveness of QMS Implementation of planning Effectiveness of Action taken fro Risk and Opportunities External provider performance Improvements needed Analysing and evaluation of data From monitoring and measurement
- 72. Internal Audit QHSE Solutions To Conform organization requirement to QMS and standard requirements Implementation and Maintenance • Audit Programme • Audit Criteria & Scope • Selection of Auditor • Reporting of Result • Action for findings • Retention of Documents
- 73. Management Review QHSE Solutions Management Review will be performed at planned Intervals to ensure • Suitability • Adequacy • Effectiveness • Alignment with strategic direction • Management Review Input • Management Review Output
- 74. Management Review Input QHSE Solutions Status of Action Changes in issues Performance and Effectiveness Effectiveness of Action taken Adequacy of resources Opportunities for Improvement
- 75. Management Review Output QHSE Solutions • Improvement Opportunities • Needed changes • Needed Resources Decisions and action
- 76. 10.Improvement QHSE Solutions Determination and selection of Opportunities for Improvement to meet Customer Requirements and Enhance Customer satisfaction Determination of Opportunities in the area of • Correcting • Preventing • Reducing undesired effects • Improvement Products and services • Future needs and expectation • Improvement on performance and effectiveness of QMS
- 77. Non conformity and Corrective action QHSE Solutions When non conformity occurs Reacting to Non conformity by taking action and dealing with consequences Evaluating the action to eliminate the cause Implementing the action needed Update risk and opportunities Reviewing effectiveness of action taken Necessary changes
- 78. 10.Continual Improvement QHSE Solutions By • Result of analysis and evaluation • Management Review Outputs • Determining Needs and Opportunities