ISO 9001 - 2008 Awareness training programme by Salamah.pptx

Introduction to ISO 9001

1. ISO 9001:2008 Awareness Training

2. Self Introduction Participant Introduction Introduction

3. Introduction to ISO & ISO 9001:2008 Background of Quality Management 8 Quality Management Principles ISO 9001:2008 standard requirements Setting Quality objectives Guidelines for documentation and implementation Continual improvement Written Examination Presentation Road Map

4. Interactive Presentation & Discussions CGT – Concept Grasping Test Presentation Methodology:

5. What is ISO 9001? Why do organizations go for ISO 9001? Define the term QUALITY ? Write down one most important aspect within your work area you would like it to improve. Exercise 1: Basics of ISO & Quality Answer the following questions on the blank paper provided to you and submit it. Time allotted:- 5 minutes

6. “Companies not learning & speaking the language of QUALITY MANAGEMENT will become as obsolete as TYPEWRITERS . The days of functional management are gone. We can no longer afford to think of ourselves as Marketing Manager, Finance Manager, H R Manager or Operations Manager – we have to think ourselves as CUSTOMER SATISFIERS.” Bill Gates Microsoft Who are we…….

7. Fitness for use Conformance to standards Totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs……… What is Quality ?

8. Director/Chairman / President Manager Employees When it will be possible ? What they want ?

9. Q uality & ……….ISO 9001 is the most effective way for managing Quality.

10. What is ISO 9001:2008? ISO 9001:2008 is an international standard for implementing a quality management system

11. ISO -Greek word “isos” means “equal” pronunciation “eye-soh” ISO is a worldwide federation of national standards from more than 140 countries. ISO is a non-governmental organization established in 1947 with head quarters in Geneva, Switzerland. What is ISO ?

12. To promote the development of standardization with a view to facilitate international exchange of goods and services. Provide a single set of standards that are recognized and respected everywhere. MISSION OF ISO

13. An International Standard Intended for Organizations in all Types of Industries for Quality Management. ISO 9000 Focuses on Managing an Organization’s Key Processes for optimum & consistent out-put quality. WHAT IS ISO 9000?

14. To provide a framework for organizational effectiveness To assure consistency in products and services delivered to customers Increase customer satisfaction Objectives of ISO 9000 Who are our customers…?

15. Who are our customers ? External Customers: Companies buying products / Services from your organiation. Internal Customer: Various Departments/Process of Your Organization. Identification of Customers Each process/department is customer to some process/department and supplier to some process/department… Satisfy internal customers first….External will follow

16. Each participant to identify supplier and customer for his/her department Identify Internal customer and internal suppliers

17. Worldwide Business Requirement Complete System for Quality Management Best way to improve internal operations of the organization Competitive Advantage Excellent Marketing Tool WHY ISO 9000?

18. ISO 9000 - Fundamentals and Vocabulary Provides an introduction to Quality Management Systems (QMS) and vocabulary. (Updated in 2005) ISO 9001 - Requirements Specifies requirements for a QMS where capability to provide product/Service that meets customer and regulatory requirements needs to be demonstrated ISO 9004 - Guidelines for Performance Improvement Provides guidance on using an established QMS to further enhance customer satisfaction and product/service quality IS0 9001:2008 Series of Standards

19. How Quality conscious work Environment is created ? PRE-ISO Stage ISO Implemen--tation Stage ISO Stabilization Stage Business Excellence Model Stage Doing wrong things without knowledge Doing wrong things with knowledge Doing right things with knowledge Doing right things without knowledge

20. Quality Control System (1989) Quality Assurance System(1994) Quality Management System (2000 & 2008) Changing scope of ISO

21. Document what you do Do what you document Maintain it and improve it ISO 9001 in three lines

22. During world war 2 Initiated by British Army to manage the suppliers that were supplying arms and ammunitions Later refined by British Standards and published as BS 9001 Formally inducted in ISO family in the year 1989 History of ISO 9001 QMS

23. ISO 9001 TQM TPM Six Sigma CMM Kaizen Various Quality Management Tools

24. Principles of new standard Based on eight quality management principles Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus

25. Principles of new standard Customer focus Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations Leadership Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organization’s objectives Involvement of People People of all levels are essence of an organization Their full involvement for organization’s benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process

26. Principles of new standard System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency Continual improvements Continual improvement of the organization’s overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships An organization & its suppliers are interdependent Mutually beneficial relationship enhances the ability of both to create value

27. Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs Ensure continual improvements Identify the processes Do it for all value adding processes Establish measuring criteria Identify the Interactions to other processes Identify the Inputs & outputs

28. E.g. - Purchasing Process Performance Measurements Delivery status – On-time, no. of rejections etc Supplier evaluation Outputs Receipt of Material Purchasing Procedure Interactions to Storage Inspection and Testing Manufacturing Finance Inputs Required item / quantity / date Applicable specs Supplier source Suppliers capability to meet our requirements

29. Processes Recruitment Training and induction Salary Management Exit and full-final settlement HR Department

30. Each participant to prepare process sheet for his/her own department Exercise 2

31. Process approach – Continual improvements of Process PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK Understandings & meeting requirements PLAN

32. ISO 9001:2008 is based on all these 8 principles and these principles are covered in different clauses of ISO 9001 QMS

33. Exercise 3 On the basis of the allocated specific quality management principle, present how that particular principle is practiced and implemented in your company.

34. ISO 9001:2008 QMS Requirements

35. Identify how many processes are needed Process means input, activities, output How these processes are related to each other. Process effectiveness measurement parameters. If any activity is outsourced then control over outsourced activities needs to be determined. 4.1 – General Requirements

36. Documented statement of quality policy & objectives Quality manual Mandatory procedures / system documents Functional Documents Documents can be in any medium (hard / soft / combination) 4.2.1 – Documentation Requirements - General

37. Scope of the QMS Should clearly mention any exclusion if applicable along with justification. Either SOPs (mandatory & functional) themselves or a reference to them Process interaction 4.2.2 – Quality Manual

38. 1 st of the 6 mandatory procedures SOP must be available How to approve documents prior to issue Each doc needs to have a revision date and revision no on it. Master list of documents How to periodically review docs Document change / revision process Documents of external origin To prevent unintended use of obsolete docs & identification on them 4.2.3 – Control of documents

39. 2 nd of the 6 mandatory procedures SOP must be available Difference between document and record Record matrix containing details like Name of the record, retention period, location, disposal mechanism, disposal authority Records needs to be identifiable & retrievable. 4.2.4 – Control of records

40. Some kind of evidence by top management that they are committed to the QMS by Formal / informal communication to the employees about how important it is to meet customer needs & complying legal / statutory requirements Establishing quality policy and quality objectives Conducting MRM Resource planning and provision 5.1 – Management Commitment

41. How stated and implied needs of the customers are determined. A customer satisfaction measurement process What is done by top mgmt to enhance customer satisfaction 5.2 – Customer Focus

42. Kind of long term goal, vision and mission for the company Where I want to see my company in future Defined & signed by top management. Displayed at prominent places in the company / website / screen savers Appropriate to the nature of business of the organization. 5.3 – Quality Policy

43. Must cover 3 mandatory requirements Commitment towards customers Commitments towards employees Commitments towards continual improvements Provides a framework to establish quality objectives. Communicated & understood by everybody Must be reviewed at regular interval 5.3 – Quality Policy

44. Means to reach quality policy Either corporate quality objectives and then departmental / process qualtiy objectives or just corporate quality objectives in case of a small company or just departmental / process quality objectives Must be measureable and time bound Should be on SMART basis Planning for objectives and it’s tracking 5.4.1 / 5.4.2– Quality Objectives

45. For all the designations shown in the org chart, clearly defined roles, responsibility & authority must be documented. It must also be communicated to all the concerned employees. 5.5.1 – Responsibility & authority

46. A member of the management Must have an appointment letter from mgmt Overall in charge of the QMS Responsible for 6 mandatory procedures Organizes internal audits Conducts MRM Coordinates with external bodies like consultants / certification agency. 5.5.2 – Management representative

47. Management review meetings are conducted at regular intervals to assess continuing suitability of the QMS & overall performance of the QMS Top management shall chair the QMS Frequency decided by the organization Can be clubbed with regular business review meetings or any other such kind of forum where top mgmt, MR & process owners are present. 5.6.1 – MRM - General

48. Agenda needs to be prepared and circulated by MR to all the participants of the MRM Should cover these points minimum, it can cover any additional points depending on business requirements Minimum MRM agenda points. ……….next slide 5.6.2 – MRM Input

49. Results of last MRM & it’s status on actions identified Review of quality policy & objectives Results of audits ( internal / external) Customer feedback Process performance & product conformity Customer complaints / NCs & appropriate correction, corrective actions & preventive action Changes to QMS & improvement suggestions 5.6.2 – MRM input

50. MRM takes place as per MRM agenda Minutes must be documented against each agenda point (i.e. what discussion took place against each point of MRM agenda) Action plan to work on decisions taken during the MRM for issue related to: Effectiveness of QMS & processes Improvements related to products / services Resource required. 5.6.3 –Review output

51. Some kind of resource planning exercise should be evident to:- Achieve intent of quality policy & reach quality objectives. Enhance customer satisfaction 6.1 – Provision of resources

52. Competence mapping / evaluation needs to be carried out at a regular interval. Ideal competence for all the designations of the org chart.(education, experience, functional skills) Map with existing competence of individuals in respective designations. Identify gap in the competence. Identify training needs to bridge these gaps Prepare training calendar Training effectiveness evaluation 6.2.2 – competence, awareness & training

53. Identify infrastructure items needed to meet product / service conformity requirements. Should cover buildings, work space, associated utilities, process equipments / devices like hard ware / software & supporting services. What is required and what is available. This kind of evaluation needs to be done periodically 6.3 - Infrastructure

54. Clause 7 Product / service realization Only clause of the standard where exclusion is permitted

55. Some kind of document that gives complete idea on how the product / service will be realized from start to finish. How many processes will be there and their process document Quality objectives if required. Identification of applicable test / inspection / verification / validation activates during the realization process Criteria for product / service acceptance 7.1 – Planning of product realization

56. Applicable to mktg / sales department How requirements are determined by them. Stated needs Implied needs Any applicable legal / statutory requirements associated with products / service Enquiry log or enquiry mgmt software / lead management software 7.2.1 – determination of requirements related to product / service

57. Before commitment is made to the prospect to deliver product / service with some specifications within some time line, a formal / informal review should be done covering all the parties to the realization process to determine whether the company is in the position to deliver what is being committed. If customer has given requirements verbally, it needs to be confirmed by the org. before acceptance. 7.2.2 – Review of requirements

58. How product / service information is given to the customer How orders are received. How change in orders are documented How customer complaints are addressed How customer feedback is taken 7.2.3 – Customer communication

59. Applicable if the organization designs & develops new products / services / applications Design planning Design input Design review Design output Design verification Design validation Design changes 7.3 – Design & development

60. Supplier registration / evaluation before purchasing Supplier revaluation at a regular interval & it’s analysis 7.4.1 – Purchasing Process

61. Purchase order with clearly written specifications, deliver date, location and approval of authorized authority 7.4.2 – Purchasing information

62. Incoming inspection quality plan for products / services to identify what to inspect for what parameters and expected standard result for approval. Formal / informal inspection records to show that inspection was carried out as per incoming inspection quality plan depending on product / service and it’s importance to the overall product / service realization process. 7.4.3 – Verification of purchased products / services

63. Availability of work instructions wherever required to control process / activity appropriate equipments / applications / software are used. Monitoring and measurement devices / applications are available and used How products / services will be released, delivered and associated post delivery activities needs to be identified. 7.5.1 – Control of production & service realization

64. Any process where deficiencies / problems / non conformity is evident only after the product / service is delivered or in use, validation is required. In a simple language, for those processes where regular in-process inspection or final inspection can not identify the deficiencies that can occur later, validation is required. Example:- dummy ATM transaction for each ATM setup Records on how process will be validated and revalidated. 7.5.2 – Validation of process

65. Product / service should be identifiable during the realization process. For products tags like yet to inspected, inspected, WIP, rejected, ready to dispatch tags should be put wherever applicable. For software industry configuration management / version control process is a method for this clause. 7.5.3 – Identification & traceability

66. Covers both – physical & intellectual property Any damage done to the customer property needs to be documented 7.5.4 – Customer property

67. Preserve the product / service during internal processing & delivery to the intended destination. Covers receipt, storage, processing, storage and transportation for products. Covers data back up, virus management, Intrusion control, firewall management, access control, information security policies for service organizations. 7.5.5 – Preservation of product

68. Applicable to any physical device / instrument or software application used to monitor and measure process output / performance. Calibration frequency needs to be identified with calibration method. Records of calibration needs to be maintained. 7.6 – Control of monitoring & measurement devices

69. Required to demonstrate that products / services are conforming to requirement. To demonstrate that QMS is effective To identify improvement opportunities Appropriate data analysis / statistical methods needs to be used for this purpose that can be determined by the organization depending on size, nature, complexity and criticality of the data / information. 8.1 – Measurement, analysis & improvement - General

70. Process for evaluating customer satisfaction needs to be in place to determine satisfaction level of customers. Needs to be done at a regular interval. Can be done through a formal feedback exercise (physical, online, telephonic etc.) or any other method appropriate to the company. 8.2.1 – Customer Satisfaction

71. 3 rd of the 6 mandatory procedures. SOP must be available. Must be done at a regular interval to verify whether QMS is effectively implemented and maintained. MR prepares yearly / half yearly audit schedule. Done by trained internal auditors who can not audit their own function. Audit plan, report & NC reports are to be maintained. 8.2.2 – Internal Audit

72. Processes used for product / service realization needs to be monitored for their effectiveness. Each process needs to have one or more process effectiveness measurement parameter. Final product / service needs to be monitored & measured for it’s conformity to acceptance criteria. In case of a deviation proper correction & corrective actions with root cause needs to be documented. 8.2.3/4 – Monitoring & measurement of processes / product

73. 4 th of the 6 mandatory procedures SOP must be available. In case of any non conformity observed in the product / service, it must be documented. What it is to be done with the non conforming product / service needs to be identified. NC, Correction, root cause & corrective actions are to be available. 8.3 – Control of non conforming product / service

74. Minimum parameters to be analysed:- Customer satisfaction Customer complaints Product / service conformity Process performance / trend analysis Supplier re-evaluation analysis 8.4 – Analysis of Data

75. Some kind of evidence that the QMS in improving continually through:- Quality policy / Quality objectives Audit results Data analysis Process / product performance & conformity Some kind of continual improvement project(s) needs to be identified 8.5.1 – Continual Improvement

76. 5 th of the 6 mandatory procedures. SOP must be available. For each non conformity detected / customer complaint received, in order to eliminate the root cause of it, corrective actions are to be taken. Effectiveness of the corrective action taken must be measured to confirm that the root cause has been eliminated / dilauted. 8.5.2 – Corrective Actions

77. 6 th of the 6 mandatory procedures. SOP must be available. Corrective actions is for the non conformities that have already occurred while preventive actions are for those non conformities that are yet to occur. Identify potential non conformities across the organization / processes and identify reasons for potential non conformities. Take steps to eliminate them and review 8.5.3 – Preventive actions

78. Each participant (individual or in a team of 2) to present the assigned clause for a maximum of 10 minutes. Time given for preparation:- 30 minutes Exercise 4

79. ISO 9001:2008 documentation

80. Quality policy and quality objectives Quality Manual Functional Documentation System Documentation You will be associated with the following documents……….

81. Setting Objectives METHODOLOGY: SMART TECHNIQUE S - Specific M - Measurable A - Attainable R - Relevant T - Time-Bound

82. Revenue: To increase the market share by …%; To reduce % variation form budget; To reduce overtime costs by 15% over previous quarter; Speed : To reduce number of % of deadlines missed; To decrease document turnaround time; To improve process completion time from__ to ___ Examples of Quality Objectives

83. Examples of Quality Objectives Quantity : Number of clients contacted each week…..Month..etc ; No. of items processed each week..month..etc; % increase in business; Quality : Reduced customer complaint rate/ratio.; Reduced % work needing to be redone;

84. Functional Procedures (SOP) Process Flow Charts Work instructions / Guidelines Functional Formats Check Lists Functional Documentation Documentation starts with identification of input / SOP / Output & Performance Measurement

85. System Procedures System Formats System Documentation

86. Control of documents (Clause 4.2.3) Control of records (Clause 4.2.4) Internal Audit (Clause 8.2.2) Control of nonconforming product (Clause 8.3) Corrective action (Clause 8.5.2) Preventive Action (Clause 8.5.3) System Procedures

87. SOP is a step by step documentation of activities done in a department or process of an organization. Example of a SOP SOP – Standard Operating Procedure

88. Work instructions are prepared for important activities of a SOP where there is a fixed and well defined way of doing an activity. Work instructions tells us how do we do a particular process or activity… Example :- work instructions for installation Guidelines are prepared when there isn’t a fixed way of doing an activity like Guidelines for attending a phone call for receptionist Work Instruction / Guidelines

89. Formats are used to fill in data in a document. For example a blank customer feedback form is a document but when customer feedback related data are entered, it becomes a record. Format

90. Checklists are used to ensure that a particular activity has been carried out as per the SOP or work instruction before delivering it to the customer or next department. Example:- Checklist before dispatch of a product. Check List

91. Quality Manual containing Scope of ISO 9001 & any exclusions with justification. SOPs or reference to SOPs Description of interaction between the processes of the QMS Documented statements of Quality Policy Objectives. Mandatory Documents

92. Procedures for Control of Documents Control of Records Control of Non conforming Products / Services Internal Audit Corrective & Preventive Actions Mandatory Documents

93. Master list of documents Document issue records Document change request form Record Matrix Yearly / Half yearly schedule of internal audit Internal audit plan Internal audit report Records

94. Non Conformity Report Non Conformity Log (Process & Product) List of preventive actions Management Review Meeting Agenda Management Review Meeting Minutes Actions plan on the basis of minutes of MRM Infrastructure & resource need identification Records

95. List of applicable legal & statutory requirements. List of trained auditors Records

96. Quality Policy if required translated in local language to ensure that it is understood by everybody. Measurable and time-bound quality objectives. Planning for quality objectives. Monitoring chart for achievement status of quality objectives. QPO related documents

97. MR Appointment letter MR Related Documents

98. Management Review Meeting Agenda Management Review Meeting Minutes Actions plan on the basis of minutes of management review meeting. MRM Related documents

99. Organization chart Roles & Responsibility for all the positions as per the organization chart. Ideal competence identification for various positions. Competence gap identification between ideal competence and existing competence. Training calendar Training attendance records Training effectiveness evaluation records HR Related Documents

100. Customer enquiry details Identification of legal / statutory / regulatory requirements for customer enquiry. Some kind of document to check whether before accepting order from the customer whether internal discussions took place to determine company’s capability to meet customer requirements. Customer Complaint & it’s analysis Customer Feedback & it’s analysis Marketing Related Documents

101. Design & Development Plan Design & Development Input Design & Development Review Design & Development Verification Design & Development Validation Records of design & development changes. D & D Related Records

102. Supplier Registration – i.e. details on the basis of which a supplier was selected. List of approved suppliers Supplier Evaluation Purchase Orders Incoming inspection of purchased products / services. Purchasing Related Documents

103. Plan for product or service realization i.e. what will be the input, what will be the processing, what parameters will be checked and who will approve final delivery of the product or service. SOPs and Work Instructions wherever required for important processes during product / service realization. Production / Service Provision Related Documents / Records

104. Process Validation records Validation of Processes

105. Records of customer property that is lost, damaged or found unsuitable for use. Customer Property

106. List of devices / software that needs calibration Identification of calibration frequency Calibration Records Control of Monitoring and Measurement Devices

107. Identification of various process in the organization. Identify input, output and process effectiveness measurement parameters for each of the processes. How to implement…?

108. Awareness Training Quality Policy & Objectives Gap Analysis Documentation Implementation Internal Audit Management Review Meeting Shadow Audit Final Certification Audit – Implementation Steps

109. Difference between continuous and continual improvement ISO 9001 audit:- Compliance audit in the first year Performance audit in the subsequent audits So continual improvement is very important and each year a few continual improvement projects are to be selected by the ISO team Continual improvement

110. Thank You Question – Answer Session & Written Examination