1. ISO 9001:2000 Intro Presented By: Brad D

2. Agenda Overview of QMS Fundamentals ISO 9001:2000 Overview & Requirements

3. What is Quality ? Degree to which a set of inherent characteristics fulfills requirements ISO 9000:2000

4. Quality Conformity Assurance Consistency Customer Requirements Customer Satisfaction System Service ProductProcess

5. Quality “Maturity” 1.No quality in place 2.Quality Planning: Policies / Procedures, Resources 3.Quality Control: Reactive process in place that correct failure detected after production 4.Quality Assurance: Proactive/Preventative – Provide confidence 5.Quality Improvement: Effectiveness, Efficiency, Capability

6. Quality Product Specific: Operational Dimensional Functional Ease of use Process Related: Inputs / Outputs Resources Communication System Related Process flow Interaction Communication Service Related Response Comfort Availability

7. Quality Management Coordinated activities to direct and control an organization with respect to quality. ISO 9000:2000

8. Product The result of a process ISO 9000:2000

9. Quality Management System Set of Planning, Control, Assurance, and Improvement Activities working together to direct and control organization with respect to quality.

10. Quality Management System Create confidence in processes and products Provide basis for continual improvement Lead to customer satisfaction and mutual success

11. ISO 9000 QMS Family ISO 9000:2000QMS – Fundamentals and Vocabulary ISO 9001:2000QMS – Requirements ISO 9004:2000QMS – Guidelines for Performance Improvements ISO 19011:2002Guidelines on Quality and/or Environmental Management Systems Auditing

12. Process Approach to Management PROCESS (set of interrelating activities)‏ INPUT OUTPUT PRODUCT (result of a process)‏ PROCEDURE (Specified way to carry out an activity or process Monitoring, Measurement (Before, During, After)‏

14. ISO 9001:2000 Section Overview 6 5 7 8 General Requirements (4)‏

15. 4. General Requirements Establish, document, implement and maintain a QMS and continually improve its effectiveness by: Ensuring resources and information are available to support operation and monitoring of processes Monitoring, measuring, and analyzing these processes Implementing Actions to achieve planned results and continual improvement of processes Managing processes in accordance with this standard. Identifying the control of outsourced processes within the QMS Back

16. 4. Documentation Requirements QMS Documentation MUST include: Documented Quality Policy and Quality Objectives Quality Manual Documented Procedures required by the standard (4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3)‏ Documents needed by the organization for effective planning, operation and control Records required by the standard Back

17. 4. Documentation Requirements Minimum Documented Procedures Required: 4.2.3 Control of Documents 4.2.4 Control of Records 8.2.2 Internal Audits 8.3 Control of Non Conforming Product 8.5.2 Corrective Action 8.5.3 Preventative Action Back

18. 4.2.2 Quality Manual Establish and maintain quality manual which contains: Scope of the QMS Details and justification for any exclusions Documented Procedures (or references to them)‏ Description of the interaction between these processes of the QMS Back

19. 4.2.3 Control of Documents Must be a DOCUMENTED procedure, containing controls for: Approving documents for adequacy prior to issue Review, and update as necessary and re-approve Identify changes and current revision status Make relevant documentation available at points of use Ensure documents are legible and readily identifiable Identify and control use of external documents Prevent unintended use of obsolete documents Records are considered as special type of document Back

20. 4.2.3 Control of Records Must be a DOCUMENTED procedure, containing controls for: Identification Protection Retention Time Storage Retrieval Disposition Must be legible, readily identifiable, and retrievable Back

21. Stated Records Required by ISO 9001:2000 5.6.1 Management Review Records 6.2.2 Records of Education, Training, skills, and experience 7.2.2 Records of review and actions from review of requirements related to the product 7.3.4 Records resulting from Design Reviews 7.4.1 Records from evaluation/selection of suppliers 7.5.4 Records reporting to customer regarding lost property 7.6 Records from the result of calibration or verification of equipment 8.2.4 Records of conformity of product with respect to the acceptance criteria (including personnel authorizing release)‏ 8.2.5 Records of non-conformity and subsequent actions taken / concessions 8.5.2 Records resulting from correction actions taken 8.5.4 Records resulting from preventive actions taken 8.2.2 Audit Records ! Back

22. 5.1 Management Commitment Top management to provide evidence of its commitment to develop and implement the QMS and continually improve it’s effectiveness to: Express importance of meeting requirements (customer, statutory, regulatory)‏ Establish the quality policy Ensure quality objectives are established Conduct management reviews Ensure the availability of resources Back

23. 5.2 Customer Focus Top management must: Determine and meet customer requirements Aim to enhance customer satisfaction related to clauses: 7.2. and 8.2.1 Back

24. 5.3 Quality Policy Top management must ensure quality policy: Is appropriate to the purpose of the organization Provides a framework for establishing quality objectives Is communicated and understood within the organization Is reviewed for continuing suitability Includes a commitment to conform with requirements and continuously improve the effectiveness of the QMS Back

25. 5.4 Quality Planning Top management must: Ensure measurable quality objectives are established at relevant functions and levels within the organization that are consistent with the quality policy. Including those objectives needed to meet product requirements. Back

26. 5.4.2 QMS Planning Top management must: Ensure QMS planning is carried out to meet 4.1 requirements (and quality objectives)‏ Maintain integrity of QMS when changes to QMS are planned and implemented Back

27. 5.5 Responsibility, Authority, and Communication Top management must ensure responsibilities and authorities are defined and communicated within the organization. Back

28. 5.5.2 Management Representative Top management must: Appoint a member it’s own top management Give responsibility and authority to: Ensure processes needed for QMS are established, implemented, and maintained Report to top management on QMS performance and any need for improvement Ensure promotion of awareness of customer requirements throughout the organization Back

29. 5.5.3 Internal Communication Top management must ensure: Appropriate communication processes are established within the organization Communication takes place on the effectiveness of the QMS Back

30. 5.6 Management Review Top management must: Perform reviews of QMS at planned intervals Ensure QMS is suitable, adequate and effective Assess opportunities for improvement Evaluate the need for any changes to QMS Evaluate changes to policy and objectives Maintain records of management reviews Back

31. 5.6.2 Review Input Review input must include information on: Results of audits Customer feedback Process performance and product conformity Status of preventive or corrective actions Follow-up actions from previous reviews Changes that could affect the system Recommendations for improvements Back

32. 5.6.3 Review Output Management review outputs should contain any decisions and actions related to: Resource Needs Improvement of QMS Process effectiveness Product related to customer requirements Back

33. 6.0 Resource Management 6.1 Provision of Resources Determine and provide needed resources to: Implement and maintain the QMS Continually improve its effectiveness Enhance customer satisfaction by meeting requirements Back

34. 6.0 Resource Management 6.2 Human Resources Ensure personnel performing work affecting product quality are competent on basis of: Education Training Skills Experience Back

35. 6.0 Resource Management 6.2.2 Competence, Awareness & Training Determine competency needs for personnel Provide training (or take other actions) to satisfy these needs Evaluate the effectiveness of actions taken Inform employees of importance of activities Ensure they know contribution to objectives Maintain appropriate records of education training, skills, and experience Back

36. 6.0 Resource Management 6.3 Infrastructure Determine, provide, and maintain the infrastructure needed for conformity to product requirements. This includes: Buildings, workspaces, and associated utilities Process equipment (hardware/software)‏ Support Services (such as transport or communication)‏ Back

37. 6.0 Resource Management 6.3 Work Environment Determine and manage the work environment needed to achieve conformity to product requirements Examples ? Back

38. 7.0 Product Realization 7.1 Planning Plan and develop processes for product realization Keep consistent with other process requirements Back

39. 7.0 Product Realization 7.1 Planning During the realization process planning determine: Quality objectives and requirements for the product Need for processes, documents, and resources Required verification, validating, monitoring, inspection, and test activities (and criteria for product acceptance)‏ Records needed as evidence that realization processes and resulting product meet requirements Back

40. 7.0 Product Realization 7.2.1 Requirements related to product Determine the product requirements both: Specified by the customer (including delivery and post-delivery activities)‏ Not stated by the customer (but needed for specific or intended use where known)‏ Including statutory and regulatory requirements Other requirements determined by organization Back

41. 7.0 Product Realization 7.2.2 Review of Requirements Conduct review of product requirements before committing to the customer to ensure: Product requirements are defined Any difference from previous expressions are resolved Organization has ability to meet customer requirements Must maintain records of review and results of any actions taken Confirm any undocumented requirements before acceptance If changed ensure documents are amended and relevant personnel updated Back

42. 7.0 Product Realization 7.2.3 Customer Communication Determine and implement arrangements for communication with the customer wrt: Product information Inquires, contracts, and order handling (amendments)‏ Customer feedback (including complaints)‏ Back

43. 7.3 Design & Development 7.3.1 Design & Development Planning: Plan & Control product design & development Determine during the planning: Design & Development Stages Review, verification and validation for each stage Responsibility and Authority Manage interfaces between involved groups Effective communication Clear Assignment of responsibility Update plan output as design & development progresses Back

44. 7.3 Design & Development 7.3.2 Design & Development Inputs: Determine inputs to product requirements Functional and performance requirements Applicable statutorily / regulatory requirements Applicable information from similar designs Requirements essential for design & development Maintain Records Review inputs for adequacy Must be complete, unambiguous and not in conflict Back

45. 7.3 Design & Development 7.3.3 Design & Development Outputs Provide outputs in a form that enables verification against inputs. Approve outputs prior to release Prepare design & development output to: Meet design & development input Provide appropriate information for purchasing, production & service Back

46. 7.3 Design & Development 7.3.4 Design & Development Review Perform systematic review at suitable stages (as per plan in 7.3.1)‏ Evaluate ability of design and development results to meet requirements Identify any problems and propose actions Include representatives of concerned groups Maintain records of reviews and any actions Back

47. 7.3 Design & Development 7.3.4 Design & Development Verification Perform verification as per plan from 7.3.1 Ensure outputs satisfy input requirements Maintain records of verification and actions Back

48. 7.3 Design & Development 7.3.4 Design & Development Validation Perform validation as per plan from 7.3.1 Ensure Product requirements are met (for specified application or intended use are known)‏ Complete before delivery or implementation (whenever possible)‏ Maintain records of validation and actions Back

49. 7.3 Design & Development 7.3.4 Design & Development Changes Identify changes and maintain records Review, verify, and validate the changes (as appropriate)‏ Approve the changes before implementation Evaluate effect of changes on constituent parts and product already delivered Maintain records of change reviews and any actions Back

50. 7.4 Purchasing 7.4.1 Purchasing Process Ensure product conforms to purchase requirements Base the type and extent of control (of suppler and product) upon the effect of product on the subsequent product realization and final product Evaluate and select suppliers base on their ability to supply product in accordance with requirements Set criteria for selection, evaluation, and re- evaluation Maintain records of evaluation results and actions Back

51. 7.4 Purchasing 7.4.2 Purchasing Information Describe the product to be purchased Where appropriate, include in purchasing information the requirements for: Approval of product and procedures Approval of processes and equipment Qualification of personnel QMS Ensure specified requirements are adequate before communicating to supplier Back

52. 7.4 Purchasing 7.4.3 Verification of Purchased Product Establish and implement inspection or other activities necessary to ensure product meets specified purchase requirements (refer also to clause 8.2.4)‏ For any verification at supplier premises (by organization or customer, state in Purchase Order)‏ Intended verification arrangements Method of product release Back

53. 7.5 Production & Service Provision 7.5.1 Control of Production & Service Plan and carry out production and service under controlled conditions (as applicable)‏ Availability / Use of product characteristics Work instructions Suitable equipment Monitoring and measuring devices Implementation of monitoring and measuring Implementation of release, delivery, post-delivery activities Back

54. 7.5 Production & Service Provision 7.5.2 Validation of processes Establish arrangements as applicable Criteria for review and approval of processes Approval of equipment Qualifications of personnel Use of specified methods and procedures Requirements for records Revalidation Validate any process if output can not be verified by monitoring and measurement (special processes)‏ Back

55. 7.5 Production & Service Provision 7.5.3 Identification and Traceability Identify product by suitable means throughout product realization (where appropriate)‏ Identify status of product with respect to monitoring and measuring requirements Control and record unique identification (where traceability is a requirement)‏ Note: Configuration Management Back

56. 7.5 Production & Service Provision 7.5.5 Preservation of Product Preserve product conformity during internal processing and delivery to destination Include identification, handling, packaging, storage and protection Apply also to constitute parts of product Back

57. 7.6 Control of Monitoring and Measuring Devices Determine monitoring and measurements to be undertaken (and devices needed) to provide evidence of product conformity (see 7.3.3)‏ Establish processes t ensure meonioring and measurement can be carried out (and are carried out) consistent with requirements Back

58. 7.6 Control of Monitoring and Measuring Devices When necessary to ensure valid results: Calibrate or verify at specific intervals, or prior to use, against traceable measurement standards Record basis for calibration if no such standard Adjust or re-adjust equipment as necessary Identify to determine the calibration status Safeguard from improper adjustments Protect from damage and deterioration Back

59. 7.6 Control of Monitoring and Measuring Devices When necessary to ensure valid results: Assess and record the validity of previous results if device does not meet requirements Record results of calibration and verification Confirm ability of software to satisfy intended application 9confirm prior to initial use and re- confirm as necessary)‏ Back

60. 8.0 Measurement, Analysis & Improvement 8.1 General Plan and implement monitoring, measurement, analysis and improvement of processes to: Demonstrate conformity of product Ensure conformity of QMS Continually improve effectiveness of QMS Determine applicable methods, including statistical techniques, and extent of use. Back

61. 8.0 Measurement, Analysis & Improvement 8.2.1 Customer Satisfaction Monitor information on customer perception (has the organization met the customer’s requirements ?)‏ Include as QMS performance measurement Determine methods to obtain and use information Back

62. 8.0 Measurement, Analysis & Improvement 8.2.2 Internal Audit Conduct internal audits at planned intervals to determine if QMS conforms to: Planned arrangements ISO 9001 requirements Organization requirements AND is EFFECTIVELY implemented and maintained. Back

63. Basic Auditing Terminology What is a non-conformance ? Is conformance the same as compliance ? What is the difference between auditing and inspecting ?

64. 8.0 Measurement, Analysis & Improvement 8.2.2 Internal Audit Plan the audit program taking into consideration: Status and importance of processes and areas Results o previous audits Define criteria, scope, frequency, and methods Select auditors and conduct audits to ensure: Objectivity Impartiality Of the audit process (Auditors do not audit their own work)‏ Back

65. 8.0 Measurement, Analysis & Improvement 8.2.2 Internal Audit Prepare a documented procedure to address responsibilities and requirements for: Planning and conducting audits Reporting results Maintaining Records Actions must be taken without undue delay Verify actions have been taken and report the results Back

66. 8.0 Measurement, Analysis & Improvement 8.2.3 Monitoring and Measurement of Process Apply suitable methods for monitoring and where applicable, measurement of processes Demonstrate the ability of processes to achieved planned results If results not achieved take corrective action to ensure conformity Back

67. 8.0 Measurement, Analysis & Improvement 8.2.4 Monitoring and Measurement of Product: Monitor and measure product characteristics Verify product requirements have bee met Carry out at appropriate stages of process (according to plan)‏ Maintain evidence of conformity with criteria Indicate person(s) authorizing product release Complete before product release & service delivery Unless approved by relevant authority / customer Back

68. 8.0 Measurement, Analysis & Improvement 8.3 Control of Nonconforming Product Identify and control nonconforming product to prevent its unintended use or delivery Define controls and responsibilities in a documented procedure Deal with non-conforming product Take action to eliminate the non-conformity Authorize use, release, acceptance (concession)‏ Preclude its original intended use or application Back

69. 8.0 Measurement, Analysis & Improvement 8.3 Control of Nonconforming Product Maintain records of nature of nonconformity and subsequent actions (and concessions)‏ Verify corrected product to show conformity When detected after delivery or use, take action appropriate to the effects (or potential)‏ Back

70. 8.0 Measurement, Analysis & Improvement 8.4 Analysis of Data Determine, collect and analyze appropriate data Demonstrate QMS suitability and effectiveness Evaluate where improvements can be made Include monitoring and measurement of data Analyze data to provide information on Customer Satisfaction Suppliers Conformity to product requirements Characters/Trends of processes and product Including opportunities for preventative action Back

71. 8.0 Measurement, Analysis & Improvement 8.5 Continual Improvement Continually improve effectiveness of QMS through use of: Quality policy and quality objectives Audit results Analysis of data Corrective and preventive action Management Revious Back

72. 8.0 Measurement, Analysis & Improvement 8..5.2 Corrective Action Take action to eliminate cause of nonconformities to prevent their recurrence Take action appropriate to the effects of problem Must be a documented procedure containing steps for: Review nonconformities (including complaints)‏ Determine he causes of nonconformities Evaluate need for actions to prevent recurrence Determine and implement corrective action Record results and review of actions taken Back

73. 8.0 Measurement, Analysis & Improvement 8.5.3 Preventative Action Determine action to eliminate cause of potential nonconformities to prevent their occurrence Take action appropriate to the effects of problem Must be a documented procedure containing steps for: Determining potential nonconformities and causes Evaluate need for actions to prevent occurrence Determine and implement the needed action Record results and review of actions taken Review results of action taken Back

74. Summary Key features of an ISO 9001:2000 QMS must address: Continual Improvement Customer Focus Infrastructure & Work Environment Planning (QMS, Resources, processes, production, measuring/monitoring)‏ Internal Communication Company Wide, Departmental and Functional Objectives Employee “Quality” Awareness Training – Competency, Effectiveness Analysis of Data Top Management Involvement Back