Iso 9001 understanding rev3


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  • Use this presentation to introduce the project plan to the ISO Steering Team and to the Task teams. The first team meeting is a good place to present this program.
  • Iso 9001 understanding rev3

    1. 1. Automated Packaging Understanding ISO 9001 / Documentation Requirements
    2. 2. GAP ANALYSIS Of ISO- 90011. Minimum knowledge (ISO Requirements)2. Current quality manual repeats the standard (Not used)3. QPM procedures missing that show compliance to key processes and interaction with ISO
    3. 3. GAP ANALYSIS Of ISO- 90014. Too many work instructions to control5. Internal audits not auditing to a process approach system.6. Process approach not mentioned7. SGS
    4. 4. Internal StandardOrganizationISO-9001:2008 Piece Of The Puzzle
    5. 5. 4.1 General Requirements : Shall establish, document, implement and maintain. Identify the processes needed; Determine the sequence needed; Determine criteria and methods needed; Availability of resources necessary to support an operation; Monitor, measure and analyze the processes; Implement actions necessary to achieve planned results. 4.2 Documentation Requirements: Quality Policy Quality Goals Quality Manual Procedures: 6 Required Maintain records: 13 different types 4.2.2 Quality Manual: Scope Justification for any Exclusions , Reference to Procedures, Description of the interaction between processes.Clause 4 – Quality Management SystemSets requirements to identify, plan, document, operate and 4.2.3 Control of Documents:control QMS processes and to continually improve the Approval of documents prior to use Documented procedureeffectiveness of our QMS system. (5 elements) Review and update and re-approval Changes and current revision is identified Current revisions available at use Remain legible External documents are identified Distribution controlled Prevent use of obsolete documents Apply suitable identification if retained for any purpose. 4.2.4 Control of Records: Documented Procedure Remain legible Readily identifiable Retrievable Storage Protection Retention time and disposition of records.
    6. 6. 5.1 Management Commitment:Top Management shall:Communicate importance of meeting customers requirementsEstablish a Quality Policy ManagementEstablish Quality ObjectivesConduct Management ReviewsEnsure availability of Resources Responsibility5.2 Customer FocusRequirements DeterminedRequirements are metAim to enhance customer satisfaction5.3 Quality PolicyAppropriate to the OrganizationCommitment to comply with requirementsFramework for establishing and reviewing Quality ObjectivesCommunicated and understoodReviewed continually #1 Commandment5.4. Quality ObjectivesEstablished Thou shall have ManagementMeet requirements for product CommitmentMeasurable and consistent with the Quality Policy Clause 5 – Management Responsibility – Top5.5 Responsibility, Authority and CommunicationResponsibility and Authority is defined and communicated Management shall provide evidence of itsAppoint a Member of Management for Management Reviews commitment to the development, implementation andProcess are established, implemented and maintainedReport to Top Management continually improving the QMS system. (6 elements)Promotion of Customer RequirementsAppropriate communication process established and takes place5.6 Management ReviewTop Management must attendPlanned IntervalsReview InputReview Output
    7. 7. 6.1 Provision of ResourcesDetermine and provide resources needed to implement and maintain Quality System continually improve its effectiveness enhance customer satisfaction meeting customer requirements6.2 Human ResourcesCompetent PersonnelAppropriate education, training, skills and experience Resource6.3 InfrastructureDetermine, provide and maintain to achieve product requirementsInfrastructure includes: Management building workspace associated utilities process equipment (both hardware and software) supporting services (transport and communication)6.4 Work EnvironmentDetermine and Manage to achieve product requirements Clause 6 – Resource Management Sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements. (4 elements)
    8. 8. 7.1 Planning of Product Realization Plan and develop process Consistent with requirements Maintain quality objective Establish documentsClause 7 – Product Realization Provide resources specific to processSets requirements to plan, operate and control Verification, validation, monitoring, inspection and test activities for product acceptance Records as evidence that processes and product meet requirementsthe specific QMS processes that determinedesign, produce and deliver APS’s product 7.2 Customer-related Processesand services. (6 elements) Determination of requirements related to the product Review of requirement related to the product 7.3 Design and Development No Applicable to CRT 7.4 Purchasing Purchasing Process Purchasing Information Verification of purchased product 7.5 Production and Service Provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of Product 7.6 Control of Monitoring and Measuring Devices Management Determine what monitoring and measurement devices needed Devices needed to provide evidence of conformity Analysis and Establish processes were monitoring and measurement can be carried out Processes carried out that is consistent with requirements Measuring equipment calibrated, prior to use, against standards and verification recorded Improvement
    9. 9. 8.1 GeneralDemonstrate conformity of productEnsure conformity to the quality management systemContinually improve the effectiveness Clause 8 – Measurement, Analysis and Improvement8.2 Monitoring and Measurement Sets requirements to plan, measure, analysis and improve8.2.1 Customer Satisfaction processes that demonstrate product and QMS conformityMonitor information relating to customer perception and continually improve QMS effectiveness. (10 elements)8.2.2 Internal AuditAudits at planned intervalsAudits conducted on planned arrangementsAudits conducted on International StandardAudit conducted on the Quality Management SystemDocumented Procedure Define scope, frequency and methods Determine status and importance Results of previous audits shall be taken in consideration Auditor can not audit their own work Corrective Action must be taken without delay Follow-up activities required.8.2.3 Monitoring and Measurement of ProcessesApply suitable methods for monitoring and measuring the processDemonstrate ability to achieve planned results of the process8.2.4 Monitoring and Measurement of ProductCharacteristics of the product requirements are met ManagementCharacteristics are measured at different stages of the processRecords of conformity is maintainedRecords must have authorized personnel listedProduct release and service delivery can not happen until planned arrangements are satisfactory. Analysis and Improvement
    10. 10. 8.3 Control of Nonconforming ProductEnsure nonconforming product is identified and controlledDocumented Procedure 8.5.3 Preventive Action Take action to eliminate nonconforming material Determine action to eliminate the causes of potential nonconformities Release nonconforming product by relevant authority only Be appropriate to the effects of the potential problems Prevent its original intended use by taking action Documented ProcedureMaintain records determine potential nonconformitiesRe-verification to demonstrate conformity determine and implement actionProduct is detected after delivery, action must be taken maintain records review preventive action8.4 Analysis of DataDetermine, collect and analyze data for suitability and effectivenessProvide information relating to Customer Satisfaction Conformity to Product Requirements Characteristics and trends of process and product Opportunities for preventive action Suppliers8.5 Improvement8.5.1 Continual ImprovementContinually improve through use of Quality Policy Quality Objectives Audit Results Analysis of Data Corrective and Preventive Action Management Review8.5.2Corrective ActionTake action to eliminate the cause of nonconformitiesAppropriate to the effects of the nonconformities encounteredDocumented Procedure Management Analysis and review nonconformities determining the causes evaluating the need for action ensure nonconformities do not recur determining and implementing action needed records of results Improvement reviewing corrective actions
    11. 11. Internal Standard OrganizationISO 9001:2008 Quality Management Systems Quality Management Management Responsibility System Resource Management Management Management Analysis and Analysis and Improvement Improvement
    13. 13. To some companies, the point of ISO 9001 registrationis to get a certificate.While important to convince customers that certainprocedures are in place, a certificate can be a veryexpensive piece of paper if that is the only benefitrealized by an organization. The QMS Quality Management System must be planned and implemented by Top Management.In most cases the understanding of the requirements is thata lot of procedures and documents are needed. So the mythof ISO 9001 being a documentation nightmare is still acommon misconception at many levels of management.
    14. 14. To some organization, the point of ISO 9001 registrationis to get a certificate to convince customers thatprocedures are in place and they comply to thestandard. A certificate can be a very expensive piece ofpaper if that is the only benefit realized by anorganization.The (QMS) Quality Management System must be plannedand implemented by Top Management.
    15. 15. One of the major issues of the previous revision of thestandard was that it required extensive documentation. Thenew revised standard has significantly reduced mandatorydocumented procedures. It has given greater flexibility todetermine the documented procedures and instructionsbased on the nature of activities and processes.
    16. 16. 4.2 DOCUMENTATION REQUIREMENTS 21 Required Records: 5.6.1 Management reviews 6.2.2 (e) Education, training, skills and experience 7.1 (d) Company-defined records needed to provide evidence that the realization processes and resulting product fulfill requirements 7.2.2 Results of the review of requirements related to the product and actions arising from the review 7.3.2 Design and development inputs relating to product requirements 7.3.4 Results of design and development reviews and any necessary actions 7.3.5 Results of design and development verification and any necessary actions 7.3.6 Results of design and development validation and any necessary actions 7.3.7 Results of the review of design and development changes and any necessary actions 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations 7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement 7.5.3 The unique identification of the product, where traceability is a requirement 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use 7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist6 Required Procedures: 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements 7.6 Results of calibration and verification of measuring equipment 8.2.2 Internal audit results and follow-up actions 8.2.4 Indication of the person(s) authorizing release of product. 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained 8.5.2 Results of corrective action 8.5.3 Results of preventive action
    17. 17. So does our Quality Management System have to becomplicated and cumbersome?Complying with ISO 9001:2008 does not have to be a“document nightmare.” Understanding the requirements ofthe standard and developing ways to meet them is what weneed, “A review of the standard”.ISO 9001 can only be a documentation nightmare if wechoose to make it so. We Need To Avoid Drowning in Detail…..
    18. 18. The old adage frequently applied to ISO 9001 is “Say whatyou do and do what you say.” Some of us seem to take thisto mean “Write down everything you do,” but that is notrequired by the standard. The actual requirement is thatprocesses are well-defined and responsibilities clearlycommunicated. This can be accomplished through a lot ofmethods that require little documentation, such as training.The key concept is that the goal is to use the ISO 9001standard to improve our business, and if it becomes aburdensome paper bureaucracy, then that is probably nothappening. Using a Leaner (meaning not wasteful) approachto ISO 9001 is one way to ensure saving time in ourdocumentation and cost in revising / reviewing documents.
    19. 19. ISO 9001 Quality Management SystemThere is nothing in the ISO requirements that says a Quality Manual /QMS Quality Management System procedures needs to be 50 pagesor more. However, most Quality Manual seem to follow the pattern ofaddressing each and every ISO 9001 “shall” statement by essentiallyrepeating the standard’s requirements as we have in our APS QualityManual. This is an incredible waste of time and cost! (see examples) •Waste is hidden in all processes •Identifying and eliminating waste •When waste is identified, it becomes clear that it adds no value to the customer and increases our operating cost.
    20. 20. ISO 9001 Quality Management SystemClause 4.2.2 of ISO 9001:2008 states the following:The organization shall establish and maintain a qualitymanual that includes;a)the scope of the quality management system, includingdetails of and justification for any exclusions.b)the documented procedures established for the (QMS)Quality Management System, or reference to them.c)and a description of the interaction between theprocesses of the (QMS) Quality Management System.
    21. 21. APS Current Quality Manual Repeats Standards
    22. 22. APS Current Quality Manual Repeats StandardsOver 1500 Work Instructions
    23. 23. Leaner ISO 9001 QMS – Quality Management System Purposing a revised Quality Manual Core Quality Manual for all of PlasticOperations with basic statements showingTop Managements commitment to comply with ISO-9001:2008 See attached Quality Manual examplesIf approved my management to move forward. This quality manual will replace the current APS manual in lotus notes
    24. 24. Purposed QMSQuality Management System Procedures Interact With Other Clauses And Elements Of The Standard
    25. 25. Purposed Quality Management System Revised Format Purposed 24 QMS Procedures Interact With Other Clauses And Elements Of The StandardThe Quality Manual must be reviewed and implemented byTop Management.The QMS Quality Management System documentationmust be reviewed and implemented by Process OwnedManagement.
    26. 26. Lean ISO 9001 Quality Management SystemsThe goal of our QMS Quality Management System proceduresis to document key processes. The ISO 9001 Standard doesnot specify any format for writing procedures, nor does itspecify a length. Since no one wants to read long-winded,boring procedures – why write them? Why not write one, twoor three page procedures using brief and easy to understand?I am proposing using a LEAN approach which makesprocedures more useful so they can benefit us instead of beinga paper burden.
    27. 27. ISO- Level 1 9001:2008 Standard Quality Manual, Quality Policy Level 2 (QMS) Quality Management System Procedures Level 3 Plastics Operations Training Instructions, Work Instructions, Operator InstructionsLevel 4 Records, Forms, historical data
    28. 28. TOP Level Core ManualLevel 1The Quality Manual is the core of the quality system gives abrief description of APS’s quality policy, objectives and isseparate and distinct from the (QMS) Quality ManagementSystem procedures.The purpose of this level of documentation is used externally /internally to introduce our (QMS) Quality Management Systemto our customers and other external organizations orindividuals to show that Top Managements is commitment inimplementing and complying with ISO-9001:2008requirements.
    29. 29. QMS – Quality Systems Procedures Process ApproachLevel 2 Uses a process approach (QMS) QualityManagement System that which define the methods,interaction, assign responsibilities and authorities, tasks andactivities in meeting ISO 9001:2008 requirements.Section 4.1 c) of the ISO 9001:2008 standard requires we areto determine criteria and methods needed to ensure that boththe operation and control of processes are effective. It doesnot require the methods and criteria to be defined inprocedures; other methods may be used.
    30. 30. Work Instructions Level 3This level of documentation is very detailed on "how" toaccomplish a specific job, task or assignment.For example, a work instruction could be developed for aproduct with step-by-step instructions including such detail astesting requirements.Individual work instructions are very specific to theprocess(s).Supplemental documentation may be used including UsersManuals, Engineering or Technical Manuals, TechnicalSupport notes, Manufacturing Notes, etc., in order to createdetailed work instructions.
    31. 31. Level 4 - Forms and other DocumentsThe last level of documentation can include forms, records,checklists, surveys, and other documents used in theproduction or delivery of a product or service.
    32. 32. ISO-9001:2008 Clause .2 Process ApproachWhat Is Process Approach?
    33. 33. Promote Clause .2 Process ApproachThe ISO-9001:2008 Standard promotes the adoption of aprocess approach when developing, implementing andimproving the effectiveness of a QMS System.
    34. 34. Clause .2 Process Approach (COP’s)"Core" processes (also known as Customer-Oriented-Processes) are product realization processes that determinecustomer requirements. These processes have a directimpact on the customer.Examples of core processes include:•Design & Development•Production (manufacturing, outsourcing, testing, etc.)•Invoicing
    35. 35. Clause .2 Process Approach(SOP’s) “These processes (SOPs) (also known as Support- Oriented-Processes) provide the necessary resources to COP’s to facilitate product realization. Some support functions are: Purchasing - Supplier management processes, Requisitions, Request for Quote Others – Quality, HR, IT, Engineering, Training
    36. 36. Clause .2 Process Approach(MOP’s) “These processes (MOPs) (also known as Management- Oriented Processes) provide the commitment, leadership, resources, review and decision-making by Top Management. Examples of management processes include: •Quality policy and objectives •Planning (Strategic, Operational) •Resource management •Customer focus •Management reviews •Corrective Action •Control of documents and records
    37. 37. Clause .2 Process Approach MOP’s MOP’s Management Oriented Processes Continual Improvement, Internal Customer Analysis of Policy Corrective & Preventive Action Auditing Satisfaction Data Management Quality Quality Review Objectives PlanningCustomer Needs / Requirements COP’s Customer Satisfaction CORE PROCESSES = COP’s Customer Oriented Process Customer Art, Imaging, Shipped Shipping Sales Graphics Extruding Service Plates Internally Printing Converting Input Output Shipped Internally SOP’s Support Oriented Processes Control of Control of Purchasing Maintenance Training Calibration Documents Records
    38. 38. Promoting The Use Of ProcessApproach During Internal Auditing
    39. 39. A Change In Internal Auditing Process Based AuditingCurrent Internal Audits: are conducted as an independent examination orreview of the single process (Department).Proposed Processed BasedAudits audit reviews system of linked processes such as Inputs: that comeProcessinto the process, Outputs: of what you expect from the process .Each process uses resources to transform inputs into outputs. Since the outputof one process becomes the input of another process, processes interact andare interrelated by means of such input-output relationships. These processinteractions create a single process-based QMS system. system Using Turtle Diagrams
    40. 40. Clause .2 Process Approach Turtle Diagram Resources / With What With Who / Responsible Parties Detail what are the necessary Enter details of the personnel involved, machines, raw materials, equipment, training, skills and competence software infrastructure etc. criteria etc. Inputs What Come in Output What do you And What Does The expect And What Requirements Requirements Customer Want? Does The Customer Process Get? Enter details of the actual inputs required Name OF Process Enter details of the by the process. Name Of Owner actual output of the process, records, Enter internal customer quality requirements, external Products, customer requirements, tools, satisfaction, etc.materials, schedules etc. Key Criteria / Measure Operational Control / How Enter how is the analysis of the process effectiveness accomplished? Enter details objectives, measurables of details objectives, measurables of the process effectiveness, targets, and the process effectiveness, targets, and results etc. results etc.
    41. 41. Clause .2 Process Approach Turtle Diagram Resources / With What With Who / Responsible Parties ISO-9001, Cross-Functional Audit Top Management, Department Team, CAR System, Business Plan, Managers Performance MeasurablesInputs What Come in And What Does The Requirements Requirements Output What do you Customer Want? Process Audited expect Output InputsISO Requirements, Resources, Management Policy, Objectives,Infrastructure, Plant Responsibility Customer Layout, Required Satisfaction, QMSRecords, Customer Compliance, Specifics, Training, Controlled Records, Quality Objectives, Continual Communication Improvements Operational Control / Key Criteria / Measure QMS Procedures Internal Audits, Performance QMS Procedures, Core Clauses: Measurables, Management Review, Customer Specifics, 4.1, 4.2, 5.1, Customer Satisfaction, CAR 5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 7.2.3, System, measurables of the process 7.3.4, 8.2.1, 8.4, 8.5 effectiveness, targets, and results etc.
    42. 42. Master Audit Checklist Score 0730MANUFACTURING INTERNAL AUDIT REPORT BEDFORD GARFIEL ❑ SANTA FE ❑ SPO KEYSERFACILITY AUDITED: STREETSBORO DATE OF ❑ ❑ AUDIT: AUDITOR: AUDITEE(S)SHIFT(s) AUDITED: ❑ 1st Shift 2nd Shift ❑ 3rd Shift AUDITEE(S) Evaluation Guideline Audit Results Rating Guideline Score (%) Classification 3 Is In Place And Being Followed 90 -100 Complies Total Possible Points 0 2 In Place But Not Being Followed For All Processes 75 89- Observation Total Points This Audit 0 1 Is In Place But Not Being Followed 61 - 74 Minor Issue Audit Classification MajorMP! Not In Place And No Evidence 60 Or Less Overall Audit Score -100.000% N/A Not Applicable Question Does Not Apply Clause Score Results Clause Score Results4.1 General Requirements 0.0% Major 7.1 Planning of Product Realization 0.0% Major4.2 Documentation Requirements 0.0% Major 7.2 Customer-Related Processes 0.0% Major5.1 Management Commitment 0.0% Major 7.3 Design and Development 0.0% Major5.2 Customer Focus 0.0% Major 7.4 Purchasing 0.0% Major5.3 Quality Policy 0.0% Major 7.5 Production and Service Provision 0.0% Major Control of Monitoring and Measuring5.4 Planning 0.0% Major 7.6 Equipment 0.0% Major Responsibility, Authority and Communication5.5 0.0% Major 8.1 General 0.0% Major5.6 Management Review 0.0% Major 8.2 Monitoring and Measuring 0.0% Major6.1 Provision of Resources 0.0% Major 8.3 8.4 Analysis of Data 0.0% Major6.2 Human Resources 0.0% Major 8.4 Analysis of Data 0.0% Major6.3 Infrastructure 0.0% Major 8.5 Improvement 0.0% Major6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major
    43. 43. SGS Registrar
    44. 44. FICCI CE Examples For Revision Of Our Policies Quality PolicyWith the dedication of all employees, we as a companyconstantly strive to meet our customer needs through quality and continuous improvements. Environmental PolicyWith the dedication of all employees, we as a company constantly strive to protect the environment andprevent pollution through continual improvement and compliance to environmental regulations and procedures.
    45. 45. That’s a wrap! Thank you!