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Iso 9001 understanding rev3

The document discusses documentation requirements for ISO 9001 certification. It notes that some organizations see ISO certification as simply a way to get a certificate, but that the true value comes from implementing an effective quality management system. It emphasizes that top management must plan and implement the QMS. The document also discusses reducing documentation requirements in the revised ISO 9001 standard and taking a lean approach to documentation to avoid creating an unnecessary paperwork burden. It proposes a tiered documentation structure with a high-level quality manual at the top level and more detailed procedures, instructions, and records at lower levels.

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Automated Packaging Understanding ISO 9001 / Documentation Requirements
GAP ANALYSIS Of ISO- 9001 1. 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
GAP ANALYSIS Of ISO- 9001 4. Too many work instructions to control 5. Internal audits not auditing to a process approach system. 6. Process approach not mentioned 7. SGS
Internal Standard Organization ISO-9001:2008 Piece Of The Puzzle
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 System Sets 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 procedure effectiveness 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.
5.1 Management Commitment: Top Management shall: Communicate importance of meeting customers requirements Establish a Quality Policy Management Establish Quality Objectives Conduct Management Reviews Ensure availability of Resources Responsibility 5.2 Customer Focus Requirements Determined Requirements are met Aim to enhance customer satisfaction 5.3 Quality Policy Appropriate to the Organization Commitment to comply with requirements Framework for establishing and reviewing Quality Objectives Communicated and understood Reviewed continually #1 Commandment 5.4. Quality Objectives Established Thou shall have Management Meet requirements for product Commitment Measurable and consistent with the Quality Policy Clause 5 – Management Responsibility – Top 5.5 Responsibility, Authority and Communication Responsibility and Authority is defined and communicated Management shall provide evidence of its Appoint a Member of Management for Management Reviews commitment to the development, implementation and Process are established, implemented and maintained Report to Top Management continually improving the QMS system. (6 elements) Promotion of Customer Requirements Appropriate communication process established and takes place 5.6 Management Review Top Management must attend Planned Intervals Review Input Review Output
6.1 Provision of Resources Determine and provide resources needed to implement and maintain Quality System continually improve its effectiveness enhance customer satisfaction meeting customer requirements 6.2 Human Resources Competent Personnel Appropriate education, training, skills and experience Resource 6.3 Infrastructure Determine, provide and maintain to achieve product requirements Infrastructure includes: Management building workspace associated utilities process equipment (both hardware and software) supporting services (transport and communication) 6.4 Work Environment Determine 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)
7.1 Planning of Product Realization Plan and develop process Consistent with requirements Maintain quality objective Establish documents Clause 7 – Product Realization Provide resources specific to process Sets requirements to plan, operate and control Verification, validation, monitoring, inspection and test activities for product acceptance Records as evidence that processes and product meet requirements the specific QMS processes that determine design, produce and deliver APS’s product 7.2 Customer-related Processes and 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
8.1 General Demonstrate conformity of product Ensure conformity to the quality management system Continually improve the effectiveness Clause 8 – Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Sets requirements to plan, measure, analysis and improve 8.2.1 Customer Satisfaction processes that demonstrate product and QMS conformity Monitor information relating to customer perception and continually improve QMS effectiveness. (10 elements) 8.2.2 Internal Audit Audits at planned intervals Audits conducted on planned arrangements Audits conducted on International Standard Audit conducted on the Quality Management System Documented 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 Processes Apply suitable methods for monitoring and measuring the process Demonstrate ability to achieve planned results of the process 8.2.4 Monitoring and Measurement of Product Characteristics of the product requirements are met Management Characteristics are measured at different stages of the process Records of conformity is maintained Records must have authorized personnel listed Product release and service delivery can not happen until planned arrangements are satisfactory. Analysis and Improvement
8.3 Control of Nonconforming Product Ensure nonconforming product is identified and controlled Documented 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 Procedure Maintain records determine potential nonconformities Re-verification to demonstrate conformity determine and implement action Product is detected after delivery, action must be taken maintain records review preventive action 8.4 Analysis of Data Determine, collect and analyze data for suitability and effectiveness Provide information relating to Customer Satisfaction Conformity to Product Requirements Characteristics and trends of process and product Opportunities for preventive action Suppliers 8.5 Improvement 8.5.1 Continual Improvement Continually improve through use of Quality Policy Quality Objectives Audit Results Analysis of Data Corrective and Preventive Action Management Review 8.5.2Corrective Action Take action to eliminate the cause of nonconformities Appropriate to the effects of the nonconformities encountered Documented 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
Internal Standard Organization ISO 9001:2008 Quality Management Systems Quality Management Management Responsibility System Resource Management Management Management Analysis and Analysis and Improvement Improvement
ISO DOCUMENTATION
To some companies, the point of ISO 9001 registration is to get a certificate. While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized 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 that a lot of procedures and documents are needed. So the myth of ISO 9001 being a documentation nightmare is still a common misconception at many levels of management.
To some organization, the point of ISO 9001 registration is to get a certificate to convince customers that procedures are in place and they comply to the standard. A certificate can be a very expensive piece of paper if that is the only benefit realized by an organization. The (QMS) Quality Management System must be planned and implemented by Top Management.
One of the major issues of the previous revision of the standard was that it required extensive documentation. The new revised standard has significantly reduced mandatory documented procedures. It has given greater flexibility to determine the documented procedures and instructions based on the nature of activities and processes.
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 exist 6 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
So does our Quality Management System have to be complicated and cumbersome? Complying with ISO 9001:2008 does not have to be a “document nightmare.” Understanding the requirements of the standard and developing ways to meet them is what we need, “A review of the standard”. ISO 9001 can only be a documentation nightmare if we choose to make it so. We Need To Avoid Drowning in Detail…..
The old adage frequently applied to ISO 9001 is “Say what you do and do what you say.” Some of us seem to take this to mean “Write down everything you do,” but that is not required by the standard. The actual requirement is that processes are well-defined and responsibilities clearly communicated. This can be accomplished through a lot of methods that require little documentation, such as training. The key concept is that the goal is to use the ISO 9001 standard to improve our business, and if it becomes a burdensome paper bureaucracy, then that is probably not happening. Using a Leaner (meaning not wasteful) approach to ISO 9001 is one way to ensure saving time in our documentation and cost in revising / reviewing documents.
ISO 9001 Quality Management System There is nothing in the ISO requirements that says a Quality Manual / QMS Quality Management System procedures needs to be 50 pages or more. However, most Quality Manual seem to follow the pattern of addressing each and every ISO 9001 “shall” statement by essentially repeating the standard’s requirements as we have in our APS Quality Manual. 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.
ISO 9001 Quality Management System Clause 4.2.2 of ISO 9001:2008 states the following: The organization shall establish and maintain a quality manual that includes; a)the scope of the quality management system, including details 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 the processes of the (QMS) Quality Management System.
APS Current Quality Manual Repeats Standards
APS Current Quality Manual Repeats Standards Over 1500 Work Instructions
Leaner ISO 9001 QMS – Quality Management System Purposing a revised Quality Manual Core Quality Manual for all of Plastic Operations with basic statements showing Top Managements commitment to comply with ISO-9001:2008 See attached Quality Manual examples If approved my management to move forward. This quality manual will replace the current APS manual in lotus notes
Purposed QMS Quality Management System Procedures Interact With Other Clauses And Elements Of The Standard
Purposed Quality Management System Revised Format Purposed 24 QMS Procedures Interact With Other Clauses And Elements Of The Standard The Quality Manual must be reviewed and implemented by Top Management. The QMS Quality Management System documentation must be reviewed and implemented by Process Owned Management.
Lean ISO 9001 Quality Management Systems The goal of our QMS Quality Management System procedures is to document key processes. The ISO 9001 Standard does not specify any format for writing procedures, nor does it specify a length. Since no one wants to read long-winded, boring procedures – why write them? Why not write one, two or three page procedures using brief and easy to understand? I am proposing using a LEAN approach which makes procedures more useful so they can benefit us instead of being a paper burden.
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 Instructions Level 4 Records, Forms, historical data
TOP Level Core Manual Level 1 The Quality Manual is the core of the quality system gives a brief description of APS’s quality policy, objectives and is separate and distinct from the (QMS) Quality Management System procedures. The purpose of this level of documentation is used externally / internally to introduce our (QMS) Quality Management System to our customers and other external organizations or individuals to show that Top Managements is commitment in implementing and complying with ISO-9001:2008 requirements.
QMS – Quality Systems Procedures Process Approach Level 2 Uses a process approach (QMS) Quality Management System that which define the methods, interaction, assign responsibilities and authorities, tasks and activities in meeting ISO 9001:2008 requirements. Section 4.1 c) of the ISO 9001:2008 standard requires we are to determine criteria and methods needed to ensure that both the operation and control of processes are effective. It does not require the methods and criteria to be defined in procedures; other methods may be used.
Work Instructions Level 3 This level of documentation is very detailed on "how" to accomplish a specific job, task or assignment. For example, a work instruction could be developed for a product with step-by-step instructions including such detail as testing requirements. Individual work instructions are very specific to the process(s). Supplemental documentation may be used including User's Manuals, Engineering or Technical Manuals, Technical Support notes, Manufacturing Notes, etc., in order to create detailed work instructions.
Level 4 - Forms and other Documents The last level of documentation can include forms, records, checklists, surveys, and other documents used in the production or delivery of a product or service.
ISO-9001:2008 Clause .2 Process Approach What Is Process Approach?
Promote Clause .2 Process Approach The ISO-9001:2008 Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS System.
Clause .2 Process Approach (COP’s) "Core" processes (also known as Customer-Oriented- Processes) are product realization processes that determine customer requirements. These processes have a direct impact on the customer. Examples of core processes include: •Design & Development •Production (manufacturing, outsourcing, testing, etc.) •Invoicing
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
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
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 Planning Customer 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
Promoting The Use Of Process Approach During Internal Auditing
A Change In Internal Auditing Process Based Auditing Current Internal Audits: are conducted as an independent examination or review of the single process (Department). Proposed Processed Based Audits audit reviews system of linked processes such as Inputs: that come Process into the process, Outputs: of what you expect from the process . Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single process-based QMS system. system Using Turtle Diagrams
Clause .2 Process Approach Turtle Diagram Resource's / 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.
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 Measurables Inputs What Come in And What Does The Requirements Requirements Output What do you Customer Want? Process Audited expect Output Inputs ISO Requirements, Resources, Management Policy, Objectives, Infrastructure, Plant Responsibility Customer Layout, Required Satisfaction, QMS Records, 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.
Master Audit Checklist Score 0730MANUFACTURING INTERNAL AUDIT REPORT BEDFORD GARFIEL ❑ SANTA FE ❑ SPO KEYSER FACILITY 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 Major MP! 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 Results 4.1 General Requirements 0.0% Major 7.1 Planning of Product Realization 0.0% Major 4.2 Documentation Requirements 0.0% Major 7.2 Customer-Related Processes 0.0% Major 5.1 Management Commitment 0.0% Major 7.3 Design and Development 0.0% Major 5.2 Customer Focus 0.0% Major 7.4 Purchasing 0.0% Major 5.3 Quality Policy 0.0% Major 7.5 Production and Service Provision 0.0% Major Control of Monitoring and Measuring 5.4 Planning 0.0% Major 7.6 Equipment 0.0% Major Responsibility, Authority and Communication 5.5 0.0% Major 8.1 General 0.0% Major 5.6 Management Review 0.0% Major 8.2 Monitoring and Measuring 0.0% Major 6.1 Provision of Resources 0.0% Major 8.3 8.4 Analysis of Data 0.0% Major 6.2 Human Resources 0.0% Major 8.4 Analysis of Data 0.0% Major 6.3 Infrastructure 0.0% Major 8.5 Improvement 0.0% Major 6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major
SGS Registrar
FICCI CE Examples For Revision Of Our Policies Quality Policy With the dedication of all employees, we as a company constantly strive to meet our customer needs through quality and continuous improvements. Environmental Policy With the dedication of all employees, we as a company constantly strive to protect the environment and prevent pollution through continual improvement and compliance to environmental regulations and procedures.
That’s a wrap! Thank you!

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Iso 9001 understanding rev3

  • 1.
    Automated Packaging Understanding ISO 9001 / Documentation Requirements
  • 2.
    GAP ANALYSIS OfISO- 9001 1. 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.
    GAP ANALYSIS OfISO- 9001 4. Too many work instructions to control 5. Internal audits not auditing to a process approach system. 6. Process approach not mentioned 7. SGS
  • 5.
  • 6.
    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 System Sets 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 procedure effectiveness 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.
  • 7.
    5.1 Management Commitment: TopManagement shall: Communicate importance of meeting customers requirements Establish a Quality Policy Management Establish Quality Objectives Conduct Management Reviews Ensure availability of Resources Responsibility 5.2 Customer Focus Requirements Determined Requirements are met Aim to enhance customer satisfaction 5.3 Quality Policy Appropriate to the Organization Commitment to comply with requirements Framework for establishing and reviewing Quality Objectives Communicated and understood Reviewed continually #1 Commandment 5.4. Quality Objectives Established Thou shall have Management Meet requirements for product Commitment Measurable and consistent with the Quality Policy Clause 5 – Management Responsibility – Top 5.5 Responsibility, Authority and Communication Responsibility and Authority is defined and communicated Management shall provide evidence of its Appoint a Member of Management for Management Reviews commitment to the development, implementation and Process are established, implemented and maintained Report to Top Management continually improving the QMS system. (6 elements) Promotion of Customer Requirements Appropriate communication process established and takes place 5.6 Management Review Top Management must attend Planned Intervals Review Input Review Output
  • 8.
    6.1 Provision ofResources Determine and provide resources needed to implement and maintain Quality System continually improve its effectiveness enhance customer satisfaction meeting customer requirements 6.2 Human Resources Competent Personnel Appropriate education, training, skills and experience Resource 6.3 Infrastructure Determine, provide and maintain to achieve product requirements Infrastructure includes: Management building workspace associated utilities process equipment (both hardware and software) supporting services (transport and communication) 6.4 Work Environment Determine 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)
  • 9.
    7.1 Planning ofProduct Realization Plan and develop process Consistent with requirements Maintain quality objective Establish documents Clause 7 – Product Realization Provide resources specific to process Sets requirements to plan, operate and control Verification, validation, monitoring, inspection and test activities for product acceptance Records as evidence that processes and product meet requirements the specific QMS processes that determine design, produce and deliver APS’s product 7.2 Customer-related Processes and 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
  • 10.
    8.1 General Demonstrate conformityof product Ensure conformity to the quality management system Continually improve the effectiveness Clause 8 – Measurement, Analysis and Improvement 8.2 Monitoring and Measurement Sets requirements to plan, measure, analysis and improve 8.2.1 Customer Satisfaction processes that demonstrate product and QMS conformity Monitor information relating to customer perception and continually improve QMS effectiveness. (10 elements) 8.2.2 Internal Audit Audits at planned intervals Audits conducted on planned arrangements Audits conducted on International Standard Audit conducted on the Quality Management System Documented 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 Processes Apply suitable methods for monitoring and measuring the process Demonstrate ability to achieve planned results of the process 8.2.4 Monitoring and Measurement of Product Characteristics of the product requirements are met Management Characteristics are measured at different stages of the process Records of conformity is maintained Records must have authorized personnel listed Product release and service delivery can not happen until planned arrangements are satisfactory. Analysis and Improvement
  • 11.
    8.3 Control ofNonconforming Product Ensure nonconforming product is identified and controlled Documented 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 Procedure Maintain records determine potential nonconformities Re-verification to demonstrate conformity determine and implement action Product is detected after delivery, action must be taken maintain records review preventive action 8.4 Analysis of Data Determine, collect and analyze data for suitability and effectiveness Provide information relating to Customer Satisfaction Conformity to Product Requirements Characteristics and trends of process and product Opportunities for preventive action Suppliers 8.5 Improvement 8.5.1 Continual Improvement Continually improve through use of Quality Policy Quality Objectives Audit Results Analysis of Data Corrective and Preventive Action Management Review 8.5.2Corrective Action Take action to eliminate the cause of nonconformities Appropriate to the effects of the nonconformities encountered Documented 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
  • 12.
    Internal Standard Organization ISO9001:2008 Quality Management Systems Quality Management Management Responsibility System Resource Management Management Management Analysis and Analysis and Improvement Improvement
  • 13.
  • 14.
    To some companies,the point of ISO 9001 registration is to get a certificate. While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized 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 that a lot of procedures and documents are needed. So the myth of ISO 9001 being a documentation nightmare is still a common misconception at many levels of management.
  • 15.
    To some organization,the point of ISO 9001 registration is to get a certificate to convince customers that procedures are in place and they comply to the standard. A certificate can be a very expensive piece of paper if that is the only benefit realized by an organization. The (QMS) Quality Management System must be planned and implemented by Top Management.
  • 16.
    One of themajor issues of the previous revision of the standard was that it required extensive documentation. The new revised standard has significantly reduced mandatory documented procedures. It has given greater flexibility to determine the documented procedures and instructions based on the nature of activities and processes.
  • 17.
    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 exist 6 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
  • 18.
    So does ourQuality Management System have to be complicated and cumbersome? Complying with ISO 9001:2008 does not have to be a “document nightmare.” Understanding the requirements of the standard and developing ways to meet them is what we need, “A review of the standard”. ISO 9001 can only be a documentation nightmare if we choose to make it so. We Need To Avoid Drowning in Detail…..
  • 19.
    The old adagefrequently applied to ISO 9001 is “Say what you do and do what you say.” Some of us seem to take this to mean “Write down everything you do,” but that is not required by the standard. The actual requirement is that processes are well-defined and responsibilities clearly communicated. This can be accomplished through a lot of methods that require little documentation, such as training. The key concept is that the goal is to use the ISO 9001 standard to improve our business, and if it becomes a burdensome paper bureaucracy, then that is probably not happening. Using a Leaner (meaning not wasteful) approach to ISO 9001 is one way to ensure saving time in our documentation and cost in revising / reviewing documents.
  • 20.
    ISO 9001 QualityManagement System There is nothing in the ISO requirements that says a Quality Manual / QMS Quality Management System procedures needs to be 50 pages or more. However, most Quality Manual seem to follow the pattern of addressing each and every ISO 9001 “shall” statement by essentially repeating the standard’s requirements as we have in our APS Quality Manual. 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.
  • 21.
    ISO 9001 QualityManagement System Clause 4.2.2 of ISO 9001:2008 states the following: The organization shall establish and maintain a quality manual that includes; a)the scope of the quality management system, including details 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 the processes of the (QMS) Quality Management System.
  • 22.
    APS Current QualityManual Repeats Standards
  • 23.
    APS Current QualityManual Repeats Standards Over 1500 Work Instructions
  • 24.
    Leaner ISO 9001 QMS – Quality Management System Purposing a revised Quality Manual Core Quality Manual for all of Plastic Operations with basic statements showing Top Managements commitment to comply with ISO-9001:2008 See attached Quality Manual examples If approved my management to move forward. This quality manual will replace the current APS manual in lotus notes
  • 25.
    Purposed QMS Quality ManagementSystem Procedures Interact With Other Clauses And Elements Of The Standard
  • 26.
    Purposed Quality ManagementSystem Revised Format Purposed 24 QMS Procedures Interact With Other Clauses And Elements Of The Standard The Quality Manual must be reviewed and implemented by Top Management. The QMS Quality Management System documentation must be reviewed and implemented by Process Owned Management.
  • 27.
    Lean ISO 9001 Quality Management Systems The goal of our QMS Quality Management System procedures is to document key processes. The ISO 9001 Standard does not specify any format for writing procedures, nor does it specify a length. Since no one wants to read long-winded, boring procedures – why write them? Why not write one, two or three page procedures using brief and easy to understand? I am proposing using a LEAN approach which makes procedures more useful so they can benefit us instead of being a paper burden.
  • 28.
    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 Instructions Level 4 Records, Forms, historical data
  • 29.
    TOP Level CoreManual Level 1 The Quality Manual is the core of the quality system gives a brief description of APS’s quality policy, objectives and is separate and distinct from the (QMS) Quality Management System procedures. The purpose of this level of documentation is used externally / internally to introduce our (QMS) Quality Management System to our customers and other external organizations or individuals to show that Top Managements is commitment in implementing and complying with ISO-9001:2008 requirements.
  • 30.
    QMS – QualitySystems Procedures Process Approach Level 2 Uses a process approach (QMS) Quality Management System that which define the methods, interaction, assign responsibilities and authorities, tasks and activities in meeting ISO 9001:2008 requirements. Section 4.1 c) of the ISO 9001:2008 standard requires we are to determine criteria and methods needed to ensure that both the operation and control of processes are effective. It does not require the methods and criteria to be defined in procedures; other methods may be used.
  • 31.
    Work Instructions Level 3 This level of documentation is very detailed on "how" to accomplish a specific job, task or assignment. For example, a work instruction could be developed for a product with step-by-step instructions including such detail as testing requirements. Individual work instructions are very specific to the process(s). Supplemental documentation may be used including User's Manuals, Engineering or Technical Manuals, Technical Support notes, Manufacturing Notes, etc., in order to create detailed work instructions.
  • 32.
    Level 4 -Forms and other Documents The last level of documentation can include forms, records, checklists, surveys, and other documents used in the production or delivery of a product or service.
  • 33.
    ISO-9001:2008 Clause .2 Process Approach What Is Process Approach?
  • 34.
    Promote Clause .2Process Approach The ISO-9001:2008 Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS System.
  • 35.
    Clause .2 ProcessApproach (COP’s) "Core" processes (also known as Customer-Oriented- Processes) are product realization processes that determine customer requirements. These processes have a direct impact on the customer. Examples of core processes include: •Design & Development •Production (manufacturing, outsourcing, testing, etc.) •Invoicing
  • 36.
    Clause .2 ProcessApproach (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
  • 37.
    Clause .2 ProcessApproach (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
  • 38.
    Clause .2 ProcessApproach 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 Planning Customer 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
  • 39.
    Promoting The UseOf Process Approach During Internal Auditing
  • 40.
    A Change InInternal Auditing Process Based Auditing Current Internal Audits: are conducted as an independent examination or review of the single process (Department). Proposed Processed Based Audits audit reviews system of linked processes such as Inputs: that come Process into the process, Outputs: of what you expect from the process . Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single process-based QMS system. system Using Turtle Diagrams
  • 41.
    Clause .2 ProcessApproach Turtle Diagram Resource's / 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.
  • 42.
    Clause .2 ProcessApproach Turtle Diagram Resources / With What With Who / Responsible Parties ISO-9001, Cross-Functional Audit Top Management, Department Team, CAR System, Business Plan, Managers Performance Measurables Inputs What Come in And What Does The Requirements Requirements Output What do you Customer Want? Process Audited expect Output Inputs ISO Requirements, Resources, Management Policy, Objectives, Infrastructure, Plant Responsibility Customer Layout, Required Satisfaction, QMS Records, 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.
  • 43.
    Master Audit ChecklistScore 0730MANUFACTURING INTERNAL AUDIT REPORT BEDFORD GARFIEL ❑ SANTA FE ❑ SPO KEYSER FACILITY 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 Major MP! 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 Results 4.1 General Requirements 0.0% Major 7.1 Planning of Product Realization 0.0% Major 4.2 Documentation Requirements 0.0% Major 7.2 Customer-Related Processes 0.0% Major 5.1 Management Commitment 0.0% Major 7.3 Design and Development 0.0% Major 5.2 Customer Focus 0.0% Major 7.4 Purchasing 0.0% Major 5.3 Quality Policy 0.0% Major 7.5 Production and Service Provision 0.0% Major Control of Monitoring and Measuring 5.4 Planning 0.0% Major 7.6 Equipment 0.0% Major Responsibility, Authority and Communication 5.5 0.0% Major 8.1 General 0.0% Major 5.6 Management Review 0.0% Major 8.2 Monitoring and Measuring 0.0% Major 6.1 Provision of Resources 0.0% Major 8.3 8.4 Analysis of Data 0.0% Major 6.2 Human Resources 0.0% Major 8.4 Analysis of Data 0.0% Major 6.3 Infrastructure 0.0% Major 8.5 Improvement 0.0% Major 6.4 Work Environment 0.0% Major AIB Pest Control 0.0% Major
  • 45.
  • 46.
    FICCI CE Examples For Revision Of Our Policies Quality Policy With the dedication of all employees, we as a company constantly strive to meet our customer needs through quality and continuous improvements. Environmental Policy With the dedication of all employees, we as a company constantly strive to protect the environment and prevent pollution through continual improvement and compliance to environmental regulations and procedures.
  • 47.

Editor's Notes

  • #2 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.