Lmi introduction to iso 9000 final vs 25 min

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  • 01 Introduction to ISO9001:2008 Ludlum Measurements, Inc. Sweetwater, Texas Since 1962
  • 02 What is ISO 9000? An Introduction. The best definition of ISO 9000 is the planning and implementation of the Best Business Practices that meet Customer Requirements, promotes Customer Satisfaction, and insures the success of the Company. Best Business Practices differ from one Company to another, which is why ISO 9000 is a generic Quality Management Standard.
  • 03 For example, the prevailing wisdom of the Electronics Industry has always been to Outsource what you can and to do the one thing you do exceedingly well. But the Vision of Ludlum Measurements has always been to do as many phases as it can locally, to control Quality, Price, and to assure itself of an Uninterrupted Supply Chain. For LMI, this is its Best Business Practices.
  • 04 The accomplishments of fifty years have been called successful, though there have been challenges from time to time. It is ironic, though, that the greatest challenges we face for the future are the fruits of these successes. As a much larger Company, LMI will find it increasingly difficult to deliver the same individualized service that has gained it Customer Loyalty and Customer Satisfaction.
  • 05 It is with this challenge in mind, giving our Customers individualized Service as a large Company, that we seek ISO 9000 Registration at this time. Merging the Best Business Practices of Ludlum Measurements with the Best Business Practices presented by the ISO 9000 Standard will produce a Company we already know and a Company that complies with the ISO 9000 Standard at the same time.
  • 06 This merger of Practices has to be done with care and with balance. If it is not, the Company we end up with will neither be the Company the Board of Director wants, nor the Company the ISO 9000 Committee suggested that it becomes. Before we review the ISO 9000 Standard, we shall consider some guidance from the ISO 9000 Committee itself, regarding its Requirements as a whole .
  • 07 Because many Companies thought ISO wanted a complicated documentation system, they built a system that managed documents, not Quality. ISO clarifies this in their “Guidance on the Documentation Requirements of ISO 9001:2008”: “ It is stressed that ISO 9001 requires (and always has required) a ‘Documented quality management system’, and not a ‘system of documents’.”
  • 08 The ISO Committee not only allows for a flexible system, but one with a minimum of documentation: “ ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes
  • 09 In conclusion, then, the ISO 9001 Requirements are designed to put tools into the hands of Management and into the hands of Employees at all levels in the organization. These tools are: Planning, Implementation, and Documentation of the Best Business Practices and are designed to meet Customer Requirements, promote Customer Satisfaction, and insure the Success of the Company.
  • 10 Introducing ISO 9000.
  • 11 Complications of ISO 9000. We are about to review a complicated International Standard, with a myriad set of Requirements. Take heart! Most of the complications and details are designed to be transparent to most people . T he complications and details are behind-the-scenes and they describe the way things are planned and organized. Most of you will deal with just the way things are done. That’s all.
  • 12 What are the ISO 9000 standards? The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are 25 documents in the collection altogether.
  • 13 What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. This covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems.
  • 14 ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement.
  • 15 ISO 9004:2000 Quality management systems - Guidelines for performance improvements. This covers continual improvement, specifically. It also gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.
  • 16 What are the ISO 9001 requirements? The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements . The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continual improvement of the system.
  • 17 What are the Requirements of ISO 9001? The requirements in ISO 9001 include: a set of procedures that cover all key processes in a business monitoring processes to ensure they are effective keeping adequate records checking output for defects, with appropriate and corrective action where necessary regularly reviewing individual processes and the quality system itself for effectiveness Focus on continual improvement
  • 18 What are the ISO 9001:2008 Quality Management System Requirements? The ISO9001:2008 Standard consists of the following sections: Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement
  • 19 Quality Management System Highlights. In this section, we call out some highlights that will give you some idea of what each of the sections of the ISO 9001:2008 Standard contains. This is presented as a mere outline and does not cover any of the details inside the clauses of the Standard. We skip the first three parts, which contain introductory material. So, we will begin with Part 4, which is the beginning of the Standard’s Quality Requirements.
  • 20 Section 4: Quality Management System. Section 4 sets the stage, and deals with the basic documentation requirements. Here we find, that there is a hierarchy of documentation. As we move through this section, we see the themes of the Standard being established. Customer and regulatory requirements are at the beginning, and they are the foundation. Document Control, requires that we produce the documents, that are going to make meeting these Customer, and regulatory requirements possible. We produce procedures, and drawings and patternboards, and work instructions, that tell us what to do, to meet these requirements. And the Document Controls, tell us how to use and maintain these documents, so that the necessary documents are always up-to-date, and that they are where they are used. It is a foregone conclusion that these Company-supplied documents are to be used, and are not to be substituted by other things, like our memories, and our notebooks. If there is a print, we should be trained how to use it, and we must always, use it. If there is a Procedure, we should be trained how to use it and always, use it. This is the Document Control System. Record Control, tells us what kinds of records we should be keeping, where they are, how they should be stored, how long we should keep them, and what we do with them when the storage time has ended. Most Companies that fail ISO 9001 audits fail because they do not have adequate Documentation and Record controls, or because they do not follow the documentation and record procedures. These things are an important part of any job. We have a process to do. when we have a document that tells us how to do it, we have it right there and we actually use it. And when we have records to fill out about the process, we fill them out. We do these things each and every time. These controls are an important part of the process we’re doing at any given moment. This is the Document and Records Control System.
  • 21 Section 5: Management Responsibility Section 5 is directed at Management. It begins with Senior Management's Commitment, to the Quality Management System, and it ends with the Senior Management Review, of the Quality Management System. Along the way, there has been the delegation of authority by Senior Management, to various people who become responsible for establishing, and maintaining the Quality Management System. This keeps things in perspective. The lesson to be learned is that Senior Management is not obligated to the Quality Management System, the Quality Management System answers to Senior Management.
  • 22 Section 6: Resource Management. This is another Management section. In section 5, Senior Management, was committed 2, and provided 4, the Quality System. Here in Section 6, Senior Management is committed 2, and provides 4, the resources that are required, to take raw materials, and process them into a finished product. This encompasses the physical buildings, the man power, the internal organization, and the actual work environment that Employees work in.
  • 23 Section 7: Product Realisation Section 7 is a long-one. We’ll be spending two pages on it. This is where we plan to do stuff, and then start to do it. This is where it all begins. Planning of Product Realization. After such a beginning, it covers how we deal with the Customer. We take an order and get the requirements that the Customer expects us to fulfill. Then we have a Sales Order Meeting, where we determine if we can do it, before we sign on the dotted line. That’s called a Contract Review. Next, the Standard covers the planning of Production, and how we communicate information, within the Company ,and with the Customer. Then, it covers all the controls for designing and developing instruments and probes. Purchasing is covered next, where we control what comes in, so that other peoples problems, don’t become our problems. Various things are required of our suppliers, and various inspections are made on in-coming materials, as needed. We keep other people's problems, out of the building. And finally, we cover methods of communicating with our Suppliers. In this first part of Section 7, we have covered a lot. We’ve planned how to do things, and we have controlled what comes into the Company from outside.
  • 24 Section 7: Product Realisation. In Section 6, the buildings and equipment and work environment, were all supplied by Senior Management, and all the necessary Training, was provided for, under Human Resources. At the beginning of Section 7, Production was planned, and by the middle of the Section, Engineering provided all the documents that Production is required to use on the job. Here, in Section seven point five, the Controls of Production, are set forth. The primary Production Control, under Product Realisation, is the availability of product-characteristics-information, which is to say, Procedures and work instructions, like drawings and patternboards and Pick Lists. A lot has been said about the the word availability in "the availability of procedures and work instructions", as though they must be supplied by the Company, and be made available to the Employee, but they are not required, to be used, by the Employees. Company-supplied-Product-Requirement-Documents, are mandatory, and must be used at all times, while producing Company Product. A number of other Controls are listed, as you can see, but the most important Provision is the use of the Company-supplied information. Engineering has said that whenever there is a problem, either the Procedure was wrong, the Procedure was not understood, or the Procedure was not followed. The use of Procedures, under the ISO 9001 Standard, is mandatory. Section 7 ends with the Controls of Monitoring and Measurement Equipment. Whenever you are in doubt, direct your questions to the Quality Assurance Librarian, who will assist you.
  • 25 Section 8: Measurement, Analysis and Improvement Section 8 is the last section, and deals with Measuring, Analyzing, and improving. This section begins with measuring things, and it ends with improving them. The ISO 9000 Standard, calls for us to measure some things, so we can evaluate Customer Satisfaction. Then, we measure the Quality System itself, by performing a Quality Management System Internal Audit. After this, we measure our various Processes. And finally, we measure our Product itself, and initialize our Procedure for dealing with the Product that does not conform to specifications. In response to these nonconformances, we fill out our Corrective Action Requests, and follow-up on them. This covers Customer Complaints, Process and Product dificiencies. And from the analysis of all this, we derive our preventive Actions. And the whole Process, when working together in this way, produces Improvement. So, we have just reviewed some of the highlights of the ISO 9000 Standard in the context of what it means to us, how we respond to it, and what we do about it. We move on to a very brief, overview of documentation and record-keeping requirements.
  • 26 Quality Management System Documentation: Manuals, Procedures, and Records.
  • 27 What are the ISO 9001:2008 Quality Management System document requirements? The ISO 9001:2008 standard, requires a Quality Policy and Procedure Manual. These manuals describe all their supporting documentation, which includes their internal, and external formal documents, their forms, and their quality records. Other supplementary documents may be listed in some detail. We turn our attention to some of them, now.
  • 28 ISO 9001:2008 requires a Quality Policy in the Policy Manual: The quality policy is a formal statement from management, closely linked, to the business and marketing plan, and to customer needs. The quality policy is understood and followed at all levels, and by all employees. Each employee needs measurable objectives to work towards. These measureable objectives are documented. Procedures are maintained in our Procedure Manual.
  • 29 What are the ISO 9001:2008 Quality Management System document requirements? ISO 9001:2008 refers specifically to only 6 documented procedures. But since we design our own instruments, our minimum requirement is 7. Other documentation may be required in order to manage some processes that are necessary for the effective operation of the quality management system. This is presently under review by the Quality Assurance Manager, who also manages the ISO 9000 Project.
  • 30 What are the ISO 9001:2008 Quality Management System Procedure Requirements? The standard specifies six compulsory procedures, but since we design our own instruments, we add a seventh: Control of Documents (4.2.3) Control of Records (4.2.4) Design and Development (7.3) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) In addition to these ISO 9001:2008 requires a Quality Policy and Quality Manual
  • 31 Our Seven Compulsory Procedures: 1. Control of Documents (4.2.3) The ISO 9001:2008 standard, requires that we need a documented procedure, to control quality documents. All employees must have access to up-to-date documents, and be aware of how to use them. The use of Company Supplied Documents, is mandatory.
  • 32 2. Control of Records (4.2.4) The ISO9001:2008 standard requires that we need to control and maintain Quality Records to provide evidence of conformance to the ISO 9001 Standard. This Procedure must provide for the identification, storage, retrieval, protection, and retention time, as well as cover the final disposition of Quality Records.
  • 33 3. Design and Development (7.3) The ISO 9001:2008 standard requires that we must plan the development of our instruments, document it at various stages, record any changes to it, validate that it’s what the Customer wants and verify that it conforms to requirements. And that it works.
  • 34 4. Internal Audits (8.2.2) The ISO 9001:2008 standard requires that we must plan and conduct periodic Internal Audits of the Quality Management System. Timely Corrective Action must be taken on deficiencies with follow-up actions to verify the Corrective Actions. Internal Audits are reviewed during Management Review.
  • 35 5. Control of Nonconforming Product / Service (8.3) The ISO 9001:2008 standard requires that we identify and control Nonconforming Product to prevent its unintended use or delivery to a Customer. Nonconforming Product must be corrected and be re-verified before use.
  • 36 6. Corrective Action (8.5.2) The ISO 9001:2008 standard requires that we take Corrective Action to rectify non-conformances. It is a requirement to keep records of these activities and monitor their effectiveness.
  • 37 7. Preventive Action (8.5.3) The ISO9001:2008 standard requires that we need to take Preventative Action to eliminate potential causes of problems. It is a requirement to keep records of these activities and monitor their effectiveness.
  • 38 What are the ISO 9001:2008 Quality Records Requirements? The ISO 9001:2008 standard has an absolute requirement to maintain the following records: Management Review Minutes Training Record Product Release Record Design and Development Records - Results of the review of customer requirements - Design and development inputs - Results of design and development reviews and actions - Results of design and development verification and actions - Results of design and development validation and actions - Results of the review of design and development changes Supplier Assessment Record
  • 39 Validation Record Identification and Traceability Record Register of Customer Property Calibration Record - Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist - Validity of the previous measuring results when the measuring equipment is found not to conform to requirements - Results of calibration and verification of measuring equipment Internal Audit Record Records of Non-conforming Product Corrective Action Request Form Preventative Action Request Form
  • 40 This Wraps up our Overview of the ISO 9001:2008 Quality Management System requirements.
  • Lmi introduction to iso 9000 final vs 25 min

    1. 1. Introduction to ISO 9001:2008 Ludlum Measurements, Inc. Sweetwater, Texas Since 1962 @ 25 Min..
    2. 2. What is ISO 9000? An Introduction• The best definition of ISO 9000 is the planning and implementation of the Best Business Practices that meet Customer Requirements, promotes Customer Satisfaction, and insures the Success of the Company.• Best Business Practices differ from one Company to another, which is why ISO 9000 is a generic Quality Management Standard.07/20/12 Ludlum Measurements, Inc. 2
    3. 3. What is ISO 9000? An Introduction• For example, the prevailing wisdom of the Electronics Industry has always been to Outsource what you can and to do the one thing you do exceedingly well.• But the Vision of Ludlum Measurements has always been to do as many phases as it can locally, to control Quality, Price, and to assure itself of an Uninterrupted Supply Chain. For LMI, this is its Best Business Practices.07/20/12 Ludlum Measurements, Inc. 3
    4. 4. What is ISO 9000? An Introduction• The accomplishments of fifty years have been called successful, though there have been challenges from time to time.• It is ironic, that the greatest challenges we face for the future are the fruits of these successes. As a much larger Company, LMI will find it increasingly difficult to deliver the same individualized service that has gained it Customer Loyalty and Customer Satisfaction.07/20/12 Ludlum Measurements, Inc. 4
    5. 5. What is ISO 9000? An Introduction• It is with this challenge in mind, giving our Customers individualized Service as a large Company, that we seek ISO 9000 Registration at this time.• Merging the Best Business Practices of Ludlum Measurements with the Best Business Practices presented by the ISO 9000 Standard will produce a Company we already know and a Company that complies with the ISO 9000 Standard at the same time.07/20/12 Ludlum Measurements, Inc. 5
    6. 6. What is ISO 9000? An Introduction• This merger of Practices has to be done with care and with balance. If it is not, the Company we end up with will neither be the Company the Board of Directors wants, nor the Company the ISO 9000 Committee suggested that it becomes.• Before we review the ISO 9000 Standard, we shall consider some guidance from the ISO 9000 Committee itself, regarding its Requirements as a whole.07/20/12 Ludlum Measurements, Inc. 6
    7. 7. What is ISO 9000? An Introduction• Because many Companies thought ISO wanted a complicated documentation system, they built a system that managed documents, not Quality. ISO clarifies this in their “Guidance on the Documentation Requirements of ISO 9001:2008”:• “It is stressed that ISO 9001 requires (and always has required) a ‘Documented quality management system’, and not a ‘system of documents’.”07/20/12 Ludlum Measurements, Inc. 7
    8. 8. What is ISO 9000? An Introduction• The ISO Committee not only allows for a flexible system, but one with a minimum of documentation:• “ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes....”07/20/12 Ludlum Measurements, Inc. 8
    9. 9. What is ISO 9000? An Introduction• In conclusion, then, the ISO 9001 Requirements are designed to put tools into the hands of Management and into the hands of Employees at all levels in the organization.• These tools are: Planning, Implementation, and Documentation of the Best Business Practices and are designed to meet Customer Requirements, promote Customer Satisfaction, and insure the Success of the Company.07/20/12 Ludlum Measurements, Inc. 9
    10. 10. Introducing ISO 900007/20/12 Ludlum Measurements, Inc. 10
    11. 11. Complications of ISO 9000• We are about to review a complicated International Standard, with a myriad set of Requirements.• Take heart! Most of the complications and details are designed to be transparent to most people. The complications and details are behind-the-scenes and they describe the way things are planned and organized. Most of you will deal with just the way things are done. That’s all.07/20/12 Ludlum Measurements, Inc. 11
    12. 12. What are the ISO 9000 standards?• The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management.• There are 25 documents in the collection altogether.07/20/12 Ludlum Measurements, Inc. 12
    13. 13. What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. This covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems.07/20/12 Ludlum Measurements, Inc. 13
    14. 14. What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. This covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems. ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement.07/20/12 Ludlum Measurements, Inc. 14
    15. 15. What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. This covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems. ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement. ISO 9004:2000 Quality management systems - Guidelines for performance improvements. This covers continual improvement, specifically. It also gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.07/20/12 Ludlum Measurements, Inc. 15
    16. 16. What are the ISO 9001 requirements?• The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements.• The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continual improvement of the system.07/20/12 Ludlum Measurements, Inc. 16
    17. 17. What are the Requirements of ISO 9001?The requirements in ISO 9001 include: a set of procedures that cover all key processes in a business monitoring processes to ensure they are effective keeping adequate records checking output for defects, with appropriate and corrective action where necessary regularly reviewing individual processes and the quality system itself for its effectiveness Focus on continual improvement07/20/12 Ludlum Measurements, Inc. 17
    18. 18. What are the ISO 9001:2008 Quality Management System Requirements?The ISO 9001:2008 Standard consists of the following sections:Section 1: ScopeSection 2: Normative ReferenceSection 3: Terms and definitionsSection 4: Quality Management SystemSection 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Product RealizationSection 8: Measurement, analysis and improvement07/20/12 Ludlum Measurements, Inc. 18
    19. 19. Quality Management System Highlights07/20/12 Ludlum Measurements, Inc. 19
    20. 20. Quality Management System Requirements: Section 4: Quality Management System Quality Management System Section 4 ISO9001:2008 ISO 9001:2008 Clause Highlights Introduction to the Quality Management System Section 4.1 Document Hierarchy Documentation Requirements Customer, Statutory and Regulatory Requirements Section 4.2 Document Control Procedure Record Control Procedure07/20/12 Ludlum Measurements, Inc. 20
    21. 21. Quality Management System Requirements: Section 5: Management Responsibility Management Responsibility Section 5 ISO9001:2008 ISO 9001:2008 Clause Highlights Section 5.1 Senior Management Commitment Section 5.2 Customer Focus Section 5.3 Quality Policy Quality Management System Planning Section 5.4 Quality Objectives Responsibility, Authority and Communication Responsibility & Authority Section 5.5 Management Representative Internal Communication Section 5.6 Management Review 2107/20/12 Ludlum Measurements, Inc.
    22. 22. Quality Management System Requirements: Section 6: Resource Management Resource Management Section 6 ISO9001:2008 ISO 9001:2008 Clause Highlights Section 6.1 Provision of Resources Section 6.2 Human Resources Section 6.3 Infrastructure Section 6.4 Work Environment07/20/12 Ludlum Measurements, Inc. 22
    23. 23. Quality Management System Requirements: Section 7: Product Realisation Product Realisation Section 7 ISO9001:2008 ISO 9001:2008 Clause Highlights Section 7.1 Planning of Product Realisation Customer Related Processes Contract Review Production Planning Section 7.2 Communication Customer Communication Authority Communication Section 7.3 Design and Development Purchasing Purchasing Documents Supplier Assurance and Approval Section 7.4 Verification of Purchased Materials Supplier Performance Review Suppliers and Contractor Communication 2307/20/12 Ludlum Measurements, Inc.
    24. 24. Quality Management System Requirements: Section 7: Product Realisation Product Realisation Section 7 ISO9001:2008 ISO 9001:2008 Clause Highlights Control of Production and Service Provision Identification and Traceability Customer Property Systems of Preservation of Product Housekeeping Policy Cleaning Policy Section 7.5 Pest Control Policy Control of Visitors and Contractors Despatch and Distribution Maintenance Waste Management Crisis Management Control of Monitoring and Measurement Section 7.6 Equipment 2407/20/12 Ludlum Measurements, Inc.
    25. 25. Quality Management System requirements: Section 8: Measurement, Analysis and Improvement Measurement, Analysis and Improvement Section 8 ISO9001:2008ISO 9001:2008 Clause Highlights Measurement, Analysis and Improvement of the Section 8.1 Quality Management System Monitoring and Measurement Customer Satisfaction Section 8.2 Internal Audits Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Non-Conforming Product Section 8.3 Product Recall Section 8.4 Analysis of Data Corrective Action Section 8.5 Preventative Action Improvement07/20/12 Ludlum Measurements, Inc. 25
    26. 26. Quality Management System Documentation: Manuals, Procedures, and Records07/20/12 Ludlum Measurements, Inc. 26
    27. 27. What are the ISO 9001:2008 Quality Management System Document Requirements?The ISO 9001:2008 standard requires a Quality Policy and Procedure Manual Obsolete Versions07/20/12 Ludlum Measurements, Inc. 27
    28. 28. What are the ISO 9001:2008 Quality Management System requirements?ISO 9001:2008 requires a Quality Policy in the Policy Manual:•The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. These measureable objectives are documented.•Procedures are maintained in our Procedure Manual.07/20/12 Ludlum Measurements, Inc. 28
    29. 29. What are the ISO 9001:2008 Quality Management System Document Requirements? ISO 9001:2008 refers specifically to only 6 documented procedures. But since we design our own instruments, our minimum requirement is 7. Other documentation may be required in order to manage some processes that are necessary for the effective operation of the quality management system. This is presently under review by the Quality Assurance Manager, who also manages the ISO 9000 Project.07/20/12 Ludlum Measurements, Inc. 29
    30. 30. What are the ISO 9001:2008 Quality Management System Procedure Requirements?The standard specifies six compulsory procedures, but since we design our own instruments, we add a seventh:3. Control of Documents (4.2.3)4. Control of Records (4.2.4)5. Design and Development (7.3)6. Internal Audits (8.2.2)7. Control of Nonconforming Product / Service (8.3)8. Corrective Action (8.5.2)9. Preventive Action (8.5.3)07/20/12 Ludlum Measurements, Inc. 30
    31. 31. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:1. Control of Documents (4.2.3)The ISO 9001:2008 standard requires that we need adocumented procedure to control quality documents.All employees must have access to up-to-date documentsand be aware of how to use them.The use of Company-supplied Documents is mandatory.07/20/12 Ludlum Measurements, Inc. 31
    32. 32. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:2. Control of Records (4.2.4)The ISO 9001:2008 standard requires that we need tocontrol and maintain Quality Records to provide evidence ofconformance to the ISO 9001 Standard.This Procedure must provide for the identification, storage,retrieval, protection, and retention time, as well as cover thefinal disposition of Quality Records.07/20/12 Ludlum Measurements, Inc. 32
    33. 33. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:3. Design and Development (7.3)The ISO 9001:2008 standard requires that we must plan thedevelopment of our instruments, document it at variousstages, record any changes to it, validate that it’s what theCustomer wants and verify that it conforms to requirements. And that it works.07/20/12 Ludlum Measurements, Inc. 33
    34. 34. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:4. Internal Audits (8.2.2)The ISO 9001:2008 standard requires that we must plan andconduct periodic Internal Audits of the Quality ManagementSystem.Timely Corrective Action must be taken on deficiencies withfollow-up actions to verify the Corrective Actions. InternalAudits are reviewed during Management Review.07/20/12 Ludlum Measurements, Inc. 34
    35. 35. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:5. Control of Nonconforming Product / Service (8.3)The ISO 9001:2008 standard requires that we identify andcontrol Nonconforming Product to prevent its unintendeduse or delivery to a Customer.Nonconforming Product must be corrected and bere-verified before use.07/20/12 Ludlum Measurements, Inc. 35
    36. 36. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:6. Corrective Action (8.5.2)The ISO 9001:2008 standard requires that we take CorrectiveAction to rectify non-conformances. It is a requirement to keeprecords of these activities and monitor their effectiveness.07/20/12 Ludlum Measurements, Inc. 36
    37. 37. What are the ISO 9001:2008 Quality Management System requirements?Our Seven Compulsory Procedures:7. Preventive Action (8.5.3)The ISO 9001:2008 standard requires that we need to takePreventative Action to eliminate potential causes of problems.It is a requirement to keep records of these activities andmonitor their effectiveness.07/20/12 Ludlum Measurements, Inc. 37
    38. 38. What are the ISO 9001:2008 Quality Records Requirements?The ISO 9001:2008 standard has an absolute requirement to maintain thefollowing records:•Management Review Minutes•Training Record•Product Release Record•Design and Development Records - Results of the review of customer requirements - Design and development inputs - Results of design and development reviews and actions - Results of design and development verification and actions - Results of design and development validation and actions - Results of the review of design and development changes•Supplier Assessment Record 07/20/12 Ludlum Measurements, Inc. 38
    39. 39. What are the ISO 9001:2008 Quality Management System requirements?•Validation Record•Identification and Traceability Record•Register of Customer Property•Calibration Record - Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist - Validity of the previous measuring results when the measuring equipment is found not to conform to requirements - Results of calibration and verification of measuring equipment•Internal Audit Record•Records of Non-conforming Product•Corrective Action Request Form•Preventative Action Request Form 07/20/12 Ludlum Measurements, Inc. 39
    40. 40. This Wraps up our Brief Overview of the ISO 9001:2008 Quality Management System Requirements07/20/12 Ludlum Measurements, Inc. 40

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