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    Handwerkskammer fr Mnchen und Oberbayern, Max-Joseph-Strae 4, 80333 Mnchen

    30. August 2012Quality Management System 230. August 2012 2

    Quality Management System ISO 9000:2000

    1. History of ISO 9000

    2. Definition Quality

    3. Benefits of Quality Mangement

    4. Four Core Standards

    5. Major focus points

    6. Eight Quality Mangement Principles

    7. Related Management Systems

    8. Content of ISO 9001:2000

    9. Summary

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    1. History of ISO 9000

    1987 Version

    1994 Version

    2000 Version

    Neue Version: 9001:2008 since September 5, 2008

    The Headquarter of ISO Organisation is located in Geneva

    (Switzerland)

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    2. Definition of Quality (ISO 9000:2000)

    The degree to which a set of inherent characterstics fulfils

    requirements.

    Customers are interested that the product/service they buy meets the

    quality they are offered.

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    3. Benefits of Quality Management

    International practices for quality management.

    Common language for dealing with customers and suppliers worldwide in

    B2B (Business to Business).

    Increase efficiency and effectiveness by early recognising problems.

    Model for continual improvement.

    Model for satisfying customers and other stakeholders.

    Build quality into products and services from design onwards.

    Address environmental concerns of customers and public, and comply with

    government regulations.

    Integrate with global economy.

    Optimizing processes for production and information

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    4. Four Core Standards

    1. Definitions, vocabulary, fundamentals of ISO 9000

    2. Requirements of the quality management system

    3. ISO 9004: 2000: Guidelines for performance improvements

    4. ISO 19011: guidelines for quality and/or environmental managementsystems audit

    http://www.iso.org/iso/iso_catalogue/management_standards.htm

    Of these, only ISO 9001 is a certifiable standard (i.e. ISO9001 is

    the only standard that you can be assessed against), with the

    others being for guidance and information purposes only.

    http://www.iso.org/iso/iso_catalogue/management_standards.htmhttp://www.iso.org/iso/iso_catalogue/management_standards.htm
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    5. Major focus points

    1. Customer focus

    2. Contiunual improvement

    http://www.tqmc.org/iso9000.php

    http://www.tqmc.org/iso9000.phphttp://www.tqmc.org/iso9000.php
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    6. Eight Quality Management Principles

    1: Customer focus

    2. Leadership

    3. Involvement of people

    4. Process approach

    5. System approach to management

    6. Continual improvement

    7. Factual approach to decision making

    8. Mutually beneficial supplier relationships

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    7. Related Management Systems

    ISO 13485 : 2003-2007 For medical devices: ISO 9001:2000certification is mandatory

    ISO TS 16949:2001 Quality management systems - Particularrequirements for the application of ISO 9001:2000 for automotiveproduction and relevant service part organizations

    EN ISO 14001:2005 - 2004 Environmental management systems

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    8. Quality System Requirements

    ISO 9001 is a quality assurance model made up of 20 sets of qualitysystem requirements.

    This model applies to organizations that design, develop, produce, install,and service products.

    ISO expects organizations to apply this model, and to meet theserequirements, by developing a quality system.

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    Clause 4: Quality Management:

    4.1 General requirements

    Define a quality policy. Your policy should describe your

    organization's attitude towards quality.

    Define the organizational structure that you will need in order to

    manage your quality system. Define a procedure that your senior managers can use to review the

    effectiveness of your quality system.

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    4.2 Document requirements

    Develop a quality system and a manual that describes it.

    Develop and implement quality system procedures that are

    consistent with your quality policy.

    Develop quality plans which show how you intend to fulfill qualitysystem requirements. You are expected to develop quality plans

    for products, processes, projects, and customer contracts.

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    4.2 Quality Manual

    It includes the policies and targets, process description,

    process instructions and process responsibility.

    Not quantity is the key! , but adequacy, functionality

    and continuity create transparency and acceptance ofstaff and executives.

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    4.2 Document control

    The procedure of Control of Notes comprises,

    the creation, the determination of marking, storage,

    protection /data security, retrievability, safekeeping periods

    and responsibilities of who possesses the notes or has

    access.For example:

    Where and how long are the documents stored?

    Which documents are useful?

    How are outdated documents marked?

    Quality Management System

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    5.2 Customer focus

    Quality is what the customer requires.

    The topmost aim must be to meet your customers requirements and

    win, retain and further increase their confidence and satisfaction.

    Identify your customers desires and expectations

    Clarify product-related obligations e.g. legal requirements

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    5.3 Quality policy

    The quality policies should be written down in your QM manual

    Aims:

    Customer satisfaction, development of stuff, future improvement

    Which Ressources do you provide

    Customer requirements should be at the centre of attention.

    Mandatory: The commitment to continuous improvement

    On-going review of the quality policies and its adequacy for the company

    Formulate the guidelines concerning the planned business position anddevelopment very clearly, and underpin them with quantifiable aims, so that

    they can be put into practice.

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    5.4 Quality objectives and planning

    Quality policies are the orientation frame for the formulation of

    measurable quality targets and the registration of activities and means

    that are necessary to achieve these targets.

    Identify the procedures that have a direct impact on company success

    and customer satisfaction.

    Determine measurable targets that concretely state what you intend to

    achieve in a defined period, e.g. with regard to customer expectations,

    procedures, your market and the current product requirements.

    Define the activities necessary for achieving the targets.

    Communicate these targets and measures and provide the necessaryresources.

    Moreover, you have to plan changes in your QM system in such a way

    that the system can seamlessly continue to function.

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    5.5 Responsibility, authority and communications

    Delegate responsibilities and authorization to employees in the whole

    company, you will achieve that quality becomes the concern of employees of

    all levels and the QM system will be implemented in practice.

    By systematically promoting internal communication and targeted information

    transfer you can make sure that quality policies become well-known, your staff

    feels included and is able to contribute to the companys success and its furtherimprovement.

    Define responsibilities and authorization of those employees who will have to

    take decisions that are relevant for quality.

    Name a QM representative as member of the topmost management in larger

    companies, or in smaller companies you can take on the responsibility yourself.

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    5.6 Management review

    A QM system is never perfect and final! It is a highly vital system and has tobe adapted to the ever changing customer requirements and desires, market

    requirements, internal quality requirements, necessary product improvements,

    manufacturing processes and other given facts.

    The management has to assess if the QM system is well-suited, adequate,

    and efficient or needs to be changed, and enhance the quality policies andquality targets.

    Assess the efficiency of your QM system and its processes on a regular basis.

    The results of internal audits and previous assessments, customer feedback,

    process efficiency, faults and customer complaints as well as considering

    changes that affect your QM system provide the basis for this assessment.You should write down these results and announce them in your company.

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    Clause 6: Resource Management

    6.1 Provision of resources

    You strive for customer satisfaction and business success. You can only

    achieve and secure this if you have qualified staff and sufficient tangible

    resources.

    6.2 Human resources

    Your employees have to be qualified, motivated and willing to work hard.

    6.3 Infrastructure

    Building, work place, equipment and the corresponding service and

    disposal facilities have to be in compliance with the state of the

    technology and thus also with the legal requirements, e.g. occupational

    health and safety.

    6.4 Work environment

    Working environment positively influences the motivation of the persons

    involved in the production and service process.

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    Clause 7: Product Realisation

    7.1 Planning of product or service realisationCustomers will not accept that you break promises concerning deadline,

    number of units, and product requirements and quality.

    Monitor and enhance the quality targets

    7.2 Customer related processes

    Identify whether the quality characteristics of the product or service arecompletely determined and whether you are able to fulfil the quality

    requirements before you place an offer or accept an order. See to a clear

    communication with the customer.

    7.3 Design and development

    Can the product be produced easily or with a huge effort?You have to fulfil this QM requirement only if you develop products/services in

    your company.

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    4

    Clause 7: Product Realisation

    7.4 Purchasing

    Make a clearly defined order which contains quantities, price and date of

    delivery, clear quality statements with technical details. Make a list of suitable

    suppliers. Assess your suppliers. Document the assessment. Is your supplier

    certified? Make goods inward test to ensure that requirements are met.

    7.5 Production and service provision

    You have to provide the adequate manufacturing facilities, auxiliary means,

    documents, staff and their qualification. The requirements have to be stated in

    e.g. QM process instructions, work instructions, process descriptions,

    workflows, hiring plans and shop floor papers.

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    Clause 7: Product Realisation

    7.5.1 Control of product and service provisionAppropriate production facilities have to be selected.

    Measurement equipment is available. The staff needs to be qualified by training

    and instructions and has to document the measurement. Selection and extent of

    the applicable methods depend e.g. on type and number of units of the product,

    on the product features that have to be controlled, on process capabilities and

    customer requirements.

    7.5.2 Validation of processes of production and service provision

    Staffs need to be qualified. The criteria for a continuous monitoring and control

    have to be determined in a process instruction und notes have to be made on

    these issues. You have to provide for regular checks (anew validation) in order

    to detect deviations in good time.

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    Clause 7: Product Realisation

    7.5.3 Identification and traceabilityDocument changes of product.

    In case of non-conformity the product could be traceable all over product

    lifetime. For example for security installations like airbags in cars which contain

    explosive capsules.

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    Clause 7: Product Realisation

    7.5.4 Customer propertyHas to be carefully handled

    Make a goods inward inspection (completeness, identity and transport

    damages) and ensure correct storage.

    7.5.5 Preservation of product

    In-house treatment of productsAttention when shipping the product:

    Needed time for transport, sensitivity to shock and vibration, other

    environmental conditions and the means of travel and transportation

    required by the customer.

    Consistency with the shipping documents and legal requirements (for

    example military goods).

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    Clause 7: Product Realisation

    7.6 Control of monitoring and measuring devicesTesting equipment has to show the required accuracy.

    You have to determine the required accuracy and the adequate test equipment.

    Tests and testing devices have to be monitored, calibrated and serviced after use

    or at regular intervals.

    You have to calibrate and register all test equipment used in your company in an

    inventory list and label it with a distinctive mark (e.g. identification number).

    The calibration certificates have to be stored.

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    8: Measurement, Analysis and improvement

    8.1 GeneralDefinitions of procedures to ensure product conformity.

    8.2 Measurement and Monitoring

    Continually adaption to new requirements of market and customers.

    Adapt also effectiveness and efficiency of the processes and the QM system.

    On the basis of data, facts and information analyses have to be made and thefoundation for making decisions has to be prepared.

    8.2.1 Customer Satisfaction

    Customer feedback, complaints and surveys, sales information, field studies,

    etc.

    The information should be selected and analyzed systematically in order to

    obtain statements on developments, e.g. by means of a defined process of

    complaints.

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    8: Measurement, Analysis and improvement

    8.2.2 Internal Audits

    Plan internal quality audits systematically. Define responsibilities and

    frequency as well as the areas to be audited.

    Make sure in a system audit that your QM system is effective and complete.

    Carry out process audits by checking the effectiveness of your instructions and

    processes.Define the time frame for the internal audits.

    You can commission a customer of yours or an external auditor.

    Make sure that the results summarized in an audit report are discussed with

    the persons concerned, and that the required corrections will be carried out

    and their effectiveness will be examined.

    Results of quality audits are an integral part of the management assessment.

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    8: Measurement, Analysis and improvement

    8.2.3 Monitoring and measurement of processesThe basis of improvement of processes is controlling and measuring them.

    With regard to serial production, fulfil the requirements by examining machine

    capabilities.

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    8: Measurement, Analysis and improvement

    8.2.4 Monitoring and measurement of productIt is possible to conclude whether the customers requirements are met by

    means of testing the product.

    Documented tests serve as a proof that your product has left your factory

    flawlessly. This can also play an important role with regard to product liabilities.

    The instructions with regard to tests and documentation have to be

    documented in QM process instructions and QM plans.

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    8: Measurement, Analysis and improvement

    8.3 Control of nonconforming product

    Use the opportunity to learn from mistakes and implement measures of

    optimization.

    Defective products must not be processed further or delivered.

    Mark defective parts and products, write down defects which were

    discovered and report them to the persons concerned so that evaluations ofdefects can be carried out and further measures can be discussed, e.g. the

    handling of defective products and measures of correction.

    It must be taken care that the parts which were reworked will be tested once

    again with regard to the concerned characteristics before releasing them.

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    8: Measurement, Analysis and improvement

    8.3 Control of nonconforming product

    Use the opportunity to learn from mistakes and implement measures of

    optimization.

    Defective products must not be processed further or delivered.

    Mark defective parts and products, write down defects which were

    discovered and report them to the persons concerned so that evaluations ofdefects can be carried out and further measures can be discussed, e.g. the

    handling of defective products and measures of correction.

    It must be taken care that the parts which were reworked will be tested once

    again with regard to the concerned characteristics before releasing them.

    Quality Management System

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    8: Measurement, Analysis and improvement

    8.4 Analysis of data

    Decisions should be made based on data, analysis and information.

    In your company, suitable data has to be determined which will support you

    in assessing the effectiveness of the QM system. This data has to be

    collected, recorded and analysed.

    The data analysis has to present evidence on Customer Satisfaction:

    meeting the product requirements,

    process and product characteristics and their further development

    including the possibility to take pre-emptive measures,

    Suppliers.

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    8: Measurement, Analysis and improvement

    8.5 Improvement

    Analysis of the results of internal audits, data analyses, preventive and

    corrective measures as well as management assessments help you to

    improve your system.

    Measures to stop these problems and avoid repeating them have to be

    determined.Customer complaints: Show your customers that you take their complaints

    seriously. Use complaints as a help for improving your processes and

    procedures.

    In order to achieve a constantimprovement an entrepreneurial culture isneeded which is marked by openness and dialogue. Being open towards

    mistakes and giving and receiving constructive criticism, not only with regardto the employees, but also the management and direction are essential. The

    employees motivation to take part in the process of constant improvement

    will be destroyed if no measures are following the proposals.

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    9: Summary

    If you have an existing quality management system you find non conform

    products earlier than without systematically looking for them.

    You want your customer to come back and not the product you will provide it

    by conform products.

    If you hear the complaints from your customer you will react.

    Registration to DIN EN ISO 9000:2000 Standards provides an objective

    testimony that the company has implemented an effective quality

    management system.

    Is certification itself important to the marketing plans of the company?

    Even without certification, companies should utilize the ISO 9000 model as a

    benchmark and a guideline to assess the adequacy of its quality programs in

    the European market.

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    Thank you