Quality Management System: Introduction in Small and Medium-Sized Enterprises by Franz Ertl

PHARE Business Support Programme of the European Union UEAPME - SME FIT II
Quality Management System

Introduction in Small and Medium-sized Enterprises
By Franz Ertl
This project is funded by the European Union under the PHARE Business Support Programme and implemented by UEAPME and its partners. The content of this document does not necessarily reflect the opinion of the European Commission.
Handwerkskammer fr Mnchen und Oberbayern, Max-Joseph-Strae 4, 80333 Mnchen
Quality Management System ISO 9000:2000 1. 2. 3. 4. 5. 6. 7. 8. 9. History of ISO 9000 Definition Quality Benefits of Quality Mangement Four Core Standards Major focus points Eight Quality Mangement Principles Related Management Systems Content of ISO 9001:2000 Summary
Quality Management System Handwerkskammer fr Mnchen und Oberbayern, Max-Joseph-Strae 4, 80333 Mnchen
30. August 2012
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 management systems 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.
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5. Major focus points

1. Customer focus
2. Contiunual improvement
http://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 9001:2000 certification is mandatory ISO TS 16949:2001 Quality management systems - Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations
EN ISO 14001:2005 - 2004 Environmental management systems
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8. Contents ISO 9001:2000

Section 1: Scope Section 2: Fundamentals of quality management systems Section 3: Terms and definitions Section 4: General requirements Section 5: Management responsibility Section 6: Resource management Section 7: Product realization
Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 needs implementing within a QMS.
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8. Quality System Requirements

ISO 9001 is a quality assurance model made up of 20 sets of quality system requirements. This model applies to organizations that design, develop, produce, install, and service products.
ISO expects organizations to apply this model, and to meet these requirements, 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 quality system 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 of staff 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?
Clause 5: Management Responsibilities 5.1 Management Commitment

A QM system is a matter for the Management
It is no longer possible to delegate the responsibility Communicate the requirement to your stuff Make Quality policy and quality targets Create key figures for performance / benchmarking
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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 and development 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 necessary resources. 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 further improvement.
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 to be 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 and quality 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 realisation Customers 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 are completely 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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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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7.5.1 Control of product and service provision Appropriate 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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7.5.3 Identification and traceability Document 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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7.5.4 Customer property Has 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 products Attention 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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7.6 Control of monitoring and measuring devices Testing 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 General Definitions 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 the foundation 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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8.2.2 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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8.2.3 Monitoring and measurement of processes The 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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8.2.4 Monitoring and measurement of product It 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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8.3 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 of defects 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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8.3 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 of defects 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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8.4 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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8.5 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 constant improvement an entrepreneurial culture is needed which is marked by openness and dialogue. Being open towards mistakes and giving and receiving constructive criticism, not only with regard to 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.
Quality Management System Handwerkskammer fr Mnchen und Oberbayern, Max-Joseph-Strae 4, 80333 Mnchen 30.08.2012 3 6
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
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Quality Management System: Introduction in Small and Medium-Sized Enterprises by Franz Ertl

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PHARE Business Support Programme of the European Union UEAPME - SME FIT II

Quality Management System

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

30. August 2012

1. History of ISO 9000

The Headquarter of ISO Organisation is located in Geneva (Switzerland)

30. August 2012

2. Definition of Quality (ISO 9000:2000)

The degree to which a set of inherent characterstics fulfils requirements.

30. August 2012

3. Benefits of Quality Management

Increase efficiency and effectiveness by early recognising problems.

30. August 2012

4. Four Core Standards 1. Definitions, vocabulary, fundamentals of ISO 9000

2. Requirements of the quality management system

30. August 2012

5. Major focus points

30. August 2012

30. August 2012

EN ISO 14001:2005 - 2004 Environmental management systems

30. August 2012

8. Contents ISO 9001:2000

Section 8: Measurement, analysis and improvement

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8. Quality System Requirements

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Clause 4: Quality Management: 4.1 General requirements

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4.2 Document requirements

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4.2 Document control

Clause 5: Management Responsibilities 5.1 Management Commitment

5.2 Customer focus

5.3 Quality policy

Quality objectives and planning

5.5 Responsibility, authority and communications

5.6 Management review

Clause 6: Resource Management

Clause 7: Product Realisation

Clause 7: Product Realisation

Clause 7: Product Realisation

Clause 7: Product Realisation

Clause 7: Product Realisation

Clause 7: Product Realisation

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

8: Measurement, Analysis and improvement

30. August 2012

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