OAS REGIONAL PROJECT

QUALITY MANAGEMENT

What percentage of time in the work

day do you have to devote to solving

PROBLEMS?- ours or someone else´s (suppliers, customers,

persons with whom we collaborate?)

How much time is given to

preventing problems?

How high are the costs due to:

• Misinterpretation of Clients’ requests?

•Settling complaints?

•False expectations created in customers?

•Incorrect diagnosis?

•Inadequate use of documents?

•Lack of information?

Rules for Team Work

• Participate actively• Express yourself concisely• Be united, not one against the other• All opinions have the same value• Give only objective criticism, not personal• Active listening• Do not talk during a meeting, while others are

talking• Do not use destructive phrases• Each one is responsible for succeeding to the end

PRODUCTIONENVIRONMENT

TRANSFORMATIONPROCESS

FEEDBACK

OUTPUTS- Goods- Services- Information

INPUTS(Resources)- Human- buildings- Equipment- Technology- Information

SYSTEMS FOCUS

PROCESS MODEL

Process: the COMBINATION of activities that take INPUTS and convert them into OUTPUTS.

The effective functioning of an organization means the determination, description, management and improvement of processes of the organization.

The development of Quality Plans from identified Processes in the organization, form the basis of a documented Quality Management System.

ISO 9001:2000 Quality Management Systems

ISO 9001:2000 Quality Management Systems

ISO 9001:2000 WHAT IS ISO?

ISO is the International Organization for Standardization: Founded in 1946 to promote the development of international

standards and related activities The ISO 9000 series was published in 1987, developed by the

technical Committee 176, in relation to quality systems These standards are the base for the development of a Quality

Management System In 1994, a new version was published from standards 9001,

9002 and 9003. On December 15, 2000, the latest version of ISO 9000, ISO 9001

and ISO 9004 standards was approved. These standards focuses on Quality Management Systems and Processes

Quality Management PrinciplesISO 9000:2000

Principle 1 – Customer Focus• Understand current and future customer needs, satisfy customer

requirements and strive to exceed customer expectations.

Principle 2 - Leadership• Leaders establish objectives, unity of purpose and direction of the

organization. Create an adequate internal environment.

Principle 3 – Involvement of People• Employees at all levels are the essence of an organization. Their full

involvement enables their abilities to be used for the benefit of the organization.

Principle 4 - Process Approach• Activities and related resources are managed as a process.

Quality Management Principles ISO 9000:2000

Principle 5 - System Approach to Management• Identifying, understanding and managing interrelated processes

as a system

Principle 6 – Continual Improvement • Continual improvement as a permanent objective

Principle 7 - Factual Approach to Decision-making• Decisions are based on analysis of data and information

Principle 8 - Mutually Beneficial Supplier Relationship• Mutually beneficial relationships with suppliers enhances the

ability of both to create value.

Activities that give value Information flow

C

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M E R

Management Responsibility

Resource Management

Measurement, Analysis &

Improvement

Product Realization Inputs Outputs Product

Satis

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Req

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men

ts Quality Management System

Continuous Improvement

Quality Management System

C

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Activities that add value Information flow

PROCESS MODEL ISO 9001:2000

ISO 9001:2000 4- Quality Management System

4.1- General Requirements Identification, interaction, operation, control, measurement and processes improvement, assuring the necessary resources assignment.

4.2- Documentation Requirements Quality Manual: pursuit (justifying exclusions), documented procedures (or reference from them), processes interaction.

Documents control : approving, revision, actualization.

Records control: identification, storing, protection, recuperation, retention time and disposition.

ISO 9001:2000 5- Management Responsibility

5.1- Management Commitment

5.2- Customer Focus

5.3- Quality Policy

5.4- Planning

5.5- Responsibility, Authority and Communication

5.6- Management Review

ISO 9001:2000 5.1- Management Commitment

Commitment to: Communicating the importance of meeting customer,

statutory and regulatory requirements. Focus on the CUSTOMER.

Establishing the Quality Policy Ensuring that Quality Objectives are established Conducting Management Reviews Ensuring the Availability of Resources

ISO 9001:2000 5.6 Management Review

Auditing of Quality Management System at definite intervals, ensuring its continuing:

suitability adequacy effectiveness

ISO 9001:2000 5.6 Management Review

Input Elements:

Audit results Client feedback Processes performance Product conformity Status of preventive and corrective

action Follow-up actions from previous

reviews Changes that may affect the Quality

Management System Recommendations for improvement

Output Elements:

May include actions related to:

Improvement of the Quality Management System and its processes

improvement related to customer requirements

Resources needs

ISO 9001:2000 6- RESOURCES MANAGEMENT

Human Resources - Competent staff assigned on the basis of appropriate:

Education Training Skills ExperienceCompetence: ability demonstrated to apply knowledge and abilities

Competence, Awareness and Training: Determine the necessary competence for personnel performing work

affecting product quality Provide Training Evaluate effectiveness of actions taken Ensure personnel are aware of their relevance and importance to

achievement of quality objectives

Maintain appropriate records on education, training skills and experience

ISO 9001:2000 6 - RESOURCES MANAGEMENT

Infrastructure Determine, provide and maintain the infrastructure needed to

achieve conformity to product requirements. Infrastructure includes:

Buildings, workspace and associated utilities Process equipment (both hardware and software) Supporting services (e.g. transportation, communication)

Work environment Determine and manage the work environment (physical and

human) needed to achieve conformity to product requirements

ISO 9001:2000 7- PRODUCT REALIZATION

7.1- Planning of Product Realization 7.2- Customer-related Processes 7.3- Design and Development 7.4- Purchasing 7.5- Production and Service Provision 7.6- Control of Monitoring and Measuring Devices

ISO 9001:2000 7.2- Customer-related Processes

Determination of requirements related to the product Connected needs with product including availability, delivery,

support.

Other needs to adequate its use

Legal and official aspects

Checking of the requisites from product and/or service-

Organization may assure that it has capacity to accomplish with the clients requisites, the same as its eventual modifications.

Communication with the client-

Implement communication mechanisms about: product information, consultations, contract, feedback, complaints.

ISO 9001:2000 7.3- Design and development

Design and development processes are a tool to respond in a efficient and effective manner to requirements and expectations of the customer and other interest groups.

Planning: design and development

Input elements of design and development

Output elements of design and development

Review of design and development

Verification of design and development

Validation of design and development

Modifications and control of design and development

ISO 9001:2000 7.4- Purchases-

Purchase control -

Control the purchase processes to assure that the purchased products comply with what was asked for.

So suppliers will be evaluated periodically and they will be selected according to the established criteria.

Purchase information-

Clear description and specifications of the product that is to be acquired.

Verification of the product bought

Necessary measurements will be implemented to verify the product bought.

ISO 9001:2000 7.5 Production and service operations-

Identification and traceability-

Product identification at all stages of the process.

Customer Property-

Keeping the property of the customer while it is under the control of the organization.

Identify, verify, protect and maintain the property of the customer that is given to be used or incorporated in the product.

Preserve the product

Keeping the product during all internal processes up to its delivery or end of the loan period.

Process validation -

Determine any process where the output element is not verified by measurement or monitoring.

ISO 9001:2000 7.6- Control of Monitoring and measuring devices -

Processes include: inquiries, simulations, measurement properties and characteristics of the processes, products and services.

To bring confidence in the data, the Monitoring and Control processes have to include the confirmation that the products can be used.

The measurement equipment may be calibrated or verified according to a plan, with definite frequencies.

Calibration state must be identified for the relevant equipment.

Calibration must be traceable.

ISO 9001:2000 8- MEASUREMENT, ANALYSIS AND IMPROVEMENT-

Monitoring and MeasurementCustomer Satisfaction- as a system performance measurement. Internal Audit – measurement of conformity of the QMS to planned

arrangements and requirements of the standard; system implementation and its effectiveness.

Processes- as a management tool the organization monitors and measures its processes to demonstrate the ability of the processes to achieve planned results. It verifies their effectiveness financially (relative quality costs), process capacity, reaction time, yields, wastes reduction.

Product- verification that product requirements have been met; evidence of conformity with the acceptance criteria; product release only when all planned arrangements have been met.

Control of Non- conforming Products

ISO 9001:2000 8- MEASUREMENT, ANALYSIS AND IMPROVEMENT -

Data analysisDecisions may be based on the data analysis of different sources: client satisfaction, conformity to product requirements, characteristics and trends of products and processes including opportunities for preventive action and suppliers

Evaluation of the suitability and effectiveness of the QMS is measured against the plans and objectives. It identifies areas for improvement.

Improvement Continual improvement - policy, objectives, audit results, analysis of

data, corrective and preventive actions and management reviews

Corrective actions

Preventive actions