ISO 9001-2000 training (engl).ppt

1 Corporate Quality Rev 1.0 07/29/02

ISO 9001:2000ISO 9001:2000TL 9000 Telecom TL 9000 Telecom

Quality Management Systems Quality Management Systems (QMS) Requirements (QMS) Requirements


ISO 9000:2000 Core Standards9000:2000 •Provides (QMS) principles and fundamentals

•Describes the ISO series •Lists basic definitions of terms

9001:2000 •States requirements for quality management

9004:2000 •Provides guidance for establishing a (QMS) •States requirements to meet and exceed customer expectations

TL 9000 •Quality Management System Requirements Handbook•Provides quality management system requirements

TL 9000 •Quality Management System Measurements Handbook•Provides metrics collection information


This class was developed to meet the following instructional needs:

Provide a basic understanding of ISO 9001: 2000, quality management systems(QMS) requirement Provide an overview of TL 9000 registration requirements

Purpose of Course


Audience:

Management Quality and Process Engineering Process Owners in all functions (I.e. Finance, HR,

IT, Materials, etc.)

Audience


Participants will be able to:

Discuss how ISO 9001 and TL 9000 fits into Solectron’s strategies and policies

Describe the philosophy of the new standards Define implementation strategies associated with

the standard

Course Objectives


I Quality Management Systems(QMS) OverviewII Philosophy of New StandardIII Implementation Strategies

Course Outline


The philosophy of QMS Standards is based on defining tools, and criteria necessary to meet customer’s expectations.

Criteria: Satisfy customer requirements Provide consistency and repeatability Support company's needs for internal efficiencies

QMS Philosophy



Course Outline


Customer satisfaction is required, not implied Quality processes required in all sectors, not just

manufacturing Efficient processes, with known inputs and outputs Data and nonconformance data used for continuous

improvement

Evolution of Quality Systems


The new ISO 9001 Standard is built on 8 principles of Quality Management Systems:

1. Customer Focused Organization

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual process Improvement

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

Quality Management


ISO 9001-2000 and MBNQA

ISO 9001-20001. Customer Focused Organization2. Leadership3. Involvement of People4. Process Approach5. System Approach to Management6. Continual Process Improvement7. Factual Approach to Decision

Making8. Mutually Beneficial Supplier

Relationships

MBNQA3. Customer and Market Focus1. Leadership5. Human Resource Development &

Management6. Process Management6. Process Management, 2. Strategic Planning6. Process Management4. Information and Analysis, 7. Business

Results6.3 Supplier and Partnering Processes

ISO 9001-2000 and MBNQA have similar concepts and organization9000

http://www.iso.ch/


Principle 1

Organizations depend on their customers and therefore should;

•understand current and future customer needs

•meet customer requirements

•strive to exceed customer expectations

Tools that Solectron uses are the CFT’s and weekly CSI process.

Customer Focused Organization


Principle 2

Leaders should;

•establish unity of purpose and direction of the organization

•create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives

LEADERSHIP

Tools Solectron uses are Hoshin planning, AOP and LRP processes.


Principle 3

Involvement of People•People at all levels are the essence of an organization

•Employee’s full involvement enables their abilities to be used for the organization’s progress


Principle 4

A desired result is achieved more efficiently when related resources and activities are managed as a process

Process Approach

Tools Solectron uses are SIPOC, process mapping and clearly documented process.


Principle 5System Approach to Management

Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency


Principle 6Continual Improvement

Continual improvement should be a permanent objective of the organization

Focus is on the Seven Step improvement process at Solectron Corporation.


Principle 7Factual Approach to Decision Making

Effective decisions are based on the analysis of data and information


Principle 8Mutually Beneficial Supplier

RelationshipsAn organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value



Course Outline


4 Quality Management System

4.1 General requirements 4.2 Documentation requirements


GeneralThe organization will document, implement and maintain a QMS and and continually improve its effectiveness.

The organization shall Identify processes needed for the QMS Determine sequence and interaction of

processes Monitor, measure and analyze these processes Implement actions necessary to achieve

planned results


DocumentationRequirements:

• Documented statements of a quality policy and quality objectives

• A quality manual

• Documents needed by the organization to ensure the effective planning, operation and control of its processes

• Control of Customer-Supplied Documents and Data

• Maintain records


DocumentationControl of Documents, including

Customer documents and data:

• Approve documents for adequacy prior to issue

• Review and update as necessary and re-approve

• Ensure that changes and the current revision status of documents is identified

• Ensure that relevant versions of applicable documents are available

• Ensure that documents of external origin are identified and their distribution controlled


Documentation

Control of Records:

• Records should remain legible

• Readily identifiable

• Retrievable

A documented procedure should be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.


5. Management Responsibility

5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility and Communication


Management CommitmentTop Management will provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness.

The organization shall Communicate the importance of meeting

customer and regulatory requirements Establish a quality policy Conduct management reviews Ensure the availability of resources


Customer FocusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.Top management establishes and maintains customer relationshipsProcedures are established for customer communication and joint reviews


Quality Policy

• Is appropriate to the purpose of the organization

• Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system

• Provides a framework for establishing and reviewing quality objectives

• Is communicated and understood within the organization

• Reviewed for continuing suitability



Quality PolicySolectron is committed to total quality management and

the requirements of its quality management system to provide product and product-related services that conform to all established requirements. We are committed to defining measures that are effective and drive decisions from factual and current data. Through the continual improvement of our management systems, we are committed to achieving total customer satisfaction, exceed the expectations of our customers, and provide error-free, competitive products/solutions on time with customer satisfaction second to none.


PlanningQuality Objectives

The organization shall

Top management ensures that quality objectives, including those needed to meet requirements for product, are established at relevant functions. This includes TL 9000 metrics.

Quality Management System Planning Management ensures that that short and

long term planning is implemented and the integrity of the QMS is maintained

Customer and supplier input is used for planning


Management Representative Top management will appoint a member of

management, who will have the responsibility and authority that includes:

Establishing QMS processes Report the performance of QMS and any need for

improvement Reports results of audits, customer feedback,

process performance, product conformity, preventive and corrective actions, and changes that could affect the QMS

This individual is the Quality Manager for California Site


6. Resource Management

6.1 Provision of Resources 6.2 Human Resources


6 Provision of ResourcesThe organization shall Implement and maintain the QMS and continually

improve its effectiveness Enhance customer satisfaction by meeting

customer requirements


Human ResourcesCompetence Awareness and Training

The organization shall Determine the necessary competence for

personnel performing work affecting product quality and define requirements for all positions affecting quality

Provide training, including quality improvement techniques

Evaluate the effectiveness of the training, including internal course development

Maintain appropriate records of education, training, skills and experience


Training• ESD training is required for all

employees handling sensitive devices

• Advanced quality training is available for all employees that need it

• Hazardous material handling training is required for all employees that handle hazardous material

• Operators are qualified, not just trained, to do their jobs


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


The organization shall plan and develop the processes needed for product realization, and will be consistent with the requirements for other processes.

The organization shall Determine quality objectives and

requirements for the product Establish processes, documents, and

provide resources specific to the product Verify, validate, monitor, and test activities

specific to the product

Planning of Product Realization


More Planning Requirements• Life cycle model – a set of integrated

guidelines covering the life cycle of the product

• New Product introduction procedure• Disaster recovery plans• End of life planning• Configuration management


Customer-related ProcessesDetermination and Review of Requirements Related to the Product

The organization shall Determine requirements specified by the

customer Determine Statutory and regulatory

requirements related to the product Ensure that product requirements are defined Implement arrangements for effective

customer communication, including: product information, contracts, and feedback


Customer-related Processes

• Notification about problems• Problem severity• Problem escalation• Customer feedback• Recall process


Design and DevelopmentProcedures to control, verify, and validate product design and supporting software. A design control process in operation that has adequate resources and assigned responsibilities.

The organization shall Determine the design and development

stages Determine functional and performance

requirements Meet input requirements, regulations and

statutory law


Design and DevelopmentThe organization shall

Provide output verifications through Alternative calculations Qualification tests

Validate the design by Ensuring that design verification is successful Confirm that the final product meets user needs Assess the need for multiple validations


Design and Development• Project Plan• Requirements traceability• Test Planning• Customer and Supplier Input• Design and development requirements• Content of requirements• Change management process• Informing customers • Problem resolution• Component Changes


PurchasingThe organization will ensure that purchased product conforms to specified purchase requirements. Also, evaluate and select suppliers based on their ability to supply product.

The organization will Prepare, review, and approve purchasing

documents Establish criteria for determining supplier

acceptability Develop a supplier classification system Establish a record system


Production and Service ProvisionThe organization will plan and carry out production

and service provision under controlled conditions.

Controlled conditions include: Availability of information that describes the

characteristics of the product Use of work instructions The use of suitable equipment The availability and use of monitoring and

measuring devices


Production and Service ProvisionValidation of processes for production and service

provision

The organization shall Define criteria for review of processes Use specific methods and procedures Revalidate Approve of equipment and qualification

personnel


Production and Service Provision

• The organization shall identify product by suitable means throughout product realization

• Product status shall be identified with respect to monitoring and measurement requirements

• Recall traceability shall be maintained• Design traceability to identifiable dates,

lots or serial numbers


Production and Service ProvisionCustomer Property

The organization shall Exercise care with customer property while it

is under the organization’s control or being used by the organization

Identify and verify, protect and safeguard customer property provided for use or incorporation into the product


Control of Monitoring and Measuring Devices

A process to ensure that equipment is properly calibrated and will remain so. The organization shall: Verify and calibrate at specific intervals the measuring equipment, prior to use, based on standard traceable to national measurement standards Adjust or re-adjust equipment as necessary Identify as to calibration status


Control of Monitoring and Measuring Devices

Safeguard from adjustments that would invalidate the measurement results

Protect equipment from damage and deterioration during handling, maintenance and storage

Label equipment that is either inactive or unsuitable for measurement and remove from use.

All monitoring and measurement devices that do not requirement calibration shall be identified


8 Measurement, Analysis and Improvement

8.1 General 8.2 Monitoring and Measure 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement


General

The organization shall Demonstrate conformity of the product Ensure conformity of the QMS Continually improve the effectiveness of the

QMS


Monitoring and MeasurementAn active plan to search out and put to use information

that reflects the degree of satisfaction being experienced by customers.

The organization shall Monitor information relating to customer Conduct internal audits at planned intervals Demonstrate the ability of the processes to

achieve planned results Verify that product requirements have been

met



Monitoring and MeasurementThe organization shall

• Document with detail inspection and test requirements

• Keep test and inspection records• Perform periodic retesting• Ensure initial and periodic retest is more

extensive than initial testing• Document frequency of testing• Test return and repair appropriately• Establish test documentation


Control of Nonconformingproduct

The organization will Identify nonconforming product Evaluate degree and extend of the

nonconformance Dispose of nonconforming product according

to quality plan or procedures Notify concerned parties


Analysis of DataA process for identifying the need for collecting the data required for establishing, controlling, and verifying process capability and product quality. The organization shall perform trend analysis of the nonconforming data.

The organization shall analyze data relating to Customer satisfaction Conformity to product requirements Characteristics and trends of processes and

products


ImprovementA constant search for ways to improve the QMS, and an investigation and elimination of causes of nonconforming product, at any point in the process, distribution, and installation.

The organization shall Review nonconformities (including customer

complaints) Determine the causes of nonconformities Determine and implement action needed Review corrective actions taken Implement Quality Improvement Programs


The End

A good Quality Management System makes life easier for everyone by providing an efficient way to run a

business.