Awareness to ISO 9001:2000

Tutor’s Introduction

Course Objectives
Be able to understand and interpret the requirements of the standard Planning to implement the requirements of the standard

Workshops to enable delegates to increase their understanding regarding ISO 9001:2000 version and to experience Quality Management System implementation practices.Course Structure Lectures and value added discussions on each topic. .

ISO ISO14 International Organization for Standardization SA8 0 00 ISO 9000 001 49 169 S O/T IS OHSAS1 8001 .

INTRODUCTION .

Origin ISO 9000:87 ISO 9000:94 ISO 9001:2000 BS5750 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s) .

iso.ch http://www.bsi.What is ISO? International Organization for Standardization Develops standards do not certify companies Around 140 countries members Around 13000 standards produced Technical Committees are formed to produce standards TC 176 for ISO 9000 International Organization for Standardization Email: central@iso.ch Web: http://www.uk/iso-tc176-sc2.org. .

-3 on Auditing ISO 10012-1 & -2. ISO 10013:1995 Guidelines for Quality manuals . -2.ISO 9000:2000 Family of Standards CORE STANDARDS ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS Requirements ISO 9004:2000 Guidelines for Performance Improvement SUPPORTING STANDARDS ISO 10005:1995 Guidelines for Quality Plans ISO 10006:1997 Guidelines for Project Management ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1. Quality Assurance for Measuring Eqpt.

ISO 9000:2000 Family of Standards ISO/TR 10014:1998 Guidelines for managing economics of quality ISO 10015 Guidelines for Training ISO/TR 10017:1999 Guidelines on Statistical techniques .

New Structure 20 clauses abandoned Now 8 sections .What’s New? 1. New Standard ISO 9002 and 9003 dropped ISO 9001 modified 2.

or (satisfying your customer by managing your resources.QMS Quality Management System A System of coordinated activities which is meant to “direct” and “control” an organization with regard to quality. through a standardized system) .

Design Control Corrective & Preventive Actions Production & Process Controls Management Human Resource Controls Material. Documents. & Change Controls . Equipment & Facility Controls Records.

QUALITY MANAGEMENT PRINCIPLES What are they? The basic principles on which the ISO 9000:2000 standards are based Quality Management Principles .

Principles of new Standard r t Cussomeer Cu tom us foccus fo l Mutuaal Mutu al ef i beeneiccial b n fi er uppl ssuppilier el l ttion hip rreaaionsship t l Faacuaal F c tu to pproach aapproach to ision deecision dc ki maakng m ing dership Leeadership La ight ne ased on e ight B ased o B y qualitty quali nt e managem ent agem man ples prrnci iples p i inc ol l ement Invvovvement In pl offpeeopee po l o ces s Prrocess Po pproach aapproach l Continuaal Continuent ovem imprrovement imp t m Syyseem S s t to pproach aapproach to nagement Maanagement M .

.PRINCIPLE 1 CUSTOMER-FOCUSED ORGANISATION Organization depend on their customers and therefore should understand current and future customer needs. meet customer requirements and strive to exceed customer expectations.

.PRINCIPLE 2 LEADERSHIP Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

PRINCIPLE 3 INVOLVEMENT OF PEOPLE People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit. .

.PRINCIPLE 4 PROCESS APPROACH A desired result is achieved more efficiently when related resources and activities are managed as a process.

understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency.PRINCIPLE 5 SYSTEM APPROACH TO MANAGEMENT Identifying. .

PRINCIPLE 6 CONTINUAL IMPROVEMENT Continual improvement should be a permanent objective of the organization. .

.PRINCIPLE 7 FACTUAL APPROACH TO DECISION MAKING Effective decisions are based on the analysis of data and information.

. and a mutually beneficial relationship enhances the ability of both to create value.PRINCIPLE 8 MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS An organization and its suppliers are interdependent.

.Process Any activity that takes “inputs” and converts them to “outputs” Process Approach The systematic identification and management of these activities and the interaction between activities.

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On spec. On spec.Example . etc etc •Supplier evaluation •Supplier evaluation . •Delivery status – On-time.Purchasing Process •• Demand for Demand for material material •• Item specs and Item specs and Date Date •• Supplier source Supplier source •• Suppliers Suppliers capability to capability to meet our meet our requirements requirements Inputs Inputs Purchasing Purchasing Procedure Procedure •Storage •Storage •Inspection and Testing •Inspection and Testing •Manufacturing •Manufacturing •Finance •Finance Interactions to Interactions to Outputs Outputs •• Receipt of Receipt of Material on right Material on right condition condition •• Right Quality Right Quality Right Quantity Right Quantity •• Right Time Right Time Performance Measurements Performance Measurements •Delivery status – On-time.

analysis and improvement Output Service realization S a t i s f a c t i o n Product .Process Approach Model CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM C U S T O M E R R e q u i r e m e n t s Management responsibility Resource management Input C U S T O M E R Measurement.

Important changes •More emphasis on customer satisfaction •Commitment to comply with legal and statutory requirements •Need to review suitability of quality policy •Need to define quantified and measurable quality objective at different functions and levels •More emphasis on human resource management •Re-evaluation of suppliers on the basis of their performance •Analysis of data for continual improvement •Need to maintain suitable work environment •Term “Subcontractor” replaced with “Supplier” and “Supplier” replaced with “organization” •Exclusions defined .

analysis and improvement .The Structure 0 1 2 3 4 5 6 7 8 Introduction Scope Normative reference Terms and definitions Quality management system requirements Management responsibility Resource management Product realization Measurement.

2) Infrastructures(6.4) Analysis of data(8.2) Quality policy(5.4) Production & service provision(7.2 ) Design & development(7.System Requirements / Structure of the Standard 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement General requirements (4.1) Documentation Requirements(4.5) Control of monitoring & measuring devices(7.5) .3) Purchasing(7.6) Responsibility.4) Provision of resources(6.3) Planning(5.4) Control of NCP(8.6) Improvements(8.3 ) Work environment(6.5) Management Reviews (5. 1) Customer focus (5. authority & communication( 5.1) Planning(7.1) Customer related processes(7.2) Management Commitment(5.2) Monitoring & measurement(8.1) Human resources(6.3) General (8.

0. OHSM or Financial management .4 Compatibility with other Management Systems Standard is intended to be compatible with other management systems It is aligned with ISO 14000 to enhance compatibility Standard does not include requirements for other management system such as EMS.

1.2 Applications Requirements may be excluded if not appropriate due to : nature of product customer requirements applicable regulatory requirements Exclusions must: Not affect ability to provide conforming product Be limited to clause 7 .

4 Quality Management System 4.1 General Requirements
Establish, document, implement, maintain and continually improve QMS in accordance with the standard.

4.2 General Requirements
To implement the QMS the Organization shall Identify and manage processes necessary for QMS Determine the sequence and interaction of processes Determine criteria and methods to ensure effective operation and control of the process Ensure availability of information needed to support the operation and monitoring of processes Measure, monitor, analyze processes and act as necessary to achieve planned results and continual improvements Manage the process in accordance with the standard

4.2 Documentation Requirements General
Extent Size and type of organization Complexity and interaction of processes Competence of personnel Note3 (Documentation may be in any type of media) To Include Documented procedures required by standard Documents required by organization to ensure effective operation and control process Note 1 (Where the term “documented procedure” appears)

4.2 Documentation Requirements
4.2.2 Quality Manual The organization shall establish a Quality Manual that include: Scope of QMS Documented procedures or reference to them Description of interaction between the process of QMS

4.2 Documentation Requirements
4.2.3 Control of Documents Documents required by the QMS shall be controlled Approve, Review, Ensure current & relevant version, Identification of external origin documents, Prevent unintended use of obsolete documents. 4.2.4 Control of Quality Records Documented Procedure shall be established for identification, storage, protection, retrieval, retention time and disposition. Records shall be: Established and maintained to provide evidence. Legible, readily identifiable and retrievable.

5 Responsibility.2 Review input 5.3 Review output .2 Customer Focus 5.5.3 Quality policy 5.5 Management Responsibility 5.5.1 Responsibility & authority 5.4.5.3 Internal communication 5.4 Planning 5.2 Quality Planning 5.4. authority and communication 5.6 Management Review 5.6.2 Management representative 5.6.1 General 5.1Quality objectives 5.6.1 Management Commitment 5.

1 Management Commitment Provide evidence of commitment to the development and improvement of QMS by: Communicating the importance of meeting customer and legal/regulatory requirements. Establishing quality policy and objectives.5. . Management Reviews Provision of resources.

2 Customer Focus Top Management shall ensure that customer needs & expectations are determined.5. converted into requirements & fulfilled with the aim of achieving customer satisfaction .

5.3 Quality Policy Appropriate to the purpose of organization. Commitment to meeting requirements and continual improvements Frame work for establishing and reviewing quality objectives Communicated and understood at appropriate levels Is reviewed for continuing suitability .

1 Quality Objectives Establish quality objectives at relevant functions and levels Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement Include those needed to meet requirements for product .5.4.4 Planning 5.

4 Planning 5.1 Quality Objectives (Cont) Quality Objectives should be: • Specific • Measurable • Achievable • Realistic / Related • Time Bound .5.4.

2 Quality Management System Planning Identify and plan processes needed to achieve quality objectives • • • Plan the development of QMS Plan the implementation of QMS Plan the improvement of QMS .4.5.

5.5.5 Responsibility.1 Responsibility and authority Functions and their interaction. Authority and Communication 5. responsibilities and authorities shall be defined and communicated to facilitate effective quality management .

5.2 Management Representative Member of the management who has responsibility and authority for ensuring that processes of the QMS are established and maintained Reporting on performance of QMS including needs for improvement Promoting awareness of customer needs and requirements Note: Responsibilities may include liaison with external parties in relation to QMS .5.

5.3 Internal Communication Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness .5.

ensure QMS suitability. adequacy and effectiveness Evaluate the need for changes to QMS including policy and objectives Records from Management Reviews shall be maintained (see 4.2.6.5.4). .6 Management Review 5.1 General Review of QMS by top management at planned interval to.

2 Review Input Review performance and improvement opportunities related to: Audit results Customer feedback Process performance and product conformance Status of preventive and corrective actions Follow up actions from earlier reviews Change that could affect the QMS Recommendations for improvement .5.6.

3 Review Output Output to include actions related to improvement of the effectiveness QMS and its processes improvement of product related to customer requirements resource needs .6.5.

1 Provision of resourses 6.1 General 6.2.3 Infrastructure 6.2.4 Work environment .2 Competence.6 Resource Management 6.2 Human resources 6. awareness and training 6.

1 Provision of Resources The organization shall determine and determine the resources needed for : implement and maintain the QMS and continually improve its effectiveness. .6. Enhance customer satisfaction by meeting customer requirements.

1 General Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education. skills and experience .2 Human Resources 6.2.6. training.

qualification and experience .6. training.2. Awareness and Training Identify competency needs Provide required training Evaluate the effectiveness of training provided Ensure staff is aware of relevance and importance of their activities and contribution to achieving quality objectives Maintain appropriate records of education.2 Competency.

3 Infrastructure Identify. hardware and software Supporting services (transport or communication) . provide and maintain the infrastructure needed to achieve product conformity This shall include : Workspace & associated utilities Equipment.6.

4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. .6.

6 Control of measuring & monitoring devices .5 Production & service operation 7.7 Product Realization 7.3 Design & development 7.2 Customer related processes 7.4 Purchasing 7.1 Planning of product realization 7.

documentation.1 Planning of Product Realization Sequence of process to achieve product Consistent with QMS and documented to suit method of operations Quality objectives and requirements for the product The need for processes. resources and facilities specific to the product Verification and validation activities and acceptance criteria Records .7.

2.2 Customer Related Processes 7.3 Customer communication .2.7.1 Determination of requirements related to the product 7.2 Review of product requirements 7.2.

7. including regulatory and legal requirements any additional requirements determined by the organization .1 Determination of requirements related to the product Product requirements specified by the customer including requirements for delivery and post-delivery activities Requirements not specified but necessary for intended or specified use Obligations related to product.2.

Product requirements are defined For verbal orders requirements are confirmed Difference between tender and contract are resolved Organization has ability to meet the requirements Records of the results arising from the review shall be recorded.7.2. .2 Review of requirements related to the product Review identified requirements and ensure before commitment to supply product that.

contract or order handling.3 Customer Communication Identify and implement arrangements for communication with customers relating to: product information inquiry.2.7. including amendments Customer feedback including complaints .

3.6 Design & development validation 7.1 Design & development planning 7.3 Design & development outputs 7.3.4 Design & development review 7.3 Design & Development 7.3.7.5 Design & development verification 7.3.7 Control of design and development changes .3.3.3.2 Design & development inputs 7.

1 7.7.3 Purchasing process Purchasing information Verification of purchased product .2 7.4.4.4 Purchasing 7.4.

1 Purchasing Process Purchased product meets requirements Type & extend of control depends on effect purchased product may have on realization processes and their output Selects suppliers based on their ability to supply conforming product Define criteria for selection and periodic evaluation and re-evaluation of suppliers Results of evaluation and follow up actions must be recorded .7.4.

Quality management system requirements. .2 Purchasing Information Purchasing information shall describe the product to be purchased. processes and equipment.procedures.7.4. including where appropriate: Requirements for approval of product. Requirements for qualification of personnel.

organization must specify in purchasing information: verification arrangements method of product release. .4.3 Verification of Purchased Product Identify and implement activities needed to verify purchased product Where organization or its customer purpose verification at supplier premises.7.

5.5.3 7.5 Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer Property Preservation of Product .5.1 7.7.2 7.5.4 7.5.

delivery and post delivery activities .7.5.1 Control of production and service provision Control production & services operations through: Availability of information specifying product characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring devices Implementation of monitoring activities Implementation of defined processes for release.

7.5.2 Validation of Processes Validation arrangements must be defined and must include as applicable qualification of the process qualification of equipment and personnel use of defined methodologies & procedure requirements for record re-valuation .

3 Identification & Traceability Where appropriate identify product through all stages of operations Identify status with respect to measurement & monitoring requirements Where traceability is required control & record unique identification of product I can not remember .5.7.

protection & maintenance of customer property provided for use or incorporation Any customer property that is lost.4 Customer Property Care for customer’s property being under organization’s control or being used by organization Identification.suitable must be recorded & reported to customer Customer Property tangible / intangible .5.7. damaged or found un. verification.

storage and protection This applies to constituent parts of product .5 Preservation of Product Preserve conformity of product during internal processing and final delivery to intended destination Include identification. handling.5. packaging.7.

7.6 Control of monitoring & measuring devices Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use Traceability to international or national standards. maintenance or storage Record results of calibration Assess validity of previous results when devices found to be out of calibration . Where no such standard exist record the basis Safeguard MMD from adjustments invalidating calibration Protect MMD from damage or deterioration during handling.

2.2 Internal audit 8.3 Monitoring and measurement of processes 8.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.8 Measurement.1 General 8.5 Improvement 8.2.1 Customer satisfaction 8.4 Analysis of data 8. Analysis and Improvement 8.1 Continual improvement 8.5.2.5.5.3 Preventive action .2.2 Monitoring & Measurement 8.2 Corrective action 8.

8.1 General Define. plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement This include determination of the need and use of applicable methodologies and statistical techniques .

2 Monitoring and Measurement 8.8.1 Customer Satisfaction Organization shall monitor information on customer satisfaction and /or dissatisfaction The methodologies for obtaining and utilizing such information must be determined .2.

2 Internal Audit Conduct periodic internal audit to determine if QMS: Conforms to the requirements of the standard Has been effectively implemented & maintained Plan the audit program considering: Status and importance of the activity results of previous audits Define audit scope. frequency and methodologies performed by personnel not performing audited work .8.2.

2 Internal Audit The documented procedure must cover: Responsibilities & authorities for conducting audits Ensuring independence Recording results and reporting to management Timely corrective actions Follow up to verify & report implementation of verification results .8.2.

2.3 Measurement and Monitoring of Product Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.8. .

8. records must indicate the authority responsible for release of product Release 5/01deliveryPmust not proceed until or AS OLD / H 19 SE have been allIFIED specified activities the D R VE completed unless otherwise approved by the customer .3 Measurement and Monitoring of Product Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes Evidence of conformity with the acceptance criteria must be documented.2.

regulatory or other body .3 Control of Non conforming Product Documented procedures for control of non conforming product to prevent unintended use or delivery Non conforming product shall be corrected Re-verify after correction If non-conformance detected after delivery take appropriate action It is often required that the proposed rectification be reported for concession to the customer.8. the end user.

determine suitability and effectiveness of QMS and to identify improvements that can be made Data from measurement & monitoring & other related sources Analyze data provide info on: Customer satisfaction and/or dissatisfaction Conformance to customer requirement Process.8.4 Analysis of Data Collect & analyze data. product characteristics and their trends Suppliers .

8.5 Improvement 8.5.1 Continual improvement Planning for Continual Improvement The organization must plan and manage processes necessary for continual improvement of the QMS Facilitate continual improvement using: quality policy objectives audit results analysis of data corrective actions preventive actions Management Review .

8.2 Corrective Action Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence Action appropriate to the impact of problem Documented procedures shall define requirements for: identifying non conformities determine the causes evaluating the need for corrective action determine corrective action needed and implemented Recording results of action .5.

5.8.3 Preventive Action Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences Actions appropriate to the impact of potential problem Documented procedures must define the requirements for Identification of potential nonconformances and their causes Determining and ensuring implementation of preventive action needed Recording results of action taken .

Non-conformities observed during audits.Situation Warranting Corrective Action Identification of major non-conformance. The reoccurrence of a problem with a process or activity. Non-conforming deliveries from vendors. . Large number of minor non-conformities. Customer Complaints.

Stages of Corrective & Preventive Action REPORTING INVESTIGATION ACTION FOLLOWUP CLOSING .

EXPECTED BENEFITS Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability Planning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced Continuos Improvements Program launched Market Reputation .

Thank You .

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