ISO 9001.2008 Awarness | Verification And Validation | Audit

Fitness for use  Conformance to requirements  Accuracy  Perfection  Zero Defect  Adequacy  Cost Effectiveness


 A group of interacting, interrelated, or interdependent elements forming a complex whole  Set of detailed methods ,procedures and routines established or formulated to carry out a specific activity , perform a duty , or solve a problem

Quality Management System
A System of coordinated activities which is meant to “direct” and “control” an organization with regard to quality.

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r t Cussomeer Cu tom us foccus fo l Mutuaal Mutu l ef ia beeneiccial b n fi er uppli ssupplier elattion hip rrelaionsship t l Faacuaal F c tu to pproach aapproach to isi deecison d c ion king maaking m adership Leeadership L ht sed on eig ht n eig Ba sed o Ba y qualitty quali nt e managem ent managem s prrnciple s p i inciple olvement Invvolvement In ople offpeeople o p ce ss Prrocess Po pproach aapproach l Continuaal ontinuent C o vem imprrovement imp st Syysem S temto pproach aapproach to nagement Maanagement M .

Principle 1 .

 Leaders must set the direction of the organization Leaders must create and maintain internal environment that encourages people to achieve the organization’s objectives Principle 2 .

 Must help people to develop and use their abilities Must encourage the involvement of people at all level Principle 3 .

Control Input Activities + Resources Output A desired result is more efficiently achieved when A desired result is more efficiently achieved when resources and activities are managed as a process resources and activities are managed as a process Principle 4 .

Processes – understand interaction Process A Process C Process B Input Output Control Process D .

.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.


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

Identifying . understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency Principle 5 .

Customer Focus PLAN Deming’s Deming’s wheel wheel (P.) DO ACT ISO 9000 CHECK Continual Improvement Principle 6 Continual improvement of the organization's overall performance should be a permanent objective of the organization.) (P.C.D.D.A.A.C. .

The “Plan-Do-Check-Act” Cycle (Deming’s Cycle) .

Effective decisions are based on the analysis of data and information Principle 7 .

An organization and its suppliers are interdependent. and a mutually beneficial relationship enhances the ability of both to create value Principle 8 .

Continual improvement of the Quality Management System Management Responsibility Satisfaction CUSTOMERS CUSTOMERS Resource Management Measurement. Analysis and Improvement Requirements Input Data Product / Service Realization Output Data Product Service .

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

2) Planning(5.3 ) Work environment(6.3) Purchasing(7.5) Control of monitoring & measuring devices(7.1) General (8.6) Improvements(8.1) Provision of resources(6. 5) Management Reviews (5.6) Responsibility.2) Quality policy(5.3) Monitoring & measurement(8.5) .2) related processes(7.4) Analysis of data(8.4) Production & service provision(7. authority & communication(5.3) Human resources(6.4) Infrastructures(6.4) Control of NCP(8.2) Design & development(7.2) Management Commitment(5.1) Planning(7.1) Customer Customer focus (5.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.

implement and maintain a QMS and continually improve its effectiveness in accordance with the standard . document .4.1 General requirements Establish .

4.1 General Requirements  Determine the processes necessary for QMS  Determine the sequence and interaction of processes  Determine criteria & methods to ensure effective operation & control of the processes  Ensure availability of resources and information needed to support the operation & monitoring of the processes  Measure . monitor and analyze processes  Implement action necessary to achieve planned results & continual improvement .

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 quality management system shall be controlled Documented procedures to:  Approve documents prior to issue  Review , update as necessary and re-approve documents  To identify the changes and the current revision status of documents  To ensure documents remain legible , readily identifiable  Ensure relevant versions of applicable documents are available at points of use  Ensure that the documents of external origin are identified and distribution controlled  Obsolete documents are prevented from unintended use and identified if kept for any reason

4.2 Documentation Requirements 4.2.4 Control of Records
 Records must be established and maintained  Records must be legible , readily identifiable and retrievable  Documented procedure for control of identification , storage , retrieval ,retention time and disposition of quality records

5.1 Management Commitment 5.2 Customer Focus 5.3 Quality policy 5.4 Planning – 5.4.1Quality objectives – 5.4.2 Quality Planning

• • •

5.5 Responsibility, authority and communication – 5.5.1 Responsibility & authority – 5.5.2 Management representative – 5.5.3 Internal communication 5.6 Management Review – 5.6.1 General – 5.6.2 Review input – 5.6.3 Review output

– Establishing quality policy and objectives.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. . – Management Reviews – Provision of resources.5.

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

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 • • • .5.3 Quality Policy • • Appropriate to the purpose of organization.

1 Quality Objectives (Cont) • 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 .4.4 Planning 5.5.

4 Planning 5.4.1 Quality Objectives (Cont) Quality Objectives should be: • Set • Measurable • Achievable • Realistic • Timed .5.

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 .

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

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.

adequacy and effectiveness – Evaluate the need for changes to QMS including policy and objectives Records from Management Reviews shall be maintained (see 4. – ensure QMS suitability.4).1 General • Review of QMS by top management at planned interval to.5.2.6 Management Review 5.6. .

5.6.2 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 .

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 .5.

• • • • 6.2.2 Competence.3 Infrastructure 6.1 General – 6. awareness and training 6.2 Human resources – 6.1 Provision of resources 6.2.4 Work environment .

.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.

skills and experience . training.6.1 General • Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education.2.2 Human Resources 6.

6. 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. qualification and experience • . training.2.2 Competency.

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

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

6 Planning of product realization Customer related processes Design & development Purchasing Production & service operation Control of measuring & monitoring devices .1 7.2 7.3 7.4 7.7 Product Realization • • • • • • 7.5 7.

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.7. documentation. resources and facilities specific to the product • Verification and validation activities and acceptance criteria • Records .

2 7.1 Customer Related Processes Determination of requirements related to the product Review of product requirements Customer communication .7.2.2 7.

1 Determination of requirements related to the product • • • • Product requirements specified by the customer including requirements for delivery and postdelivery activities Requirements not specified but necessary for intended or specified use Obligations related to product. including regulatory and legal requirements any additional requirements determined by the organization .2.7.

– 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. .2 Review of requirements related to the product • Review identified requirements and ensure before commitment to supply product that.2.7.

including amendments – Customer feedback including complaints .7. contract or order handling.2.3 Customer Communication • Identify and implement arrangements for communication with customers relating to: – product information – inquiry.

7 Control of design and development changes .3.3.1 Design & development planning 7.6 Design & development validation 7.4 Design & development review Design & development inputs 7.3.3 Design & development outputs 7.3.5 Design & development verification 7.3 Design & Development • • • • • • • 7.

3 Purchasing process Purchasing information Verification of purchased product .4 Purchasing • • • 7.4.1 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.

including where appropriate: – Requirements for approval of product. processes and equipment.7. – Requirements for qualification of personnel.2 Purchasing Information • Purchasing information shall describe the product to be purchased.4.procedures. . – Quality management system requirements.

7. 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 Preservation of Product • • • .5 Production & Service Provision • 7.2 Validation of processes for production and service provision 7.4 Customer Property 7.5.1 • Control of production and service provision 7.3 Identification and traceability

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. delivery and post delivery activities .7.5.

7.2 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 .5.

7.5.3 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 .

damaged or found un. 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.7.suitable must be recorded & reported to customer • Customer Property tangible / intangible . verification.5.

packaging.5. handling. storage and protection • This applies to constituent parts of product .7.5 Preservation of Product • Preserve conformity of product during internal processing and final delivery to intended destination • Include identification.

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.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.7.

1 General • 8.4 Monitoring and measurement of product .3 Monitoring and measurement of processes – 8.3 Control of nonconforming product • 8.5.8 Measurement.1 Continual improvement – 8.2. Analysis and Improvement • Preventive action • Improvement – 8.2 Corrective action – 8.1 Customer satisfaction – 8.2 Monitoring & Measurement – 8.2 Internal audit – 8.2.4 Analysis of data • 8.

8. 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 .1 General • Define.

2 .1 Customer Satisfaction • Organization shall monitor information on customer satisfaction and /or dis-satisfaction • The methodologies for obtaining and utilizing such information must be determined 8.2.Monitoring and Measurement 8.

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.

2.8.3 Measurement and Monitoring of Processes • Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements. .

Measure & monitor product characteristics to verify conformance at appropriate • stages of realization processes Evidence of conformity with the acceptance criteria must be documented. records • must indicate the authority responsible for release of product Release or delivery must not proceed until all the specified activities have been • completed unless otherwise approved by the customer 8.3 Measurement and Monitoring of Product / 19 D FIE RI VE 1 5/0 PA SS ED O LD H .2.

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. regulatory or other body . the end user.8.

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.4 Analysis of Data • Collect & analyze data. product characteristics and their trends – Suppliers .8.

5 Improvement 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 .

5.8.2 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 .

5.3 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 .8.

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