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“ISO 9000 is a globally recognized series of International Standards of Quality Management System (QMS)
For Manufacturing as well as Service Sector
Has been developed by a Swiss based International Organization for Standardization (ISO)”
–Interconnected and interdependent processes–Provides a systematic approach to delivering products or services meeting customer requirements–Enables continuous improvement in achieving defined objectives
What is ISO 9000?What is ISO 9000?
ISO 9000:2000
PDCA MethodologyPDCA Methodology
Plan
Do
check
Act
Standard RequirementsISO 9001:2000 OverviewISO 9001:2000 Overview
ISO 9001:2000 is contained in three ISO 9001:2000 is contained in three primary documents.primary documents.
ISO 9000 Quality management systems – ISO 9000 Quality management systems – Fundamentals and vocabularyFundamentals and vocabulary
ISO 9001 Quality management systems – ISO 9001 Quality management systems – RequirementsRequirements
ISO 9004 Quality management systems – ISO 9004 Quality management systems – Guidelines for performance improvementsGuidelines for performance improvements
A few guidance documentsA few guidance documents
Standard Requirements
1. Scope 2. Normative Reference 3. Terms and Definitions4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement
Elements of ISO 9001:2000Elements of ISO 9001:2000
4.1 General Requirements4.1 General Requirements
a) Identification of the processes for the QMSb) Determine the sequence of these processesc) Determine criteria for effective operation &
control of these processesd) Ensure the availability of resourcese) Monitor, measure and analyze these
processesf) Implement actions necessary for achieving
planned results and continual improvement
Quality Management System - 1
4.2.1 GeneralThe QMS Documentation shall include:a) Quality Policy & Quality Objectivesb) Quality Manualc) Documented procedures required by this
Standardd) Documents needed for planning, operation
and control of processese) Records required by this Standard
4.2 Documentation Requirements - 14.2 4.2 Documentation Requirements - 1Documentation Requirements - 1Quality Management System - 2
4.2.2 Quality Manuala) Scope of QMS / Justification of the
Exclusionsb) Documented procedures or reference to themc) Description of interaction between the
processes of the QMS
4.2 4.2 Documentation Requirements - 2Documentation Requirements - 2Quality Management System - 3
4.2.3 Control of documentsEstablish documented procedure to define method to:a) Approve documentsb) Review, update and re-approve documentsc) Identify the revision status / changes d) Ensure availability of relevant versions at point of
usee) Ensure documents are legible and readily identifiablef) Identification and Control the external documentsg) Identification and Control of obsolete documents
4.2 4.2 Documentation Requirements - 3Documentation Requirements - 3Quality Management System - 4
4.2.4 Control of recordsa) Establish / Maintain records to demonstrate
conformity to this International Standard b) Keep records legible, readily identifiable and
retrievable c) Establish documented procedure for
identification, storage, protection, retrieval, specify retention time and their disposition
4.2 4.2 Documentation Requirements - 4Documentation Requirements - 4Quality Management System - 5
a) Communication to the organization the importance of meeting customer, statutory and regularity requirements
b) Establish Quality Policy & Quality Objectivesc) Conducting Management Reviewsd) Ensuring the availability of resources
5.1 Management Commitment 5.1 Management Commitment Management Responsibility - 1
5.2 Customer Focus 5.2 Customer Focus
Determine and meet the customer requirements for enhancing customer satisfaction
a) Is appropriate to the purpose of the organizationb) Includes a commitment to the comply with and
continually improve the QMSc) Provides framework of establishing and
reviewing Quality Objectivesd) Is communicated and understood within
organizatione) Is reviewed for continuing suitability
5.3 Quality Policy 5.3 Quality Policy
Management Responsibility - 2
5.4.1 Quality Objectivesa) Needed to meet the requirements of the
product are established at relevant functions within the organization
b) Are measurable and consistent with the Quality Policy
5.4 5.4 Planning - 1Planning - 1
Management Responsibility - 3
5.4.2 Quality Management System PlanningTop Management shall ensure thata) Planning is done for meeting the requirements
of this standard (4.1) and Quality Objectivesb) Integrity of the QMS is maintained when
changes to QMS are planned and implemented
Management Responsibility - 4
5.4 5.4 Planning - 2Planning - 2
5.5.1 Responsibility and AuthorityAre defined and communicated
5.5.2 Management RepresentativeThe Management Shall appoint a Management Representative responsible to :
a) Ensure that processes for QMS are established, implemented and maintained
b) Reporting to top management on performance of QMS and any need for improvement
c) Ensure the promotion of awareness of customer requirements throughout the organization
5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 1 - 1
Management Responsibility - 5
5.5.3 Internal Communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of quality management system.
Management Responsibility - 65.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 2 - 2
5.6.1 GeneralThe management shall review the QMS at planned intervals to ensure it’s continued suitability, adequacy and effectivenessThe review shall include :
a) Assessing opportunities for improvement and need for changes to the QMS
b) Review of the Quality Policy and Quality ObjectivesRecords of the reviews must be kept
5.65.6 Management Review - 1Management Review - 1Management Responsibility - 7
5.6.2 Review InputsThe Inputs shall include information on:a) Results of audits b) Customer feedback c) Process performance and product conformity d) Status of preventive and corrective action e) Follow-up actions from previous
management review f) Changes which could affect the QMS g) Recommendations for improvement
Management Responsibility - 8
5.65.6 Management Review - 2Management Review - 2
5.6.3 Review OutputsThe Outputs shall include any decisions and actions on:a) Improvement of the effectiveness of quality
management system and processes,b) Improvement of product related to customer
requirementsc) Resources needs
Management Responsibility - 9
5.65.6 Management Review - 3Management Review - 3
The Organization shall determine and provideresources needed to :a) Implement and maintain the QMS and
continually improve its effectiveness b) Enhance customer satisfaction by meeting
customer requirements.
Resource Management - 1
6.16.1 Provision of ResourcesProvision of Resources
6.2.1 GeneralCompetent persons should perform work effecting quality
6.2.2 Competence, awareness and training a) Determine the necessary competence for the personnel
performing work effecting qualityb) Provide training and take action to satisfy these needsc) Evaluate the effectiveness of the action takend) Ensure that its personnel are aware of relevance and
importance of their activities and how they contribute to the achievement of the quality objectives
e) Maintain appropriate records of education, training, skills and experience
6.26.2 Human ResourcesHuman Resources
Resource Management - 2
The organization shall determine, provide and maintain the infrastructure needed to achieve product conformity, it includes:
a) Building, workplace and associated utilities b) Process equipment (both hardware and
software) c) Supporting services(such as transport or
communication)
6.36.3 InfrastructureInfrastructure
Resource Management - 3
The organization shall determine and manage the work environment needed to achieve conformity to product requirements
6.46.4 Work EnvironmentWork Environment
Resource Management - 4
Organization shall plan and develop the processes needed for product realization, while considering the Following factors as appropriate: a) Quality objective and requirements for the product b) Need to establish processes, documents, and
provide resources specific to the product c) Required verification, validation, monitoring,
inspection and test activities specific to the product and the criteria for product acceptance
d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)
7.17.1 Planning of Product RealizationPlanning of Product Realization
Product Realization - 1
7.2.1 Determination of requirements related to the productThe organization shall determine: a) Requirements specified by customer including
(delivery conditions & post Delivery activities)b) Requirements not stated but necessary for the
intended use, where knownc) Statutory & regulatory requirements related to
productd) Any additional requirement determined by the
organization
7.27.2 Customer Related Processes - 1Customer Related Processes - 1
Product Realization - 2
7.2.2 Review of Requirements Related to the Product
Review following before the acceptance of contract :a) Product requirements are definedb) Contract or order requirements differing from those
previously expressed are resolvedc) The organization has the ability to meet the defined
requirements.
Results of the reviews must be maintainedAny change in requirements is communicated to all
7.27.2 Customer Related Processes - 2Customer Related Processes - 2
Product Realization - 3
7.2.2 Customer Communication
The organization shall define and implement Effective arrangements for communicating with customers in relation to :a) Product informationb) Enquiries, contracts or order handling,
including amendments, and c) Customer feedback, including customer
complaints
7.27.2 Customer Related Processes - 3Customer Related Processes - 3
Product Realization - 4
7.3.1 Design and Development Planning Organization shall determine thea) Design and development stages,b) Review, verification and validation that are
appropriate to each design and development stage, and
c) Responsibilities and authorities for design and development Planning output shall be updated, as appropriate, as the design and development progresses
7.37.3 Design and Development - 1Design and Development - 1
Product Realization - 5
7.3.2 Design and Development InputsInputs related to product requirements including followingshall be determined,a) Functional and performance requirements,b) Applicable statutory and regulatory requirements,c) Where applicable, information derived from previous
similar design, and d) Other requirements essential for design and
developmentThe requirements must be complete, unambiguous and not in conflict in each otherThe requirements must be reviewed for adequacy and records must be maintained
7.37.3 Design and Development - 2Design and Development - 2Product Realization - 6
7.3.3 Design and Development OutputsThe design and development outputs shall:a) Meet the input requirements for design and
developmentb) Provide appropriate information for
purchasing, production and for services provision
c) Contain or reference product acceptance criteria
d) Specify the characteristics of the product that are essential for its safe and proper use
7.37.3 Design and Development - 3Design and Development - 3
Product Realization - 7
7.3.4 Design and Development Review
Reviews by representatives of the functionsconcerned shall be performed in accordance withplanned arrangements (see 7.3.1) to :
a) Evaluate the ability of the results of design and development to meet requirements, and
b) Identify any problems and propose necessary actions.
Records of reviews and any necessary actionsshall be maintained
7.37.3 Design and Development - 4Design and Development - 4Product Realization - 8
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that design and development outputs have met the design and development input requirements.Records of the results and any actions shall be maintained.
7.37.3 Design and Development - 5Design and Development - 5
Product Realization - 9
7.3.6 Design and development validationValidation shall be performed in accordance with planned arrangements (7.3.1) to ensure that Resulting product is capable of meeting requirements for intended use, where known. Where practicable, validation shall be completed prior to the delivery or implementation of the productRecords of the results and any actions shall be maintained.
7.37.3 Design and Development - 6Design and Development - 6
Product Realization - 10
7.3.7 Control of design and development changes The changes will be reviewed, verified and validated as appropriate and approved before implementation.The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered. Records of the changes and any actions shall be maintained.
7.37.3 Design and Development - 7Design and Development - 7
Product Realization - 11
7.4.1 Purchasing ProcessThe organization shall ensure that purchased product conforms to specified purchase requirementsThe type and extent of control applied shall be dependent upon the effect on the final product
7.47.4 Purchasing - 1Purchasing - 1
Product Realization - 12
7.4.2 Purchasing InformationPurchasing information shall describe the purchased product, including where appropriate:a) Requirement for approval of product,
procedures, process and equipmentb) Requirement for qualification of personnelc) Quality management system requirements
7.47.4 Purchasing - 2Purchasing - 2
Product Realization - 13
7.4.3 Verification of the Purchased ProductEstablish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information.Where verification at the supplier’s premises is required by organization / customer, it shall be indicated so in the purchase information.
7.47.4 Purchasing - 3Purchasing - 3
Product Realization - 14
7.5.1Control of Production and Service ProvisionProduction and service provision shall be carried outunder controlled conditions, as applicable:a) Availability of information that describes the
characteristics of the product,b) Availability of work instructions, as necessary,c) Use of suitable equipment,d) Availability and use of monitoring and measuring
devices,e) Implementation of monitoring and measurement, and f) Implementation of release, delivery and post-delivery
activities.
7.57.5 Production and Service Provision - 1Production and Service Provision - 1
Product Realization - 15
7.5.2Validation of processes for production and service provision
Validation of process shall be done where the resulting output cannot be verified by subsequent monitoring or measurement, the following shall be addressed: a) Defined criteria for review and approval of the
processesb) Approval of equipment and qualification of
personnelc) Use of specific methods and proceduresd) Requirements for recordse) Revalidation
7.57.5 Production and Service Provision - 2Production and Service Provision - 2Product Realization - 16
7.5.3Identification and Traceability
Identification of product by suitable means throughout product realization
Identification of the product status with respect to the monitoring and measurement requirements
Where traceability is required the organization shall control and record the unique identification of the product
7.57.5 Production and Service Provision - 3Production and Service Provision - 3
Product Realization - 17
7.5.4Customer Property
The organization shall
a) Identify, verify, protect and safeguard customer property
b) In case of loss, damage or unsuitable for use customer must be informed
c) Records must be maintained
7.57.5 Production and Service Provision - 4Production and Service Provision - 4
Product Realization - 18
7.5.5Preservation of Product The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product
7.57.5 Production and Service Provision - 5Production and Service Provision - 5
Product Realization - 19
The equipment Shall be:a) Calibrated or verified at specific intervals, or prior to use,
against measurement standards traceable to international or national measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded
b) Adjusted or re-adjusted as necessaryc) Identified to enable the calibration status to be determinedd) Safeguarded from adjustments that would invalidate the
measurement resulte) Protected from damage and deterioration during handling,
maintenance and storagef) Records shall be maintained
7.67.6 Control of Monitoring and Measuring DevicesControl of Monitoring and Measuring Devices
Product Realization - 20
Organization must plan and implement the monitoring
measurement, analysis and improvement processes needed to :a) Demonstrate conformity of the product b) Ensure conformity of the QMS c) Continually improve the effectiveness of QMS
Determine applicable method including StatisticalTechniques and extent of their use
8.18.1 GeneralGeneral
Measurement, Analysis and Improvement - 1
8.2.1 Customer Satisfaction
Establish a method for obtaining and using the information about customer perception as to whether the organization has met customer requirements
8.28.2 Monitoring & Measurement - 1Monitoring & Measurement - 1
Measurement, Analysis and Improvement - 2
8.2.2 Internal AuditDocumented procedures Shall be established and internal audits shall be conducted at regular intervals to determine whether the QMS :a) Conforms to standard and other requirements
determined by organizationb) Is effectively implemented and maintainedAudit shall be:1. Planned, Criteria / Scope / Frequency and method be
defined.2. Selection / conduct of audit shall ensure impartiality3. Follow-up activities shall be performed4. Records shall be maintained
8.28.2 Monitoring & Measurement - 2Monitoring & Measurement - 2
Measurement, Analysis and Improvement - 3
8.2.3 Monitoring and measurement of processes
Apply methods for monitoring and where applicable measurement of QMS processes.
Methods shall demonstrate the ability of the processes to achieve the planned results.
In case planned results are not obtained Corrective / Preventive actions must be taken to ensure the conformity to the product.
8.28.2 Monitoring & Measurement - 3Monitoring & Measurement - 3
Measurement, Analysis and Improvement - 4
8.2.4 Monitoring and measurement of productMonitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.1)Evidence of conformity and acceptance criteria must be defined. No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person. Records shall also be maintained.
8.28.2 Monitoring & Measurement - 4Monitoring & Measurement - 4
Measurement, Analysis and Improvement - 5
The nonconforming products must be identified and controlled to prevent unintended use or delivery.Documented procedure stating responsibility and authority to deal with nonconforming products shall be defined.
8.3 Control of Nonconforming Product - 18.3 Control of Nonconforming Product - 1
Measurement, Analysis and Improvement - 6
The organization shall deal with nonconforming products by :a) Taking action to eliminate the detected non
conformity b) Authorizing its use, release / acceptance under
concession by relevant authority if allowed by customer.
c) Take action to prevent its original intended useRecords and actions taken shall be recorded.Incase of rework product shall be re-verifiedIncase the product has been delivered appropriate actions shall be taken
8.3 Control of Nonconforming Product - 28.3 Control of Nonconforming Product - 2
Measurement, Analysis and Improvement - 7
Determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made.Analysis of data shall provide information relating to:
a) Customer Satisfaction (see 8.2.1)b) Conformity of product requirements (see 7.2.1)c) Characteristics and trends of processes and and
products including opportunities of Corrective actiond) Suppliers
8.48.4 Analysis of DataAnalysis of Data
Measurement, Analysis and Improvement - 8
8.5.1 Continual ImprovementThe organization shall continually improve the effectiveness of QMS through the use of :
Quality Policy Quality Objectives, Audit Results Analysis of data, Corrective and Preventive Actions Management Review
8.58.5 Improvement - 1Improvement - 1
Measurement, Analysis and Improvement - 9
8.58.5 Improvement - 2Improvement - 28.5.2 Corrective Action
Corrective actions shall be taken to eliminate causes of nonconformities to prevent their recurrence. Documented procedure shall be established to define requirements for: a) Reviewing nonconformities (including customer
complaints)b) Determining the causes of nonconformitiesc) Evaluating the need for action to ensure that
nonconformities do not recur
Measurement, Analysis and Improvement - 10
8.58.5 Improvement - 3Improvement - 3
d) Determining and implementing action needed e) Records of the action taken resultsf) Reviewing corrective action taken
Measurement, Analysis and Improvement - 11
8.5.3 Preventive Action
Preventive actions shall be taken to eliminate causes of potential nonconformities to prevent their occurrence. Documented procedure shall be established to define requirements for:a) Determining potential nonconformities and their
causesb) Evaluating the need for action to prevent
occurrence of nonconformitiesc) Determining and implementing action needed
8.58.5 Improvement - 4Improvement - 4
Measurement, Analysis and Improvement - 12
d) Records of results action taken e) Reviewing preventive action taken
8.58.5 Improvement - 5Improvement - 5
Measurement, Analysis and Improvement - 13
ISO 9000:2000
DocumentsDocumentsProcedure for measurement and monitoring of processes for effective
control.Methods for use of statistical techniques for process control and data
analysis for improvement.Procedure for inspection and release of final product.Procedure for dealing with non conforming product and use of material
under concession.Procedure for monitoring customer satisfaction and dealing with customer
complaints.
Clause 8Clause 8
Documentation Requirements
ISO 9000:2000
DocumentsDocumentsProcedure of internal audit of QMS, along with check list.Procedure for corrective and preventive action.Procedure for collection and analysis of data for effectiveness and
improvement of QMS.RecordsRecordsProcess monitoring data and corrective action taken for process controlRecord of product non conformities and products accepted on concession.
Clause 8 contnd..Clause 8 contnd..
Documentation Requirements
ISO 9000:2000
RecordsRecordsData analysis and activities for continual improvement.Result of internal audits and follow up action.Data on customer feedback and action taken on customer complaints.
Clause 8 contnd..Clause 8 contnd..
Documentation Requirements
ISO 9000:2000
RecordsRecordsData analysis and activities for continual improvement.Result of internal audits and follow up action.Data on customer feedback and action taken on customer complaints.
Clause 8 contnd..Clause 8 contnd..
Documentation Requirements
ISO 9000:2000
No bodyNo body
Can AchieveCan Achieve
QQUUALITYALITYWithoutWithout
UU
ISO 9000:2000
Thank you !!!Thank you !!!