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What is ISO 9000?

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

PDCA Methodology



ISO 9000:2000

Standard Requirements

ISO 9001:2000 Overview

ISO 9001:2000 is contained in three primary documents.

ISO 9000 Quality management systems Fundamentals and vocabulary ISO 9001 Quality management systems Requirements ISO 9004 Quality management systems Guidelines for performance improvements A few guidance documents

Standard Requirements Elements of ISO 9001:2000 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System

6. 7. 8.

Management Responsibility
Resource Management Product Realization Measurement, Analysis and Improvement

Quality Management System - 1 4.1 General Requirements a) Identification of the processes for the QMS b) Determine the sequence of these processes c) Determine criteria for effective operation & control of these processes d) Ensure the availability of resources e) Monitor, measure and analyze these processes f) Implement actions necessary for achieving planned results and continual improvement

Quality Management System - 2


Documentation Requirements - 1

4.2.1 General The QMS Documentation shall include: a) Quality Policy & Quality Objectives b) Quality Manual c) Documented procedures required by this Standard d) Documents needed for planning, operation and control of processes e) Records required by this Standard

Quality Management System - 3


Documentation Requirements - 2

4.2.2 Quality Manual a) Scope of QMS / Justification of the Exclusions b) Documented procedures or reference to them c) Description of interaction between the processes of the QMS

Quality Management System - 4


Documentation Requirements - 3

4.2.3 Control of documents

Establish documented procedure to define method to: a) Approve documents b) Review, update and re-approve documents c) Identify the revision status / changes d) Ensure availability of relevant versions at point of use e) Ensure documents are legible and readily identifiable f) Identification and Control the external documents g) Identification and Control of obsolete documents

Quality Management System - 5


Documentation Requirements - 4

4.2.4 Control of records a) 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

Management Responsibility - 1 5.1 Management Commitment

a) Communication to the organization the importance of meeting customer, statutory and regularity requirements b) Establish Quality Policy & Quality Objectives c) Conducting Management Reviews d) Ensuring the availability of resources
5.2 Customer Focus Determine and meet the customer requirements for enhancing customer satisfaction

Management Responsibility - 2 5.3 Quality Policy

a) Is appropriate to the purpose of the organization b) Includes a commitment to the comply with and continually improve the QMS c) Provides framework of establishing and reviewing Quality Objectives d) Is communicated and understood within organization e) Is reviewed for continuing suitability

Management Responsibility - 3 5.4 Planning - 1

5.4.1 Quality Objectives a) 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

Management Responsibility - 4 5.4 Planning - 2

5.4.2 Quality Management System Planning Top Management shall ensure that a) Planning is done for meeting the requirements of this standard (4.1) and Quality Objectives

b) Integrity of the QMS is maintained when changes to QMS are planned and implemented

Management Responsibility - 5
5.5 Responsibility, Authority and Communication - 1

5.5.1 Responsibility and Authority

Are defined and communicated

5.5.2 Management Representative

The Management Shall appoint a Management Representative responsible to : Ensure that processes for QMS are established, implemented and maintained Reporting to top management on performance of QMS and any need for improvement
Ensure the promotion of awareness of customer requirements throughout the organization



Management Responsibility - 6
5.5 Responsibility, Authority and Communication - 2

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 - 7 5.6 Management Review - 1 5.6.1 General The management shall review the QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness The review shall include : a) Assessing opportunities for improvement and need for changes to the QMS b) Review of the Quality Policy and Quality Objectives Records of the reviews must be kept

Management Responsibility - 8 5.6 Management Review - 2 5.6.2 Review Inputs The 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 - 9 5.6 Management Review - 3

5.6.3 Review Outputs The 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 requirements c) Resources needs

Resource Management - 1 6.1 Provision of Resources

The Organization shall determine and provide resources needed to : a) Implement and maintain the QMS and continually improve its effectiveness b) Enhance customer satisfaction by meeting customer requirements.

Resource Management - 2 6.2 Human Resources 6.2.1 General

Competent persons should perform work effecting quality

6.2.2 Competence, awareness and training

a) b) c) d) Determine the necessary competence for the personnel performing work effecting quality Provide training and take action to satisfy these needs Evaluate the effectiveness of the action taken Ensure that its personnel are aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives Maintain appropriate records of education, training, skills and experience


Resource Management - 3 6.3 Infrastructure

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)

Resource Management - 4 6.4 Work Environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements

Product Realization - 1


Planning of Product Realization

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)

Product Realization - 2


Customer Related Processes - 1

7.2.1 Determination of requirements related to the product

The 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 known c) Statutory & regulatory requirements related to product d) Any additional requirement determined by the organization

Product Realization - 3


Customer Related Processes - 2

7.2.2 Review of Requirements Related to the Product Review following before the acceptance of contract : a) b) c) Product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has the ability to meet the defined requirements.

Results of the reviews must be maintained Any change in requirements is communicated to all

Product Realization - 4


Customer Related Processes - 3

7.2.2 Customer Communication

The organization shall define and implement Effective arrangements for communicating with customers in relation to : a) Product information b) Enquiries, contracts or order handling, including amendments, and c) Customer feedback, including customer complaints

Product Realization - 5


Design and Development - 1

7.3.1 Design and Development Planning

Organization shall determine the a) 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

Product Realization - 6 7.3 Design and Development - 2 7.3.2 Design and Development Inputs
Inputs related to product requirements including following shall 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 development The requirements must be complete, unambiguous and not in conflict in each other The requirements must be reviewed for adequacy and records must be maintained

Product Realization - 7


Design and Development - 3

7.3.3 Design and Development Outputs The design and development outputs shall: a) Meet the input requirements for design and development b) 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

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Design and Development - 4

7.3.4 Design and Development Review Reviews by representatives of the functions concerned shall be performed in accordance with planned arrangements (see 7.3.1) to :


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 actions shall be maintained

Product Realization - 9 7.3 Design and Development - 5

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.

Product Realization - 10 7.3 Design and Development - 6

Validation 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 product Records of the results and any actions shall be maintained.

7.3.6 Design and development validation

Product Realization - 11 7.3 Design and Development - 7

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.

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Purchasing - 1

7.4.1 Purchasing Process The organization shall ensure that purchased product conforms to specified purchase requirements

The type and extent of control applied shall be dependent upon the effect on the final product

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Purchasing - 2

7.4.2 Purchasing Information Purchasing information shall describe the purchased product, including where appropriate: a) Requirement for approval of product, procedures, process and equipment Quality management system requirements

b) Requirement for qualification of personnel c)

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Purchasing - 3

7.4.3 Verification of the Purchased Product Establish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information. Where verification at the suppliers premises is required by organization / customer, it shall be indicated so in the purchase information.

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Production and Service Provision - 1

7.5.1Control of Production and Service Provision Production and service provision shall be carried out under 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.

Product Realization - 16


Production and Service Provision - 2

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 processes b) Approval of equipment and qualification of personnel c) Use of specific methods and procedures d) Requirements for records e) Revalidation

Product Realization - 17 7.5 Production and Service Provision - 3

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

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Production and Service Provision - 4

7.5.4Customer Property

The organization shall a) Identify, verify, protect and safeguard customer property


In case of loss, damage or unsuitable for use customer must be informed

Records must be maintained

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Production and Service Provision - 5

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination.

7.5.5Preservation of Product

This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product

Product Realization - 20
7.6 Control of Monitoring and Measuring Devices 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 necessary

c) Identified to enable the calibration status to be determined d) Safeguarded from adjustments that would invalidate the measurement result

e) Protected from damage and deterioration during handling, maintenance and storage
f) Records shall be maintained

Measurement, Analysis and Improvement - 1



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 Statistical Techniques and extent of their use

Measurement, Analysis and Improvement - 2


Monitoring & Measurement - 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

Measurement, Analysis and Improvement - 3 8.2 Monitoring & Measurement - 2

8.2.2 Internal Audit

Documented 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 organization b) Is effectively implemented and maintained Audit shall be:
1. 2. 3. 4. Planned, Criteria / Scope / Frequency and method be defined. Selection / conduct of audit shall ensure impartiality Follow-up activities shall be performed Records shall be maintained

Measurement, Analysis and Improvement - 4


Monitoring & Measurement - 3

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.

8.2.3 Monitoring and measurement of processes

Measurement, Analysis and Improvement - 5


Monitoring & Measurement - 4

Monitoring and measurement of product

Monitor 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.

Measurement, Analysis and Improvement - 6

8.3 Control of Nonconforming Product - 1

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.

Measurement, Analysis and Improvement - 7

8.3 Control of Nonconforming Product - 2

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 use Records and actions taken shall be recorded. Incase of rework product shall be re-verified Incase the product has been delivered appropriate actions shall be taken

Measurement, Analysis and Improvement - 8 8.4 Analysis of Data

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 action d) Suppliers

Measurement, Analysis and Improvement - 9


Improvement - 1

8.5.1 Continual Improvement

The 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

Measurement, Analysis and Improvement - 10


Improvement - 2

8.5.2 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 nonconformities c) Evaluating the need for action to ensure that nonconformities do not recur

Measurement, Analysis and Improvement - 11


Improvement - 3

d) Determining and implementing action needed e) Records of the action taken results f) Reviewing corrective action taken

Measurement, Analysis and Improvement - 12 8.5 Improvement - 4

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 causes b) Evaluating the need for action to prevent occurrence of nonconformities c) Determining and implementing action needed

Measurement, Analysis and Improvement - 13 8.5 Improvement - 5

d) Records of results action taken e) Reviewing preventive action taken

Documentation Requirements Clause 8 Documents Procedure 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.

ISO 9000:2000

Documentation Requirements Clause 8 contnd.. Documents Procedure 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. Records Process monitoring data and corrective action taken for process control Record of product non conformities and products accepted on concession.

ISO 9000:2000

Documentation Requirements Clause 8 contnd.. Records Data analysis and activities for continual improvement. Result of internal audits and follow up action. Data on customer feedback and action taken on customer complaints.

ISO 9000:2000

Documentation Requirements Clause 8 contnd.. Records Data analysis and activities for continual improvement. Result of internal audits and follow up action. Data on customer feedback and action taken on customer complaints.

ISO 9000:2000

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ISO 9000:2000

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ISO 9000:2000