A Guide to the Contents of ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS

FOR

ACQUIRING ISO 9001:2000 CERTIFICATION FOR A TECHNICAL INSTITUTE

Presented by : Prof. D.D. Sharma Prof. & Head, EDIC Deptt. TTTI, Chandigarh

BENEFITS OF ISO 9000

CUSTOMER SATISFACTION MANAGEMENTS CONFIDENCE EMPLOYEES MORALE IMPROVED QUALITY HIGHER PRODUCTIVITY HIGHER PROFITABILITY ACCESS TO GLOBAL MARKET

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ISO 9000 ADOPTED BY

INDUSTRIAL ORGANISATIONS SERVICE ORGANISATIONS EDUCATIONAL INSTITUTIONS SOFTWARE ORGANISATIONS ALL THOSE ORGANISATIONS WHO WANT TO SURVIVE & GROW

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A GENERAL OVERVIEW OF ISO 9001:2000 : QMS Requirements

This is the standard which assessment bodies will use for SURVEILLANCE or CERTIFICATION purposes. This standard promotes adoption of PROCESS APPROACH in improving effectiveness of QMS RELATIONSHIP WITH ISO 9004 A Guidance document to be used in conjunction with ISO 9001 for moving beyond ISO 9001 to link to other quality systems, such as TQM, Business Excellence etc.
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- COMPATIBILITY WITH OTHER MANAGEMENT SYSTEMS : This International Standard has been aligned with ISO 14001:1996 in order to enhance the Compatibility of two standards A USER FRIENDLY STANDARD * Requirements and Language * Caters to all sizes of company including those that provide service

A Requirement to Demonstrate CUSTOMER SATISFACTION & a clear requirement for CONTINUAL IMPROVEMENT OF THE QMS
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PROCESS APPROACH Application of System of Processes within an Organization together with their Identification, Interaction and Management IMPORTANCE TO: - Understanding and Meeting Requirements to Customer Satisfaction - Processes to Add Value - Obtaining Results of Performance & Effectiveness - Continual Improvement of Processes based on Objective Measurement
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Continual improvement of the quality management system

Value adding activities Information Flow

Management responsibility

Customers
Resource management

Measurement, analysis & improvement

Customers

Requirements Input
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Product realization

Product

Satisfaction

Output
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Model of a process-based quality management system

QMS Requirements 1. SCOPE 2. NORMATIVE REFERENCE

3. TERMS AND DEFINITIONS 4. QUALITY MANAGEMENT SYSTEM 5. MANAGEMENT RESPONSIBILITY 6. RESOURCE MANAGEMENT 7. PRODUCT REALIZATION 8. MEASUREMENT, ANALYSIS & IMPROVEMENT

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SCOPE 1.1: General

CLAUSE 1

Need for an Organization: -To demonstrate its ability to provide consistently product that meets customer and applicable regulatory requirements. -To aim to enhance customer satisfaction through effective application of system processes for continual improvement of the system and assurance of conformity to Customer & Applicable Regulatory Requirements.
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SCOPE 1.2 Application

CLAUSE 1

All requirements are generic & applicable to organizations regardless of TYPE, SIZE & PRODUCT Gives information on the Permissible Exclusions The only exclusions permitted are those that do not affect an organizations ability to provide product that meets customer and applicable regulatory requirements.

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The exclusion may be due to : - nature of the organization's product - customer requirements - applicable regulatory requirements Permitted exclusions only apply to Clause 7. NORMATIVE REFERENCE CLAUSE 2

For Dated Ref subsequent amendments, revision do not apply. For Undated Ref.. . ISO 9000-2000. QMS Fundamentals & Vocabulary the latest edition.
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TERMS & DEFINITIONS

CLAUSE 3

* Old Terms : Subcontractor Supplier .. Customer * New Terms: Supplier Organization Customer In the Standard, wherever the term PRODUCT occurs it can also mean SERVICE Other terms & definitions as given in ISO 9000.

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QUALITY MANAGEMENT SYSTEM 4.1 General Requirements Organization shall - Establish, Document, Implement, Maintain & Continually Improve QMS - Steps :

CLAUSE 4

a) Identify processes for QMS b) Determine sequence & interaction of these processes c) Determine criteria & methods for effective operation and control of these processes

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QUALITY MANAGEMENT SYSTEM (Contd..)

CLAUSE 4

d) Ensure the availability of resources and information necessary to support operation and monitoring of processes. e) Monitor, Measure & Analyze processes f) Implement actions to achieve planned results and continual improvement of processes. (Include control of outsourced processes)

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QUALITY MANAGEMENT SYSTEM (Contd..) 4.2: Documentation Requirements

CLAUSE 4

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

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QUALITY MANAGEMENT SYSTEM (Contd..) 4.2: Documentation Requirements 4.2.1 General (Contd.) * Documented Procedure: Established, Documented, Implemented & Maintained

CLAUSE 4

* Documented Procedure Is Explicitly required for : i) Control of documents ii) Control of Quality records iii) Internal Audit iv) Control of Non-conforming Product v) Corrective Action vi) Preventive Action
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QUALITY MANAGEMENT SYSTEM (Contd..) 4.2 4.2.1 # # # Documentation Requirements

CLAUSE 4

General (Contd.) Extent of QMS documentation may differ due to: Size of organization & type of activities Complexity of processes & their interactions Competence of personnel Document is Information & its supporting medium The documentation can be in any form or type of medium i.e. Paper, Magnetic, Electronic, Optical CD, Photograph or Combination thereof.
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QUALITY MANAGEMENT SYSTEM (Contd..)

CLAUSE 4

4.2 Documentation Requirements 4.2.2 Quality Manual Establish & Maintain a Quality Manual. It shall include :a) Scope of QMS b) Exclusions (Requirements of Standard that have not been addressed) with justification and details. c) Processes of QMS with description of interaction between them d) Inputs & outputs for each process e) Display of overall flow chart Sequence & Interaction
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QUALITY MANAGEMENT SYSTEM (Contd..)

CLAUSE 4

4.2 Documentation Requirements (Contd.) 4.2.2 Quality Manual e) Documented procedures for QMS with cross referencing f) Introduction to the organization g) Organization chart h) Brief description of Policy with respect to each applicable requirement of the standard

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QUALITY MANAGEMENT SYSTEM (Contd..) 4.2 Documentation Requirements

CLAUSE 4

4.2.3 Control of Documents a) Documents required by QMS shall be controlled b) A documented procedure shall be established to define the controls needed to: - approve document for adequacy before issue - review and update as necessary & re-approve - ensure documents are identified with changes & current revision status
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QUALITY MANAGEMENT SYSTEM (Contd..)

CLAUSE 4

4.2 Documentation Requirements (Contd.) 4.2.3 Control of Documents - ensure that relevant versions of applicable documents are available at points of use - ensure that documents are legible and readily identifiable - ensure that documents of external origin are identified and their distribution controlled - prevent unintended use of obsolete documents, and to apply suitable identification to them, if they are retained for any purpose.
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QUALITY MANAGEMENT SYSTEM (Contd..) 4.2 4.2.4 a) b)

CLAUSE 4

c) d)

Documentation Requirements Control of Records Records are special type of document Records shall be established and maintained to provide evidence to conformity to requirements and effective operation of QMS Records shall be legible, readily identifiable, & retrievable Establish a documented procedure for controls needed for records defining: Identification, Storage, Protection, Retrieval, Retention Time, & Disposition.
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MANAGEMENT RESPONSIBILITY

CLAUSE 5

5.1: Management Commitment Top Management shall provide evidence of its commitment by: a) Communicating to the organization, importance of meeting customer as well as statutory & regulatory requirements b) Establishing Quality Policy & Quality Objectives c) Conducting Management Reviews d) Ensuring availability of necessary Resources 5.2 Customer Focus Top Management shall ensure that customer requirements are determined and are met with the aims of achieving/enhancing customer satisfaction
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MANAGEMENT RESPONSIBILITY (Contd..)

CLAUSE 5

5.3: Quality Policy (QP) Top Management shall ensure that the Quality Policy: a) is appropriate to the purpose of the organization b) includes commitment to comply with the requirements and continually improve the effectiveness of the QMS c) provides framework for establishing and reviewing quality objectives d) is communicated and understood with in the organization e) is reviewed for continuing suitability Quality Policy
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Controlled & Documented

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MANAGEMENT RESPONSIBILITY (Contd..) 5.4: Planning

CLAUSE 5

5.4.1 Quality Objectives Top Management shall ensure that the Quality objectives: (Including those needed to meet requirements of product) - are established at relevant function & levels - are measurable & consistent with the Quality Policy

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MANAGEMENT RESPONSIBILITY (Contd..) 5.4.2 QMS Planning Top Management shall ensure that :

CLAUSE 5

a) Planning of QMS is carried out in order to meet the requirements given in (Clause 4.1) as well as the quality objectives (i.e. plan for development, implementation, improvement and modification of the QMS) b) The integrity of the QMS is maintained when changes to the QMS are planned & implemented.
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MANAGEMENT RESPONSIBILITY (Contd..) 5.5 5.5.1

CLAUSE 5

Responsibility, Authority & Communication Responsibility & Authority

Top Management shall ensure to: a) Define & clarify Responsibilities and Authorities b) Communicate Responsibilities & Authorities within the organization
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MANAGEMENT RESPONSIBILITY (Contd..)

CLAUSE 5

5.5 Responsibility, Authority & Communication 5.5.2 Management Representative (MR) Top Management shall appoint a member of Management (called MR), irrespective of other responsibilities with Responsibility & Authority to: a) ensure that the processes of QMS are established, implemented and maintained b) report to top management on the performance of QMS and any need for improvement c) ensure promotion of awareness of customer requirements throughout the organization
NOTE: Management Representative can include liaison with external agencies on matters relating to QMS
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MANAGEMENT RESPONSIBILITY (Contd..)

CLAUSE 5

5.5: Responsibility, Authority & Communication 5.5.3 Internal Communication Top Management shall ensure that a) Appropriate internal communication processes are b) established Communication occurs throughout the organization regarding effectiveness of QMS,

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MANAGEMENT RESPONSIBILITY (Contd..) 5.6 Management Review

CLAUSE 5

5.6.1 General Review QMS Top Management shall a) Review QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness Assess opportunities & need for improving QMS Maintain records of review
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b) c)

MANAGEMENT RESPONSIBILITY (Contd..)

CLAUSE 5

5.6 Management Review (Contd.) 5.6.2 Review Inputs Top Management shall examine the following: * * * * * * * Audit Results Customer Feedback Process performance information & product conformity data Status of corrective & preventive actions Changes that could affect the QMS Follow-up actions from previous management review Recommendations for improvement
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MANAGEMENT RESPONSIBILITY (Contd..)

CLAUSE 5

5.6

Management Review

5.6.3 Review Outputs Shall include generating decisions and actions: a) to improve effectiveness of QMS and its processes b) to improve product related to customer requirements c) to address resource needs
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RESOURCE MANAGEMENT 6.1 * *

CLAUSE 6

Provision of Resources Identify & provide quality resources needed to support QMS Improve continually QMS effectiveness and customer satisfaction Human Resources

6.2

6.2.1 General * Ensure that the personnel have right and appropriate education, training, skills and experience
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RESOURCE MANAGEMENT 6.2

(Contd..)

CLAUSE 6

Human Resources(Contd.)

6.2.2 Competence, Awareness & Training: * Define acceptable levels of competence * * * * * Identify training and awareness needs Deliver training and awareness programmes Evaluate effectiveness of training and other actions taken Ensure awareness about relevance and importance of their activities in achieving the objectives Maintain appropriate records of education, training, skills and experience
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RESOURCE MANAGEMENT 6.3: -

(Contd..)

CLAUSE 6

Infrastructure (Provide Quality Infrastructure) Identify needs related to infrastructure i.e. building, workspace, hardware, software, utilities, equipment & support services Provide & Maintain needed infrastructure : Provide & Maintain needed buildings, workspace, hardware, software, utilities, equipment & support services. Work Environment Identify & Manage Human & Physical factors of the work environment needed to achieve conformity of product.
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6.4: -

PRODUCT REALISATION 7.1 * Planning of Product Realization

CLAUSE 7

Plan Product Realization Processes - Define product quality objectives and requirements - Identify product realization needs and requirements Develop product realization processes - Develop product realization documents - Develop product realization record keeping system Develop methods to control quality during product realization
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.2: Customer Related Processes 7.2.1 Determination of Requirements related to the product (Identify Customers Product Requirements) * Determine the requirements that customer wants you to meet including delivery and post delivery activities * Determine the requirements that are dictated by the products use * Determine the requirements that are imposed by external agencies (i.e. Statutory and Regulatory) * Determine the requirements that the organization wishes to meet
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.2: CUSTOMER RELATED PROCESSES (Contd..) 7.2.2 Review of Requirements Related to the Product * Review requirements prior to acceptance of orders, submission of tenders, changes to contract from the customers Define product requirements Ensure that the organization has ability to meet the requirements Maintain record of the product requirement reviews Control changes in product requirements
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* * * *

PRODUCT REALISATION 7.2:

(Contd..)

CLAUSE 7

Customer Related Processes (Contd..)

7.2.3 Customer Communication * Develop a Process to control communication with customers * Implement customer communication process These shall relate to Product information, Enquiries, Contracts, Orders, Amendments, Feedback & Complaints.

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PRODUCT REALISATION 7.3:

(Contd..)

CLAUSE 7

Design & Development

7.3.1 Design & Development Planning * Determine product design and development stages * Review, verify & validate each design & development stage appropriately * Clarify design and development responsibilities and authorities * Manage interface between different groups involved in Design & Development * Update design & Development plans as changes occur
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.3: Design & Development (Contd..) 7.3.2 Design & Development Inputs * Specify product design and development inputs, which shall include functional & performance requirements applicable statutory & regulatory requirements information from previous design other essential requirements * Maintain records of design and development inputs * Review design and development inputs

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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.3 Design & Development (Contd..) 7.3.3 Design & Development Outputs: * Generate product design & development outputs meeting input requirements * Approve design & development outputs prior to release * Provide appropriate information for purchasing, production & for service provisions * Specify product acceptance criteria * Specify product characteristics for safe and proper use
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.3 Design & Development (Contd..) 7.3.4 Design & Development Review: * Perform systematic review at suitable stages of design & development as per planning - to evaluate the ability of the results - to identify any problem and propose necessary action Record & Maintain the result of reviews

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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.3

Design & Development (Contd..)

7.3.5 Design & Development Verification (Perform Design & Development Verification) * Perform product design & development verification to ensure output meets input requirements * Record & Maintain design & development verification

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PRODUCT REALISATION 7.3

(Contd..)

CLAUSE 7

Design & Development (Contd..)

7.3.6 Design & Development Validation * Perform design & development validation as per planned arrangements (7.3.1) * Validation shall ensure that the resulting product meets the requirements of the intended use * Record and Maintain the results of validation and other related actions.

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PRODUCT REALISATION 7.3

(Contd..)

CLAUSE 7

Design & Development (Contd..)

7.3.7 Control of Design & Development Changes * * * * * * Identify changes in product design & development Record changes in product design & development Review changes in product design & development Verify changes in product design & development Validate changes in product design & development Approve changes in product design & development

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PRODUCT REALISATION 7.4

(Contd..)

CLAUSE 7

PURCHASING (CONTROL PURCHASING FUNCTION)

7.4.1 Purchasing Process Control Purchasing Process * * * * Ensure that purchased products meet requirements Ensure that suppliers meet organizations requirements Establish criteria for selection, evaluation & revaluation Maintain records of results of evaluation

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PRODUCT REALISATION 7.4

(Contd..)

CLAUSE 7

PURCHASING (CONTROL PURCHASING FUNCTION)

7.4.2 Purchasing Information * * Describe the product being purchased Specify the requirements that must be met in relation to approval of product, procedures, processes & equipment qualifications of personnel QMS requirements
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.4 PURCHASING (CONTROL PURCHASING FUNCTION) 7.4.3 Verification of Purchased Product Establish & implement inspection and other activities to verify purchased product at own premises Verify purchased products at suppliers premises (when required)

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PRODUCT REALISATION 7.5 7.5.1 *

(Contd..)

CLAUSE 7

PRODUCTION & SERVICE PROVISION (Control Operational Activities) Control of Production & Service Provision: Plan & carryout production and service provisions under controlled conditions. Controlled conditions shall include as applicable Information describing product characteristics Availability of work instructions Use of suitable equipment Availability & use of monitoring and measuring devices Implementation of monitoring and measurement Implementation of release, delivery and post delivery activities
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.5

PRODUCTION & SERVICE PROVISION (Control Operational Activities) 7.5.2 Validation of Processes for Production & Service Provision: * Validation shall : - Demonstrate the ability of the processes to achieve planned results - Demonstrate process personnel can produce planned results - Demonstrate that process equipment can produce planned results
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.5

PRODUCTION & SERVICE PROVISION (Control Operational Activities) 7.5.3 Identification & Trace ability when appropriate : * Establish identity of the products Maintain identity of the products Identify status of the products with respect to monitoring & measurement Record identity of the products
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.5

PRODUCTION & SERVICE PROVISION (Control Operational Activities) 7.5.4 Customer Property (Protect property supplied by customers) * * Identify property supplied by customers Verify property supplied by customers

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PRODUCT REALISATION 7.5

(Contd..)

CLAUSE 7

PRODUCTION & SERVICE PROVISION (Control Operational Activities) 7.5.5 Preservation of Product * * Preserve the products & constituent parts during internal processing Preserve the products & constituent parts during final delivery Preservation Identification, Handling & Packaging, Storage & Protection
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.6 Control of Monitoring & Measuring Devices * * * * Determine monitoring & measuring needs to be undertaken Select monitoring & measuring devices that meet the monitoring and measuring needs Establish processes to ensure that monitoring and measurement is carried out in a consistent manner. Calibrate monitoring & measuring devices Perform Calibration Record Calibration
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PRODUCT REALISATION

(Contd..)

CLAUSE 7

7.6 CONTROL OF MONITORING & MEASURING DEVICES(Contd.) * Protect monitoring & measuring device from unauthorized adjustment, damage or deterioration * Validate monitoring & measuring software before use * Revalidate monitoring & measuring software when necessary * Use monitoring and measuring devices to ensure evidence of conformity of product requirements.

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MEASUREMENT, ANALYSIS & IMPROVEMENT CLAUSE 8 8.1 GENERAL Plan & Implement Monitoring, Measurement, Analysis & Improvement Processes to: a) b) c) * Demonstrate conformity of the product Ensure conformity of the QMS Continually improve the effectiveness of QMS Includes determination of extent and use of applicable methods including statistical techniques

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.2 Monitoring & measurement

8.2.1 Customer Satisfaction: * * Monitoring information relating to customer perception of whether customer requirements have been met. Determine methods for obtaining and using such information

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.2 Monitoring & measurement (Contd.) 8.2.2 Internal Audit * Conduct Internal Audit at planned intervals to determine whether QMS - conforms to planned arrangements (7.1) - is effectively implemented & maintained * Define the audit criteria, scope, frequency, areas to be audited & methods * Selection of auditors & conduct of audit shall ensure objectivity and impartiality * Auditors shall not audit their own work
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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.2 Monitoring & measurement (Contd.)

8.2.2 Internal Audit * Responsibilities & Requirement of planning, conduct of audit,reporting results and record maintenance shall be (as per 4.2.4) in documented procedures. * Ensure actions without delay to eliminate detected nonconformities and their causes * Follow- up for verification of actions taken & for reporting results
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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.2 Monitoring & Measurement (Contd.) 8.2.3 Monitoring & Measurement of Processes: a) Apply Monitoring & measurement of processes of the QMS, where applicable b) Demonstrate the ability of processes to achieve planned results. c) Correct and take corrective action, if required

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.2 Monitoring & Measurement (Contd.) 8.2.4 Monitoring & Measurement of Products: a) Monitor & measure the product characteristics (as planned, at appropriate stages) to verify that product requirements are met (7.1) b) Maintain record of evidence of conformity with acceptance criteria c) Indicate person(s) authorizing release of product * Product release & service delivery shall not proceed until the planned arrangements are satisfactorily completed.
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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.3 a) b) c) Control of Non-Conforming Product Ensure to identify & control to prevent unintended use or delivery of non-conforming product(s) Define the controls & related responsibilities & authorities for dealing with non-conforming products Deal with non-conforming products in one or more of following ways : - Take action to eliminate non-conformity - Authorize its use/release/acceptance under concession by an appropriate authority - Take action to preclude its original intended use
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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.3 d) e) f) Control of Non-Conforming Product Maintain records of non-conformities, subsequent actions & concessions obtained Re-verify the corrected non-conformed product to demonstrate its conformity Take action appropriate to the effects/potential effects, when non-conformity of product is detected after its delivery

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.4 Analysis of Data a) Determine, collect & analyze appropriate data b) Demonstrate suitability & effectiveness of QMS and for identifying areas of continual improvement by data analysis * Include data as a result of monitoring and measurement and from other sources

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.5 IMPROVEMENT 8.5.1 Continual Improvement: a) * Continually improve Effectiveness of the QMS Continual improvement shall be facilitated through use of Quality Policy, Quality Objectives, Audit Result, Analysis of Data, Corrective & Preventive actions, Management Review.

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.5 IMPROVEMENT 8.5.2 Corrective Action a) Take action to eliminate the causes of non-conformities to prevent recurrence * Corrective action shall be appropriate to the effects of the non-conformities in terms of magnitude and impact of problems b) Establish a documented procedure to define requirements for reviewing non-conformities, determining causes, evaluating actions taken, results of corrective actions,reviewing corrective actions.
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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8 8.5 IMPROVEMENT(Contd.) 8.5.3 Preventive Action a) Take action to eliminate the causes of potential nonconformities to prevent their occurrence * Preventive actions shall be appropriate to the effects of the potential problems b) Establish a documented procedure to define requirements for determining potential non-conformities, records of action taken, review of actions.

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MEASUREMENT, ANALYSIS & IMPROVEMENT (Contd..) CLAUSE 8

Monitoring & Measurement NonConformities Analysis of Data Improvement

yCustomer Satisfaction yInternal Audit yProcess yProduct

Taking Action to Eliminate/Correc Determine, t the nonCollect & conformity Analyze Appropriate Data

yContinual Improve-ment yCorrective Actions yPreventive Action

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