ISO 9001: 2000 CLAUSES

4.0 QUALITY MANAGEMENT SYSTEM :

4.1 GENERAL REQUIREMENT :
- Identification of processes
- Sequence & interaction of these processes
- Criteria & methods for effective operations & control
- Information availability
- Measurement, monitoring & analysis of processes
- Continual improvement
4.2 DOCUMENTATION REQUIREMENT :

4.2.1 GENERAL :
- Quality policy & quality objectives
- Quality Manual
- Documents needed by organization to ensure effective planning,
operation & control of its processes.
- Records required by this international standards.

The extent of QMS documentation will be a function of

- Size & type of organization
- Complexity & interaction of processes
- Competence of personnel
Document can be in any media
4.2.2 QUALITY MANUAL :
It includes,
- Scope of QMS
- Exclusion & justifications
- Sequence & interaction of processes of QMS
4.2.3 CONTROL OF DOCUMENTS :
Documented procedure shall be established to ;
- Approve the documents for adequacy
- Review, update & re-approve documents.
- Identify the current revision status of documents

- Ensure that relevant versions of applicable documents are available

at point of use.
- Ensure documents remain legible, readily identifiable & retrievable
- Ensure that external origin documents are identified & controlled.
- Prevent unintended use of obsolete documents, their method of
identification & retention.

4.2.4 CONTROL OF RECORDS :

Documented Procedure to ensure system for ;
- Controlling
- Identification
- Storage
- Retrieval
- Protection
- Retention time
- Disposal

5 MANAGEMENT RESPONSIBILITY :
5.1 MANAGEMENT COMMITTMENT :
- Communicating to the organization the importance of meeting customer
requirements, regulatory & legal requirements
- Establishing the quality policy
- Ensuring quality objectives are established
- Conducting management reviews
- Ensuring availability of resources
5.2 CUSTOMER FOCUS :
Customer needs & expectations
Customer Requirements
Customer Satisfaction


5.3 QUALITY POLICY :

To ensure that Quality policy has following features ;

- Appropriate to the purpose of the organization
- Commitment to meet requirements & continually improve
the effectiveness of the QMS
- Should provide frame work for establishing & reviewing objectives
- Is communicated & understood within the organization
- Is reviewed for continuing suitability
5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
Including those needed to meet product requirements - should be
- Measurable
- Consistent with the quality policy
- Quality objectives shall be established at relevant functions and levels
within the organization

5.4.2 QMS PLANNING :

Planning of QMS is carried out in order to meet the ;
- Requirements of 4.1 & Controlling
- Quality objectives
- Integrity of QMS is maintained during the changes to the QMS
5.5.1 RESPONSIBILITY , AUTHORITY & COMMUNICATION
Top management shall ensure that responsibilities and
authorities are :
- Defined & Communicated
5.5.2 MANAGEMENT REPRESENTATIVE :
Shall have the responsibility & authority for :
- reporting the performance of QMS to top Management
- reporting any need for improvement
- promoting awareness of customer requirements
- external liasions pertaining to QMS

5.5.3 INTERNAL COMMUNICATION :

Internal communication between various levels & functions of QMS
5.6. MANAGEMENT REVIEW :
5.6.1 GENERAL :
Review to QMS includes,
- Ensure continuing suitability, adequacy & effectiveness
- Opportunity for improvements
- Evaluate the need for changes in QMS including Quality Policy &
Quality Objectives
- Done at planned intervals
- Record shall be maintained.
5.6.2 MANAGEMENT REVIEW INPUT :
- Audit results
- Customer feedback
- Process performance & product conformity
- Corrective & Preventive Action status
- Follow up actions from earlier review
- Change affecting QMS.
- Recommendations for improvement

5.6.3 MANAGEMENT REVIEW OUTPUT :

- Improvement of the effectiveness of QMS & its processes
- Improvement of product related to customer requirement
- Resource needs.
6
6.1

RESOURCE MANAGEMENT :
PROVISION OF RESOURCE :
Organization shall determine and provide resource
- To implement and maintain QMS
- To continually improve its effectiveness
- To enhance customer satisfaction

6.2
HUMAN RESOURCES :
6.2.1 GENERAL :
Personnel performing work affecting quality shall be Competent
on the basis of appropriate,
- Education
- Experience
- Training
- Skills

6.2.2 COMPETENCE, AWARENESS & TRAINING :

Organization shall ensure,
- determine the necessary competence for personnel performing
work affecting product quality
- Provide training or take actions to satisfy these needs
- Evaluate the effectiveness of actions taken
- Employee awareness regarding relevance & importance of their
activities & their contribution to quality objectives.
- Maintain records of education, training, experience & qualification
6.3

INFRASTRUCTURE :
Infrastructure includes, as applicable
- Buildings, workspace & associated utilities
- Process equipments
- Supporting services - transport, communications

6.4

WORK ENVIRONMENT :

Organization shall determine & manage the work environment needed

to achieve the conformity to product requirement.

PRODUCT REALIZATION :

7.1 PLANNING OF PRODUCT REALIZATION :

It includes,
- Quality objectives and requirements for the product
- Need to establish processes, documents & provide resources
- Verification, validation, monitoring, inspection & test activities specific
to product
- Criteria for product acceptance
- Records
7.2 CUSTOMER RELATED PROCESSES :
7.2.1 DETERMINATION OF REQUIREMENT RELATED TO PRODUCT :
- Product requirement specified by customer
- Product requirement not specified by customer
- Statutory & regulatory requirement
7.2.2

REVIEW OF REQUIREMENTS RELATED TO PRODUCT :

- Review of customer requirements(submission of tender, acceptance
of order)
- Dissolving of differences
- Capability to meet customer requirements

Records of review to be maintained.

Amendment to contract to be communicated to concerned.
7.2.3 CUSTOMER COMMUNICATION :
Effective arrangement for customer communication relating to ;
- Product information
- Enquiries, contract or order handling including amendments
- Customer feedback, including complaints
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7

DESIGN & DEVELOPMENT :

D&D PLANNING :
D&D INPUTS :
D&D OUTPUTS :
D&D REVIEW :
D&D VERIFICATION :
D&D VALIDATION :
D&D CHANGE :

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7.4 PURCHASING :
7.4.1 PURCHASING PROCESS :
- Purchase product confirm to specified requirements
- Type & extent of Control
- Evaluation & selection of suppliers
- Records of evaluation
7.4.2 PURCHASING INFORMATION :
It shall describe the product to be purchased, where appropriate ;
requirement of approval of :
- product
- Procedure
- Processes
- Equipments
- Personnel qualification
- QMS requirements
Ensure adequacy of requirement before release

.
7.4.3 VERIFICATION OF PURCHASED PRODUCT :
- System for inspection activities for suitable verification of purchased
product
- When verification is performed at supplier premises - verification
arrangement methods of product release should be part of purchasing
information.
7.5 PRODUCTION & SERVICE PROVISION :
7.5.1 CONTROL OF PRODUCTION & SERVICE PROVISION :
Production & service provision under controlled conditions :
- Availability of information specifying product characteristics
- Availability of work instructions, as necessary
- Usage of suitable equipments
- Availability & use of monitoring & measuring devices
- Implementation of monitoring & measuring activities
- Implementation of defined processes for release, delivery & post
delivery activities

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7.5.2 VALIDATION OF PROCESS FOR PRODUCTION & SERVICE
PROVISION :
Validation of process is required where :
- Resulting output can not be verified by subsequent monitoring &
measurement.
- The deficiencies may become apparent only after the product is in
use or service has been delivered.
Validation shall demonstrate the ability to achieve planned results.
7.5.3 IDENTIFICATION & TRACEABILITY :
- Identification of product
- Identification of status of product
- Where traceability is a requirement, system for controlling &
recording of unique identity
7.5.4 CUSTOMER PROPERTY :
- Identification, verification, protection & maintenance of customer
property when provided for use in incorporation in to product

- Recording & reporting of loss or damage

- Customer property may include intellectual property
7.5.5 PRESERVATION OF PRODUCT :
- System for identification, handing, packaging, storage & protection
- Preservation also applies to constituent part of the product
7.6

CONTROL OF MONITORING & MEASURING DEVICES :

- Identification of devices for product conformity
- Control of devices to ensure consistency of measurement capability
with measured requirement.
- Where necessary to ensure valid results, the measuring equipments :
- Shall be calibrated
- Calibration status to identified
- Safeguarded, protected for damage & deterioration
- Calibration records to be maintained
- Assessment of results if out of calibration
- Software used shall be validate/confirmed before use.

8
8.1

MEASUREMENT, ANALYSIS & IMPROVEMENT :

GENERAL :
- To demonstrate conformity of the product
- To ensure conformity of QMS
- To continually improve effectiveness of QMS

Use of applicable statistical techniques

8.2
MONITORING & MEASUREMENT :
8.2.1 CUSTOMER SATISFACTION :
- Monitor information related to customer perception to determine
whether the organization has met customer requirements.
- One of the evaluation criteria for measurement of QMS performance
8.2.2 INTERNAL AUDIT :
System for ;
- Periodic audits
- Planned audit program
- Defined audit scope, frequency & methodology
- Auditors independence
- Conducting audits
- Audit results & reporting
- Corrective Preventive Actions
- Follow up & closing

8.2.3

MONITORING & MEASUREMNT OF PROCESS :

- Monitoring & where applicable measurement of QMS processes
- When planned results not achieved - correction & corrective actions
shall be taken to ensure conformity of product.

8.2.4

MONITORING & MEASUREMENT OF PRODUCT :

- Verification of product characteristics by measurement & monitoring
- Acceptance criteria & products conformity to acceptance criteria
should be recorded.
- Authorization for release of product
- Product release & service delivery shall not proceed till planned
arrangements are fulfilled, unless otherwise approved by relevant
authority or customer.

8.3

CONTROL OF NON-CONFORMING PRODUCT :

- Identification of non-conforming product
- Control to prevent unintended use
- Dealing non-conforming product by :
- Taking action to eliminate non-conformity, authorising use, release
or acceptance by authority or by customer.
- To preclude its original intended use
- Record of NC product to be maintained.

8.4

ANALYSIS OF DATA :
The analysis of data shall provide information related to ;
- Customer satisfaction
- Conformity to product requirement
- Characteristics & trends of processes & products
- Suppliers
8.5
IMPROVEMENTS :
8.5.1 CONTINUAL IMPROVEMENT :
Continually improve the effectiveness of QMS through the use of
- Quality Policy
- Quality Objectives
- Audit results
- Analysis of data
- Corrective & preventive actions
- Management review
8.5.2 CORRECTIVE ACTION :
Documented procedure shall be established to define requirement for ;
- Reviewing non-conformities (including customer complaints)
- Cause of non-conformities
- Evaluating the needs for action to ensure that non-conformities do not
re-occur
- Implementing actions needed.

8.5.3

PREVENTIVE ACTION :
Documented procedure shall be established to define requirement for ;
- Determine potential non-conformities & their causes
- Evaluating the needs for action to prevent occurrence of non-conformity
- Determining & implementing actions needed.
- Records of results of actions taken.
- Reviewing preventive actions taken.