Recovered Power Point 1

8/8/2019 Recovered Power Point 1

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Quality Management System


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Ch apter XXII Quality Mgt. System.

A. Introduction: Changes and improvements cannot beconsolidated in the absence of a proper system in theorganisation.

ISO 9000 : 2000 standards force the organisation toevolve a system for managing quality in the organisation.ISO 9001 :2000 calls for documentation of quality policyand its wide circulation in the org.

All the employees must be educated in knowing themeaning of quality policy statement of the CEO.


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ISO 9001 : 2000 standards, if implemented in truespirit, will help organisations to be managed efficientlyand effectively. These standards help the org. to establish a

documented system, which will not give rise to differentinterpretations by different employees.

The first step towards attaining Total Quality

Management (TQM ) is getting certified by an independentcertifying body for ISO 9001 : 2000 standards.


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B . W h at is ISO ? ISO is the abbreviation for International Organisation for Standardisation, withheadquarters in Geneva , Switzerland. Most countries aremembers of this organisation.

ISO is engaged in formulating standardspecifications in a variety of disciplines like QualityManagement, Information Technology, Metrology etc.

ISO has published many standards. One of the mostacclaimed standards worldwide is the ISO 9000 family of standards.


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The first edition of ISO 9000 series of standards( ISO 9001 , ISO 9002 , ISO 9003 and ISO 9004) was

prepared in 1987 and revised in 1994. The third edition of ISO 9001 : 2000 has cancelled and replaced the secondedition ( ISO 9001 : 1994 ), together with ISO 9002 : 1994and ISO 9003 : 1994.

Those organisations, which were usingISO 9002: 1994 and ISO 9003 : 1994, should use thisstandard, by excluding certain requirements.

The quality management principles stated inISO 9004 were taken into account, during the development

of ISO 9001 : 2000.


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C . B enefits of ISO 9001 : 2000 C ertification:

1) This certification has been made the minimumrequirement by many customers;

2) It is a status symbol for the organisation;

3) It improves the morale of the employees, because of improvement in the system;

4) The customers get the benefits directly, because of better products and services;

5) The suppliers get to know the exact requirements;


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6 ) The organisation benefits, because every contract has to be reviewed before acceptance. This reduces waste; and

7) Since the certification is targeted towards practicingTotal Quality Management (TQM ), the organisation

becomes healthy and prosperous in the long run.


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D . Process Approac h :The standard promotes the adoption of a process

approach for developing, implementing and improving theeffectiveness of the quality management system, and for enhancing customer satisfaction by meeting hisrequirements.

The advantages of process approach are:1) Understanding and meeting customer requirements.2) The need to consider processes in terms of added value.3) Obtaining results of process performance andeffectiveness.4) Continuous improvement of processes based onobjective measurements.


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E . ISO 9001 : 2000 Requirements:ISO 9001:2000 aims at customer satisfaction through

quality assurance and is supported by another standard ISO9004 ; 2000 to give guidance in understanding it.

The various requirements of the standard are:

1) C lause 4 --- Quality Mgt. System --- The purpose of this clause is to ensure that the org. adopts the processapproach to establish, document, implement and maintainits QMS and continuously improve its effectiveness.

Clause 4.2.2 requires the org. to ensure establishingand maintaining Quality Mgt.System Manual, whichshould include scope of areas of activities of the org. ;details of exclusions (design, customer property, product

traceability, and outsourced processes) ;


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Cross reference to documented procedures and descriptionof the interaction between identified processes ;Clause 4.2.3 requires control of all QMS documents andclause 4.2.4 control of all records.

2) C lause 5--- Management Responsibility --- The topmgt. must be visibly committed to a quality mgt. system by:

a) Communicating to the org. the importance of meeting thecustomer as well as statutory and regulatory requirements;

b) Establishing and propagating a Quality Policy;

c) Ensuring that the quality objectives are established;


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d) Conducting mgt. review meetings; ande) Ensuring availability of resources.

Clause 5.5 requires that the responsibilities andauthorities are defined and communicated within theorganisation.

Clause 5.5.2 makes it mandatory to appoint a Management Representative from among the members of the mgt., who should coordinate the various requirementsof the QMS.

Clause 5. 6 requires regular review of the QMS bythe top mgt.


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3 ) C lause 6--- Resource Management --- To ensure thatthe org. determines and provides all the needed resources( human, infrastructure and work environment) needed to:

a) Implement and maintain the QMS and continuouslyimprove its effectiveness; and

b) Enhance customer satisfaction by meeting hisrequirements.

The work environment refers to factors such aslayout, facilities, social environment, comfortable and safeworking conditions, cleanliness and hygiene, control of

pollution etc.


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4) C lause 7---Product Realisation ---To ensure that planning covers all aspects of process development, quality

objectives, resource mobilisation, documentation etc.

The following are to be decided by the organisation:a) Requirements for the product;

b) Provide resources specific for the product;

c) Required verification, validation, monitoring, inspection

and test activities specific to the product and the criteria for product acceptance; and

(d) Records needed to provide evidence that the realisation

processes and resulting product meet requirements.


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This includes:Customer Communication ( cl.7. 2.3);

Design and Development ( cl.7. 3);

Purchasing (cl.7.4), including verification of purchased product ( cl.7. 4.3);

Production and service provision ( cl. 7.5), includingcustomer property ( cl.7.5.4), and control of monitoringand measuring devices (also called calibration---cl.7. 6 ).


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5) C lause 8- Measurement, Analysis and Improvement --The org. should plan and implement the monitoring,

measurement, analysis and improvement processes neededto:a) Demonstrate conformity of the product;

b) Ensure conformity of the QMS; and

c) Continuously improve the effectiveness of the QMS.

This clause refers to: Customer perception or satisfaction ( cl.8.2.1);

Internal Audit ( cl.8.2.2 );Monitoring and measurement of processes and products( cl.8.2.3 & 8.2.4);Control of nonconforming product (cl.8.3); and

ImprovementCorrective and Preventive action( cl.8.5)


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F . Auditing t h e Quality Mgt. System:

1. Quality Audit: A quality audit is a systematic,independent and documented process of examining anyactivity of an org. based on objective evidence, to examine:

a) The extent to which quality activities and related resultscomply with the planned arrangements;

b) The extent to which these arrangements have been

implemented effectively; and

c) Whether these arrangements are suitable to achieve thequality objectives.


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2.Adequacy Audit vs. C ompliance Audit: Adequacy Audit is the process of comparing the QMS

manual against the requirements of ISO 9001:2000, toensure that the manual has satisfactorily addressed all therequirements of the standard and meets these requirementsin full.

Unless the QMS manual passes an adequacy audit,no certifying agency will proceed further.

C ompliance Audit is the process of checking whether the org. has implemented what they have stated.


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3 . Types of Audit:a) F irst party audit or Self-audit or Internal audit --- Carriedout by employees of the org. to examine its own QMS.

b) Second party audit or audit by customers ---Carried out by customer on the org. or by the org. on the suppliers .

c) Third party audit or External audit --- Carried out by anexternal independent agency to assess compliance, usuallyfor the purpose of certification.


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4. Internal Audit:An audit should have a positive approach with the

objective of F inding facts rather than faults. H owever, inthe case of internal audit, where the primary goal isC orrection and Improvement, the more faults found, themore the corrections and the greater the compliance.

These audits must be conducted regularly inaccordance with the audit plan and as per schedules

prepared each time for the audit.


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4.1 Requirements for Internal Audit:

a) Plan --- The audit plan is a formal document, whichcovers every area, process and department for the auditactivity. It is normally prepared for a full year and specifiesthe following:

(i) The area, process or dept. to be audited;(ii) The frequency of audit---as a good practice, every area,

process or dept. should be audited at least once every year;

(iii) The qualification of the auditors---the standardrequires they should be trained suitably;(iv) The procedure to be followed; and

(v) The method of reporting the audit findings.


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b) Timing --- The best time to audit is when people are busy. H owever, the convenience of the auditee is essential

and their readiness and concurrence should be obtained before proceeding with the audit.

c) Sc h edule --- The audit schedule is a document that gives

details of the area, process or dept. to be audited during thescheduled audit. It also specifies the following:

(i) The dates of the audit;

(ii) The names of the auditors and the corresponding auditeearea, process or dept.; and(iii) The provision for acceptance of the scheduled audit byeach auditor and auditee in token of accepting convenience

and readiness for the audit on the scheduled date.


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d) Internal Auditors ---Internal auditors are employeesfrom within the organisation, who have been trained toconduct the audits. The most important precaution to betaken is to ensure that people do not their own work ( toavoid bias).

e) Ch ecklist --- Checklists are a methodical way of ensuring that all necessary areas are audited. The auditorsshould adopt a flexible approach and use their own

judgement to deviate, if necessary.

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