Quality Systems

ISO 9000 Quality Management System

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• What if there are no standards? • Products and equipments do not fit

and are incompatible• When products meet our

expectations, we take it for granted• We only notice when they do not

meet our expectations

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WHAT IS ISO?

• ISO stands for International Organisation for Standardisation

• World’s largest developer of standards • Standards make trade between countries

easier and fairer • Also used to safeguard consumers, and

users, of products and services

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• ISO - network of national standards institutes of 146 countries, based in Geneva

• ISO from Greek word, isos, meaning “equal”. • Objective to facilitate organisation,

coordination and unification of industrial standards

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• Suppliers can base development on globally accepted specifications

• Customers have a wide choice from competition among suppliers

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• ISO 9000 and ISO 14000 most widely known generic standards

• “generic” - same standards can be applied to any organisation

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• ISO 9000 is concerned with quality management

• ISO 14000 is concerned with environmental management

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• ISO 9000 was developed by ISO Technical Committee(TC) 176 - first published in 1987

• Developed for use in two-party contractual situations and internal auditing

• Universally accepted with worldwide emphasis on quality and adoption by EC

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• In a two-party system, supplier and

customer may end-up with multiple audits• This is replaced by a third party registration

system• Assessment and periodic surveillance audit

of adequacy of supplier’s quality system by a third-party - registrar

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Most organisations found that registration leads to :

• Fewer on-site audits by customers• Increased market share• Improved quality, both internally and externally• Improved product and service quality levels from

suppliers• Greater awareness of quality by employees• A documented formal system• Reduced operating cost

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ISO 9000 series: 1994 version1. ISO 9000 : Quality Management and Quality

Assurance Standards -- Guidelines for Selection and Use.

2. ISO 9001 : Quality Systems -- Model for Quality Assurance in Design, Development, Production, Installation and Servicing. (manufacturing)

3. ISO 9002: Quality Systems -- Model for Quality Assurance in Production, Installation and Servicing.

4. ISO 9003: Quality Systems -- Model for Quality Assurance and Final Inspection and Test. (calibration and testing)

5. ISO 9004 : Quality Management and Quality System Elements -- Guidelines.

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ISO 9000 Series: 2000

ISO 9000: 2000 – Quality Management Systems – Fundamentals and Vocabulary

ISO 9001: 2000 : Quality Management Systems – Requirements

ISO 9004: 2000 : Quality Management Systems – Guidelines for Performance Improvements

The quality management system includes:

• A quality policy- statement describes how organisation approaches quality

• The quality manual – Must address each clause of the ISO 9000 standard.

• Quality objectives-Goals sought or aimed• Quality procedures-Describe step-by-step what the

company does to meet quality policies • Forms, records and so on- provide proof of activities

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• The original standards and1994 revision only required to have a documented, verifiable process

• Can comply with standards and produce poor quality product

• Dissatisfaction resulted in ISO 9001:2000 series.

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Eight Principles for 2000 version

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ISO 9000: 2000 version has been developed based upon 8 principles.

(1)    Customer focus: To understand and satisfy customers requirements and exceed their expectations.

(2)    Leadership: Establishing direction and purpose of organization and creating a supportive working environment.

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3)  Employee Involvement: Ensuring that employees at all levels of the organization take part in quality improving activities.

(4)    Process approach: All work should be done using processes and these processes are to be carefully managed.

(5)    System approach: Management: problems should be solved using system approach, not considering any singular part of the system.

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(6)    Continuous improvement: Recognizing the fact that improvement is not one shot job, continuous improvement of the system of production or service should be the philosophy of the organization.

(7)    Management by facts: Every move, every decision, every action in the organization must be made based upon factual data.

(8)    Supplier partnership: Creating a collaborative business environment for mutual benefit and creating a win-win situation.

• ISO 9000:2000 revision aligns closer to quality management

• Measure customer satisfaction and dissatisfaction• Manage a system of interrelated process• Different from “document what you do”

requirements of earlier version

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Implementation of ISO 9000

• Top management commitment – CEO must be willing to commit resources to get

ISO certification

• Appoint the Management Representative – Responsible for coordinating implementation and

maintenance of quality system

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• Create awareness and exposure • Appoint an Implementation Team drawn from

all levels and areas • Selection of scope for implementation. Top

management to identify the core process • Time schedule for implementation and

registration of system

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• Conduct gap analysis between existing system and requirements of ISO 9000

• Documentation of quality manual, procedures and work instructions

• Internal audit. Identify officers who are trained to conduct audit

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• Management Review. Review conducted in order to determine effectiveness of stated quality goals

• Implementation of ISO 9000– Implement after adequacy audit – Adequacy audit after QMS has been fully documented

• Auditing for registration - recommended certificate if compliance audit conducted and corrective actions taken

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Eg: of ISO 9000 Consultants in Malaysia

• CAI-Oxbridge (Malaysia) Sdn. Bhd.• East Asia Quality Consultants • QPIC Consultants Sdn. Bhd. • Malaysia Institute of Quality Assurance• National Productivity Corporation (NPC)• QAI Sdn. Bhd.

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Internal Audit

• Checks must be made to ensure system is being followed and expected results obtained

• Objectives of internal audit:– Determine actual performance conforms to

documented QMS– Initiate corrective action in response to

deficiencies

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– Follow-up on non-compliance. – Provide continued improvement in system. – Cause auditee to think about process and

therefore encourage possible improvements.

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• Auditing methods– Examination of documents

• Documents examined in a systematic manner, eg: check purchase order if purchases made conform to requirements

– Observation of activities• Eg: observe teaching in classroom

– Interviews

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5.3 Quality policy: (eg: of audit for quality policy)

The mgmt. should ensure the following regarding quality policy:

• It is appropriate to the purpose of the org.• It includes a commitment to comply with

requirements and continuously improve the effectiveness of the QMS

• It is communicated and understood within the organization

EXAMPLE

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Specific tasks:

• The management will establish, document and publicize its policy, objectives and commitment to quality

• the management will designate a representative with authority and responsibility for implementing and maintaining the requirements of the standards

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Management review tasks: 

·    Follow up internal audit findings, especially non-compliances

·             ISO 9000 registrar audits

·             Customer satisfaction survey results

·             Customer complaints

·         Adequacy of existing quality policy and objectives

·         Adequacy of existing documented quality system

·             Cost of poor quality

·             Training needs/issues

·             Organizational structure/ staffing

Auditor’s Questions

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• Who is your management representative? Where is this documented?

• Is there any alternative person in case of absence of the management representative?

• Who reviews the quality system to ensure its continued suitability and effectiveness in satisfying the requirements of ISO 9000 and the company’s stated quality policy and objectives?

• How often does the management review the quality system? How are review findings recorded?

Registration

– Registration bodies registered with MOF and accredited by Dept of Standards• SIRIM QAS International Sdn. Bhd.• Moody International Certification (M)

Sdn. Bhd• CI Certification Malaysia Sdn. Bhd.• SGS (Malaysia) Sdn. Bhd.• RWTUV (Malaysia) Sdn. Bhd.

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• Base selection of registrar on qualification and experience, and certificate recognition

• Eg: SIRIM QAS accredited– Department of Standards Malaysia (DSM)– United Kingdom Accreditation Service (UKAS)

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• Certification is valid for three years• Surveillance audit once in every 12 months• May be suspended or revoked if system is

found not to be satisfactorily maintained

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Begin

Complete and SubmitQuestionnaire to

Registrar

Review QuestionFrom Registrar

Is QuoteAcceptable?

SubmitApplication Form

Submit DocumentedQuality System to

Registrar for Review

Make any necessaryChanges to Documented

Quality System

Plan Pre-assessmentDate (optional)

Pre-assessment Visit(Report issued at

Conclusion)

Plan AssessmentDate

Format Assessment(Report issued at

conclusion)

RegistrationRecommended

First SurveillanceVisit

SurveillanceCycles Begin

Yes

No

Yes

No

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Issues in ISO

(i) The major issue in ISO 9000 is document (or manual) preparation

(ii) Analyze the trade-off between cost and benefit

(iii) ISO 9000 may be redundant in a mature total quality environment

• Gaining a market advantage is the wrong motivation for adopting ISO 9000

• ISO registration is usually applied to a unit of the company

• ISO registration is more popular in Europe

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6. Resource Management

4. QMS Continual Improvement

8. Measurement Analysis and Improvement

7. Product Realization

5. Management Responsibility

OutputProductInput

Requirements

CustomerSatisfaction