What is Quality ?
Quality is a state of mind and can be delivered better by people who are having fun than by people who live dull, regulated lives surrounded by slogan and exhortations.
Quality means satisfying the customer. According to TQM, the quality is totally defined by the customer’s perceptions. It doesn’t matter what we think, it matters what our customers think, and the customers’ perceptions are constantly changing. It is up to us to make sure our organization is fast and flexible enough to respond to their demand of better products/services.
Quality management, as specified in ISO-9000, is about managing our organization with the objective of satisfying our customers’ needs.
According to Arnold Fiegenbaum (consultant), the cost of correcting mistakes can easily be 15 to 40 % of the plant’s productivity.
What is ISO-9000?
ISO-9000 is the generic name used to describe the International Standard Organization (ISO) 9000 series of management system standards. The peak standard of ISO-9000 series is ISO-9001, which is titled ‘Quality Systems—Model for quality assurance in design/development, production, installation and servicing’. This is the standard to which an organization can be certificated for the design, develop- ment, installation, and maintenance of products and services (e.g., software development, operation, and support) [Jenner, Michael G.].
ISO-9001: is known by different names in different countries as shown below.
• ANSI/ASQC ISO-9001 in USA
• EN ISO-9001 in Europe
• BS/EN ISO-9001 in the UK
• AS/NZS ISO-9001 in New Zealand and Australia
• SS ISO-9001 in Singapore ISO-9002
• For organizations that do not do their own design.
• Titled ‘Quality Systems—Model for quality assurance in production, installation and servic- ing’.
ISO-9003
• Titled ‘Quality Systems—Model for quality assurance in final inspection and test’.
• This is used by organizations that perform final inspection and testing of products purchased from external suppliers.
ISO-9000.3
• Titled ‘Quality Management and Quality System elements—Guidelines for development, supply and maintenance of software’.
• Is a guideline on the use of ISO-9001 in computer software development.
ISO-9004.2
• Titled ‘Quality management and quality system elements—Guidelines for services’.
• Is a guideline on the application of ISO-9001 and ISO-9002 to services. An organization cannot be certificated to ISO-9004.2 and it is not used during the certification process.
• This can be applied to the following:
n Hospitality services: catering, hotels, tourist services, entertainments, radio, TV, etc.
n Communications: airports, airlines, roads, rail, sea transport, telecommunications, post office, etc.
n Health: medical practitioners, hospitals, ambulances, medical labs, dentists, opticians, etc.
n Maintenance: electrical, mechanical, vehicles, heating systems, air-conditioning, building, computer.
n Utilities: cleansing, waste management, water supply, grounds maintenance, electricity, gas and energy supply, fire, police, public services, etc.
n Trading: wholesale, retail, stockist, distributor, marketing, packaging.
n Financial: banking, insurance, pensions, property services, accounting.
n Professional: architecture, surveying, legal, law enforcement, security, education, engineering, quality management, etc.
n Administration: personnel, computing, office services, etc.
n Technical: consultancy, photography, test labs, etc.
n Scientific: research, development, studies, decision aids, etc.
ISO-9004.4
‘Guidelines for quality improvement’ provides a concise reference source for information and tech- nique relating to quality improvement.
ISO-10011
‘Guidelines for auditing quality systems’ is a valuable guide for internal auditors.
ISO-10013
‘Guidelines for developing quality manuals’
ISO-9126
‘Information technology—software product evaluation—quality characteristics and guidelines for their use’, defines the terminology to be used as the basis for software quality metrics.
Why ISO-9001 ?
Because it provides a clear way to structure your operation to empower your people, reduce paperwork and bureaucracy, constantly delight your customers, and survive in business over the long term.
Benefits of implementing an ISO-9000 based system can be two folds: (i) Financial, and (ii) Personal.
• Staff and customers are more satisfied because the services provided are close to customers’
needs.
• We can achieve significant savings from satisfied customers. With our improved reputation and credibility, we can offer our services at premium prices.
• We will find ourselves being taken seriously when the prestigious contracts are being bid. In fact, being certified to international quality management standard is increasingly a prerequi- site for bidders on Government and industry contracts worldwide.
• Indirect benefits include improved staff motivation and reduced management frustration.
• Winning more work-orders with less efforts due to enhanced credibility.
• Increase profitability due to better products at lower costs.
What does ISO stand for? Where is it situated?
ISO stands for International organization for Standardization. It has it’s head office at Geneva, Switzer- land and it comprises National Standard Bodies of 91 countries including India.
How does ISO-9000 emerge?
Over the past two decades it has been felt by big companies that there should be some efficient ways of assuring reliable product quality in advance of delivery rather than waiting to find the failures when it might be too late. As a result in early 70s many companies started specifying their own QA Standards to their suppliers. But this was not found economical by suppliers and the customers requirements were not consistently met.
Thus thinking developed to formulate a set of uniform Standards, on Quality systems and Qual- ity management, which if implemented could satisfy all the customers. The UK and Canada took the lead and the success of these standards became known in other countries. The ISO then prepared a Standard in the form of ISO-9000 series of Standards.
What are ISO-9000 standards?
ISO-9000 Standards are the contractual, functional and technical requirements for all quality activities to ensure that a product, process, service or system is fit for it’s intended purposes. It was developed in 1987.
What is it’s Indian equivalent?
It’s Indian equivalent is IS-14000.
How many standards are there in ISO-9000 series?
ISO-9000 Series has 5 standards, viz;
ISO-9000 ISO-9001 ISO-9002 ISO-9003 ISO-9004
What are the applications of each standard?
ISO-9000: provides guidelines for selection in use of a series of ISO-9001, ISO-9002, ISO-9003, and ISO-9004. This standard, therefore, is not to be used for contractual purposes.
ISO-9001: This is for use when the contract specially requires that the supplier assure quality throughout the whole cycle from the Design through Production, installation and Servicing.
ISO-9002: This is for use when the specified requirements for products are stated in terms of an already established design or specification.
ISO -9003: This is applicable in a situation where only the Suppliers’ capabilities for inspection and tests (conducted on products as supplied) can be satisfactorily demonstrated. This standard is for contractual use.
ISO-9004: This is for internal use which describes a basic set of quality system e1ements which help to develop a sound and comprehensive quality management system.
What are the ingredients of a quality system?
The ingredients are:
• Clearly defined responsibilities and authority.
• Documented procedures, Instructions and controls.
• Knowledge and understanding of responsibilities, authority, procedures and instructions.
• Correct operation of procedures by the authorized and responsible personnel.
• Adequacy of personnel, equipment, facilities and general resources.
• Effectiveness of the system when correctly operated.
What type of systems are required?
ISO-9000 requires a documented quality system comprising the following:
• A policy document mentioning the Company’s intention to ensure that the system exists and to guarantee consistent product quality.
• Operating procedures which are instructions on equipment operation, Inspection and tests, documentation, etc.
• Specific instructions relating to particular contracts which include drawings, specific test procedures, quality plans etc.
What are the quality system requirements specified by the Standard ? The standard specifies 20 sections of quality systems requirements. They are:
Management Responsibility
Requires that quality Policy defined, documented and communicated throughout the organization; that responsibility regarding quality be clearly defined; that in-house resources are available for verification activities; that the management representatives be appointed to ensure quality system requirements are being met; and that the management representative lead a management review periodically to ensure the continuing suitability and effectiveness of the quality system.
Quality System
Requires a quality system that meets the criteria of the applicable ISO-9000 Series standard be estab- lished and maintained (documented as a quality system manual and implemented) as a means of ensur- ing that product conforms to requirements.
Contract Review
Requires review of contracts to ensure requirements are adequately defined and to ensure the capability exists to meet the requirements.
Design Control
Requires procedures for controlling and verifying product design to ensure that specified requirements are being met and to include procedures for design/development planning, design input/output, design verification, and design changes.
Document Control
Requires establishing and maintaining procedures for controlling documentation through approval, issue, change. and modification.
Purchasing
Requires that purchased products conform to specified requirements; ensure through subcontractor assessments, clear & accurate purchasing-data, and verification of purchased product.
Purchaser-Supplied Product
Requires procedures for verification, storage and maintenance of purchaser product.
Product Identification and Traceability
Requires procedures for identifying a product during all stages of production, delivery and installation, and individual product or batch-unique identification as needed.
Process Control
Requires procedures to ensure that production and installation processes are carried out under control- led conditions which include documentation, monitoring and control of suitable process and product characteristics, use of approved equipment, criteria for workmanship.
Inspection and Testing
Requires that procedures for inspection and test at receiving in process, and final stations be in place as documented in quality plan; must include maintenance of records and deposition of product.
Inspection, Measuring and Test Equipment
Requires procedures for selection, control, calibration and maintenance of measuring and test equip- ment.
Inspection and Test Status
Requires that marking, stamps or labels be affixed to product throughout production and installation to show conformance ,or nonconformance to tests and inspections.
Control of Nonconforming product
Requires control of nonconforming product to ensure it is not inadvertently used; includes identifica- tion, segregation and evaluation.
Corrective Action
Requires procedures for investigation of causes of nonconformance, taking action to rectify them, and creating controls to prevent future occurrence.
Handling, Storage, Packaging and Delivery
Requires procedures for handling, storage, packaging and delivery of product.
Quality Records
Requires procedures of identification, collection, indexing, filing and storage of quality records.
Internal Quality Audits
Requires a system of internal audits to verify whether quality activities comply with requirements and to determine the effectiveness of the quality system.
Training
Requires procedures for identifying training needs and providing for all personnel to meet those needs.
Servicing
Requires procedures for performing servicing as required by contract.
Statistical Techniques
Requires procedures for identifying the use of statistical techniques in process, product and service.
What are the elements of the total documentation for a Comprehensive quality system?
There are four elements namely:
• Quality policy, Organization structure for Quality, Responsibility and authority for quality across the Company.
• Quality Procedures.
• Work Instructions.
• Forms -Records -other documents.
What comprises a quality management system ‘documentation’ ? It comprises a quality manual and procedures.
What is a quality manual?
It is a document which communicates the quality policy and objectives of the company to its staff and customers and outlines the Organisation Structure, the responsibilities and authorities for quality across the entire Company functions and documentation of activities undertaken to ensure a consistent ap- proach to meet the specified quality goal. It is the foundation of the quality systems which should be acceptable by all. It contains quality procedures detailing the working practices in all the primary areas affecting quality and ensure that consistency in quality is achieved in these activities.
What is the purpose of a ‘quality manual’ ?
The purpose of this is to communicate the quality policy and objectives of the Management of a Com- pany to its staff and customers and provide guidelines for consistent approach to meet the specified quality goals.
What does it explain?
It explains the manner in which the company intends to comply with the Standards say, in terms of direction, listing responsibilities and authorities and documenting the activities, to ensure a consistent approach.
What is an assessment of a ‘manufacturer’s quality system’ ?
It is a formal appraisal to establish whether or not the system meets the criteria laid down in the quality system standard ISO-9000.
What is involved in the ‘assessment process’ ?
It involves a documentation review and physical checking to see if the quality management system (a) exists (b) is correctly operated and maintained and (c) is effective.
What does the assessment process look for ?
It looks to see whether the quality system is being correctly managed.
Is ISO-9000 only for an external assurance?
No, it is for both external quality assurance and the development of an internal quality system?
Who are the certifying agencies country wise ?
• Bureau Veritas Quality International, UK
• Intertek, USA
• Vincotte, USA
• AT & T’s Quality Registrar, USA
• Lloyd’s Register Q.A, USA
• ABS Quality Evaluations, UK Which are the consulting agencies in India?
• CII
• Lloyd’s Register Q.A.
• ABS Quality Evaluations.
Which are the Indian companies currently under the ISO certification?
n M/s. Sundram Fasteners, Madras
n M/s. Kirloskar Cummins Ltd, Pune
n M/s Ralliwolf Ltd, Mumbai
n M/s Kirloskar Brothers, Pune
n M/s Widia Industries, Bangalore
What must be ensured before calling a ‘third party certification body’ for an assessment of a manufacturer’s quality system ?
The quality system must be allowed to run for a sufficient period of time. Procedures and work instruc- tion must be available at the time of assessment. Management must ensure that the Company has been operating in the desired manner for a sufficiently high period of time to demonstrate that they can be effective.
Is this period same for all companies?
No, it varies from Company to Company.
What does this period ensure?
This period ensures that the system has become routine and its effectiveness has been reviewed.
Before a formal assessment, what should be done ?
The system should be internally audited prior to the formal assessment.
What is the certification maintenance procedure?
(a) Certification to be renewed every 3 years.
(b) System assessment by the certifying agency every 6 months.
In case of withdrawal of registration, the name of the company will be published in various publication media.
Why do we need ISO-9000 ?
• For export to European Countries.
• Other importing Countries may also like to align with the E.C. Requirements.
• ISO-9000 Standards may be asked for Self-Certification by Govt. of India.
• Domestic market may also require certification to this Standard.
• Strengthen System Discipline, which will help in the overall quality, leading towards World- class Quality.
What are some of ISO-9000 standard’s advantages?
It ensures product interchangeability, reduces quality costs and other costs, and provides opportunity for evaluating supplier’s goods and services consistently and uniformly regardless of the location of the supplier.
What are the benefits of the ISO-9000 standards?
• ISO-9000 Standards have universal acceptance.
• The supplier audits are fewer and have more focus.
• Easier, faster and more comprehensive learning, resulting in increased productivity and quality.
• Giving rise to better market sales.
What are some of the short-comings of the ISO-9000 standards ?
• It does not tell a Company how to document the Quality System.
• It does not specify what makes up an adequate quality policy.
• It does not mention or make provision for continuous improvement.
• It requires no evidence of a satisfactory track record of performance.
• It doesn’t differentiate suppliers with respect to their Industry base, their Company size and what portion of the Company is being registered.
Is ISO-9000 ultimate in the road to quality?
No, it should be seen only as a first step in continuing improvement.
Is adherence to ISO-9000 standards sufficient to do business with Europe after 1992 ? Not necessarily. The customer requirement may be more than the general application of the ISO-9000 Standards.
What is the requirement for world class quality?
We have to go much beyond ISO-9000 Standards, and look at continuous quality improvement and customer satisfaction.
Understanding ISO and ISO 9000
ISO is a nickname—not an acronym—for the International Organization for Standardization which facilitates the creation and voluntary adoption of world wide industrial and manufacturing standards.
This international body developed the ISO 9000 Standards to ensure that products and services of member countries secure global acceptance.
ISO 9000 is a written set of standards which describe and define the basic elements of the quality system needed to ensure that an organization’s products and/or services meet or exceed cus- tomer needs and expectations. The implementation of the standards will help ensure that products and services that are produced meet the required specifications on a continuous basis.