ISO- Effective Quality Implementation Tool
Mr.Sohan S.Chitlange
ISO is “International organization for standardization”. Need of ISO 9001; 2000 certification is for competitive advantage, to improve customer demand, to protect business, for new prospects, for easy and cost effectiveness, quality for government contracts, increased creatibility and to develop new customers.
Preparation of policy and procedures manuals, their implementation, i.e., it say what you do and do what you say’’ are necessary for achieving certification of ISO 9001; 2000.
The advantages of ISO certification are better product design, to improve product quality and credibility, efficient utilization of men, machines and materials resulting in higher productivity, creation of quality, awareness and greater jog satisfaction among employees, improving the company’s quality culture, reduction in scrap, rework and customer complaints and it also inspires confidence in existing / potential customer that company is capable of delivering quality goods and services.
Meaning of ISO 1,2
Because “International organization for standardization “would have differs abbreviations in different languages (IOS in English, ‘OIN ‘in French for organization internationale de normalisation), it was decided at the outset to use a word derived from the Greek isos, meaning ‘equal ‘. Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO.
What is ISO 9000? 1, 3
The international standard organization represented by association of 91 countries including India give thrust on quality systems and well knitted procedures for stringent quality standards to the manufacture on quality systems and management. This series of specification are commonly known ISO 9000.ISO 9000 is covered standard not only for the quality of product but also foe the systematic planning and management of organization as a whole. ISO has its headquarter in Geneva and outline 20 areas for quality systems, which range from recruiting and training of personnel to handling of stores and finished products.
The International organization for standards has issued models for such systems in its ISO 9000series of standards. They cover the key areas of management quality policy and leadership, market research, packing, sales and distribution, storage, after-sales service, design control, purchasing, purchaser’s supplied product, product identification and traceability, process control inspection and handling, testing, inspection and measuring testing department, packing and delivery, quality control, internal audit, training, service and statistical techniques.
What is ISO 9001:2000? 1, 3
ISO 9001; 2000 is an international standard against which your company’s quality management system can be measured independent for any specific industry or economic sector. It can also used as guide to enhance your company’s existing quality management system according to an internationally recognized set of requirements. The ISO 9001 system is indented to improve customer satisfaction, reduce the costs of poor quality and improve process efficiency and effectiveness.
Over 500000 organizations worldwide are registered to iISO9000 and at least 1400000 organizations are compliant with the standard or one of the derivative standards
The 2000 revision adds some new requirements. Among them a process approach to quality management, monitoring customer satisfaction, is setting quality objectives and continuous improvement.
What is ISO 14000? 1, 3
ISO 14000 environmental management systems are helping organization to all type s to improve their environmental performance at the same time as making a positive impact on business results.
What is ISO 9001: 2000 Compliance? 3
ISO 9000 compliance simply means that a company has completed their documentation and is in the process of implementing the ISO 9001; 2000 standards throughout their organization. Many companies will do business with compliant company just as if it was already registered; because they know that it can take as long as a year or more to archive full registration. Many firms will consider you to be compliant as soon as your policy manual is finished, and other will require that both your policy and procedure manuals are complete. In either case, compliance can bring many of benefit of ISO registration to companies who have started their ISO 9001; 2000 project.
To Whom it is Applicable? 1,3
Even a small company having a few employees may opt for ISO 9000 certification. These is no stipulation in this regards as to the size of the company
1. To all manufacturers who want to export their good to European market.
2. To all sub-contractors of an organization that have opts for ISO 9000 series standards.
3. To all regular suppliers to different government agencies
4. To all individual opting for better system in the company
Why do we need ISO 9001; 2000 Certification? 1, 3
1. Competitive Advantage :
72.3% of company with ISO certificate report a major competitive advantage. This means they are wining more business. (Source – Dum Bradstreet Survey)
2. Improve Customer Demand :
33.4% of corporations with ISO certificate report improve customer demand. This means they wining more business
3. Protect your Business :
69.3% of surveyed businesses that do not have ISO say they have lost a customer bid or proposal to an ISO certified competitor. Many of these companies said they didn’t know why they were losing the business until it was too late.
4. New Prospects ;
The iso 9000; 2001 registered company directory list over 40000 ISO 9001; 2000 certified business who want to do business with other ISO 9000 certified or compliant businesses.
5. Easy and Cost Effective :
Getting ISO 9001:2000 is no longer the costly, time consuming proposition that it once was. Using our system to become ISO 9001:2000 COMPLINT is very simple and inexpensive. It will put you way ahead of your competition and will enable you to bid on many contracts within just a few weeks of starting the process.
6. Quality for Government Contracts :
The department of defence, food and drug administration, NASA department of energy and general service administration have all approval the use of ISO 9001:2000
7. Incerased Creatibility :
You can generate significant increased in business, as many corporations will only deal with ISO 9001:2000 Registers company.
8. Develop New Customers :
Once you are registered you will be published in the ISO 9001:2000 Registers company directors. Used as a purchasing resource book by thousands of U.S. and international companies, it will bring you inquiries and opportunities you would otherwise never receive.
What Steps do we need to take to Achieve Certification? 3
Depending on the amount of time you devoted to the project, it can take as little as a few weeks to as much as a year or more to prepare. Because of this ‘’lead time’’, it’s important to get started before you being losing business to your ISO certified competitors. If you wait, you will likely lose even more business before you are able to achieve ISO certification. Here are the steps:
1. Documentation :
Preparing your policy and procedures manuals
2. Implementation :
ISO 9001:2000 is basically an instruction manual for your business. It’s’’ say what you do and do what you say’’. Implementing ISO means putting it in to practice within your company. It typically takes between three to nine months, and is the second phase of the process.
3. Inspection Audit:
When your documents are ready you have implemented them throughout the organization; it’s time to call the auditing organization, known as a registrar. They will inspect your document, do an on site inspection to verify that you are implementing properly, and make a report to the registrar for or against registration.
4. Registration :
When you pass the audit, your company will be registered as an ISO certified organization and published in the registered company directory.
Benifits of Quality Systems Based on ISO Certification 3
ISO certifications is an important marketing tool, as organizations having it can goost of certified superior quality in the domestic market and compete international companies in the export market.When ISO -9000 is implemented in an organization, the consistency in the quality of output will be maintained. Once the systems and procedures are standardized, it will pave the way to reduce losses and lapses and corrective measures can be taken on identifying deviations, if any.
For Customers :
The worldwide compatibility of technology, which is achieved when products and service are based on international standards, brings them an increasingly wide choice offers, and they also benefit from the effects of competition among supplier.
For Trade Officials :
Negotiating the emergence of regional and global markets, international standards create “a level playing field “for all competitors on those markets. The existence of divergent national or regional standards can technical barrier to trade, even when these is political trade agreements can be put into practice.
For Govenments :
International standards provide the technological and scientific based underpinning health, safety and environmental legislation.
For Developing Countries :
International standards that represent an international consensus on the state of the art constitute an important source of technological know-how. By defining the characteristics that products and services will be expected to meet on export markets, international standards give developing countries a basic for making the right decisions when investing their scarce resources and thus avoid squandering them.
For Consumers :
Conformity of products and service to international standards provides assurance about their quality, safety, and reliability.
For Everyone :
International standards can contribute to the quality of life in general by ensuring that the transport, machinery and tools we use are safe.
Advantage of ISO Certification 3,5
· Batter product design.
· Improved product quality. It helps the company achieve consistency levels of quality.
· Market share can grow up with improved credibility
· The company’s managements have greater confidence in its own internal systems.
· Insurance have more faith in the company’s products / service and make quote lover premiums to cover company’s products / services against liability suits
· System orientation facilitated by ISO series reduces the need for “ fire fighting or inefficient expenditure of time, resources and energy in solving recurring chronic problems
· Employees feel less frustrated as their efforts are more efficiently and effectively use in the absence of fire fighting
· Efficient utilization of men, machines and materials resulting in higher productivity
· Creation of quality awareness and greater jog satisfaction
· Among employees, improving the company’s quality culture
· The systematic approach to problem solving result in the eliminations of chronic problems by taking care of root causes/this enable batter utilization of management time instead of “ fire fighting “time can be devoted to planning improvement
· Reduction in scrape rework and customer complaints. The company process become cost effective as system facilitates reduction in waste and rejections
· Elimination of bottlenecks in production and tension free work environment leading to good human relations
· It inspires confidence in existing / potential customer that company is capable of delivering quality goods and /services.
· Improvement of company image and credibility in international markets, which is essential for success in export business.
ISO 9000 Series 4, 5
There are number of parts to the standards. The principal parts are 1, 2, and 3, which have the following titles:
ISO 9001: Quality system model for quality assurance in design, Development, production installation and servicing
ISO 9002: Quality system model for quality assurance in productions, installation and servicing.
ISO 9003: Quality systems model for quality assurance in final inspection and test.
9002 is little more than a reduced version of ISO 9001, repeating many of its elements and omitting others. ISO 9003 is a father-reduced version of ISO 9002.
There are a number of additional ISO published in the 9000 families.
1 An ISO9001 program s for any facility that is involved in design (engineering) of product and / or servicing of the product after sale.
2 An ISO 902 program is for facilities involve in the manufacturing g but not the design or servicing of the products.
ISO 9001 Quality management and quality assurance standards.
This is available in four separately issued parts
1 Part 1: guideline for selection and use
2 Part 2: generic guideline for the application of ISO 9001, ISO 9002 and ISO 9003
3 Part 3: guideline for the application of ISO 9001 to the development, supply and maintained
4 Part 4: guide to dependability programme management.
There main substance of ISO 9001 is its section 4 ‘quality system requirements’. This sets 20 quality system elements numbered 4.1 to 4.20
ISO 9001 SECTION 4.1 Management Responsibility
ISO 9001 SECTION 4.2 Quality System
ISO 9001 SECTION 4.3 Contract Review
ISO 9001 SECTION 4.4 Design Control
ISO 9001 SECTION 4.5 Documents and Data Control
ISO 9001 SECTION 4.6 Purchasing
ISO 9001 SECTION 4.7 Control of Purchaser Supplied Product
ISO 9001 SECTION 4.8 Product Identification And Traceability
ISO 9001 SECTION 4.9 Process Control
ISO 9001 SECTION 4.10 Inspection And Testing
ISO 9001 SECTION 4.11 Measuring And Test Equipment
ISO 9001 SECTION 4.12 Inspections and Test Status
ISO 9001 SECTION 4.13 Controls and Non Conforming Product
ISO 9001 SECTION 4.14 Corrective And Preventive Action
ISO 9001 SECTION 4.15 Handling, Storage, Packing
ISO 9001 SECTION 4.16 Control of Quality Records
ISO 9001 SECTION 4.17 Internal Quality Audits
ISO 9001 SECTION 4.18 Training
ISO 9001 SECTION 4.19 Servicing
ISO 9001 SECTION 4.20 Statistical Techniques
Whom to Contact for Ragistration 3, 4
Many private and government agencies are undertaking these types of assignments. A few government agencies are given below:
1. DEPARTMENT OF ELECTRONICS GOVERNMENT OF INDIA, Electronics Niketan 6, CGO Complex, New Delhi 110003
2. Director, ERTL (E) STQC Directorate, DN Balock, sector V Salt lack city, Calcutta 700091
Certifying Agencies in India 3
Science third party assessment is required for international accreditation of quality; several international agencies are offering their service for auditing and certification in India.
Leading certifying agencies in India are:
1. ABS Quality evolutions Inc.
2. Australian Standards Association
3. Bureau Veritas Quality International
4. Bureau of Indian standards
5. British Standard Institution
6. Det Norsek Veritas
7. Indian Register Quality/ System
8. National Inspection
Where are the Copies of the Standards Available? 1,3
The copies of standards prescribed for ISO 9000 can be had from – director – (sales)
Bureau of Indian Standards
Manak Bhavan, 9, Bahadur Shah Zafar Marg, New Delhi – 110002
Fee Particulars: 3
The following table to fees has been prescribed to get ISO- 9000 certification.
Preliminary visit fees Rs. 3000 plus expenses towards travel and accommodation during the visit, as applicable, which are charged at cost.
Application fees (Non – refundable)
A) Certification as per ISO – 9001 – Rs. 10,000
B) Certification as per ISO - 9002 – Rs. 7,500
C) Certification as per ISO – 9003 – Rs. 5,000
Assessment fees Rs. 1,500 per assessor per day plus, expenses towards travel accommodation during the assessment, as applicable, which are charged at cost.
Annual fees
A) Certification as per ISO – 9001 Rs. 30,000
B) Certification as per ISO – 9002 Rs. 25,500
C) Certification as per ISO – 9003 Rs. 20,000
The annual fee covers all expenses towards surveillance visits in a year including travel and other expenses and is payable prior to grant of certificate of registration and subsequently in advance year.
Renewal fees (Non – refundable) : Rs. 3,000 payable at the time of renewal once in 3 years. In the event of decision to conduct partial/full assessment of the registered supplier, the assessment fees plus additional expenses as specified above, under heading ‘Assessment Fee’ will be charged.
Appeal fee Rs. 3,000 plus additional expenses in connection with the appeal like special visits to supplier’s premises, travel and accommodation etc., as applicable will be charged at cost.
References:
1. www.ISO.org
3. Virendra K. Pamecha, ‘How to implement ISO 9000’, Published by excess information & service Pvt. Ltd. Indore.
4. Johan Sharp, ‘Quality in the Manufacture of Medicines and other Healthcare products’ published by Pharmaceutical presses, first published 2000.
5. Kenneth L. Arnold, ‘The Manger’s Guide to ISO 9000’ The Free Press, New York.
About Authors :
Chitlange Sohan S., Suralkar Anupama A., Bhujbal Santosh. S., Pawar Hemant.I.,AmolA.Kulkarni
Padm. Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-18.
Mr.Sohan S.Chitlange
Asst. Professor, Dept.of Pharm.Chemistry, Padm.dr.D.Y.patil institute of Pharma.Science &Resreach, Pimpri, Pune. sohanchitlange@rediffmail.com
Mr.hemant I. Pawar
M.Pharma. (Q.A.), hemu1pharma@gmail.com
Mr.Santosh S. Bhujbal
Asst.Professor, Dept.of Pharmacognosy
Ms.Anupama A. Suralkar
Lecturer, Dept.of Pharmacology.
Mr.Amol A. Kulkarni
Lecturer , Dept.of Pharm.Chemistry