The International Organization for Standardization (ISO) had developed in 1987 a series of international quality systems standards popularly known as ISO-9000 series of standards to provide the framework for the third party certification of the quality systems.
These systems were revised in 1994. The Bureau of Indian Standards (BIS) has also launched the Thirty Party Certification Scheme of Quality System known as IS: 14000 later change to (ISO: IS: 9000) series if standards in India. This series of stands provided an assurance that the quality system installed and operated conform to the international standards and will generate the confidence of the consumers in the quality offered by the firm.
The ISO 9000 series of standards were first published in India by BIS in 1988 and subsequently revised in 1994 as IS/ ISO 9000 series of standards (IS/ISO 9001,9002, 9003 etc.) with totally identical text as published by International Organization for Standardization. These have been popularized in industry and service sectors as a precluded to installation of quality management systems. The ISO-9000 series of standards are as follows:
ISO: 9000 – Quality Management and Quality Assurance Standards- Guidelines for Selection and Use
ISO: 9001 – Quality Systems- Model for Quality Assurance in Design/Development, Production, Installation and Servicing.
ISO: 9002 – Quality System – Model for Quality Assurance in Production and Installation.
ISO: 9003 – Quality Systems – Model for Quality Assurance in Final Inspection and Test.
ISO:9004 – Quality Management and Quality System Elements Guidelines
These standards have been adopted in as many as 128 countries including India. The equivalent Indian Standards are ISO/IS: 9000(series). ISO revised these standards in October 2000 and the new standards are referred to as ‘ISO 9000:2000’ Quality Management Systems Requirements.
These standards replace their first revision done in 1994. India has also adopted the revised standards and are referred to as “IS/ISO 9000:2000 Quality Management Systems- Fundamentals and Vocabulary” (second revision). The IS/ISO 9000:2000 (second revision) standards have dropped IS/ISO.9002 and IS/ISO: 9003 standards.
Features of ISO 9000:2000 Standards
The essential features of the ISO – 9000:2000 series of standards are as follows:
- They call for integration of all activities which have a direct or indirect effect on the quality of a product or service.
- They tell suppliers and manufactures as to what is expected of them in respect of a quality-oriented working system.
- These standards define the basic concepts and specify the procedure and criteria to ensure that the final product meets the customer’s requirements.
- These standards are designed to be user-friendly and are applicable to every product and services.
- These standards call for verification of quality system by the customer which gives him the confidence that the organization is capable of delivering the products or services of desired quality.
Objectives of using ISO: 9000:2000 (Series) Standards
ISO: 9000:2000 standards set out that the business firm can established, document and maintain an effective and economic quality system which will demonstrate to the customers that the business firm is committed to quality and is able to meet their quality needs. It is an internationally accepted standard and is simply laid down in an organized way.
ISO: 9000; 2000 Standards brings real economies in its wake, because the systems in the business firm adopting these standards will be controlled from the start to finish including economies in resources and time spent on replacing or modifying designs. The standards also provide an opportunity to have a complete record for every stage of activities and invaluable assets for the future of the business firms.
India’s Export and ISO-9000
European Union (EU) comprises 15 member states namely Belgium, France, Germy, Italy, Luxembourg, Netherlands, Denmark, Ireland, United Kingdom, Greece, Portugal, Spain, Sweden, Austria and Finland. Presently, the EU has directive to allow imports of various products only if these are certified for quality ISO-9000 of standards. These products are as follows:
- Simple Pressure Vessels
- Electromagnetic Compatibility
- Gas Appliances
- Personal Protective Equipment
- Medical Devices
- Active Implantable Medical Devices
- Non-Automatic Weighting Instruments
- Telecommunication terminal Equipments
- Upholstered Furniture
- Recreational Craft
- Pressure Vessels
- Lifting Equipments
- Marine Equipment
- Equipment in Explosive Atmosphere
- Temporary Structure
- Children’s Playground Equipments
- Medical Diagnostics Kits.
Benefits from ISO – 9000:2000 Certification
It is generally believed that certification of quality management system under ISO:9000 series of standards brings number of benefits for an export firm, the most important being the confidence of the buyers in the export firm and its products. These benefits are as follows:
- It helps the export firm gain competitive edge.
- It ensures introduction of efficient and sound procedure.
- It ensures optimum utilization of plant capacity
- It ensures consistent improvement in the quality of operations.
- It makes quality system of the firm transparent.
- It leads to consumer’s satisfactions.
- In ensures improvement in productivity.
- It leads to improvement in the morale and motivation of employees.
- The unit achieves economics in time and resources.
- It helps the management in fixing responsibility of the executives for decline in quality as it is essentially a quality control system.
The Confederation of Indian Industries had conducted a survey of 1000 companies certified under ISO 9000 series of standards to assess its impact on them. The survey findings are based on the information collected from 100 companies based on a questionnaire. According to the result of this survey, the benefits observed by the respondent companies after the introduction of the ISO-9000 are as follows:
- Morale of the employees had shown tremendous improvement. In fact the average gain in this respect was 100%.
- The house keeping of the companies had also changed for the better with the average gain in this field being 140 %. This means there was considerable reduction in the wastages due to inapt housekeeping.
- The decision making processes had strengthened with the increasing support of data and facts available for taking decisions. The average gain reported in this respect was 95 %.
- There was reduction in the complaints from the customers to the extent of 40 %. This led to improvement in the customer satisfaction with the average gain being 55% on this score.
- The efforts involved in the inspection of the goods for quality had also reduced on an average by 45 %.
- There was improvement in the safety in the work environment with average gain being 45 %. Some of the companies even reported reductions in the machinery break down.
- The cost of maintaining the quality had shown significant reduction with the average gain being to the extent of 60 %.
- The overall impact of all the aspect described above is the improvement in the efficiency and competitiveness of the enterprise.
Procedure for Certification under ISO- 9000/ IS-9000 Series of Standards in India
Any business enterprise desirous of obtaining certification under ISO-9000 series of standards can approach the Bureau of Indian Standards (BIS), Bahadur Shah Zafar Marg, New Delhi. BIS Quality System Certification Scheme is accredited by Raadvoor (RVA), Netherlands for issue of certification to the companies in India. Their guidelines contain useful information on processing of an appellation, procedure for grant of license, obligations and responsibilities of the firms interested in obtaining license to relevant model according to IS/ISO 9000 family of standards.
These guidelines are in the nature of extracted information from the application regulations. The interested business firm should refer to BIS (Certification) Regulation, 1988 amended up to 1991. BIS has a scheme which envisages grant of Quality Systems Certification License to firms as per the following model:
Quality Management Systems – Model for Quality Management in Design, Development, Production, Installation and Servicing.
This model enables a business enterprise to demonstrate the firm’s capability to control quality in respect of the processes for design as well as production of conforming product. The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing. It focuses on the effectiveness of quality management system to bring about continual improvement in the overall efficiency and effectiveness of enterprise.
Application and Its Processing
Firms interested in obtaining license (certification) for quality systems as per the IS/ISO 9000 family of standards should ensure that these are operating quality systems in accordance with relevant standards. They should apply on the prescribed Performa in triplicate (Form III) at the nearest Regional office of BIS along with prescribed application fee as applicable. The application fee is non-refundable.
Each application should be accompanied by a supplement questionnaire (Form IV) duly filled in along with the documented quality system (such as quality manual, quality plan, etc) prepared by the firm. The documented quality system shall be in line with the requirements of the relevant system standard.
Process of Certification for the Grant of License
The following steps are taken by the BIS to process the application for certification of the applicant firm for the grant of license.
(a) Adequacy Audit
After the application has been accepted, the documented quality system (Quality Manual/Quality etc) is examined by the BIS for verifying the conformation to relevant standards. Any significant omissions or deviation from the prescribed requirements intimated by BIS will have to be corrected by the applicant, and BIS will advise accordingly to process the application further.
(b) Preliminary Visit
BIS official (s) may visit the premises of the applicant firm to acquaint himself/themselves of the size, nature of the operation and firm’s readiness for the audit. The number of the auditors and its duration will vary accordingly to the size and nature of the operation of the firm being assessed.
(c) Assessment Fee
The BIS provide an estimate of the assessment fee payable by the applicant firm by taking into consideration the man-days expected to be spent on the audit of the firm, and the anticipated expense for travel/stay etc. The fee is payable in advance by the applicant firm.
Once, the assessment fee has been deposited by the applicant firm then an audit team from BIS visits for assessment of its compliance to the procedures and activities enumerated in the documented quality system and relevant quality systems standards.
The Assessment in done as per the following sequence:
(a) Opening Meeting
This meeting will be conducted by the leader of the audit team in which the CEO of the business firm, the business firm, the management representative and heads of all the departments being audited are expected to be present. During this meeting, the leader will explain the scope and extent of the audit and the important terms used in the assessment.
(b) Conduct of Assessment
Each auditor should be accompanied by a guide who is conversant with the activities of the department(s) the auditor is auditing. Observations recorder by the auditors must be signed by the guide as a token of acceptance.
(c) Closing Meeting and Report
- All the members present in the opening meeting should preferably be present in the closing meetings as well when the audit team presents their findings to the firm.
- The non conformities observed by the audit team will be handed over to the firm at the end of each day for necessary corrective action.
- Time frame for the corrective action (s) will be decided by the firm.
- Then non-conformity reports will be signed by Management Representative or authorized signatory as a token of acceptance.
Responsibilities of Applicant during the Audit
The responsibilities of the applicant firm during the audit are as follows:
- It should make arrangements of stay, local guidance and travel arrangements etc.
- The CEO and the Management Representative of the business firm must be present during the opening and closing meetings. As far as possible, all responsible personnel of the business firm whose departments are being audited should be present in these meetings.
- In the interest of the firm, all efforts should be made so that the time of the audit team is not wasted on account of non availability of relevant personnel, documents, records, shut down of unit(s) being audited etc.
- The firm will arrange a place/room where members of the audit team can meet and discuss during the day, and at the end of day to exchange their notices and findings.
- Before a license is granted to the applicant, the firm shall give the following undertakings:
- “We shall make no claim or implied that the license to be granted relates to any products or processes other than those that will be set out in the license and Schedule.”
Based on the findings of the audit team and satisfactory report, firm will be granted a license by BIS.
Conditions for the Grant of License
The license is granted subject to the following conditions:
- The license is granted for a period of three years.
- Grant of license is followed by surveillance visits once in size months by the Auditors (S) of BIS to verify the effective implementation and maintenance of the quality system established by the firm.
- During the operation of license, when a licensee fails to observe the conations of the Quality Systems Certification Scheme or where there have been significant changes in the organization of the licensee, license of the firm is liable to pay special visit charges, a set out in the schedule of fees.
Renewal, Deferment, Expiry and Cancellation of License
Any license granted automatically expires at the end of the period for which it is granted. A renewal notice is issued to the licensee by the concerned regional office of BIS about four months before the expiry of the current operative period. The licensee is required to submit the renewal application along with the original copy of the license at least three months in advance before the expiry of the license which will be followed by a complete audit of quality system of the firm.
If some discrepancies are found during the audit the licensee is asked to take corrective action. After the licensee has taken necessary action to remove discrepancies, the license is renewed for a period of three years.
Obligation of Licensee
A licensee on grant of certification for quality system will:
1. Only claim that he is holding a license in respect of the capability which is the subject of the license and which relates to the products or processes in accordance with the license requirements.
2. Not use the license in any manner to which the BIS may object and shall not make any statement concerning the authority of the licensee’s use of the license which in the opinion of the BIS may be misleading.
3. Submit to the BIS for approval the way in which he proposes to use the license or proposes to make references to the license.
4. Not make any change to the Quality System which forms the basis for the grant of the license and which prevents its compliance with the scheme without prior approval of the BIS.
5. Upon suspension or termination of the license, however determined, discontinue its use forthwith and withdraw all promotional and advertising matter which contains any reference thereto.
6. Submit to the BIS any amendments to the Quality manual and /or Quality Plan.
7. Document all changes made to the Quality System and make records of such changes available to Bureau’s designated officers on request. A change in key personnel in relation to quality assurance, key technological functions or senior management shall be notified to the BSI by the license.
8. Permit access to officer (s)/team (s) appointed by the BIS for purposes of assessment, audit or surveillance. Licensee shall give full details of all actions taken in response to problems arising from all allegations of defects in products or processes covered in the license, and allow BIS officer’s access to all relevant records and documents for the purpose of verifying such details.
9. Be required to produce evidence of continuing operations for the products or processes covered by the license. Licensee shall notify the BIS in writings of discontinuance in such operations exceeding there months. Discontinuance of operations in excess of six months or more many lead to cancellation of the license. In such case, a fresh application shall be lodged with the BIS.
10. Pay all financial dues to the Bureau, as prescribed even for the period during which the operations of the license remains discontinued by him or suspended by the BIS.
11. Operate and maintain procedures for handling and recoding of complaints and shall report any complaints against the quality system operated and or license to BISQSCS. Cooperate and assist BISQSCS on the investigation and resolution of such complaints.
12. Operate within the provisions of the BIS Act 1986 Rules, 1987 BIS (Certification) Regulations, (amended up to 1991) and Certification Scheme Procedure for grant of license.
Privileges of Licensee
1. Original Quality Management Systems Certifications license which can be demonstrated by the licensees to anyone concerned. If need be, it can be photocopied and displayed at various locations.
2. A very attractive plaque containing details of certification is presented as a compliment at the time of award of certificate. Additional plaques can also be provided by BIS on actual cost payment basic.
3. Use of Quality management Systems certifications Mark on letter-heads in advertisements, brochures, complementary and for other promotional purpose. However, Standard mark shall not be directly applied on the product and its packaging so as to imply that product itself is certified by BIS.
4. Each licensee shall be listed in the register of licenses maintained by BIS.
Under the Provision of BIS Act, 1989, an applicant firm can make an appeal to the competent authority of BIS against decision taken in respect of granting, withholding, renewal, suspending or cancellation of certification under the Bureau of Indian Standards Quality Management System Certification Scheme (BISQSCS). The appeal should be made formally in writing within 90 days from the date of intimation of the decision by BIS QSCS to the Appeals Committee. The decision of the Appeals Committee is final.