ISO 9000 - FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is ISO?

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies, at present comprising 140 members, one in each country. The object of ISO is to promote the development of standardization and related activities in the world with a view to facilitating international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. The results of ISO technical work are published as International Standards.

2. What is ISO 9000?

The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that meet the client’s quality requirements. These good practices have been distilled into a set of standardized requirements for a quality management system, regardless of what your organization does, its size, or whether it is in the private, or public sector. The family of ISO 9000 standards have been developed by ISO and it is made up of four core standards:

a) ISO 9000:2000 – Fundamentals and Vocabulary

b) ISO 9001:2000 – Quality Management Systems – Requirements

c) ISO 9004:2000 – Quality Management Systems – Guidelines for performance improvements

d) ISO 19011: 2002 – Guidelines for quality and/or environmental management systems auditing

3. What is the role of BIS in ISO 9000?

BIS is the National Standards Body of India and is a founder member of ISO. BIS represents India, in ISO. The Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees of ISO are responsible for the development of ISO 9000 standards. Quality and industry experts from India including BIS officers nominated by BIS participate in the meetings of the Technical Committee ISO/TC 176 and its Sub-committees.

ISO 9000 (QMS) - FAQs

4. What is the difference between ISO 9000 standards and IS/ISO 9000 standards?

There is no difference. They are exactly the same. BIS has adopted the above mentioned ISO 9000 standards and these are numbered as IS/ISO 9000:2000; IS/ISO 9001:2000; IS/ISO 9004:2000; and IS/ISO 19011:2002. These standards published by BIS are exact replica of ISO 9000 standards. BIS also provides certification against IS/ISO 9001:2000 under its Management Systems Certification activity.

5. Which IS/ISO 9000 standard is meant for certification?

Any organization can apply for certification against IS/ISO 9001:2000. The other standards i.e. IS/ISO 9000:2000; IS/ISO 9004:2000; and IS/ISO 19011:2002 are guidance standards and are not meant for certification.

6. Tell me more about IS/ISO 9004:2000.

The requirements of IS/ISO 9004:2000 should be implemented by the organizations who intend to further improve beyond the requirements of IS/ISO 9001:2000. The standard IS/ISO 9004:2000 has an important element of `self-evaluation’ and this standard is not amenable to certification.

7. Where can copies of the IS/ISO 9000 standards be obtained?

Copies of the IS/ISO 9000 standards may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website.

8. What is the difference between a certification body and a registration body?

None. The term `certification body’ is used in some countries, like, India, because BIS as certification body issue certificates (licences). Elsewhere, they prefer to say that they `register’ organizations complying with ISO 9000.

9. I want to be an ISO 9000 auditor: where can I get training?

Contact National Institute of Training for Standardization (NITS) of Bureau of Indian Standards at the address: Deputy Director General (Training), National Institute of Training for Standardization, A-20&21, Institutional Area, Sector-62, Noida – 201 307 (Tel: 0120-2402204-07; Fax: 0120-2402203; Email: nits@bis.org.in; Website: www.bis.org.in). Also refer IS/ISO 19011:2002 standard, for auditor’s qualification, training, experience,etc.

10. My organization provides services. How are the IS/ISO 9000 standards applicable to us?

The IS/ISO 9000 standards are applicable to all types of organizations. The definition of the term `product’ in IS/ISO 9000:2000 also include services and their combination. Therefore, the requirements of IS/ISO 9001:2000 are equally applicable to service sector as it is applicable to product manufacturing company.

11. How to implement the requirements of IS/ISO 9001:2000 in my organization?

As a minimum you should familiarize yourself not only with the requirements of IS/ISO 9001:2000 but also with the content and philosophies given in IS/ISO 9000:2000, IS/ISO 9004:2000 and the Quality Management Principles. You have to clearly understand your organization’s activities and processes and appropriately interpret the requirements of the standards. Implement the requirements in the various activities and processes adding value to these processes and activities. For training programmes on general awareness on the requirements, content and philosophies of the IS/ISO 9000 standards, our BIS, National Institute of Training for Standardization (NITS) may be contacted.

12. What are the main benefits of implementing IS/ISO 9001:2000 Quality Management System Requirements?

- Provides an opportunity to increase value to the activities of the organization

- Improve the performance of processes/activities continually

- Satisfaction of customers

- Attention to resource management

- Implementation of statutory and regulatory requirements related to product/services

- Better management control

ISO 9000 (QMS) - FAQs

13. What is accreditation?

In simple terms, accreditation is like certification of the certification body. `Accreditation’ should not be used as an interchangeable alternative for certification or registration. BIS Quality Management Systems Certification activity has been accredited by Raad voor Accreditatie (RvA) of Netherlands, to carry out IS/ISO 9001:2000 certification in 23 business sectors.

14. How should I obtain IS/ISO 9001:2000 certification?

The information is available in this BIS website under Management Systems Certification. The application form (Form IV), questionnaire (Form V) and fee structure can also be downloaded from BIS website. A copy of the `Guidelines for Applicants – IS/ISO 9001:2000’ can be obtained from Regional or Branch Offices of BIS or from Headquarters at New Delhi.

15. For more details

Contact nearby branch office of BIS or any of the Regional Offices of BIS located at Mumbai, Kolkata, Chandigarh, Delhi and Chennai or Head (Management Systems Certification), Bureau of Indian Standards, Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi - 110002.

ISO 14000 - FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is ISO 14001?

ISO 14000 is the general term used for ISO 14000 family of standards. ISO 14001:1996 `Environmental Management Systems – Specifications with Guidance for use’ is a standard published by International Organization for Standardization (ISO) (About ISO, please see ISO 9000 – Frequently Asked Questions, Answer to Question No. 1) and adopted by BIS as IS/ISO 14001:1996. IS/ISO 14001:1996 is the exact replica of ISO 14001:1996. This standard provides for the framework for the Management System for an organization to meet its Environmental obligations reliably and consistently. IS/ISO 14001:1996 is the only certification standard in the IS/ISO 14000 family.

IS/ISO 14001 is a requirements standard. It contains a set of requirements to define the operation of the Environmental Management System. Since the requirements are expressed in a general form, it has the flexibility to be applied to any organization.

2. Who has formulated ISO 14001:1996 standard?

ISO has published ISO 14000 family of standards including ISO 14001:1996 standard. The Technical Committee of ISO i.e. ISO/TC 207 Environmental Management Systems is responsible for formulation of these standards. BIS represents India as participating member on this Committee. Experts from India including BIS officers are nominated on this Committee to put forth India’s viewpoints on EMS.

3. What are the other standards in ISO 14000 family of standards?

The other standards of ISO 14000 family have also been adopted by BIS as IS/ISO 14000 and are exact replica of ISO 14000 standards. These standards are:

IS/ISO 14004:1996 – Environmental management systems – General guidelines on principles, system and supporting techniques

IS/ISO 14020:1998 – Environmental labels and declarations – General principles

IS/ISO 14021:1999 – Environmental labels and declaration – Self-declared environmental claims (Type II Environmental labeling)

ISO 14000 (EMS) - FAQs

IS/ISO 14024: 1999 – Environmental labels and declaration – Type 1 Environmental labelling – Principles and procedures

IS/ISO 14031:1999 – Environmental management – Environmental performance evaluation – Guidelines

IS/ISO 14040:1997 – Environmental Management – Life cycle assessment – Principles and framework

IS/ISO 14041:1998 – Environmental management – Life cycle assessment – Goal and scope definition and inventory analysis

IS/ISO 14042:2000 – Environmental management – Life cycle assessment – Life cycle impact assessment

IS/ISO 14043:2000 – Environmental Management – Life Cycle Assessment – Life Cycle Interpretation

IS/ISO 14050:2002 – Environmental Management - Vocabulary

4. What is IS/ISO 14004?

ISO 14004 has been adopted by BIS as IS/ISO 14004 which is exact replica of ISO 14004 and is the companion standard to IS/ISO 14001. For those organizations implementing the Environmental Management System specified in IS/ISO 14001, IS/ISO 14004 provides guidance and illustrations of `what to do’ and `how to do it’. As this is a guidance standard, it is not meant for certification.

5. What are the benefits of implementing IS/ISO 14001:1996?

Following are the benefits to an organization by implementing IS/ISO 14001:1996:

- Provides framework for

§ Pollution prevention and waste reduction

§ Compliance with legislative and regulatory requirements

- Reduction in liability/risks

- Competitive advantage for `Green’ products Globally

- Creation of an improved community goodwill

- Improved environmental performance

ISO 14000 (EMS) – FAQs

- Assures customers of commitment to demonstrate environmental management

- Improved Industry Government relations

- Helps in conservation of raw materials and energy

- Reduces incidents that results in liability

6. How to implement the requirements of ISO 14001:1996 in my organization?

As a minimum you should familiarize yourself not only with the requirements of IS/ISO 14001:1996 but also with the content and philosophies given in :

IS/ISO 14050:2002 `Environmental Management - Vocabulary ‘

IS/ISO 14004:1996 `Environmental Management Systems – General Guidelines on Principles, System and Supporting Techniques’

IS/ISO 19011: 2002 `Guidelines for quality and/or environmental management systems auditing’

In addition to the above you may also refer other standards of ISO 14000 family of standards as mentioned at answer to question no 3.

You have to clearly understand your organization’s obligations towards environment and effect of organization’s activities and processes on the environment and appropriately interpret the requirements of the standards. For training programmes on general awareness on the requirements, content and philosophies of the IS/ISO 14000 standards, our BIS, National Institute of Training for Standardization (NITS) may be contacted.

7. I want to be an ISO 14000 auditor: where can I get training?

ISO 14000 (EMS) - FAQs

8. What is the role of BIS in ISO 14001:1996 certification?

BIS is operating IS/ISO 14001:1996 certification under the Regulations framed under an Act of Parliament i.e. BIS Act, 1986. A number of organizations in the field of chemicals, cement, textiles, power generation, steel manufacturing, mining, pesticides, ceramic tiles, paper, engineering, etc., have been certified by BIS for IS/ISO 14001:1996. The other information is available in this BIS website under Management Systems Certification. The application form (Form IV) and questionnaire (Form VII) can also be downloaded from BIS website. A copy of the `Guidelines for Applicants – IS/ISO 14001:1996’ can be obtained from nearby Regional or Branch Offices of BIS or from Headquarters at New Delhi.

9. Where can copies of IS/ISO 14000 standards be obtained?

Copies of the IS/ISO 14000 standards may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website.

10. What is the difference between certification, registration and accreditation?

Please refer to Question No. 8 and 13 of ISO 9000 – FAQs.

11. For more details

HAZARDS ANALYSIS AND CRITICAL CONTROL POINT (HACCP) IS 15000:1998 - FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is HACCP?

Hazard Analysis and Critical Control Point (HACCP) is a process control system designed to identify and prevent microbial and other hazards in food production. It includes steps designed to prevent problems before they occur and to correct deviations as soon as they are detected. Such preventive control system with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food.

2. Why HACCP?

India is a signatory to WTO. The WTO Agreement on Sanitary and Phytosanitary (SPS) makes it obligatory to adopt the standards, guidelines and recommendations issued by Codex Alimentarius Commission which advocates the adoption of HACCP. The Indian Standard on ‘Food Hygiene – Hazard Analysis and Critical Control Point (HACCP) – System and Guidelines for Its Application’ IS 15000:1998 is technically equivalent to the Codex document on the subject. For food industry in India, adoption of HACCP is becoming imperative to reach global standards, demonstrate compliance to Regulations/Customer requirements besides providing safer food to our millions.

3. Is there any standard published by ISO on HACCP?

No. Presently there is no ISO standard available for HACCP certification.

4. Tell me more about HACCP.

HACCP involves a system approach to identification of hazards, assessment of chances of occurrence of hazards during each phase, raw material procurement, manufacturing, distribution, usage of food products, and in defining the measures for hazard control. In doing so, the many drawbacks prevalent in the inspection approach are avoided and HACCP overcomes shortcomings of reliance only on microbial testing.

IS 15000 (HACCP) - FAQs

5. Who can implement HACCP?

HACCP enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety. Food inspection too would be more systematic and therefore hassle-free. It would no doubt involve deployment of some additional finances initially but this would be more than compensated in the long run through consistently better quality and hence better prices and returns.

6. HACCP - HIGHLIGHTS

l Mandatory for export from certain sectors of food industry to some countries

l Pro-active system for assuring safe production of foods

l Emphasises prevention rather than inspection

l Addresses all types of Hazards-Microbiological, Physical and Chemical

l Can be integrated into a more general quality assurance plan

l Can be implemented in tiny, small, medium and large scale enterprises

7. BENEFITS OF HACCP

l Reduces contamination

l Reduces recall/product destruction

l Provides market protection

l Provides preferred supplier status

l Demonstrates conformance to international standards and regulations, and requirements of overseas markets

l Transforms commodities into branded products

l International acceptance

8. HACCP CERTIFICATION

BIS offers two Certification schemes to the food industry.

l Food Safety Certification (HACCP) against IS 15000:1998

l HACCP based Quality Management Systems Certification provides for twin Certification through one audit i.e. Certification of Quality Management Systems against IS/ISO 9001:2000 and Certification of HACCP against IS 15000:1998

IS 15000 (HACCP) - FAQs

9. HOW TO OBTAIN LICENCE?

l Establish and implement documented HACCP SYSTEM (as per IS 15000:1998) and ensure its effectiveness. For QMS-HACCP, establish and implement integrated food and quality management system (as per IS 15000:1998 and IS/ISO 9001:2000) and ensure its effectiveness .

l Submit application on prescribed proforma (Form IV) along with the questionnaire (Form XII) and necessary fees (Application Form, Questionnaire and Fee Structure are available and can be downloaded from this website – Management Systems Certification)

l Submit the quality manual and/ or concerned documents, when asked for

l Arrange audit by BIS Assessment Team

l Take actions on non-conformities observed by assessment team and get them verified. If found satisfactory, grant of licence is recommended.

l Obtain the Licence!!!

l The licence will enable the company to compete effectively in national and international markets.

10. OTHER SERVICES OFFERED BY BIS

l General Awareness Programmes on HACCP & QUALITY MANAGEMENT SYSTEM by BIS National Institute of Training for Standardization (NITS). Details on training available in this website

l Technical Information Services on Standards and Certification matters

l Pre-certification services – Trial assessment and Survey

11. Where can copy of IS 15000 standard be obtained?

Copy of the IS 15000 standard may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website.

12. What is the difference between certification, registration and accreditation?

Please refer to Question No. 8 and 13 of ISO 9000 – FAQs.

IS 15000 (HACCP) - FAQs

13. For more details

OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS (OHSMS),

IS 18001:2000-FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is OHSMS?

Health and safety are important aspects of an organization’s smooth and effective functioning. Good health and safety performance ensures an accident-free industrial environment. This demands adoption of a structured approach for the identification of hazards, their evaluation and control of risks. Bureau of Indian Standards (BIS) has formulated an Indian Standard on Occupational Health & Safety (OH&S) Management Systems, considering the above in view and a great demand from the industry for a comprehensive framework of OH&S i.e. IS 18001:2000 `Occupational Health and Safety Management Systems – Specification with Guidance for use’.

2. Is there any standard published by ISO on OHSMS?

No. Presently there is no ISO standard available for OHSMS certification.

3. Tell me more about IS 18001:2000.

This standard prescribes requirements for an OH&S Management Systems to enable an organization to formulate a policy and objectives, taking into account legislative requirements and information about significant hazards and risks, which the organization can control and over which it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the organization. All the requirements in this standard are intended to be incorporated into any OH&S management system. This standard also provides imperative guidance on the use of the specification.

4. How to obtain certification for OHSMS?

Organizations interested in obtaining licence for OH&S Management System as per IS 18001 should ensure that they are operating the system according to this standard. The organization should apply on the prescribed proforma (Form IV) at the nearest Regional Office of BIS along with Questionnaire (Form X) and the prescribed application fee as applicable. The form, questionnaire and fee structure can be downloaded from this website – Management Systems Certification.

IS 18001 (OHSMS) - FAQs

5. I want to be an IS 18001 auditor: where can I get training?

6. Where can copy of IS 18001 standard be obtained?

Copy of the IS 18001 standard may be purchased from BIS Regional/Branch offices and Headquarters at the addresses given in this website.

7. What is the difference between certification, registration and accreditation?

Please refer to Question No. 8 and 13 of ISO 9000 – FAQs.

8. For more details