This list of Frequently Asked Questions (FAQs) has been collected by EQFS Team. We thank ISO/TC 176/SC 2 to prepare the FAQ initially and to support the publication of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world. The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards. In case you want to get any new question added to this FAQ, Kindly write us at

ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using ISO 9004 in addition to ISO 9001:2008. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiencies throughout the organization.

The standards are based on 8 Quality Management Principles, which are aligned with the philosophy and objectives of most quality award programs. These principles are:

Customer focus,

Leadership,

Involvement of people,

Process approach,

System approach to management,

Continual improvement,

Factual approach to decision making,

and Mutually beneficial supplier relationships. ISO 9004 recommends that organizations perform self-assessments as part of their management of systems and processes, and includes an annex giving guidance on this approach. This is similar to many quality awards programmes. Since ISO 9000 standards are based on the best business practices adopted all over the world, hence this should be compatible to the national quality award, but it is good to compare the requirements at least once.

"Customer satisfaction" is recognized as one of the driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor the extent of customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. EQFS feels the biggest problem in the industry is to identify the “PROBLEM” if you have identified the problem, then the solution is available for that. Customer satisfaction is one of the means to ask your customer about your problems.

No standard alone can improve any thing; it is the implementation of it which makes the difference. Since the standards are based on some principles, which are known to be the best practices of business in the world. The implementation of the standard is bound to increase or improve Customer Satisfaction.

Continual improvement is the process focused on continually increasing the effectiveness and/or efficiency of the organization to fulfil its policies and objectives. Continual improvement (where "continual" highlights that an improvement process requires progressive consolidation and then practice it before identifying the next opportunity for improvement)

Any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all activities and operations involved in generating a product or providing a service are processes. For organizations to function, they have to define and manage numerous inter-linked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the ‘process approach’ to management.

The process approach is a way of obtaining a desired result, by managing activities and related resources as a process. The "process approach" is a key element of the ISO 9000 standards. For further guidance, please refer to the ISO 9000 Introduction and Support Package module: Guidance on the Concept and Use of the Process Approach for management systems.

Yes. The "process approach" is a generic management principle, which can enhance an organization’s effectiveness and efficiency in achieving defined objectives.

Identify the organizations intended outputs, and the processes needed for achieving them. These will need to include processes for Management, Resources, Realization and Measurement and Improvement. Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external. Identify the sequence and interactions of the processes.

The main purpose of documentation is to enable the consistent and stable operation of an organizations processes. Although statutory, standards or customer requirements may require certain documentation, there is no defined -catalogue, or list of processes that has to be documented in ISO 9001, apart from the 6 indicated ones. The organization should determine which processes are to be documented on the basis of: The size of the organization and type of its activities, The complexity of its processes and their interactions, The criticality of the processes and Availability of competent personnel. A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods.

The extent of detail is likely to depend upon factors such as: the size of an organisation and its types of activities, the complexity of its processes and their interactions, and the competence (level of education, training, skills and experience) of its personnel.

No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions. A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures. Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order.

There are various methods of measuring process controls and process performance, ranging from simple monitoring systems up to sophisticated statistically based systems (e.g. statistical process control, or SPC). The selection and use of any particular method will be dependent on the nature and complexity of an organizations processes and products. The effectiveness of an individual process may be measured by the conformity of its output or product to customer requirements. Its efficiency may be measured from its use of resources. In all cases the measurement of the process determines if its (measurable) objectives have been achieved. Sometimes it only requires monitoring to confirm process operations. Typical factors that are useful to consider when identifying measures of process control and process performance include: Conformity with requirements, Customer satisfaction, Supplier performance, On time delivery, Lead times, Failure rates, Waste, Process costs. Incident frequency

A "process" may be explained as a set of interacting or interrelated activities, which are employed to add value. A "procedure" is a method of describing the way or How activities shall/should be performed. ISO 9000:2005 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented.

Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and resources needed to satisfy customer requirements.

ISO 9001:2008 refers specifically to only 6 documented procedures; however, other documentation (including more documented procedures not specifically mentioned in ISO 9001:2008) may be required by an organization, in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary, depending on the size of the organization, the kind of activities in which it is involved and their complexity

Organizations have their quality management system registered/certified to ISO 9001:2008. The scope of registration/ certification will need to reflect precisely and clearly the activities covered by the organizations quality management system; any exclusion to non-applicable requirements of the standard (permitted through ISO 9001 clause 1.2 "Application") will need to be documented and justified in the quality manual.

When initially starting to use ISO 9001, an organization should familiarize its personnel with the Quality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), and consider how their guidance and requirements may affect your activities and related processes. If it then wishes to proceed to registration/certification, it should perform a gap analysis against the requirements of ISO 9001 to determine where its current quality management system does not address the applicable ISO 9001:2008 requirements, before developing and implementing additional processes to ensure that compliance will be achieved.

ISO 9001:2008 will supersede ISO 9001:2000 However, noting the IAF/ISO-CASCO/ISO TC176 agreement that accredited certification to the 2000 edition should remain possible for up to 2 years after the publication of ISO 9001:2008, copies of the 2000 edition will still be available on request from ISO and the national standards bodies during that period, and possibly for even longer.

Yes. Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008. However, certificates to ISO 9001:2000 will only remain valid until 2 years after the publication of ISO 9001:2008. Contact your certification/registration body to get details on the certificates transition process.

No standard alone can improve any thing; it is the implementation of it which makes the difference. Since the standards are based on some principles, which are known to be the best practices of business in the world. The implementation of the standard is bound to increase or improve Customer Satisfaction.

The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of approximately 157 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.

ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, are responsible for the development of the standards. The work is conducted on the basis of "consensus" among quality and industry experts nominated by the National Standards Bodies, representing a wide range of interested parties.

Copies of the standards may be purchased from your National Standards Body (see list with contact details), or from ISO Central Secretariat through the ISO Store of by contacting the Marketing and Communication department (sales@iso.org). Many National Standards Bodies have them available in local-language versions and also on subsidized rates.

There are a number of There are a number of sources of information on the ISO 9000 quality management system standards,including the website ,(www.iso.org) which carry first hand information on the standards. Your National Standards Body should be able to provide copies of the standards, and registrars/certification bodies www.iso9001eqfs.com) will be able to provide guidance on registration aggrements

ISO’s formal review process: Requires continual review to keep standards up to date. Must be initiated within 3 years of publication of a standard. User inputs from: A global user questionnaire/survey A market Justification Study Suggestions arising from the interpretation process Opportunities for increased compatibility with ISO 14001 The need for greater clarity, ease of use, and improved translation Current trends: Keeping up with recent developments in management system practices.

The revision process is the responsibility of ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties. All interested parties does mean that all certified organizations, Certification Bodies, Accreditation Boards. If you are an ISO certified organization, you may participate in reviewing the standard by giving your views to your certification body, or other wise on tech@eqfscertification.com

The revised quality management system standards (ISO 9000, 9001 and 9004) are scheduled as follows: ISO 9000:2005 already published – no major changes expected for 2009 Current plan is for small changes to ISO 9001 (an “amendment”) to be published in November 2008. More significant changes are planned for ISO 9004 (a “revision”) to be published in mid 2009.

ISO version (Taken from official website) One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize any potential costs during a smooth implementation. Any additional costs may be considered as a value-adding investment. A key factor in the development of ISO 9001:2008 was to limit the impact of changes on users. EQFS Version Cost: Expenses done for consumption purpose, where you do not get any return. Investment: Expenses done for making return from it. Implementation of the new standard takes investment, which is going to give you return on it. If you do not get return and you have the certificate in hand, it is useless and you are not following the standard as it should be.

See the ISO Catalogue on ISO Online web site that carries general information on the revision program. Your National Standards Body will give you additional information and the certification/registration bodies will be able to provide guidance on transitional arrangements in due course.

The starting point for any individual request for an interpretation should be with the certification body available with in the area. Since these are the people who are accredited for certify the system on ISO 9001 standard. Since they know the subject, they can help you on that

This is primarily an issue between your organization and your registration/certification body. ISO/TC 176 is working with the IAF (International Accreditation Forum) and ISO/CASCO (the ISO Policy Committee for Conformity Assessment) in order to provide relevant information in a timely manner. It is expected that conformity to the new ISO 9001:2008 standard will be evaluated by certification bodies during regular surveillance visits and that full reassessment will only take place once current certificates expire. However, it should be noted that ISO and the IAF have agreed that all certificates to ISO 9001 should be upgraded to ISO 9001:2008 within 2 years of publication of the amended standard. How ever this depends on the certification body’s policy. It is better to ask your certification body.

The active participation of experts from around the world in the preparation of the new standards, and the broad distribution of the draft standards, will facilitate the timely translation of the International Standards. Given the global importance of the quality management system standards, many National Standards Bodies are already working on the translation issue. ISO itself will publish the new standards in English and French, but if national language translations of the standards are currently available from your National Standards Body, we expect that they will have the translation of the revised standards ready at the time of publication by ISO or very soon thereafter. If you do not get the standard in the language you wanted, ask EQFS Certification Pvt. Ltd. to do the needful. We have the experts for almost all languages. The translation to the standard may be purchased on paid basis. That will be the translation not the interpretation of the standard. The price of the translated standard will be depending on the no. of copies and the language.

Will my organization have to re-write all its documentation? No. ISO 9001:2008 doesn’t introduce major changes to the requirements, when compared to ISO 9001:2000. However, to benefit from the changes, we suggest you get acquainted with the new version of the standard and the clarifications introduced. If, during your analysis of the clarifications you find there are differences from your current interpretation of ISO 9001:2000, then you should analyse the impact on your current documentation and make the necessary arrangements to update it. It is intended that the amendment of ISO 9001 will have minimal or no impacts on documentation.

Financial issues are not addressed in ISO 9001:2008, which is a requirements standard. The ISO 10014:2006 and ISO 9004:2000, Guidelines for performance improvements standards will emphasize the financial resources needed for the implementation and improvement of a quality management system. ISO 9001:2008 ask you to identify the process involved in Quality Management System. EQFS know that there is no specific clause for addressing financial issues, but you may address them by identifying the process and implementing the principles of ISO on it.

For ISO 9001:2008 the major benefits are: Simple to use Clear in language Readily translatable and easily understandable Compatibility with other management systems such as ISO 14001. For ISO 9004: Facilitates improvement in users’ quality management systems. Provides guidance to an organization for the creation of a quality management system that: - creates value for its customers, via the products it provides - creates value for all other interested parties - balances all interested-party viewpoints. Provides guidance for managers on leading their organization towards sustained success. Forward compatibility to allow organizations to build on existing quality management systems.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.

The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties. The management of an organization should be able to view the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue. Among the perceived benefits of using the standards are: The connection of quality management systems to organizational processes The encouragement of a natural progression towards improved organizational performance via: - the use of the Quality Management Principles - the adoption of a "process approach" - emphasis of the role of top management - requirements for the establishment of measurable objectives at relevant functions and levels - being orientated toward "continual improvement" and "customer satisfaction", including the monitoring of information on "customer satisfaction" as a measure of system performance. - measurement of the quality management system, processes, and product - consideration of statutory and regulatory requirements. - attention to resource availability

Every country has its body to work on national standard for product. That body normally acts as a participating member for the country.

The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis. (It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 range.)