New Version of ISO 9001 out
CII Organizes Webinars for wide dissemination
The fourth edition of the immensely popular ISO 9001 Standard has recently been published by ISO, the International Organization for Standardization. ISO is an association of approximately 157 members, each representing one country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards.
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. Among these only ISO 9001 contains normative requirements, which on demonstration can qualify an organization to be independently certified. Other Standards in the family, important ones being ISO 9000 and ISO 9004, are guidance documents on quality management systems.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004 the normative Standard for Environmental management systems.
First published in 1987, the ISO 9001 Standard underwent the first change on 1994. However it was in the third edition in 2000 that major changes were incorporated in the standard including the Eight Quality Management Principles, concept of ‘Process approach’, and the Plan Do Check Act Cycle. The level of obligatory documentation was considerably reduced in the 2000 version assuming that mature and simple processes could be managed without documentation as long as the monitors and controls were in place. It was positioned as the new thinking in managing systems without being too prescriptive unlike its preceding versions.
In the normal course all ISO documents are required to be reviewed periodically and if required, revised. The process must begin three years after publication. Wide scale user inputs and surveys are conducted to decide on the nature and type of changes to be made. In the case of ISO 9001:2008, the inputs and survey results identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
ISO has clarified that ISO 9001:2008 does not introduce additional requirements, nor does it change the intent of the ISO 9001:2000 standard. However the changes have been made to improve both the understanding of the intent as well as level of compliance by re-emphasizing certain key aspects.
Some of the key changes are given as under:
- The term ‘conformity to product requirements’ has been added at several places to clarify that management of the systems and processes are not the end in themselves but the means to achieve product standards and customer satisfaction
- The term ‘statutory’ has been added to ‘regulatory’ signifying that both types of legal obligations apply as part of product requirements.
- Whenever an organization outsources any activity or part of its business, it is now obligatory to exercise control on these so that product conformity can be maintained in all circumstances
- Controls on the processes should be decided based on their impact on the product conformance. Here processes include even system processes ( such as planning processes)
- Whenever an organization takes corrective or preventive actions, it now has to ensure that these actions have a lasting impact. Internal audits would now require verification of the lasting impact.
- Management Representative, the key person who manages the quality system, should be from the organization’s own management and cannot be an outside person.
- IT based processes and information need to be managed and controlled both as part of infrastructure & equipment as well as in terms of resource.
- Customer measuring and monitoring can be done in several ways such as customer satisfaction through data analysis, surveys claims, warranties, dealer reports as long as the information can be analysed.
- The purpose of training is to achieve the level of competence required to do a job, the main emphasis being on achieving competence.
While no new requirements have been introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS
ISO / IAF have also clarified that 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
The CII Institute of Quality in partnership with the British Standards Institute, who hold the Secretariat to the ISO Subcommittee that has prepared ISO 9001:2008, have been conducting Webinars( internet based seminars) in which the changes are explained through presentation and audio commentary followed by live interactive sessions. Both the content of the Webinars and the format have received very favorable response. Mr Anupam Kaul, Senior Counsellor, CII Institute of Quality, who is a member of the Task Group of ISO Committee TC 176 is the Lead faculty for the Webinars.
(For further clarifications and related information Mr Anupam Kaul can be contacted at anupam.kaul@cii.in )