Wow, now my school got ISO 9001:2008. I hope with this appreciation, my school can get International Standarized School title. But every people didn't know what's ISO. I would to give little about ISO 9001:2008 :
1. Introduction
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. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
No new requirements were introduced in ISO 9001:2008 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 9001:2008 is intended to be generic and applicable to all organizations, regardless of type, size and product category. It is recognized, however, that not all the requirements of this standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may consider the exclusion of the application of some requirements of ISO 9001:2008 from its QMS. ISO 9001:2008 makes allowance for such situations, through sub-clause 1.2 Application.
This module of the ISO 9001:2008 Support Package has been developed by ISO/TC 176/SC 2 to provide users with information regarding the intent of ISO 9001:2008 sub-clause 1.2 Application, including some typical examples of its use in practical situations (see Annex A).
2. The concept of exclusions
Sub-clause1.2 Application of ISO 9001:2008 states:
“1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.."
Therefore, an organization should consider whether all the requirements of the standard are relevant to its activities, based on the nature of the organization itself, its products, and the processes it uses to meet customer, statutory and regulatory requirements. In addition, the organization should take into account any commitments it has made in its quality policy and objectives and how these could affect the need to undertake particular realization processes. All of these can affect the scope of the organization’s QMS.
3. Justification for exclusion
If an organization identifies requirements of clause 7 of ISO 9001:2008 that cannot be applied to its activities, the organization can consider exclusion of these requirements, provided there is valid justification.
The exclusion of requirements of clause 7 of ISO 9001:2008 is only acceptable if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.” The appropriateness of the exclusion depends on considerations of items such as:
* Who is the customer ?
* What is the product ?
* What are the requirements (stated and not stated) related to the product ?
In some cases the exclusion may not be justified depending on who is the customer, and what is the product.
It should be noted that ISO 9001:2008 sub-clause 1.2 Application can be applied to individual requirements or sub-clauses of clause 7 Product realization. For example, an organization may exclude part of (f) of sub-clause 7.5.1 Control of production and service provision, if the organization has no accountability for post-delivery activities.
Sub-clause 4.2.2 Quality manual of ISO 9001:2008 states:
“The organization shall establish and maintain a quality manual that includes
(a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),..…”
All exclusions need to be expressed in the quality manual (with valid justifications) and have to be consistent with the scope of the organization’s QMS. Any publicly available documents, promoting conformance to ISO 9001:2008, should clearly state the scope of the QMS in a way that will not mislead customers and end users. This should ensure that the necessary information is available for the user to determine which categories of product and product realization processes are included. In addition, the scope of the QMS should be explicit in stating the responsibility for product design and development and other principal realization processes such as manufacturing, sales and services.
When an organization is evaluating whether it can exclude requirements from its QMS, it should carefully evaluate the impact of such exclusions from the viewpoint of its customer. If there is an impact on the customer, the exclusion would not be justified, since ensuring the conformity of delivered products to customer requirements is a key element of ISO 9001:2008.
Also, organizations considering exclusions should recognize that customers often have no knowledge of the internal operations of the organization from whom they purchase products (and really do not care how or where organizations design, manufacture or support products). The customer looks at the organization as an entity and expects all elements of the organization (e.g. design, manufacturing, purchasing, repair) to work together to ensure the conformity of its products.
4. Claims of conformity
The final paragraph of sub-clause 1.2 Application of ISO 9001:2008 states:
“Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.”
If an organization excludes requirements from its QMS which do not meet the criteria presented in sub-clause 1.2 Application, conformity to ISO 9001:2008 should not be claimed or implied. Examples of situations where conformity to ISO 9001:2008 should not be claimed are:
* Where requirements in clause 7 have been excluded because regulatory bodies do not demand compliance to them, but the requirements affect the organization’s ability to meet customer requirements,
* Where an organization excludes a requirement in clause 7 based only on the justification that this had not been previously included in the organization’s QMS, without taking into consideration whether the clarifications introduced in ISO 9001:2008 have an impact on their current interpretation of ISO 9001:2000. If the organization’s former interpretation of ISO 9001:2000 is different from the clarifications provided in ISO 9001:2008 then changes may be necessary to its QMS
* Where an organization excludes a requirement on the basis that the activity has been outsourced (for further guidance see the ISO 9000 Introduction and Support Package module: N630 R3 - Guidance on Outsourced Processes).
Source from
ISO website
