Scope of Quality Management System and Scope of International Standard ISO
Both conceptually and in practical application of the audit must learn to differentiate between the scope of ISO 9001:2008 and scope of the certification of our Quality Management System (QMS).
That is, should not be confused with the scope of the QMS, which is a term commonly used to describe the processes, products (and / or services) and sites, departments, divisions, etc.. to which the organization has a formal QMS. (Note: this does not necessarily include all processes, products, sites, departments or divisions, and so on. Of the organization.)
The scope of the QMS should be based on the nature of the products of the organization and realization processes, the result of risk assessment, commercial and contractual considerations, and legal and regulatory requirements.
Although ISO 9001:2008 is generic and applies to all organizations (regardless of type, size or product category), in some circumstances, some organizations may exclude some requirements specific clause 7, although they are allowed to declare compliance with the standard.
This is because it is recognized that not all the requirements of this clause of the standard are relevant to all organizations. ISO 9001:2008 by itself allows for such situations, through clause 1.2 Application.
Accordingly, the scope of certification includes the scope of the QMS and describes the requirements of ISO 9001 that have been excluded.
Since the terms and scope of the QMS scope of certification is exchanged frequently, this can cause confusion when a client or an end user tries to identify the parts of the organization that have been certified against ISO 9001, product lines or processes covered by the QMS and ISO 9001 requirements that have been excluded.
To dispel such confusion and allow the identification of what has been certified, the scope of certification should clearly define the following:
a) The scope of the QMS (including details of product lines and sites, departments, divisions, and so on. Related covered by it);
b) The main processes of the organization for the realization of your product or service delivery activities (such as design, manufacturing and delivery) for the covered product lines;
c) Any requirement of ISO 9001 which has been excluded.
It should be noted that the scope of certification is not the same certificate granted to an organization after successfully demonstrate compliance with ISO 9001. The certificate shall include a description commonly synthesized the scope of the certification, but not the details of the requirements of ISO 9001 that have been excluded, but may include a note referring to the fact that the exclusions are detailed in the Quality Manual of the organization.
It is important that the organization prepare a preliminary scope of certification before applying for certification. This would be discussed later by the Certification Body in the first stage of the audit to the proper planning of the second stage
The auditor is responsible for:
1 .- Ensure that the final declaration of the scope of certification should not be misunderstood;
2 .- Check that this scope only refers to processes, products, sites, departments or divisions, and so on. of the organizations that were evaluated during the certification audit, and
3 .- Verify that the scope defines any exclusions from the requirements of ISO 9001, provided justification for these exclusions and this is reasonable.
As an additional measure to combat potential confusion among customers and end users, the scope of certification should be clearly defined in the quality manual of the organization and publicly available documents (this includes, for example, promotional material and marketing).
However, promotional claims should never be included in the scope of certification.
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Tags: Management System, product lines, product or service, Regulatory requirements