What Is New In ISO 9001:2008 Standards

The new edition of ISO 9001 is an amendment and not a revision; in other words, the changes are very small. They are broadly as follows:

- the user-feedback survey on ISO 9001:2000 revealed that there were some ambiguities and some points needing clarification. These have been tidied up, along with clarification inareas that were previously too open to interpretation.

- the new edition has improved compatibility with ISO 14001 for those wishing to integrate their ISO 14001 certification with their ISO 9001 certification.

ISO 9001:2008 – What it means to certified organizations

For certified organizations, the transition period runs from 14 November 2008 to 31 December 2009. All organizations need to be compliant with ISO 9001:2008 by the end of 2009 to retain their certification. BSI’s clients will be audited against the new edition of the standard at their next continuing assessment or re-certification visit.

Antony Barrett, product marketing manager responsible for ISO 9001 at BSI Management Systems UK, comments: “We don’t see anyone having any problems in achieving the 2008 edition of the standard.” Client managers will work with clients to manage the process.

Revision Of ISO 9001:2008 In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

ISO 9001 Standards & ISO 14001 Standards

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study 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.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

ISO 9000 Standards Training Video

ISO 9000 Standards Training DVD

ISO 9000 Standards Training Video

ISO 9000 Standards Training DVD

ISO 9001 Standards Requirement – Product Realization

ISO 9001 Standards Requirement – Product Realization

Planning of Product Realization
Plan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the:
Quality objectives and product requirements
Need for processes, documents, and resources
Verification, validation, monitoring, measurement, inspection, and test activities
Criteria for product acceptance
Records as evidence the processes and resulting product meet requirements

Customer-Related Processes

Determination of Requirements Related to the Product
Determine customer requirements:
Specified for the product (including delivery and post-delivery activities)
Not specified for the product (but needed for specified or intended use, where known)
Determine:
Statutory and regulatory requirements applicable to the product
Any additional requirements considered necessary by the organization

Review of Requirements Related to the Product
Review the product requirements before committing to supply the product to the customer in order to:
Ensure product requirements are defined
Resolve any requirements differing from those previously expressed
Ensure its ability to meet the requirements
Maintain the results of the review, and any subsequent follow-up actions. When the requirements are not documented, they must be confirmed before acceptance.
If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed requirements.
NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information such as catalogs or advertising material.

Customer Communication
Determine and implement effective arrangements for communicating with customers on:
Product information
Inquiries, contracts, or order handling (including amendments)
Customer feedback (including customer complaints)