Friday, April 11, 2008

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ISO 9001:2008 - QUALITY

blog Background on Review

To keep up to date and consistent with current trends in management, ISO standards require periodic review, which is done at least every 5 years.

As a result of the last review, the new version of ISO 9001 be published in October this year (2008), while the new standard ISO 9004 is scheduled for publication in August 2009 with a new title "Managing for sustainable success - An approach from the Quality Management (Managing for Sustainable Success - A Quality Management Approach) . It is estimated that This new version has 10 chapters and 5 appendices which include a self-assessment tool at two levels: strategic review aimed at the Directorate General and operational evaluation.


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Objectives of the review

3 are the main objectives of this review:

* Improving the current rule
* provide greater clarity and ease of use
* Improved compatibility with ISO 14001:2004

Scope of changes

* Maintain the structure of the standard:
- System Requirements (clause 4)
- Responsibility, Authority and Communication (clause 5)
- Resource Management (clauses 6)
- Product Realization (clause 7)
- Measurement, Analysis and Improvement (clause 8)

* continue unchanged 8 Principles of Quality Management
* Maintain the focus of ISO processes 9001:2000.
* The rule retains its generic and its applicability to all types and sizes organizations of any sector.
* Compatibility with ISO 14001:2004 has been maintained and improved where possible.
* Maintain consistency ISO 9001 and ISO 9004 .

General considerations regarding changes

changes have been restricted to limit the impact to users. In this sense, changes were made only where clear benefits were visualized.
No conceptual or substantive changes.
The aid package will be used ISO 9001:2000 to assist editors in identifying issues that need clarification.
estimated maximum transition period of 2 years from the 2008 version publicationof (between August and October this year) and 2010 follow-up audits or recertification ISO 9001:2008 Seram against . Eventually
"coexist" companies certified under ISO 9001:2000 and ISO 9001:2008
times of transition and other elements are defined by accreditation bodies:
, etc and not by ISO itself, although it makes recommendations
Impacts and Benefits

As mentioned above, this standard of review has focused on high-profit aspects of parallel imply a low impact.

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Other considerations on the revised standard

improvements involving a high profit at the expense of a high impact will be delayed until 2012.
were analyzed responses from 941 users in 63 countries
1477 individual comments were collected.
The report contains the four product categories of ISO 9001:2000 (Hardware, Software, Products and services produced).
80% of respondents were satisfied with ISO 9001:2000
The aid package ISO 9001:2000 is used to help writers to identify aspects that need clarification.
Overview
changes

Clause - 1.1. General

The terms "legal" and "regulatory" associated with the product.

Clause 4.1. General Requirements

"Identify" instead of "identify" the processes necessary for the management system.

Clause - 4.2.1. Documentation requirements (General)

Includes "records, determined by the organization needed to ensure effective planning," which already appears in el7.1. version 2000.

Clause - 6.2.2. Competence, awareness and training:

It includes ensuring that have achieved the necessary skills in place to ensure the effectiveness of actions taken.

Clause 8.2.1. Customer satisfaction

It introduces the term "indicator" for measuring customer satisfaction as an indicator for the performance of quality management system ... "

Apart from the above are some clarifications relating to aspects already mentioned in the version the text of the standard ISO 9001 2000 , it seeks to simplify and facilitate its application to a larger number of sectors:

1.1. General (Scope)

ampla is the term "product" to purchases and any product obtained from the intermediate stages in the process of realization.

4.1. General Requirements,

Note 2: Clarifies the need for the application of paragraph 7.4 to the processes outsourced to the realization of products / services.

4.2.1. Documentation requirements (General)

Note 1 clarifies that it is possible that a single procedure can cover a number of requirements or a requirement can be met with various procedures.

Section 4.2.3. Control of documents:

Send f) clarifies that it is necessary to identify the external source documentation "necessary to the quality management system."

6.4. work environment

This concept has direct impact on meeting the product requirements.

7.2.1. Determination of requirements related to

product

Note: The post-sales activities should include guarantees, contractual obligations, maintenance and additional services such as recycling or final disposal (disposal)

7.3.1. Design and development planning

Note: In the product design planning, it is clarified that the review, verification and validation should be conducted and recorded separately or in combination as appropriate to the product or organization.

7.5.4. Customer property

Note: "personal data" are defined as customer property.

7.6 Control of monitoring and measuring equipment

Note: The suitability of software to suit the intended application must include verification management and configuration.

Paragraph 8.2.3. processes monitoring

Note: The impact on the conformity of product requirements andthe effectiveness of the System of Quality Management, will determine the degree and type of monitoring required by the process.

8.5.2. Corrective Actions / Preventive Actions 8.5.3

Clarifies the need to review the "effectiveness" of the corrective and preventive actions

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