As with other standards, the standards ISO 9001 Quality Management System are reviewed periodically, each ± 6-7 years. When this review is being conducted in the last revision of the ISO 9001 standard which was issued on December 15, 2000 to ascertain whether these standards are still relevant or not with the situation and conditions of business / industry today. At the end of 2008, this ISO will issue new standards such as ISO 9001:2008 which will replace ISO 9001:2000. Companies that have implemented ISO 9001:2000 must make a change (up grade) to ISO 9001:2008 for can still use the certificate. Usually given tolerance within 2 years from the latest version was launched.
Review (revised) conducted by the various working groups and committees within the ISO / TC 176 through the processes that produce documents, respectively: Committee Draft (CD) 1, CD 2, and the final DIS / ISO 9001:2008 . Currently, DIS / ISO 9001:2008 are in the process of ballot to be a Final Draft International Standard (FDIS).
Some things related to the revision of the ISO 9001 standard are:
Overall, the changes that occurred only a few (minor) so that the organization would not be too problematic in adopting it into their system.
The design process for ISO 9001 revision is decided that if major revisions have occurred before, then the next revision will be made minor revisions.
Significant changes contained in the ISO 9004 standard which is a guidance document (not the requirements).
Here are the changes contained in the DIS / ISO 9001:2008:
CHANGES IN STANDARD ISO 9001:2000 vs. DIS / ISO 9001:2008
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SECTION CHANGES
0.1 Para. 3 Terms of rules / regulations (statutory & regulatory) associated with the product explicitly requested (must be identified from the start).
0.4 Added explanation that considers the development of ISO 9001:2008 ISO 14001:2004 standard.
clauses 1.1 and 1.2
• Mentioned returned product regulatory requirements.
• Note 1: added that the term of the product (in product realization), including the products purchased.
• Note 2: Rules / regulations are legal requirements (legal).
clause 2 Reference used is ISO 9000:2005.
clause 3 Description of Customer - Organization - Supplier removed.
clause 4.1
• The word "identification (identify)" changed to "determined (determine)."
• The statement regarding outsourced processes gnats are emphasized but the point remains the same.
• Note 2 is added to clarify that the outsourced process may be related to clause 4.7 (Purchase).
• Note 3 expansion of the type of control. Control is performed on an outsourced process.
4.2.1
• The wording somewhat laid back but the point remains the same.
• Note 2 is added to clarify that a single document may consist of a requirement for one or more procedures. A requirement for a documented procedure to include more of the document, such as: Correction and Preventive Action documents into one document.
4.2.3.f Clarification regarding references to external documents to be required in the Quality Management System.
4.2.4
The length of this clause be significantly reduced but the requirement has not changed.
5.1.a
Added the word "statutory".
5.5.2
Added requirement that the Deputy Management needs to come from members of the organization's management.
6.2
• Change of title but the sentence remains the same (changes in the command).
• Version 2000 mentions' ... ... ... ... ... ... have an impact on product quality ', is now a' ... ... ... .... impact on the conformity to product requirements'.
• 6.2.2 b) standa 2008 states that 'if applicable' training needs to be provided to meet the required competencies.
• 6.2.2 c) 2008 standard states that guarantee the fulfillment of competence from examination of the effectiveness of training.
6.3
c) including information systems.
6.4
Added note to explain that the work environment including noise, temperature and humidity.
7.1
c Added the word measurement.
7.2.1
• a bit stressed.
• the words 'relating to' changed to 'applicable'.
• A statement of the additional requirements specified by the organization to be considered by the organization.
• Added note to explain that the word 'activity after delivery', including: provision of guarantees, etc..
7.3.1
Added note to explain that design review, verification and validation are separate activities, although its implementation may be separated or combined (combination), such as verification and validation activities performed together.
7.3.2
In the last paragraph, the word these inputs into the inputs (only).
7.3.3
• The word 'provided' is removed and the words 'according to (Suitable for)' changed to 'that can (That enables)'.
• b) the word 'for' (service provision) is removed.
• Added a note that considering the scope of 'protection products'.
7.5.3
• Additional requirements to clarify that inspection and test status should be identified during product realization.
• little emphasis on recording kemamputelusuran requirements.
7.5.4
• Emphasis on the requirement to inform customers if there are problems and record storage.
• Statement "and personal data" is added to the record of intellectual property.
7.5.5
• The emphasis of the "appropriateness of (conformity of)" to "in order to maintain / maintain conformity to requirements".
• "where appropriate (Appropriate Nowhere)" changed to "if it can be applied (as applicable)".
7.6
• The word "equipment (devices)" in the title was changed to "equipment (equipment)."
• Words Referring to 7.1 eliminated.
• c) "are identified to be" changed to "have the identification to be able to (have to enable Their identification)."
• Note 1 is added to eliminate the word Referring to 10012-2 and replaced in Note 3 to explain the neighbor verification and configuration management of computer software (if used for monitoring and measurement activities.)
8.2.1
Added note to provide some idea of how customer satisfaction can be measured.
8.2.2
• Requirements for documented procedure has been worded but remains unchanged.
• Added requirement to audit records and the results.
• Added requirements for management responsibility to the area being audited to ensure corrective and preventive actions are required.
• Note that the reference to ISO 10 011 was changed to ISO 19011.
8.2.3
• The statement "to ensure conformity of products" was omitted.
• Added note to explain that the organization should consider the type of monitoring and measurement process and its scope which affects the quality and the QMS.
8.2.4 Requirements for "maintenance of evidence conformance to acceptance criteria has been transferred but it is still a requirement.
8.3
• Terms of documented procedure has been worded but remains unchanged.
• The statement "if it can be applied (Nowhere applicable)" added the method to solve the problem of incompatible products.
• Requirements for completion of the product does not fit that covers events after the shipment has been transferred to the bullet d) but not changed.
• Terms of recordings transferred but did not change.
With this latest version of the plan to issue the authors suggest that companies are conducting or lemabaga ISO certification can choose the following 2 alternatives
1. As soon as possible to the ISO 9000 certification process prior to release the latest version
2. Delaying the process of ISO 9000 certification means to wait for the latest version
The choice of two alternatives depending on the urgency of the ISO 9000 certificate for the organization / company that will memeperolehnya.
source: CFG Consulting
