Iso 9001-2008 Vs.Iso 9001-2000 – The New Requirements And Comparison Between Them
The ISO 9001-2008 changes are as below:
Paragraph number 0.1 - Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product. Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
Paragraph number 1 - Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005 Paragraph number 3 - Explanation about what is a customer and what is an organization and what is a supplier had been removed. Paragraph number 4.1 - Clause a - The word "determine" is replacing the "identify". A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.
Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.
Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system. Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An addition for a demand that the management representative would be a member of the organization's management
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting
conformity to product requirements" Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the
necessary competence".
Clause c - you must ensure that the training is with competence rather than if it was an effective training. Paragraph number 6.3 - Clause c - information systems are included. Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environmentParagraph number 7.1 - Clause c - measurement had been added to the activities. Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word 'applicable' replaces 'related'. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of "post delivery activities". Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together. Paragraph number 7.3.3- A change of wording. A note had been added clarifying what is included in "preservation of product". Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization. Paragraph number 7.5.4 - A change of words to in the requirement to inform the customer of any problem regarding his property. The note had been amended that also personal data is included as customer's property. Paragraph number 7.5.5 - A change of words: from "conformity of" to "in order to maintain conformity to requirements" Paragraph number 7.6 - A change of words: from "devices" to "equipment" The reference to paragraph 7.2.1 had been removed. Clause c - from "be identified to enable the"to " identification to enable their"
Changes in the notes: Note 1 - the reference to ISO 100012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation. Paragraph number 8.2.2- Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011. Paragraph number 8.2.3 - A change of words: "to ensure conformity of the product" had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system. Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement. Paragraph number 8.3 - An addition - Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
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