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Iso 9001 2008 Requirement

Iso 9001 2008 Requirement

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Published by beardsley5010
Iso 9001 2008 requirement
Iso 9001 2008 requirement

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Published by: beardsley5010 on Mar 17, 2011
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11/19/2012

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Iso 9001 2008 requirement
Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008.This is really an exciting moment for quality managers. In order to celebrate this event ina way that only quality managers know how, I prepared here a comparison articlebetween the ISO 9001:2000 and the new born ISO 9001:2008. I also included mycomments regarding my experience and my perspective of things.At the end of it I will summon the new requirements from the new ISO 9001:2008standard.Paragraph number 0.1 - Changes here are a statement about whom and where thestandard includes any statutory requirements. Statutory requirement (of any kind) has thesame scale as any customer or regulatory requirements. It's also clarified that theserequirements are restricted to those applicable to the product.Paragraph number 0.4 - There is a comment that state that the new standard is made dueconsideration to ISO 14001:2004.My comment - Of course. The world is getting greener every day so they must remindyou of the ISO 14001 standard. I believe and recommend to any organization that isrequired to implement the ISO 14001 standard to implement also the ISO 9001 standard.There is a big correlation between the two. They actually support one another. It wouldbe easier for organization to obtain the ISO standard 14001 requirements if it has beenalready certified for ISO 9001.Paragraph number 1.1 & 1.2 - Statutory requirements had been referred in relation withpurchased products and product realization. Second note explains that a statutoryrequirement can be a legal requirement.My comment - After so many years of auditions the long last debate had been settled.Statutory legal requirements and regulatory requirements are applicable to the purchasingprocesses as well. It was always an open area that no one had the exact answer: Doesyour supplier must follow the law or not? Apparently yes.Paragraph number 2 - Normative reference - the ISO 9000 is now replaced by ISO9000:2005.Paragraph number 3 - The explanations about what is a customer and what is anorganization and what is a supplier had been removed.Paragraph number 4.1 - Clause a - The word "determine" replaces the word "identify". Anote had been added stating that a purchased processes are regarded as purchasing
 
products. Another note had been added demanding that these processes would becontrolled as well as products.My comment - When identifying, you are required to search and find somethingaccording to the requirement. When determining, the responsibility of the results is inyour hands...It was obvious before.... Sometime they feel a need to state the obvious.Paragraph number 4.2.1 - Slight change of words, but when you examine the change yourealize the meaning remains same.Note 2 was changed: A single document may include requirements for more than oneprocedure. Requirements of one procedure may appear in more than one document.My comment - It's about time. A lot of headaches are vowed to be save. If your auditor was one of the old schools and demanded everything by the book, you had troubles. Nowyou may document two quality requirements on one document: Job description andtrainings, for example. Or you can split one record into two documents. However it issuitable for you as long as you achieve the requirements.A good example is that it is possible to combine the corrective and the preventiveprocedures together. As long as you maintain the requirements...Paragraph number 4.2.3 - Paragraph f - A clarification that external documentation isconsidered while it is part of the quality management system.My comment - When an external document is part of your quality management system, itis required to be included under the quality procedures: documents control and recordscontrol.Paragraph number 5.1 - Clause a - the word "statutory" had been added.Paragraph number 5.5.2 - An additional requirement that the management representativewould be a member of the organization's management.My comment - That addition puts all external consultants at risk - you can no longer bethe management representative. That sets a whole new line of form and documentationsfor you to develop in order that the external consultants would be considered as amanagement representative. All external consultants would have to be creative on thisone.Paragraph number 6.2 - Change of words from "affecting product quality" to "affectingconformity to product requirements"
 
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy theseneeds" changed to "where applicable training needs to be provided to achieve thenecessary competence"Clause c - you must ensure that the training is with competence rather than if it was aneffective training.My comment - It all goes back to defining .You defined what is necessary now you mustprovide it - nothing is new. On one hand it is an improvement. The training must bereviewed before for its competence to the requirements. But we are still on this one. Wethink: instead of testing your employees if they got anything out of the training you mustnow review the training itself before or maybe both.... Only time will tell...Paragraph number 6.3 - Clause c - information systems are included.My comment - They are totally right!Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a workingenvironment.My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard...Paragraph number 7.1 - Clause c - measurement had been added to the productacceptance activities.Paragraph number 7.2.1 - Clause a - change of words - not of the meaning.Clause c - the word 'applicable' replaces 'related'. Change of words - not of the meaning.Clause d - change of words - not of meaning.A note had been added to explain the meaning of "post delivery activities".My comment - I agree with the "post delivery activities" - it wasn't clear enough for our opinion.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 words. A note had been added clarifying theinclusion of "preservation of product".My comment - The preservation of the product is to be included now in the design andthe development outputs.

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