Iso 9001 2000 iso 9001 2008

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Iso 9001 2000 iso 9001 2008

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  • 1. Iso 9001 2000 iso 9001 2008Congratulations 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. Its 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

2. 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 - Its about time. A lot of headaches are vowed to be save. If your auditorwas 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 organizations 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" 3. 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 offactories 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 wasnt clear enough for ouropinion.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. 4. Paragraph number 7.5.3 - A requirement had been added regarding the measurements andtest status must be identified throughout the product realization.My comment - This requirement so far was required in standards such as ISO 13485Standard for medical devices and the ISO/TS 16949 for the automobile industry. Therequirement assures you that the inspection activities are defined maintained andrecorded and so is the products status.Paragraph number 7.5.4 - A change of words in the requirement to inform the customerof any problem regarding his property.The note had been amended that also personal data is included as customers property.Paragraph number 7.5.5 - A change of words:"devices" in the title was changed to "equipment""conformity of" to "in order to maintain conformity to requirements".Reference to paragraph 7.1 was removedParagraph 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 thecomputer is used for monitor and measurements processes.My comment - That means that from now on, a computers that provides any kind ofmeasurements services, is considered as a monitoring and measuring device. And whenthe computer configuration has been changed - the software is required to be calibratedagain.How can one calibrate a computer? Ask your supplier or your system administrator. Theywill know better than anyone. But you would have to prove it has been done and presentevidences. 5. Paragraph number 8.2.1 - A note had been added to suggest some means of conductingcustomer satisfaction evaluation.Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.Requirements for the management responsibility had been added - The management isresponsible for ensuring preventive and corrective action to be taken.The reference to the ISO 10011 is changed to ISO 19011.My comment - As I see it, that means an addition within the Management Responsibilityprocedure or the Internal audit procedure about management ensuring that preventive andcorrective actions would be taken according to the results and decisions of the internalaudit and a reference to the validation and verification.Take a look at the next web site that provides you with prepared solutions for internalaudit procedure the9000store.com.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 themonitoring and measuring according to the processes and how will this affect the qualitymanagement system.Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity withacceptance criteria" had been removed but it is still a requirement.Paragraph number 8.3 - An addition: Clause d - specify how to deal with anonconforming product that was discovered after delivery - but actually there nothingnew only that they moved it to a new clause.So, what are the new requirements of the new standard? Statutory requirements are given scale as any other legal or customers requirements. The statutory requirements include the suppliers as well. A purchased process is just like any other product that the organization purchased. If its affecting the product it must be under the quality management system. You may include two quality processes in one document and split one process into two documents. The management representative must be a member of the top management. A requirement to ensure that trainings are suitable for the product in advance and not to examine whether the training was effective after it was taken. 6. Information system is now officially considered as a substructure. Parameters such as humidity, noise and temperatures, concerning the employees health are considered as working environment. Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes. Software configuration is a reason for re-calibrating the software. The management is now responsible for preventive and corrective actions regarding nonconformities that were revealed during internal audits. The organization should determine the type of the monitoring and measuring according to the processes and indicate how this would affect the quality management system.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards

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