Iso 9000 iso 9001


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Iso 9000 iso 9001

  1. 1. Iso 9000 iso 9001This document describes the means by which compliance to the ISO 9000 series ofstandards will be determined as registered companies change from their current revision(1994) to the year 2000 revision. Bear in mind that transition criteria may vary slightlyfrom Accreditation Body to Accreditation Body (and therefore from Registrar toRegistrar), just as the interpretation of the current requirements varies somewhat.Six Registrars were surveyed regarding the transition. The following questions wereasked of them: • Assuming that a company is currently registered to ISO 9001:1994, how and when will a Registrar determine if the companys quality system meets the requirements of ISO 9001:2008? • What criteria or guidelines have been established to make this determination?The Registrars surveyed were among those known to have an active presence in the area:ABS, BSI, BVQI, NSAI, Orion and TUV. Some background for each Registrar isprovided below, as are any specific thoughts offered in response to the above questions.Three Accreditation Bodies were also queried: RAB, RvA, and UKAS. Their responsesare addressed later.Despite the uncertainty felt by many companies faced with changing standards, registrarsfeel that they know basically how their organizations will handle the transition.Although the specific language of the standard is uncertain, the Registrars auditingapproach will probably be affected very little. Orion seemed to capture the sentiment ofthe of the group: "Its really no big deal..." Not to imply that the Registrars areunconcerned, but rather they are confident that the transition will not be difficult-evenwith the uncertainty surrounding the details.There is a distinct possibility that some transition guidance will emerge from TC 176,from the International Accreditation Forum (IAF) and/or from Accreditation Bodies. Ifno such guidance is produced, however, the year 2000 transition would most probably belike the 1994 transition.According to that scenario, heres whats likely to happen: • Each Registrar, as an organization, will adopt a set of internal criteria for handling the transition. These criteria will address not only the changes to the requirements of the standard, but they must also include a scheme by which they recommend existing clients for certification to the revised standard. • The Registrars will then create a plan for achieving the changeover. They will document this plan (a quality plan) as required by their own quality system, just
  2. 2. as a company certified to ISO 9001 will "define and document how the requirements for quality will be met". (Certainly at this juncture, as part of planning, Registrars would consider any advisement of their Accreditation Bodies or other authorities, if any is provided.)Certainly this planning will address the revision of checklists to incorporate the new orrevised requirements. It will also include plans for training the organizations auditors tointerpret and assess the new requirements. Most Registrars also plan to provide theirclients with guidance for how to address the new criteria.For companies that are already registered, the Registrar may plan to audit them to thenew requirements during a surveillance audit, or perhaps over the course of two or threesurveillance audits. Some Registrars re-certify their clients every three years anyway, sothey might plan to audit entire systems for compliance to the new requirements as part ofa re-certification audit. For those companies pursuing certification for the first time, theywill be audited to the new standard. • Registrars will then submit their transition plans to their respective Accreditation Bodies. Accreditation Bodies ensure that Registrars auditing activities remain in compliance with ISO Guide 62, the guide applying to, you guessed it, the auditing activities of Registrars. Just as a Registrar determines compliance of a quality system to ISO 9001, the Accreditation Body determines compliance of a Registrars system to ISO Guide 62. So, Accreditation Bodies will review the Registrars plans to ensure that systems are in place to handle the transition and that the systems remain compliant with the guidelines of ISO Guide 62. (If the Accreditation Body provided a Registrar with guidance earlier, the body would also here determine if the guidance was properly addressed.) As plans are approved by the Accreditation Bodies, Registrars will return to their business of determining compliance to quality standards. • The Registrars auditors will then assess their clients quality systems according to their revised checklists. As mentioned earlier, this may be done during surveillance audits or during recertification audits. The Registrar might assess compliance to just one of the new elements, planning to capture the balance of the new requirements during subsequent surveillance audits, or the entire system may be audited for compliance to all of the new elements at once. • When an audit is concluded, the Registrar will send the Audit Report to the Accreditation Body (or Bodies). The Accreditation Body will review the Audit Report (and will occasionally conduct audits) to ensure that the Registrar is sticking to the stated plan. If everything is in order a certificate will be issued, much like business as usual.As can be seen from this account, Registrars have successfully ushered in transitions tonew revisions of standards with little or no guidance from external bodies. So, anyguidelines or directives provided to them (supplemental to any Accreditation Bodyadvisement) will be more guidance than they had with the 1994 transition. Perhaps this is
  3. 3. partially the basis for the Registrars confidence that the transition will not be difficult toachieve.THE REGISTRARS:Registrar: ABS (American Bureau of Shipping) - Over 3,100 registrations worldwide tovarious standardsServices/Courses Offered: ISO, 9000, ISO 14000, AS 9000, QS 9000, TE supplementRABAccreditations: RAB, RvA, INMETROOngoing Assessment Scheme: 6-month or 12-month surveillance without re-certification at the 3-year mark*ABS had very little to say about the transition. They believed that a transition guidelinewould be published by TC 176, but a draft of the document would not be available for "afew months". To their knowledge, the document is not yet titled.Registrar: BSI (British Standards Institute) - Over 32,000 registrations worldwide tovarious standardsServices/Courses Offered: ISO 9000, ISO 14000, AS 9000, QS 9000, CE Marking,TickIT, TL 9000, Kitemark, TE Supplement, VDA 6.1, BS 7799, EN 46000Accreditations: UKAS, RvA, INMETROOngoing Assessment Scheme: RAB 6-month surveillance without renewal orrecertification*BSI says that they will allow their clients two years to complete the transition. They willdetermine compliance during surveillance audits.Registrar: BVQI (Bureau Veritas Quality International) - Over 17,000 registrationsworldwide to various standardsServices/Courses Offered: ISO 9000, ISO 14000, AS 9000, QS 9000, SA 8000, CEMarking, EN 46000, TickIT, TL 9000, TE Supplement, TSSAAccreditations: RAB, UKAS, RvA, SCC, Cofrac, Sweda, Belcert, Swiss, DAR, Sincert,Danak, JAS-ANZ, INMETRO ENAC, JABOngoing Assessment Scheme: A 3-year certificate is issued.* Surveillance audits areusually conducted every 6 months, but they may be done at 9 or 12 months, ifappropriate. There is a recertification audit after 3 years.BVQI speculated that they will offer their clients a choice. They will either audit thesystem for compliance to the new requirements during a clients three-year recertificationaudit, or, they will audit the new requirements during surveillance audits. They willrecommend the client for certification to the year 2000 revision (or whatever year ithappens to be) only after compliance to all of the new elements has been verified. Thislatter option may take a year or two to complete.Registrar: NSAI (National Standards Authority of Ireland) - Over 2,000 registrationsworldwide to various standards
  4. 4. Services/Courses Offered: ISO 9000, ISO 14000, QS 9000, CE Marking, EN 46000Accreditations: RAB, NABOngoing Assessment Scheme: NAB 6-month surveillance without recertification at the3-year mark*NSAI said that they will complete the transition with their clients within one year afterthe new standard is adopted officially. NSAI will also determine compliance duringsurveillance audits.Registrar: Orion - Over 160 registrations worldwide to various standardsServices/Courses Offered: ISO 9000, ISO 14000, QS 9000, TE Supplement, AS 9000,CE MarkingAccreditations: RvA, SCCOngoing Assessment Scheme: 6-month or 12-month surveillance without recertificationat the 3-year mark *Orion says that they will offer their clients a choice for for handling the change-over.Either it will be done in one audit prior to a three-year renewal or it will be done inincrements during surveillance audits. They said it may take a year to a year and a half toimplement the change according to the latter option.Registrar: TUV Management Services - Over 9,000 certificates issued worldwide tovarious standardsServices/Courses Offered: ISO 9000, ISO 14000, QS 9000, AS 9000, TE Supplement,EN 4600, VDA 6.1, CE MarkingAccreditations: RAB DAROngoing Assessment Scheme: Surveillance audits are conducted either every 6* or 12months. When it is done every 12 months, a recertification audit is conducted after threeyears.TUV said that to his knowledge, TUV handled the 1994 transition in a unique fashion.TUV honored the validity of the expiration date for all ISO certificates. So they gavetheir clients until the expiration date on the (three-year) certificate to be compliant to therevised standard. TUV said that, barring any external direction, the year 2000 transitionwill be handled just like the 1994 transition.* Some Accreditation Bodies require Registrars to renew or recertify clients every threeyears, especially if the Registrar performs annual surveillances. Therefore someRegistrars (like ABS, Orion or NSAI) may, at the end of the 3-year mark, review theclients quality system documentation and examine any trends in surveillance auditresults over the 3-year period. If no major negative trends are discovered, the certificatewill be re-issued or renewed. Some Registrars (like BVQI) will conduct a full systemaudit after a 3-year certificate expires, and then will recertify the client. Other Registrars(like BSI) will conduct surveillances every 6 months and will not ever require renewal orrecertification. Still other Registrars (like TUV) will offer a choice between these options
  5. 5. or some combination thereof. Of course all of the above depends upon the requirementsof the Registrars Accreditation Body.THE ACCREDITATION BODIES:Registrar Accreditation Board (RAB):RAB described the "normal process" for handling the transition between one revision of astandard to another. They described the methods by which Accreditation Bodies willusually handle a transition: • The first way that transition guidance may be established for an Accreditation Body is through the direction of an external organization, such as the body who promulgated the standard, in this case TC 176. They said that the external organization might also establish a date by which the transition must be complete. • If no direction is provided as described above, Accreditation Bodies may determine how the transition will be accomplished according to the direction of the IAF, a group of (currently sixteen) Accreditation Bodies. • The IAF may prescribe an implementation plan that will be communicated to all Accreditation Bodies, who will flow down the requirements to Registrars. Accreditation Bodies may also directly contact each other to ensure that their courses of action are consistent. If the IAF provides no direction, the scenario described earlier for what happened in 1994 takes precedence. In this case, the Accreditation Body will often provide Registrars with a "Letter of Advisement" outlining any necessary transition guidance, sometimes including a date by which the transition must be complete.RAB speculated that guidance for the year 2000 transition will be developed according tothe first method described here, although they declined to speculate as to whom thisguidance would apply. If it applies to Accreditation Bodies, the guidance may beincorporated in a Letter of Advisement, which would be sent to Registrars as describedabove. Or, if it applies to Registrars, the Registrars will include the guidelines ordirectives as part of their quality planning. Then the process described for the 1994transition could then be followed again, except the Accreditation Body would not onlyverify the Registrars internal plans for the transition, but the body would also verify thatthe Registrars plans incorporate any applicable external guidance or directives.Raad Voor Accreditatie (RvA)RvA said that they have not yet set a policy for handling the transition, as they areawaiting final acceptance and translation of the standard. They expect that the RvA willnot have an official policy until mid-2001. They said that normally when a new or revisedstandard is adopted, the RvA will establish a policy and procedure for how to proceedwith assessing and recommending clients for certification. The procedure will be floweddown to Registrars, who will normally give their clients one year to comply.
  6. 6. United Kingdom Accreditation Service (UKAS)UKAS said that the year 2000 revisions will require more auditor training than the 1994transition did. This is so because the year 2000 standard will be more geared towardimprovement, whereas the 1994 standard is more concerned with compliance. So theybelieve that some extensive, skill-based training will be in order. UKAS is also awaitingpublication of the final draft before making any definitive statements about how they willhandle the transition. They surmised that the transition will be similar to the 1994transition, except that they, too, expect some guidance from the IAF or TC 176. Theysaid that UKAS will develop a transition plan, including a completion date, and willcommunicate the plan to all of its Registrars. UKAS will likely allow one year tocomplete the transition (as they did in 1994).TWO FINAL NOTES: 1. According to a document posted on ISOs website, "A major requirement of the ISO 9000 revision process is that organizations which have implemented the current ISO 9000 standards will find it easy to transition to the revised standards... transition planning guidance is being produced." The nature of this "transition planning guidance" is not addressed, but this entry may well be alluding to the guidance being developed by TC 176.TC 176 is indeed developing transition guidance. The level at which such guidance will be introduced is as yet undetermined. Its method of publication has not yet been determined and neither has its content been finalized. As mentioned before, RAB would not speculate as to whom this guidance would apply-the Accreditation Bodies, the Registrars, or the end users. Being "close to members of TC 176″, RAB said that they do "not expect final answers to these questions anytime this year". RvA and UKAS felt that the guidance document will most probably be geared toward Registrars and/or users of the standard and not Accreditation Bodies. The publication of such a guidance document represents a difference from the transition between the 1987 and the 1994 version. No guidance document was ever published by ISO to facilitate the change-over from 1987 to 1994. However, the 1994 revisions to the standard were relatively minor when compared to the proposed year 2000 revisions. 2. The year 2000 revisions to the ISO 9000 series of standards will most likely have some effect on other ISO 9000-related standards like ISO 14000, QS 9000 and AS 9000.ISO TC 207 (the committee responsible for ISO 14000) has considered revising ISO 14000 to accommodate the revision to ISO 9000. However, further consideration is pending the official publication of ISO 9000:2008. Since QS 9000 recently underwent revision to the 3rd Edition (last year), not much is being said yet about how it will be revised to accommodate the change in ISO 9000. According to representatives from SAE the body responsible for revising AS 9000-the American Aerospace Quality Group (AAQG)-met two weeks ago. During the meeting, two major suggestions for revision to AS 9000 were considered. The first came from Boeing, who presented 17 specific proposed revisions to the standard. The second source of proposed revisions dealt with the
  7. 7. goal to harmonize AS 9000 with EN 9000 (the European standard containing requirements for the Aerospace industry above those contained in ISO 9000). Currently the group is most concerned with addressing these two bodies of revisions. The committee is not speculating about how or if AS 9000 will accommodate the year 2000 revisions to ISO 9000. Scott suggested that the committee would most likely harmonize AS 9000 with EN 9000 and incorporate the Boeing suggestions first, and then when the official revisions to ISO 9000 are adopted they will consider revising the harmonized AS/EN 9000 standard to be aligned with the new ISO 9000 standards.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards