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I SO developed separate gui del I nes for audi ti ng qual I ty and envi ronmental management systems. The two sets of standards do not differ fundamentally from each other. I SO 14012 requires that envi tor qual fi cati on audi tor have knowl edge of environmental sci ence and technol ogy.
I SO developed separate gui del I nes for audi ti ng qual I ty and envi ronmental management systems. The two sets of standards do not differ fundamentally from each other. I SO 14012 requires that envi tor qual fi cati on audi tor have knowl edge of environmental sci ence and technol ogy.
I SO developed separate gui del I nes for audi ti ng qual I ty and envi ronmental management systems. The two sets of standards do not differ fundamentally from each other. I SO 14012 requires that envi tor qual fi cati on audi tor have knowl edge of environmental sci ence and technol ogy.
separate gui del i nes for audi ti ng qual i ty and envi ronmental manage- ment systems (Figure 1). The three parts of I SO 10011 provi di ng gui d- ance on the audi ti ng of qual i ty man- agement systems were i ssued i n 1991. The three separate gui del i nes for the audi ti ng of envi ronmental manage- ment systems I SO 14010, I SO 14011 and I SO 14012, were publ i shed i n 1996. Duri ng the devel opment of the I SO 14010 series, due attention was paid to I SO 10011 and, therefore, the two sets of standards do not di ffer fundamentally from each other. I n particular, I SO 10011-1 and I SO 14011 on audit procedures, and I SO 10011-2 and I SO 14012 on audi tor qual i fi ca- ti ons, show great si mi l ari ti es. Of course, I SO 14012 requires that envi- ronmental audi tors have knowl edge of environmental management, envi - ronmental sci ence and technol ogy, and envi ronmental l egi sl ati on that i s different from the knowledge require- ments i n I SO 10011-2. Nevertheless, the framework of qual i fi cati on cri te- ri a i n terms of educati on, trai ni ng, and work and audi t experi ence i s basi cal l y the same. I N T E R N A T I O N A L I SO develops uni que standard forauditing ISO 9000 and ISO14000 systems As part of ISOs response to ISO 9000 and ISO 14000 users requirement for maximum compatibility between the two families of standards, the organization is developing a unique guideline for the auditing of both quality and environmental management systems. The draft International Standard ISO/ DIS 19011, Guidelines for quality and/ or environmen- tal management systems auditing, was published on 31 May 2001 and has been distributed to ISOs members for a five-month ballot, closing on 31 October 2001. Its publication as an International Standard is expected in the second half of 2002. ISO 19011 will complete the ISO 9000 core series also comprising the revised ISO 9000, ISO 9001 and ISO 9004, published in December 2000. It is being developed by a joint working group set up by sub- committees of two of the most well known ISO technical committees: ISO/ TC 176, Quality management and quality assurance, and ISO/ TC207, Environmental management. The development of ISO 19011 is a unique project for ISO as is it the first document to bridge the gap between the famous ISO 9000 and ISO 14000 families of standards. This article describes the background to this project and highlights the major features of the future standard. U D i ck H ortensi us i s Seni or Standardization Consultant wi th the N etherlands Standardization I nstitute N EN ) . Closely involved with the development of the I SO 1 4000 seri es on envi ronmental management, he serves as Secretary of the Joint Working G roup on Audi ti ng set by Subcommi ttees 3 and 2, respectively, of I SO Technical Committee ISO /TC 1 76 ISO 9000) and ISO /TC 207 ISO 1 4000) . Dick Hortensius, NEN, P.O. Box 5059, NL-2600 GB Delft, Netherlands. Tel. + 31 15 2 69 03 90. Fax + 31 15 2 69 01 90. E-mail Dick.Hortensius@ nen.nl Web www.nen.nl B Y DICK HORTENSIUS 38 ISOManagement Systems December 2001 More recent was the devel op- ment of a gui del i ne descri bi ng the general pri nci pl es of envi ronmental audi ti ng, I SO 14010. However, i t was not consi dered necessary to devel op a document on managi ng envi ron- mental audi ti ng programmes and, therefore, the I SO 14010 seri es does not i ncl ude a counterpart to I SO 10011-3. Focus on compatibility and alignment At the beginning of 1997, I SO/TC 176 and I SO/TC 207 paid renewed attention to their cooperation and the way in which they managed the devel- opment of compati- bl e standards, i .e. standards that are easy to use in a com- bi ned or i ntegrated manner. The reason for thi s revi val of the c o m p a t i b i l i t y debate was the fi nal i zati on of the fi rst i mportant set of I SO 14000 standards i n the second hal f of 1996 and, at the same time, the start of the revi si on process of both the I SO 9000 series and I SO 10011. I t was cl ear that both revi si ons woul d l ead to fundamental changes i n the standards, for exampl e, I SO 9001 and I SO 9004 were to be based on the process model and I SO 10011 woul d i ncorporate a new approach to the qual i fi cati on of audi tors. There- fore, the establ i shment of new mech- ani sms to ensure compati bi l i ty was consi dered i mportant. The Joi nt Co- ordi nati on Group of I SO/TC 176 and I SO/TC 207 i ni ti ated vari ous l i ai son groups, amongst whi ch the Common Study Group on Audi ti ng between the subcommi ttees (SCs) I SO/TC 176/SC 3 and I SO/TC 207/ SC 2. Thi s Common Study Group had the task of i nvesti gati ng opti ons to further al i gn the I SO standards on audi ti ng up to ful l i ntegrati on and to assess the market need, support for, and the feasi bi l i ty of these opti ons. The group met for twi ce i n 1997 and 1998. I ts most i mportant recom- mendati on to the respecti ve parent commi ttees was to consi der the devel - opment of one com- mon I SO document on envi ronmental and qual i ty audi ti ng, i f necessary wi th add-ons for speci fi c qual i ty and envi ron- mental aspects. I n March 1998, thi s recommenda- ti on was fol l owed-up by the i ssui ng of a joi nt new work i tem proposal for the devel opment of a common I SO standard on qual i ty and envi ronmen- tal audi ti ng. Thi s proposal was accepted by both I SO subcommi ttees and a joi nt worki ng group (JWG) I N T E R N A T I O N A L Figure 1 Current ISO guidelines for auditing At the beginning of 1997, ISO/ TC 176 and ISO/ TC 207 paid renewed attention to the way in which they managed the development of compatible standards ISOManagement Systems December 2001 39 ronmental ) regul atory compl i ance audits, product audi ts and process audi ts are not covered by I SO 19011. Of course, performance, regu- l atory compl i ance, prod- uct and processes are el e- ments of system audi ts, for exampl e, where the capabi l i ty of a manage- ment system to assi st the company i n compl yi ng wi th appl i cabl e l egi sl a- ti on, or i n achi evi ng per - formance objecti ves, i s assessed. However, i t was deci ded to focus I SO 19011 on those qual i ty and envi ronment rel ated audi ts that are cl osest to each other and can most readi l y be combi ned i n a standard, as wel l as actual practi ce. At the same ti me, thi s provi des a good opportuni ty to use I SO 19011 as a basi s for other management system audi ts, such as those for occupati onal heal th and safety. Figure 3 (overleaf) i ndi cates how the vari ous el ements of the current audi ti ng standards are merged i n I SO 19011. Thi s does not mean that I SO 19011 i s si mpl y a combi nati on of the current documents. was establ i shed that met for the fi rst ti me i n November 1998 to devel op the si ngl e audi ti ng standard. This JWG (Figure 2) is chaired by two co-conveners: Alistair Dalrymple, from the French certification body, AFAQ, on behalf of I SO/TC 176/ SC 3 and Andrew Gri ffi ths, from Degussa Metal s Catal ysts Cerdec, Germany, on behal f of I SO/TC 207/SC 2. Duri ng the enti re process, the Netherl ands Standardi zati on I nsti tute (NEN) pl ayed a key rol e as i t i s responsible for the secretariats of both the I SO subcommi ttees involved, as wel l as of the Common Study Group and the Joi nt Worki ng Group. Breaking new ground with ISO19011 I SO/DI S 19011, Guidelines for quality and/or environmental man- agement systems auditing, i s the product of seven meeti ngs of the Joi nt Worki ng Group and three i nternal Commi ttee Drafts. The num- ber 19011 the fi rst XX011 number avai l abl e was speci al l y granted to thi s project by I SO. The i dea behi nd thi s choi ce of number was to avoi d l i nki ng the standard excl usi vel y to ei ther the I SO 9000 or the I SO 14000 fami l y of standards, but on the other hand to mai ntai n the rel ati onshi p wi th the current audi ti ng standards (I SO 10011 and 14011). The number 19011 can al so be l ooked upon as a symbol that thi s project goes beyond the current gap between qual i ty and envi ronmental management. From a fi rst l ook at I SO 19011, i t becomes i mmedi atel y cl ear that: an expl i ci t choi ce has been made to l i mi t the scope of the standard to management system audi ts; al l el ements of the current I SO 10011 and the I SO 14010 seri es are embodi ed i n the new standard. The fi rst poi nt means that vari - ous types of audi ts, such as envi ron- mental performance audi ts, (envi - I N T E R N A T I O N A L Figure 2 Position of the JWG on Auditing Proof that quali ty and envi ronmental cultures can si t down at the same table : co-conveners of the Joi nt Worki ng G roup on Audi ti ng whi ch i s developi ng I SO 1 901 1 Left, Andrew G ri ffi ths, from D egussa Metals Catalysts Cerdec, G ermany, on behalf of I SO /TC 207/ SC 2 I SO 1 4000) , and right, Ali stai r D alrymple from the French certi fi cati on body, AFAQ, on behalf of I SO / TC 1 76/ SC 3 I SO 9000) . 40 ISOManagement Systems December 2001 Key i mprovements are: the cl ear set of defi ni ti ons cover- i ng the rel evant concepts of man- agement system audi ti ng; the conci se des- cri pti on of the essenti al charac- teri sti cs and pri n- ci pl es of audi ti ng and the audi ti ng professi on; the provi si on of the key aspects of managi ng an audi t programme i ncl udi ng cl ear l i nkages wi th the conduct of i ndi - vi dual audi ts and the process of eval uati on of audi tor compe- tence; the cl ear descri pti on of al l el e- ments of an audi t process, and the competence approach to audi - tor qual i fi cati on. I n addi ti on to these, vari ous prac- ti cal hel p boxes are i ncl uded i n the text to provi de addi ti onal detai l and to assi st, for exampl e, smal l and medi um si zed enterpri ses, al ong wi th a number of fi gures presenti ng the key concepts of I SO 19011 vi sual l y. Potential users of the standard I SO 19011 i s i ntended to be appl i - cabl e to i nternal as wel l as external management system audi ts. There- fore, the mai n target group are organi zati ons havi ng i mpl emented a qual i ty and/or envi ronmental man- agement system and thus havi ng a need to conduct i nternal system audi ts. Another i mportant target group are certi fi cati on/regi strati on bodi es that conduct external system audi ts as a basi s for the deci si on whether or not to i ssue a certi fi cate of conformi ty to a management sys- tem standard. Other potenti al users of the stan- dard i ncl ude organi zati ons i nvol ved i n audi tor trai ni ng or regi strati on, organi zati ons that provi de consul - tancy i n management systems, and accredi tati on bodi es. The gui dance i n I SO 19011 can be used to conduct audi ts on ei ther an envi ronmental man- agement system or a qual i ty management system separatel y, or to conduct combi ned audi ts on both sys- tems (whether i n- tegrated or not) at the same time. This choi ce i s at the di s- creti on of the user and i s not at al l i mposed by I SO 19011 i tsel f. However, I SO 19011 refl ects the market devel opment that many organi zati ons i mpl ement both qual i ty and envi ronmental manage- ment systems and want to opti mi ze thei r audi ti ng efforts. The concept of auditing Accordi ng to the defi ni ti on i n I SO 19011 an audi t i s a systematic, inde- pendent and documented process for obtaining audit evidence and evaluat- ing it objectively to determine the extent to which audit criteria are ful- filled. Audi t evi dence i s based on records, statements of fact or other I N T E R N A T I O N A L Figure 3 Merging of the ISO 10011 and the ISO 14010 series The number 19011 can be looked upon as a symbol that this project goes beyond the current gap between quality and environmental management ISOManagement Systems December 2001 41 i nformati on that the audi tor gathers and that can be verified. The audit cri teri a may be, for exampl e, the requi rements of a management sys- tem standard such as I SO 9001 or I SO 14001. The eval uati on of the audi t evi dence agai nst the audi t cri te- ri a l eads to fi ndi ngs of conformi ty or nonconformity with the criteria, i.e. somethi ng does or does not conform to the applicable requirements. After consi derati on of al l the fi nd- ings, the auditor can draw conclu- si ons such as whether the manage- ment system of an organi zati on does or does not conform to a manage- ment system standard. These basi c steps of gatheri ng and sel ecti ng i nformati on and l ogi cal rea- soning are shown in Figure 4 below. l Ethical conduct the foundation of professionalism l Fair presentation the obligation to report truthfully and accurately l Due professional care the appli- cation of diligence and judgment to auditing. Two further principles relate to the audi t process: l Independence the basis for the impartiality and objectivity of the audit conclusions l Evidence the rational basis for reaching reliable and reproducible audit conclusions in a systematic audit process. Adherence to these pri nci pl es i s a prerequi si te for provi di ng a rel i abl e and rel evant audi t outcome and the remai nder of the gui dance gi ven i n I SO 19011 i s therefore based on them. Management of audit programmes Accordi ng to I SO 19011, an audi t programme i s a set of one or more audits planned for a specific time frame and directed towards a specific purpose. For many organi zati ons, the audi t programme wi l l consi st of the set of i ndi vi dual audi ts whi ch are carri ed out to cover al l el ements of the management system i n al l parts of the organi zati on duri ng an audi t cycl e. The programme may al so consi st of the set of i ni ti al and survei l l ance audi ts carri ed out by a thi rd party duri ng the contractual peri od of a management system cer- ti fi cate of conformi ty. Management of an audi t programme i ncl udes al l rel evant acti vi ti es that are necessary to faci l i tate the conduct of i ndi vi d- ual audi ts, such as appropri ate pl an- ni ng, provi di ng resources (fi nanci al , human) and establ i shi ng proce- dures. Fi gure 5 (overleaf) shows the vari ous el ements of an audi t pro- gramme and the appl i cati on of the Pl an-Do-Check-Act cycl e to i t. I N T E R N A T I O N A L Figure 4 Basic steps in an audit process Principles of auditing I SO 19011 descri bes the pri nci pl es of audi ti ng that make audi ts di fferent from other types of assessment, and that make them a rel i abl e tool i n sup- port of management pol i ci es and con- trol s, and i n the provi si on of i nforma- tion to interested parties. Three of these pri nci pl es rel ate to the audi tors themsel ves: 42 ISOManagement Systems December 2001 I N T E R N A T I O N A L Conduct of audits The guidance that I SO 19011 pro- vi des for the conduct of i ndi vi dual audi ts does not di ffer fundamental l y from the gui dance gi ven i n the cur- rent auditing standards. Figure 6 below shows the parties i nvol ved i n the conduct of an audi t. I n the I SO 10011 and I SO 14010 seri es the rol es and responsi bi l i ti es of each actor were descri bed i n detai l . I n I SO 19011, these rol es and respon- si bi l i ti es are i ncl uded i n the descri p- tion of the audit process. The various stages in this audit process are given in Figure 7 on the next page and, for each element, I SO 19011 provides the necessary guidance. Auditor competence The most i nnovati ve part of I SO 19011 i s the cl ause whi ch addresses the competence of auditors. I n I SO 10011-2, as well as in I SO 14012, the qual i fi cati on cri teri a for audi tors are defi ned i n terms of mi ni mum l evel of educati on and number of years of work experi ence and hours of audi tor trai ni ng and experi ence. I n I SO 19011, the focus i s on audi tor compe- tence: to be a competent audi tor a person shoul d demonstrate the pos- sessi on of a number of personal attri butes and the abi l i ty to appl y the knowl edge and ski l l s that are neces- sary to conduct a successful audi t and achi eve the audi t objecti ves. Knowl edge and ski l l s can be acqui red by an appropri ate combi nati on of educati on, work experi ence and audi t training and experience. This concept Figure 5 Management of an audit programme Figure 6 Parties involved in an audit ISOManagement Systems December 2001 43 I N T E R N A T I O N A L of audi tor competence i s portrayed i n Figure 8 opposite. The knowl edge and ski l l s speci - fi ed i n I SO 19011 are subdi vi ded i nto those that appl y to al l management system auditors, those that only apply to audi tors of qual i ty or envi ronmen- tal management systems and those that apply to audit team leaders. The generic knowledge and skills i ncl ude those rel ated to: audi t pri nci pl es, procedures and techni ques; management systems and refer- ence documents; organizational situations, and appl i cabl e l aws, regul ati ons and other relevant requirements. Figure 7 Overview of audit activities Figure 8 Auditor competence ISO 19011 can be used to conduct audits on either an environmental management system or a quality management system separately, or to conduct combined audits on both systems 44 ISOManagement Systems December 2001 Knowl edge and ski l l s speci fi c to qual i ty management system audi tors are those rel ated to: qual i ty-rel ated methods and tech- niques, and products, i ncl udi ng servi ces and operational processes. Speci fi c to envi ronmental manage- ment system audi tors are: envi ronmental management meth- ods and techni ques; envi ronmental sci ence and tech- nology, and techni cal and envi ronmental aspects of ope- rations. As far as audi t team l eaders are concerned, I SO 19011 states that they shoul d have the knowl edge and l eadershi p ski l l s necessary to enabl e the team to conduct the audi t effi ci entl y and effecti vel y. I n addi ti on to the above, the audi - tor shoul d posses a number of per- sonal attri butes that contri bute to the successful performance of audi ts. Accordi ng to I SO 19011, an auditor shoul d be ethi cal , open mi nded, di pl omati c, observant, percepti ve, versatile, tenacious, decisive and self- reliant. The necessary knowl edge and ski l l s and the personal attri butes to appl y them effecti vel y can be acqui red by an appropri ate combi na- tion of education, work experience, audi tor trai ni ng and audi t experi - ence. I n I SO 10011-2 and I SO 14012, these bui l di ng bl ocks are quanti- fi ed by, for example, specifying the minimum level of education, the nec- essary number of years work experi- ence and the mi n- imum amount of audit experience. The authors of I SO 19011, how- ever, consi dered i t not appropri ate to set generi c r e c o mme n d e d l evel s that shoul d appl y to al l audi- tors i n al l audi t situations. I t was acknowl edged that the appropri ate l evel s wi l l vary accordi ng to such fac- tors as the size, nature and complexi- ty of the organi zati on to be audi ted and the objecti ves and extent of the audit programme. I t i s up to the organi zati on to defi ne the appropri ate l evel s. Therefore, I SO 19011 cl earl y descri bes an audi tor eval uati on process that i ncl udes the setti ng of l evel s of knowl edge and ski l l s that are needed and the educati on, audi- tor trai ni ng and work and audi t expe- rience necessary to acquire them. Auditor evaluation The evaluation of auditors occurs at di fferent stages: an i ni ti al eval uati on of persons who wi sh to become audi tors wi th- in the framework of an audit pro- gramme (for example, the internal audi t programme of a company, or ISO 19011 represents a first collaborative effort between two ISO communities qualityand the environment with their own history, culture and ways of interacting I N T E R N A T I O N A L Figure 9 Stages of auditor evaluation ISOManagement Systems December 2001 45 the external audi t programmes of a regi strati on/certi fi cati on organi za- ti on); the eval uati on of audi tors as part of the sel ecti on of an audi t team to conduct a speci fi c audi t wi thi n the audit programme, or the on-goi ng eval uati on of audi tor performance i n the audi t pro- gramme to i denti fy, for example, trai ni ng needs to mai ntai n and i mprove the necessary knowl edge and skills. These stages are represented i n Figure 9 on the preceding page. I n each case, the eval uati on process i nvol ves the fol l owi ng steps: 1. i denti fi cati on of the types and l ev- el s of knowl edge and ski l l s neces- sary to meet the needs; 2. setti ng of i ndi cators of educati on, work experience, auditor training and audi t experi ence to acqui re the l evel s i denti fi ed i n step 1; 3. sel ecti on of the appropri ate method to eval uate whether the i ndi cators i denti fi ed i n step 2 are satisfied, and 4. compl eti on of the eval uati on by compari ng the resul ts for a per- son/audi tor (by appl i cati on of the sel ected method) agai nst the i ndi - cators i denti - fi ed i n step 2. On compl e- tion of thi s pro- cess, persons/ audi tors i denti - fi ed as not meeti ng the cri- teri a may need further educa- tion, training and/ or experi ence. The necessary knowl edge and skills can vary for each stage. For example, a person may qualify as an audi tor i n the i nternal audi t pro- gramme of a chemi cal company, but not qual i fy as member of a team to conduct a speci fi c audi t i n a busi ness unit with special hi-tech processes, unl ess supported by appropri ate techni cal expert- ise. As menti on- ed above, the requi red knowl - edge and ski l l s wi l l vary for each organi za- ti on havi ng the need to conduct audi ts and, as a co n s e q u e n ce , the necessary educati on, audi tor trai ni ng and work and audi t experi ence to acqui re the competence wi l l vary as wel l . However, I SO 19011 i ncl udes a tabl e i l l ustrati ng i ndi cators of these bui l di ng bl ocks of competence I N T E R N A T I O N A L ISO 19011 includes a table illustrating indicators of the building blocks of competence which are typical for auditors conducting certification audits Figure 10 Auditor evaluation process Example of internal audit programme 46 ISOManagement Systems December 2001 whi ch are typi cal for audi tors con- ducti ng certi fi cati on audi ts, or audi ts of si mi l ar compl exi ty. I SO 19011 al so i ncl udes a tabl e wi th exampl es of the appl i cati on of the audi tor eval uati on process i n an i nternal audi t pro- gramme. Figure 10 on the preceding page rep- resents the audi tor eval uati on process, as wel l as gi vi ng some examples of its appl i cati on i n an i nternal audi t pro- gramme. Conclusion After three Commi ttee Drafts, I SO/DI S 19011 has clearly emerged as cl ose to the fi nal versi on of the I SO standard on management system audi ti ng. The project i s runni ng smoothl y and swi ftl y: from start to finish, it will take less than four years. On the one hand, it can be argued that good starti ng materi al was avai l - able, but, on the other hand, I SO 19011 represents a fi rst col l aborati ve effort between two I SO communi- ti es qual i ty and the envi ronment wi th thei r own hi story, culture and ways of interacting. Regardi ng thi s l ast poi nt, the spi ri t of cooperati on and teamwork i n the Joint Working Group i s remarkabl e and, after seven meet- i ngs, i t i s hard to tel l whi ch member ori gi - nates from the qual - i ty or envi ronmental si de. At the l ast meeti ng i n Sydney, the JWG members were compared wi th the Austral i an pl atypus a perfect combi nati on of two rather di sti nct ani mal s! Qual i ty and the envi ronment are good partners and I SO 19011 i s per- haps onl y the fi rst project i n a new seri es of I SO standards. The cata- l ogue number I SO 19001 i s sti l l avai l abl e for an ambi ti ous new project... Quality and the environment are good partners and ISO 19011 is perhaps only the first project in a new series of ISO standards I N T E R N A T I O N A L The Joi nt Worki ng G roup of TC 1 76 and TC 207 experts whi ch developed I SO 1 901 1 has been compared wi th the Australi an platypus a perfect combi nati on of two rather di sti nct ani mals!