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ISO 9001
Zahtevi koji se mogu isključiti
Jelena Cice g.

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Struktura ISO 9001
1 Predmet i područje primene 1.1 Opšte odredbe 1.2 Primena 2 Normativne reference 3 Termini i definicije
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1.2 Primena
Svi zahtevi ovog međunarodno priznatog standarda su opšti i predviđeno je da budu primenljivi za sve organizacije, bez obzira na njihov tip, veličinu i proizvode koje isporučuju.
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1.2 Primena
Kada se bilo koji zahtevi ovog standarda ne mogu primeniti, zbog prirode organizacije i njenog proizvoda, može se razmotriti njihovo izostavljanje.
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1.2 Primena
Ako su izostavljanja učinjena, izjave o usaglašenosti sa ovim standardom ne mogu se prihvatiti, osim ako su ta izostavljanja u okviru zahteva iz tačke 7 i ako ne utiču na sposobnost organizacije ili na njenu odgovornost da obezbeđuje proizvod koji ispunjava zahteve korisnika i odgovarajućih zakona i propisa.
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Koncept isključenja
Organizacija bi trebalo da razmotri sve aktivnosti na koje se obavezala u svojoj politici i ciljevima kvaliteta i kako one mogu uticati na potrebu da postoje i funkcionišu specifični procesi realizacije pored zahteva zakona i pravilnika koji se uvek moraju poštovati.
Sve to može uticati na obim SMK.
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Koncept isključenja
Sva isključenja moraju biti navedena u poslovniku kvaliteta (sa validnim objašnjenjem) i moraju biti u skladu sa obimom SMK u organizaciji.
Sva javno dostupna dokumenta koja sadrže izjave o usaglašenosti sa ISO 9001 moraju jasno sadržati obim SMK na način da ne dovode u zabludu potrošače i krajnje korisnike. Ovo bi trebalo da osigura da su neophodne informacije dostupne korisniku kao bi bi mogao da utvrdi koje kategorije proizvoda i procesi za realizaciju proizvoda su uključeni u SMK.
Kao dodatak, obim SMK bi eksplicitno trebalo da sadrži i izjavu o odgovornosti za projektovanje i razvoj proizvoda kao i druge glavne procese kao što su proizvodnja, prodaja i pružanje usluga.
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Koncept isključenja
Primer u kojem se ne može tvrditi usaglašenost sistema sa zahtevima ISO 9001:
Kada su zahtevi iz tačke 7 isključeni jer regulatorna tela ne zahtevaju usaglašenost sa njima ali zahtevi utiču na sposobnost organizacije da ispuni zahteve korisnika.
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Struktura ISO 9001
7 Realizacija proizvoda 7.1 Planiranje realizacije proizvoda 7.2 Procesi koji se odnose na korisnike 7.3 Projektovanje i razvoj 7.4 Nabavka 7.5 Proizvodnja i pružanje usluge 7.6 Upravljanje opremom za praćenje i merenje
7.1 It is hard to contemplate a situation where an organisation would be able to justify this exclusion. The clause covers production planning or, for a service provider, planning of service delivery. Consequently it would encompass scheduling of work, rotas, shifts, organising deliveries, ordering of materials, holiday cover and more. Effectively a company would be asking to be excluded from the “P” of PDCA. PDCA is fundamental and underpinning principle of ISO 9001 – this exclusion isn’t going to happen, so don’t even go there.
7.2 All organisations will have processes with inputs, activities and outputs, and there will always be a customer at one end or, more commonly, at both ends. This could be an end-consumer or end-user, or it could be an internal customer, but your processes must be working for the benefit or convenience of someone. Again this part of the standard would be impossible to exclude and reasonably justify
7.3 Many organisations don’t have a design function. They may provide a service (such as an advice line) or they may manufacture items to customer supplied designs. In considering “design” it is important that we differentiate clearly between “design” and “planning”. I once had a heated argument with a third party auditor about the applicability of the design requirements to a client’s scope. His argument was that the company (an installer of domestic central heating systems) must “design” how they will deliver their work. THIS IS NOT DESIGN. Everyone has to “design” how they deliver their work – but unless they are developing something conceptually new, then this is just good old fashioned planning. My argument was that my client was doing nothing new or innovative in the field of heating installation, they were merely executing a jobs in line with established codes of practice. There was nothing new or novel in this regard. They had not created a new concept in heating systems. IT WAS NOT DESIGN
Design is the most common exclusion to the scope of certification. Many companies happily go about their business, satisfying their customers, without creating anything conceptually new
7.4 This is a rare exclusion but it is feasible. Although it covers the selection of suppliers, and you may think that everyone must have some suppliers, there is not always any economic benefit in applying any sort of selection and approval controls to them. For example if an organisation only buys standard catalogue or boxed items (stationery, manuals, off-the-shelf hardware and software for example) and it does not use sub-contractors or agency staff, then an exclusion to 7.4 is a possibility. Since these circumstances rarely apply without some sort of exception, it is a very rare exclusion
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Struktura ISO 9001
7.5 Proizvodnja i pružanje usluge Upravljanje proizvodnjom i pružanjem usluge Validacija procesa proizvodnje i pružanja usluge Identifikacija i sledljivost Imovina korisnika Očuvanje proizvoda
7.5.1 The scope of this sub-clause is very broad. It includes the provision of workplace instructions, product specifications, equipment, and monitoring activities. An attempt to exclude this clause would be tantamount to asking to be excused from controlling activities full stop. Again, don’t go there
7.5.2 At first sight this may look like another unthinkable contender for consideration, but it is in fact a fairly common candidate. A common misconception is that this clause requires an organisation to exercise generic process control across its operational activities, but its application is in fact much, much narrower than that. The clause requires an organisation to establish process validation methods only for those processes whose outputs cannot be verified by subsequent monitoring or measurement. ISO 9001:1994 used to call them“Special Processes”. Think about that for a moment. Many companies only produce outputs that CAN be tested, they don’t have any of these so called special processes, so they can exclude this clause as it is inapplicable to them. It applies when the output can only be fully tested in a destructive way (e.g. a weld) or when it is impractical to test, for example there may simply be no time to test (e.g. in a radiological treatment agent with a half-life of 2 hours) In those cases, because we can’t test the output, we have to have absolute faith in the process, so we need additional process controls and validation. It is in these circumstances that clause applies
7.5.3 Manufacturers of high volume, low value, low risk items (e.g. clothes pegs, many items of clothing) may have no legal or customer requirement for item or batch traceability. This is a fairly common exclusion
Many manufacturers and service providers do not hold any customer property or perform work on a customer’s premises. This is a very common exclusion – but note that it can include certain types of customer information and intellectual property
This clause requires the “product” be protected from damage or deterioration. If an organisation provides a service such as “advice” then there is no potential for the output to “spoil” in any way and this clause may well be excluded
7.5.6 Many service providers don’t use measuring devices that require special controls (calibration in other words), as they don’t produce anything with specific (for example) dimensional characteristics
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11. Najčešća isključenja i primeri
7.3, 7.6, 7.5.2, 7.5.4
U primerima se pretpostavlja da pomenuta isključenja ne utiču na sposobnost ili odgovornost organizacije da pruži proizvode koji zadovoljavaju korisnike i primenljive zakonske zahteve.
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12. Imovina korisnika (intelektualna svojina) kojom upravlja banka
Opis situacije
Banka pruža raznovrsne usluge klijentima (na primer, lični računi i računi kompanija), ali je izabrala da primeni SMK samo za deo pružanja usluga preko Interneta. Za ovaj deo poslova odlučila je da izjavi da je usaglašena sa ISO U poslovniku o kvalitetu jasno je naznačeno šta je sve pokriveno kroz SMK. Banka primenjuje zahteve svih tačaka standarda za realizaciju pružanja usluga putem Interneta osim podtačke Imovina korisnika. Banka ne misli da poseduje bilo kakvu imovinu korisnika kao deo pružanja usluga putem Interneta što je navela kao opravdanje u objašnjenju za isključenje primene zahteva podtačke
Analysis and Conclusion:
The decision made by the bank to exclude sub-clause Customer property was not justified because the bank does receive information from its customers such as personal and confidential data. ISO 9001, Customer property requires an organization to exercise care with customer property while it is under the organization’s control or being used by the organization. And the note of sub-clause Customer property, clearly indicates “Customer property can include intellectual property and personal data”. In this situation, the bank’s customers provide important information in confidence when using the service, which constitutes “Customer property”. Therefore the bank has to address the requirements for customer property in its QMS.
Problem:
Da li banka može da isključi podtačku Imovina korisnika iz SMK i izjavi da je usaglašena prema zahtevima ISO 9001?
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13. Isključenje projektovanja i razvoja – podugovoreni proizvođač
Opis situacije
XYZ Electronics gradi novu fabriku za proizvodnju mobilnih telefona, kao podugovarač. Ima samo jednog korisnika koji ima odgovornost i ovlašćenja za projektovanje proizvoda. XYZ Electronics je odgovorna za nabavku svih komponenti i odgovorna je za proizvodne aktivnosti. Korisnik je dužan da dostavi XYZ Electronics specifikacije za nabavku i delove kao i da obavesti XYZ Electronics o bilo kojim izmenama u projektovanju i pruži neophodne informacije o promeni. XYZ Electronics je u razvoju svog SMK isključio zahteve tačke 7.3 i smatra da su specifikacije koje dobija od svog korisnika njegova imovina te ih tretira prema zahtevima podtačke Imovina korisnika.
Analysis and Conclusion:
XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design of the mobile phone product. Its customer provides the design.
Problem:
Da li XYZ Electronics može da isključi tačku 7.3 Projektovanje i razvoj iz SMK i izjavi da je usaglašena prema zahtevima ISO 9001?
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14. Identifikacija i sledljivost
Opis situacije
AKP Corp. je organizacija koja proizvodi električne motore koje dalje prodaju licencirani distributeri. Sledljivost komponenti u delovima proizvoda nije ni interni ni eksterni zahtev ka ovoj organizaciji. Organizacija je isključila zahteve podtačke Identifikacija i sledljivost i izjavila da je usaglašena sa standardom ISO 9001.
Analysis and conclusion:
The organization’s decision to exclude the requirements for traceability is justified. However this exclusion is not necessary, since ISO 9001:2008 only requires traceability when it “is a requirement”.
Problem:
Da li AKP Corp. može da isključi podtačku Identifikacija i sledljivost iz SMK i izjavi da je usaglašena prema zahtevima ISO 9001?
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Projektovanje usluga
Opis situacije
JWB je konsultantska frima koja sprovodi interne provere za svoje klijente, male firme koje imaju implementiran SMK prema ISO JWB razvija metodologiju i alate za sprovođenje interih provera kod klijenata na osnovu uputstava u ISO JWB pruža prilagođenu uslugu koja kao izlaz ima napisan izveštaj sa interne provere i sve ostale pomoćne podatke na osnovu audita. JWB bi želela da isključi tačku 7.3 Projektovanje i razvoj uz objašnjenje da kao pružalac usluga ne može da ima aktivnosti projektovanja i razvoja.
Analysis and conclusion:
The organization is not justified in the exclusion of sub-clause 7.3 Design and development since it has developed a customized service to meet its customer’s requirements, including the development of its methodology and tools for performing the audits and delivery of a written report.
Problem:
Da li JWB može da isključi tačku 7.3 Projektovanje i razvoj iz SMK i izjavi da je usaglašena prema zahtevima ISO 9001?
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Validacija procesa
Opis situacije
Mali proizvođač odeće vrši sečenje tekstila koji se isporučuje internom odeljenju za šivenje, za sledeću fazu procesa. Kvalitet izlaza rezanja može se proveriti nakon završetka rada. Mali proizvođač odeće je implementirao SMK i izjavio je da je usaglašen sa ISO 9001, sa izuzetkom podtačke7.5.2 Validacija procesa proizvodnje i pružanja usluge. 
Analysis and conclusion:
The organization is justified in the exclusion of the requirements of sub-clause Validation of processes for production and service provision since it can inspect the result of the cutting process to determine conformance or nonconformance to specification.
Problem:
Da li mali proizvođač odeće može da isključi podtačku Validacija procesa proizvodnje i pružanja usluge
iz SMK i izjavi da je usaglašen prema zahtevima ISO 9001?
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Projektovanje usluga
Opis situacije
Mala organizacija za treninge obezbeđuje obuku za ljude koji trenutno ne rade a želeli bi da unaprede svoje veštine. Organizacija sprovodi obuke za praktične veštine. U ovom procesu učesnici vežbaju korišćenje jednostavne merne opreme, kao što su lenjiri i viskovi. Proizvod organizacije je razvijanje veština a ne proizvodi koje su napravili učesnici obuke. Mala organizacija za treninge je uvela SMK i izjavila je da je usklađena sa standardom ISO 9001 uz isključenje tačke 7.6 Upravljanje opremom za praćenje i merenje.
Problem:
Da li mala organizacija za treninge može da isključi tačku 7.6 Upravljanje opremom za praćenje i merenje iz SMK i izjavi da je usaglašena prema zahtevima ISO 9001?
Analysis and conclusion:
In this example the simple measuring devices that have been mentioned (rules, spirit-levels and plumb lines) are a diversion and are not the correct items to be focusing on when considering the exclusion of sub-clause 7.6. Instead, it is the training that is the product being delivered and to which attention should be given. The organization should be controlling the monitoring and measuring devices that are needed to provide evidence of the conformity of the product (training/education) to requirements, e.g. tests and student satisfaction surveys, reports related to students finding jobs, etc. (In this instance, the necessary control may be demonstrated through verification or validation of the measuring and monitoring devices, e.g. though pilot testing of the survey questionnaires).
The organization may be able to justify the exclusion of those requirements in the sub-clause that specifically relate to the calibration of measuring equipment [in 7.6 bullets (a) to (e)], if it decides that the simple measuring equipment does not need to be calibrated. It may however be necessary for the organization to provide the students with training in checking the accuracy of their equipment (rules, sprit levels etc.), in which case even these requirements could not be excluded.
In conclusion, sub-clause 7.6 could not be excluded in its entirety, only in part.
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Reference
ISO/TC 176/SC 2/N 524R6:
ISO 9000 Introduction and Support Package module: Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'
Capable People Blog, Shaun Sayers
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19. “If everything seems under control, you're not going fast enough.”
- Mario Andretti
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20. 4. qualityaustria Forum, Beograd
Jelena Cice
Project Manager, Auditor, Trainer, Examiner
Quality Austria Center
Hvala na pažnji!
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