While Implementing ISO 9001:2000… What Can You Exclude From ISO 9001 Requirements? By: Gopalakrishnan Venkataraman Organizations that had obtained the ISO 9002 certification before publication of the revision to the standard in 2000 had a clear understanding that Design and Development was not really being carried out. It was easy for them to demonstrate this to the satisfaction of the auditors. For example, a cement plant, foundry, or a sugar mill could comfortably do this; however there are others who have a lack of understanding. Let us read the clause of the revised ISO 9001:2000 standard: Clause 1.2:  Application All requirements of this international standard are generic and are intended to be applicable to all organizations regardless of type, size, and product provided. Where any requirement(s) of this international standard cannot be applied due to the nature of an organization and its product, these can be considered for exclusion. Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to requirements within Clause 7. Such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. While the standard appears to give freedom to organizations to declare exclusions in the second paragraph of the clause above, it takes away in the third paragraph with its left hand what was given by its right hand. The clauses were recently examined during a workshop represented by officials from organizations of different types and sizes. Discussions that took place are briefly given below. Clauses 1 through 3 are self-explanatory. Clauses 4 through 6 are mandatory and are understood by everyone as such. One of the participants, who manages a very small franchisee set up from a courier company, mentioned that internal communication under Clause 5.5.3 may not be applicable to his outfit as he manages the operations alone. His employees, numbering only two, sit by his side in his one-room office, and all communications take place by word-of-mouth. Clause 7.2:  Customers (cannot be excluded in any type of organization) A participant projected a case where the organization seeking registration to ISO 9001:2000 was an away-center of a big organization. The entire output was being sent to the mother organization for captive consumption. Thus, a case was made out as though there is no customer, and a proposal was made to exclude customer-related processes. Then a question came as to whether the clauses under 7.2.1, 7.2.2, and 7.2.3 can be applied to internal customers. It had to be concluded that in the absence of any external customer, the user of the output in the main organization has to be given the status of the customer, and all related clauses of 7.2 have to be applied in this case. The consultant told the managers of this away-center:     "If all of us agree that we are here in an organization to serve someone, we have to     find out who that ‘someone’ is. If we do not know the answer readily, you better go     back to your place and mull over this point and find out if you are serving anyone at     all and decide that this person must be your customer." The three roles played by anyone in the organization viz. supplier, processor, and customer was discussed in detail. Clause 7.3:  Design and Development As mentioned earlier, clear cases like manufacturers of sugar, cement, steel, etc… could take exclusion. When it came to the question of a university offering graduate courses in engineering subjects, someone in the group asked, "Are we not designing engineering curriculum?" Clause 7.4:  Purchasing This author was consulting to a branch of a large organization in the Petroleum sector. This branch was designing and executing projects valued at a few million dollars. The Purchasing activity was carried out in their headquarters located at a central place in the country. Obviously, the company was trying to accumulate requirements of all such branches in order to get better prices. This branch wanted to exclude Purchasing from their scope of ISO 9001:2000. In further discussions, it came to light that major purchases were made in their headquarters, but urgent requirements had to be procured locally. It was also learned that outsourcing was utilized for some of the design activities. The major outsourced activity was contracting for construction in the field; this alone ran to a few million dollars every year. Consequently, this organization could not exclude Clause 7.4. Clause 7.5:  Production and Service Clause 7.5.1 describes the ‘controlled conditions’ which are applicable to any organization, but to varying levels. Clause 7.5.2 describes the validation of ‘special processes’ that was given in the 1994 version of the standard. There was generally a good understanding of this clause among users, but a restaurant owner asked whether he has to validate his process of making special dishes unique to his outfit. The consensus was that he has to apply this clause. In Clause 7.5.3, Identification and Traceability could be excluded where it may not be CTQ (critical to quality) for the customer. Food and Pharmaceutical industries agreed this could not be excluded. Manufacturers of standard products also apply this clause to a limited extent, especially to take care of "returns and replacements." Some of them have uniquely configured products to take care of this requirement. However, many of them agreed that the product status does not need to be identified with respect to monitoring and measuring requirements since the stages of manufacturing and in-house quality checks are well defined, and there is no confusion in this case. In Clause 7.5.4, Customer Property can be excluded for many organizations. Manufacturers of fast-moving consumer goods, restaurants, and manufacturers of food items agreed that this could be excluded. A question was asked whether the student in a university is customer property. The answer was "yes!" In Clause 7.5.5, Preservation of Product is to be applied in varying degrees, but to almost all organizations. It was agreed that this could not be excluded. Clause 7.6:  Control of Monitoring and Measuring Devices This clause is applicable to organizations mostly in the manufacturing sector. A third party inspection organization expressed that they make use of a plethora of instruments, but they own none of them; hence, this clause was not applicable. This organization verifies calibration status of instruments owned by the manufacturers before actually using them for carrying out inspection of products. One of the representatives from a Registrar organization's view was that this is applicable even where the organization does not have any measuring instruments. He was taking reference to ISO 9004 where it mentions:     "Management should define and implement effective and efficient measuring and     monitoring processes, including methods and devices for verification and validation     of products and processes to ensure satisfaction of customers and other interested     parties. These processes include surveys, simulations, and measurement and     monitoring activities." However, ISO 9001:2000 does not include this requirement. Clause 8:  Measurement, Analysis and Improvement (cannot be excluded) One of the participants mentioned that Clause 8.2.4 Monitoring and Measurement of Product is not carried out since the process itself controls the product quality. Others vetoed his concept because to ensure the product continuously meets requirements, one has to monitor the process on a regular basis. However, this was not discussed further as this clause will be a mandatory portion of the standard. In conclusion, it is the responsibility of the organization to decide the exclusions and to demonstrate its decisions to the satisfaction of the Registrar. It is possible that the various Registrars have their own internal communication and directives regarding this aspect. It is always advantageous to consult the Registrar before calling him/her for the audit of the organization. Gopalakrishnan Venkataraman President Quality Services International Chennai, India About the Author Venkat has over 35 years of Manufacturing-related experience and held various Executive Management positions at companies, such as Bharat Heavy Electricals Ltd. and Pandian Graphites Ltd. He has been a tutor for IRCA (IEMA) certified courses.  Venkat has attained his Bachelor of Engineering Degree in Mechanical Engineering from Annamalai University in India. He currently has memberships with the National Institute of Quality and Reliability and Indian Institute of Nondestructive Testing in India. Comment on this article