On this article we will review the ISO 9001 Standard requirements regarding the scope of the standard and its application. These two chapters are a little bit fuzzy. Not a lot of people even bother to read them. But plunging  through them may reveal you some new ideas and might (just might) save you some resources (time and headaches mostly) 

PARAGRAPH 1.1 – GENERAL

Important notice: the ISO 9001 Standard requirements apply the final product supplied to the customer and not apply the internal processes and intermediate or middle products. Therefore the scope shall include the final product. Customer may be considered as internal customer as well as external customer.

• Is required to demonstrate is ability to supply persistently and continually product that meets specific requirements (customer's or regulatory). The standard requirements would ensure that the organization shall achieve requirements it is obliged to.
• Has defined objectives for achieving customer's satisfaction. This objective shall be achieved by implementing effectively a quality management system. The quality management system shall include:
  • Continual improvement activities.
  • Assurance of conformity to customer's requirements 
  • Assurance of conformity to regulatory requirements

Ladies and gentlemen, welcome to the ISO 9001 standard world of requirements. That is the meaning of chapter 1. The ISO 9001 standard is aiming to meet customer's satisfaction by fulfilling his requirements and international, national or/and regulatory requirements.  The requirements are effective for the final product and not for middle processes products (as mentioned above).
The 9001 puts customer's satisfaction and continual improvement at the main objectives of the standard requirements. Customer is considered both internal customer and external customer.

PARAGRAPH 1.2 - APPLICATION

The requirements of this international standard are generic requirements that are appropriate and applicable for all kinds and sizes of organizations and appropriate and applicable for any kind of product.
The organization may exclude some of this standard's requirements.  The organization can exclude requirements only from chapter 7 (product realization) and when it is beyond any doubt and provable, that the exclusions do not affect the product's quality. The exclusion are to be made, when such standard requirements are not applicable to the organization due to the nature of the organization or the nature his of products.  
Just to make it clear, standard application refers here, to whom, where, why and how these standard requirements are to be implemented. In other words, which organizations are suitable to implement these requirements.
The ISO  9001 Standard applies for all organizations regardless to their size, kind, product or service in any sector of activity whether it is a business enterprise, a public administration or a regional government department. 

EXCLUSIONS 

• Planning of product – organization that is not required to plan the product before realizing it. Now, as much as it is hard to believe we really cannot find any examples to explain how organization can exclude these requirements. Give us some time, we haven't given up yet.
• Customer-related processes - when organization produces on a mass scale without any orders, just produces one or more products without any start point or an end point, it may exclude these requirements. Now, in our days, we are really finding it hard to believe that there are organizations, who can exclude these requirements. Even the Coca cola factories, which produce tons of the same products for years probably, work according to an order list based upon forecasts.
• Design and development – These requirements regard developing and designing processes. If the organization performs any kind of development: receiving requirements, defines a product, characterizes the product, perform developments activities, verifies, validates, and release the product for the customer's approval – then the organization is a developing organization. Only organization that receives a clear requirement for realization with all the requirements described may exclude these requirements.   
• Purchasing – The requirements regarding the purchasing processes. When the organization purchases nothing (if it does not need or other body or department is doing it for him), it may exclude this chapter. Pay attention! Services are product as well! When an organization purchases services that affect the product – then it is required to include this chapter in its quality management system. 
• Production and service provision – it may be that an organization does not perform all the processes specified on this paragraph. For example, paragraph 7.5.4 - Customer property. When the organization does not receive any of the customer's property, it may exclude this requirement.     
• Control of monitoring and measuring devices – requirement regarding the control and maintenance and documentation of measuring and controlling devices. When an organization performs no measuring to its products or processes it may exclude this chapter.  If the organization is measuring its processes and/or its product, and does not want to include these requirements under its scope, it required to prove that the measuring do not affect the quality of the product and that measuring are not part of his product or services realization.

Any other requirements from any other chapters (1, 2, 3, 4, 5, 6 and 8) are obligatory in order to meet the standard's requirements – the organization cannot exclude them.  When excluding any requirement, the organization must prove that this requirement is excluded due to the nature of the organization or the nature of the products. The organization must also, prove that the exclusion does not affect the quality of the product. Exclusions usually are mentioned during the quality manual. The simplest example is chapter 7.3 - Design and development. An organization that does not develop anything, may exclude this chapter.
List of exclusion shall appear in the quality manual. Let's see an example (only an example – it may differ from organization to the other):

SUMMARY

• This ISO 9001 international standard specifies requirements for a quality management system where an organization
• Throughout implementing the ISO 9001 standard requirements the organization shall demonstrate its ability to supply persistently and continually product that meets specific requirements.
• Throughout implementing the ISO 9001 standard requirements the organization shall set objective that would ensure implementing effectively a quality management system. The quality management system with a continual improvement to maintain its effectiveness.
• The requirements of the ISO 9001international standard are generic requirements that are appropriate and applicable for all kinds and sizes of organizations and appropriate and applicable for any kind of product.
• The organization may exclude some of this standard's requirements.  The organization can exclude requirements only from chapter 7 (product realization) and when it is beyond any doubt and provable, that the exclusions do not affect the product's quality.
• When any requirement specified by the 9001 is irrelevant to the organization due to its nature of activity or nature of its products, it may exclude this requirement with a reasonable explanation.
• Any other requirements from any other chapters (1, 2, 3, 4, 5, 6 and 8) are obligatory in order to meet the standard's requirements – the organization cannot exclude them.

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