ISO/DIS 9001 - Scope and Normative reference
Keshav Ram Singhal
Clause 1 to 3 of ISO/DIS 9001 are organized as under:
2 Normative references
3 Terms and definitions
In ISO/DIS 9001 the 'scope' title is not sub-divided, as it is sub-divided in ISO 9001:2008 QMS standard - 1.1 - General and 1.2 - Application. Requirements of application of ISO/DIS 9001 are now part of sub-clause 4.3 under the title 'Determining the scope of the quality management system'.
Scope of ISO/DIS 9001 mentions the extent of the area or subject matter to which ISO/DIS 9001 is relevant. ISO/DIS 9001 specifies requirements for a quality management system:
- where an organization needs to clearly show the existence of the organization's ability by giving proof or evidence (demonstrate the organization's ability) to consistently provide product or service that fulfils: (i) customer requirements, and (ii) applicable legal (= statutory + regulatory) requirements, and
- where the organization aims to increase, strengthen or further improve the value of (enhance) customer satisfaction through: (i) the effective application and continual improvement of the system and processes, and (ii) the assurance of conformity to customer requirements and applicable legal (= statutory + regulatory) requirements.
All requirements mentioned in ISO/DIS 9001 are generic. These are intended to be applicable to all organizations without consideration (regardless) of type, size and product/service. Accordingly, ISO/DIS 9001 requirements are applicable to all types of businesses, whether they are manufacturing industries (such as, chemical, electronic, paper, steel, pharmaceutical etc.) or services (such as, banking, insurance, health, transportation, travel, hotel etc.).
In ISO 9001:2008 QMS standard, the term 'product' is used for the product intended for a customer, or the product required by a customer, and it includes services. As such, ISO 9001:2008 QMS standard used the term 'product' to include all output categories (hardware, services, software and processes materials), which is changed to 'product and service' in ISO/DIS 9001. The specific inclusion of 'service' in ISO/DIS 9001 is intended to highlight the difference between product and service.
ISO/DIS 9001 does not mention any normative references.
Terms and definitions
ISO/DIS 9001 includes 69 terms and definitions that apply to the purpose of ISO/DIS 9001 document. All terms and definitions are sourced from ISO/DIS 9000:2014, which is also under revision process.
Note: The ISO 9001 revision process moves on to the next stage. Readers should note that there may be some changes in the requirements. The above article is for academic purpose. Readers' comments are invited. Thanks.