ISO 9001:2015 Standard requirements – Scope
On this article we will review the ISO 9001 Standard requirements regarding the scope of the standard. This clause is a little bit fuzzy. Not a lot of people even bother to read it. But plunging through it may reveal you some new ideas and might (just might) save you some resources (time and headaches mostly)
Clause 1 – Scope
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. Now, after clearing this, let’s get down to business. Clause 1 of the ISO 9001 Standard is used to present the purposes and concepts of the standard and define the scope of application of the standard to your quality management system. The following aspects are covered in this clause:
- The goals and purposes of the standard
- The approach and reference to customer requirements
- The approach and reference to regulatory or statutory requirements
- Applicability of the standard requirements
For me, clause 1 is an important introduction to the ISO 9001 Standard and I consider it crucial for
- The understanding of the expectations of the standard from an organization: What is the purpose of a QMS?
- Future definitions of a QMS: How may the QMS reach its purpose?
The Principles of the ISO 9001:2015 Standard
Clause 1—Scope presents us with the principles and concepts of the standard. The ISO 9001 Standard is aimed to satisfy customers by fulfilling its requirements along with applicable international and national regulations. This is expressed through four principles:
- The goal and objective of the standard is to initiate a QMS that acts to consistently meet customer requirements as well as applicable regulatory requirements.
- The requirements of this standard initiate harmonization between a QMS of an organization and applicable regulatory requirements.
- The requirements suggested in the ISO 9001 Standard facilitate an improvement of processes included in the QMS and assurance of conformity to customer or regulatory requirements.
- The requirements suggested in the ISO 9001 Standard are applicable to all sorts of organizations regardless of their size or type, the type of their customers, and the type of products or services that they are providing.
The international ISO 9001 standard specifies requirements for a quality management system where an organization:
- 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
This webpage contains only a fragment of the chapter 1 Scope from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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