ISO 9001
· Period:2020/8/24 - 2023/8/24
· No.:19817QH088R1M
· Certification bodies:Beijing XInjiyuan Certification Co., Ltd
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
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:
1. 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.
2. The requirements of this standard initiate harmonization between a QMS of an organization and applicable regulatory requirements.
3. 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.
4. 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