ISO 9001 Flashcards
What is ISO 9001?
The ISO 9001 specifies requirements (minimum requirements) for a quality management system. This means that the ISO 9001 contains binding formulations (e.g. „The organization shall …“). Thus, ISO 9001 is used as a basis for certification and/or contractual agreements between customers and suppliers.
What exactly is a process approach?
A process approach contains the establishment of processes, the control (target-oriented acting) of processes and their interactions so as to achieve the intended results in accordance with the quality policy, quality objectives and strategic direction of the organization. The control of processes and the system as a whole can be achieved by using the PDCA cycle.
What are the main clauses of ISO 9001?
1) Scope
2) Normative references
3) Terms and definitions
4) Context of the organization
5) Leadership
6) Planning
7) Support
8) Operation
9) Performance evaluation
10) Improvement
Explain risk-based thinking?
It is essential for increasing the effectiveness of a quality management system, achieving improved results and preventing negative effects.
It is also important to address and use opportunities (can arise as a result of a situation favorable to achieving an intended result).
Why is it important to apply the standard requirements?
All the requirements specified in ISO 9001 are generic and intended to be applicable to any organization, regardless of its type, size, or the products and services it provides.
The terms „products“ and „services“ in ISO 9001 only apply to products and services intended for, or required by, a customer.
The non-applicability shall be determined and justified in documented information. The company should be able to objectively (sound) present the non-applicability in the course of a certification audit.
