ISO 9001:2015 – Quality Management Systems

Purpose

Pursuing the satisfaction of its customers and the continuous improvement of its business performance have always been the objective of a Quality Management System.  In a constantly changing market, like today’s, satisfying customer needs may no longer be enough: for this reason, since September 2015, the latest revision of ISO 9001, which introduces the concept of managerial risk in order to ensure Business Continuity, has been issued.

What is Business Continuity?

By Business Continuity, we mean the company’s ability to continue to respond to market needs over time, guaranteeing continuity to its service/product. To do this, the entrepreneur is faced with the challenge of having to prevent problems that could afflict his company in the future. The New ISO 9001 :2015 introduces, in this regard, a new tool: the “Based Risk Thinking” or more simply the Risk Analysis.

What is “Based Risk Thinking”?

The “Based Risk Thinking” is a new approach to business management based on risk, through assessment methodologies that, starting from a “Context Study”, identify risks and “Stakeholders” with their expectations.

How to obtain ISO 9001 :2015 Certification?

Contrary to the old ISO 9001 :2008, the new revision no longer provides for mandatory procedures, let alone a manual. In fact, documented information such as:

Scope of application of the Quality System (paragraph 4.3)
Quality policy (paragraph 5.2)
Quality objectives (paragraph 6.2)
Criteria for the evaluation and selection of suppliers (paragraph 8.4.1)
Records related to monitoring and measurement of instruments * (paragraph 7.1.5.1)
Records related to training, skills, experience and qualifications (Subsection 7.2)
Review of product and service requirements (Subsection 8.2.3.2)
Review of design and development outputs * (8.3.2)
Review of design and development inputs * (8.3.3)
Records of controls performed during design and development * (8.3.4)
Records of design and development outputs * (8.3.5)
Design and development change records * (8.3.6)
Characteristics of the product to be produced and the service to be provided (8.5.1)
Customer ownership records (8.5.3)
Change control records for products and services (8.5.6)
Records of compliance of products and services with the relevant acceptance criteria (section 8.6)
Non-compliant output records (section 8.7.2)
Results of monitoring and measurement (Subsection 9.1.1) Internal audits (Subsection 9.2)
Management review (Subsection 9.3)
Results of corrective actions (paragraph 10.1)

This document structure allows the management system to be more flexible, adapting to companies of all sectors and sizes.