Tag Archives: iso 9001 2015 requirements

ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard

ISO 9001:2015 Requirements Clause 0.1 – Purpose of the Standard The major purpose of the ISO 9001 requirements for an organization is to identify and meet the needs and expectations of its customers and other stakeholders and to gain competitive advantage. One of the strategies it might use to achieve these goals is to employ… Read More »

ISO 9001 Requirements v2015 QMS – Clause 1.0 Scope

ISO 9001:2015 Requirements QMS Clause 1.0 – Scope 1 Scope This clause defines the set of requirements that form the scope of the ISO 9001 standard. This clause does not define the scope of your QMS which is discussed under clause 4.3. It defines a set of ISO 9001 requirements that you can use to… Read More »

ISO 9001 Requirements QMS v2015 Clause 2&3 Normative references, terms & definitions

ISO 9001 Requirements QMS v2015 Clause 2 – Normative references and Clause 3 – Terms and definitions The ISO 9001 Requirements QMS v2015 – Fundamentals and vocabulary – is a reference document that describes quality management system fundamentals and vocabulary. Only the terms and definitions given in ISO 9000:2015 apply to ISO 9001:2015. Most times… Read More »

ISO 9001 Requirements clause 4.1- Context of the organization

ISO 9001 Requirements v2015 Clause 4.1 Understanding the organizational context  In clause 0.1 Introduction and 1.0 Scope we talked about how this ISO standard provides a generic set of control requirements for all organizations and how these generic requirements must be tailored to fit the nature of each business and their products and services. A… Read More »

ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs

ISO 9001 Requirements ISO 9001 Requirements-Clause 4.2 Understanding interested parties needs Let’s start with paraphrasing what the standard (not just this clause) says and requires regarding RIP’s: 1. An RIP may affect your ability to consistently provide conforming products and services to customers. 2. We need to identify each RIP and ascertain exactly in what… Read More »

ISO 9001 Requirements Clause 4.3 Determining the scope of your QMS

ISO 9001 Requirements ISO 9001 Requirements – Clause 4.3 Determining the scope of your QMS In clause 1 we discussed the scope of the ISO 9001 standard and the flexibility it provided in selecting those requirements that applied to your business and being able to tailor them to suit your QMS requirements. Here we will… Read More »

ISO 9001 Requirements Clause 4.4 QMS and its processes

Understanding ISO 9001:2015 ISO 9001 Requirements Clause 4.4 QMS and its processes In my opinion this is the most important clause of the ISO 9001 standard. This clause coupled with Clause 0.3 Process Approach form the backbone of this ISO standard. Definition of a Quality Management System (QMS) ISO 9000:2015 defines a QMS as comprising… Read More »

ISO 9001 Requirements Clause 5.1 Leadership and commitment

ISO 9001 Requirements ISO 9001 Requirements Clause 5.1 Leadership and commitment The 2015 version of the ISO 9001 standard has significantly broadened the role of top role in demonstrating leadership and commitment in ensuring the success of the QMS. It uses words like accountability, ensuring, promoting, communicating, engaging, directing, supporting, etc., to encompass a broad… Read More »

ISO 9001 Requirements Clause 5.1.2 Customer focus

ISO 9001 Requirements ISO 9001 Requirements Clause 5.1.2 Customer focus Organizations depend on their customers. Without customers there would be no need for most organization to exist. Focusing on the customer provides a unity of purpose when all activities and efforts are directed towards achieving customer and regulatory requirements. It is top managements responsibility to… Read More »

ISO 9001 Requirements Clause 5.2 Quality policy

ISO 9001 Requirements ISO 9001 Requirements Clause 5.2 Quality policy Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, including establishing the quality policy and objectives. The quality policy is the organization’s expression of its strategic direction and commitment to quality. It is typically… Read More »

ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities

ISO 9001 Requirements ISO 9001 Requirements Clause 5.3 Organizational roles, responsibilities and authorities Before we begin, let’s clarify some definitions: Role: is the defined or expected behavior associated with a particular position, function or status in an organization. Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. Authority… Read More »

ISO 9001 Requirements Clause 6.1 Actions to address risks and opportunities

ISO 9001 Requirements ISO 9001 Requirements Clause 6.1 Actions to address risks and opportunities An organization’s external and internal environment is subject to constant change and change is characterized by uncertainty which in turn pose risks. Uncertainty may be defined as having insufficient or no knowledge of a potential event to determine whether or not… Read More »