ISO 9001

2015 - A Complete Guide to Quality Management Systems

Itay Abuhav

• Publisher: CRC Press
• Year: 2017
• ISBN:
  9781315352787
• Edition: 1
• Topic: Commerce
• Subtopic: Commerce Général

What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001: 2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.

1    Scope

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

Before we start to understand the requirements of clause 1—Scope, let us review them first:

•  The ISO 9001 Standard is an international standard for the establishment, design, and implementation of a quality management system (QMS) in an organization.

•  Applying the ISO 9001 Standard requirements enables an organization to demonstrate its ability to consistently provide products or services that meet customer requirements.

•  Applying the ISO 9001 Standard requirements enables an organization to demonstrate its ability to consistently provide products or services that meet applicable statutory or regulatory requirements.

•  Applying the ISO 9001 Standard requirements enables an organization to enhance customer satisfaction through the use of quality management instruments that include methods for planning and improvements of processes and ensuring conformity to customer and applicable statutory and regulatory requirements.

•  The requirements of this standard are generic and apply to any sector and area of business and may be implemented in any organization regardless of its size or the type of its products or services.

•  Note 1—The use of the words “product” or “service” in this standard refers to a product or a service as intended or required by the customer.

•  Note 2—Legal requirements may be regarded as statutory and regulatory 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 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.

Harmonization between a QMS of an organization and applicable regulatory requirements means brining the applicable and relevant international, national, local, and regulatory requirements into consensus with QMS aspects, for example, the planning and implementation of processes and activities, the design of documentation, and the training qualification of human resources.

The Ability to Provide Appropriate Product

What are actually the requirements here? When an organization decides to implement the ISO 9001 Standard, it is required, through the use and application of the methods and instruments presented in this standard, to prove its ability to identify customer requirements and provide products and services according to these requirements. And while identifying customer requirements, the organization must consider the application of relevant applicable regulatory, statutory, or other requirements, for example, codes or practices. In other words, the purposes presented in this clause must be reflected through the QMS of the organization. How? Through applying the quality management tools and instruments that are suggested in the standard, such as setting defining quality policy, quality objectives, planning processes, and much more.

2    Normative References

The meaning and purpose of normative references is the indication that terminology and nomenclature specified in this standard is not open for debate or an interpretive discussion. A normative reference refers to a document that includes terms, fundamental concepts, principles, and vocabulary that are essential for the application of the ISO 9001 Standard. The ISO 9001 Standard requirements are as follows:

•  When dated normative references are used, only the edition cited applies (the ISO 9000:2015 Standard).

•  When undated normative references are used, the latest edition of this referenced document (including any amendments) applies.

•  The document ISO 9000:2015, Quality management systems—Fundamentals and vocabulary are to be normatively referred to while establishing a quality management system (QMS) according to the ISO 9001 Standard requirements.

A normative reference lists other ISO or IEC documents or standards that are necessary for the application of the standard. In other words, which documentation may assist you in how to comply with the requirements stated in the ISO 9001 Standard. The objective of a normative reference is to relate to a standard that is applicable to the implementation of the ISO 9001:2015 Standard and to relate to directives, definitions, or understanding of the ISO 9001:2015 Standard.

The ISO 9001 Standard refers us to a specific document, “ISO 9000:2015: Quality management systems—Fundamentals and vocabulary.” In case questions or misunderstanding regarding the definitions or the requirements of the ISO 9001 Standard arises during the implementation and application of the standard requirements, you can turn to this document. For example, when you are discussing and planning activities related to customer focus and you are not sure what the definition of customer focus is, you may turn to the ISO 9000 Standard and understand how the ISO 9001 Standard interprets the issue of customer focus.

3    Terms and Definitions

Clause 3 of the standard—Term and Definitions is necessary to clarify matters and disputes regarding the terms and definitions mentioned in the ISO 9001 Standard. The terms and definitions mentioned and discussed in the ISO 9000 Standard—Quality management systems, Fundamentals and vocabulary—are applicable to this standard (the ISO 9001 Standard). The ISO 9001 Standard requirements are as follows:

•  The terms and definitions given in ISO 9000:2015 apply for the purposes of the ISO 9001 Standard.

ISO 9000:2015 Standard

The ISO 9000 Standard provides the fundamental concepts, principles, and vocabulary that are to be used when establishing a quality management system according to the requirements stated in the ISO 9001 Standard. In other words, when you stumble upon a term in the ISO 9001 Standard that are unfamiliar to you, you cannot interpret it correctly or you have a dispute with another on the meaning, you may turn to the ISO 9000 Standard and resolve the conflict. A good example may be the term “risk”; you may consider it as one thing but your auditor may see it as another. In order to avoid unnecessary disputes in advance, I advise you to review this standard and learn the terms and definitions that are mentioned there.

4 Context of the Organization

4.1 Understanding the Organization and Its Context

Understanding the context of an organization is now standard requirement. It is not a new concept but it is officially adopted by the ISO 9001:2015 Standard, and when developing a quality management system (QMS), it is required to identify, analyze, and understand the business environment in which the organization conducts its business and realizes its product.

Any organization is a combination of different business entities (functions or systems—internal or external) that relate and interact with each other and exchange information and materials. The context of the organization is an outline of the interaction and integration of these business entities. It is the set of functions, factors, processes, inputs and outputs, and conditions and limitations that create the business environment of an organization—these encompass both internal and external issues. These issues have an impact on the ability of the organization to provide the product and thus affect the goals and objectives of the organization. Thus the deduction: when determining your business strategy and setting the objectives of your QMS, you should understand, consider, and refer to these aspects. Understanding the context of the organization is key to a correct business strategy, let alone a correct quality strategy.

Before we plunge into this topic, let us review what the ISO 9001:2015 Standard requirements are:

• The organization must determine the organizational context in which it is active. The organizational context includes issues that

• Are relevant to its purpose

• Are relevant to the scope of the QMS

• Are relevant to its strategy (goals and objectives)

• Affect the organization’s ability to achieve the intended results and customer expectations

• Internal and external information and issues related to the context of the organization shall be reviewed in order to evaluate changes that might affect the objectives of the organization.

• Note 1—The review may refer to positive and negative factors or conditions that may affect the QMS and its context of the organization.

• Note 2—Issues arising from legal, technological, competitive, market, cultural, social, and economic environments conditions, whether international, national, regional, or local, may be considered for the definition of the context of the organization.

• Note 3—Organizational values, perceptions, and cultural environment may help understand and form the context of the organization.

The Principle of the Context of the Organization

The ISO 9001 Standard recognizes the importance and role of the context of the organization and requires its definition when establishing a QMS. The analysis regarding the context of the organization is a natural process that each organization must follow at some point in its life. The ISO 9001:2015 aspires to institutionalize the context as the foundation for the QMS.

Organizations usually have several strategies or concepts in various fields and areas that dictate the direction of the organization: financial strategy, sales and marketing strategy, purchase strategy, IT concept, and so on. One clear objective of determining the context of the organization is to harmonize these various strategies and concepts. By determining the context of the organization, the organization identifies the scope and boundaries of its activities that will be reflected in the QMS. From the context of the organization we derive the goals and objectives of the QMS. After attending to these points, you should have a clear picture of the business environment in which your organization is active and you would be in the right position to plan and def...