ISO 9001:2015 - Introductory elements (Part 3)

With this post I am concluding the analysis of the introductory, referenced and complementary elements that make up the context of the ISO 9001: 2015 standard.

Before continuing with the Introduction clause, of which we already mentioned both the General and the Principles of quality management in the previous post, I would like to insist on the importance, for those of us who work in activities related to the establishment, operation and improvement of a quality management system in compliance with ISO 9001: 2015 standard, we should know and understand not only the text of the requirements of the standard, but also the context in which this standard should be applied, so I have dedicated, including this one, three posts identifying and analyzing that context.

We then continue with sub clause 0.3 Approach to processes, which in turn contains three sections: General; Plan-Do-Check-Act Cycle (PHVA); and Risk-based thinking.

In subsection 0.3.1 General, this standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.

Understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

a) Understanding and consistency in meeting requirements;

b) The consideration of processes in terms of added value;

c) The achievement of effective process performance;

d) Improvement of processes based on evaluation of data and information.

 

Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.

 

Figure 1 — Schematic representation of the elements of a single process

 

Regarding subsection 0.3.2 Plan-Do-Check-Act Cycle, It tells us that the PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.

 

Figure 2 — Representation of the structure of this standard in the PDCA cycle

NOTE: Numbers in brackets refer to the clauses in this standard.

 

The PDCA cycle can be briefly described as follows:

— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies, and identify and address risks and opportunities;

— Do: implement what was planned;

— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;

— Act: take actions to improve performance, as necessary.

This PHVA cycle is considered to be the basis for continuous improvement in an organization, from an operational point of view, and we can visualize it as follows.

If you have interest in this topic, the next video describes the PHVA cycle:

Subsection 0.3.3 Risk-based thinking tells us that risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.

To conform to the requirements of this standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.

Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.

The last sub clause of the Introduction clause is 0.4 Relationship with other management system standards.

This standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1).

This standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.

This standard relates to ISO 9000 and ISO 9004 as follows:

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard;

— ISO 9004 Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard.

Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176.

This standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.

Sector-specific quality management system standards based on the requirements of this standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this standard within the particular sector.

A matrix showing the correlation between the clauses of this edition of this standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at: www.iso.org/tc176/sc02/public.

Now, we arrive to Clause 1. Scope, which establishes the following:

This standard specifies requirements for a quality management system when an organization:

a) Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of this Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

 

NOTE 1 In this standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

 

In the clause 2. Normative references, we found that the following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

As the ISO 9001: 2015 standard establishes, it is essential to consult the ISO 9000: 2015 standard in order to achieve an adequate understanding and establishment of a quality management system. The guidelines contained in this standard clarify many of the doubts that generally arise when establishing, operating or improving a quality management system.

The clause 3  Terms and definitions, tells us that for the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

This point is also important because the definitions contained in this standard help us to properly understand the relevant concepts used in ISO 9001: 2015.

In addition to all the introductory elements that have been presented in these last three posts of this blog, as well as the elements that are referenced in this same standard and correspond to those contained in the ISO 9000: 2015 standard, we have some additional complementary elements, such as an Annex A Clarification of new structure, terminology and concepts, an Annex B Other International Standards on quality management and quality management systems developed by ISO/TC 176, and those listed in the bibliography of this same standard, and presented below, and which may be enriching to consult:

Bibliography

[1]    ISO 9004, Managing for the sustained success of an organization — A quality management approach

[2]    ISO 10001, Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations

[3]    ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations

[4]    ISO 10003, Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations

[5]    ISO 10004, Quality management — Customer satisfaction — Guidelines for monitoring and measuring

[6]    ISO 10005, Quality management systems — Guidelines for quality plans

[7]    ISO 10006, Quality management systems — Guidelines for quality management in projects

[8]    ISO 10007, Quality management systems — Guidelines for configuration management

[9]    ISO 10008, Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions

[10]  ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment

[11]  ISO/TR 10013, Guidelines for quality management system documentation

[12]  ISO 10014, Quality management — Guidelines for realizing financial and economic benefits

[13]  ISO 10015, Quality management — Guidelines for training

[14]  ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000

[15]  ISO 10018, Quality management — Guidelines on people involvement and competence

[16]  ISO 10019, Guidelines for the selection of quality management system consultants and use of their services

[17]  ISO 14001, Environmental management systems — Requirements with guidance for use

[18]  ISO 19011, Guidelines for auditing management systems

[19]  ISO 31000, Risk management — Principles and guidelines

[20]  ISO 37500, Guidance on outsourcing

[21]  ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2008 to computer software

[22]  IEC 60300-1, Dependability management — Part 1: Guidance for management and application

[23]  IEC 61160, Design review

[24]  Quality management principles, ISO ¹⁾

[25]  Selection and use of the ISO 9000 family of standards, ISO ¹⁾

[26]  ISO 9001 for Small Businesses — What to do, ISO ¹⁾

[27]  Integrated use of management system standards, ISO ¹⁾

[28]  www.iso.org/tc176/sc02/public

[29]  www.iso.org/tc176/ISO9001AuditingPracticesGroup

¹⁾ Available from website: http://www.iso.org.

 

Author:

Ernesto Palomares Hilton