Monday, December 21, 2015


This is a continuation of a series of articles.  If you have read the last one (Part 2 A), you can skip this introduction and start reading after the underlined break, marked Start Part 2 B
The release of the Final Draft International Standard of ISO 9001:2015 has created a great deal of hand wringing and argument that many requirements of the ISO 9001 2008 standard have been deleted, abandoned and/or lessened.  Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant Quality Management System. Many tongues have uttered the soliloquy that an organization no longer needs to have a Quality ManualQuality Objectives, or the six required procedures for their respective Quality Management Systems.  Reality: nothing could be further from the truth. The fact is that the ISO 9001 2015 standard does not reduce any requirements. It does require them in a different language, and does require/ empower the organization to decide the details.
The “Introduction” part of this series of articles provided a “30,000 ft.” view of the ISO 9001 2015 standard. This paper starts the second in the “Requirements” series, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use the ISO 9001:2008 version, and would like to know how to handle the ISO 9001 2015 version. Each of the sub parts in the Requirements series will take a portion of the ISO 900 2008 version and help the reader understand the following:

Where it is in the New Standard:

Owing to the changed structure and organization of ISO 9001 2015 version, some may find a bit of a challenge in trying to relate to the new standard from the perspective of ISO 9001 2008 version. This subsection will help in navigating the new standard.

What is Missing? 

This subsection will point out parts of the old standard ISO 9001 2008 that may have been omitted in the new standard ISO 9001 2015.

What is Added/ Changed:

This subsection will point to those requirements that did not exist in the ISO 9001 2008, and have been added to the ISO 9001 2015.
Part 3 of this series will discuss the net additions to the ISO 9001 2008 version, Part 4 will discuss implementation issues for each of the sections discussed in the Part 2 subseries, and Part 4 will discuss how to audit to the new standard ISO 9001 2015.

Start Part 2 B:

We intend to present these articles through various channels, but principally through our web site: www.qi as well as our blog page:
Below is a refresher on the requirements related to Management Responsibility in ISO 9001:2008  

What is in ISO 9001 2008 – Section 5 Quality Management System (QMS):

ISO Section 5 – Management Responsibility (5.1 – 5.6.3)

Section 5.1 Management Commitment

This subsection contains the requirement of top management that it shall provide evidence of its commitment to the development and implementation of the Quality Management System (QMS) and to continually improve it…

5.2 Customer Focus

Customer requirements are to be determined and met with the aim of enhancing customer satisfaction.

5.3 Quality Policy

Quality Policy is appropriate to the purpose of the company, has a commitment to comply with requirements and continual improvement of the Quality Management System (QMS).

5.4 1 Quality Objectives

Objectives, including those needed to meet requirement for product, are established at relevant functions and levels within the organization. 

5.4.2 QMS Planning

This subsection states that management is required to ensure that the planning of the QMS is carried out to meet the requirements of section 4.1 and the integrity of the Quality Management System (QMS) is maintained when changes are introduced.

5.5.1 Responsibility and authority

Responsibilities and authorities are to be defined and communicated within the organization.

5.5.2 Management Representative

This subsection articulates the requirement of an appointed member of top management who shall have responsibility and authority that includes ensuring processes needed for Quality Management System (QMS) are established, implemented and maintained.

5.3 Internal Communication

Appropriate communication processes are to be established within the organization.

5.6.1 Management Review

Top management shall review the Quality Management System (QMS), at planned intervals, to ensure its continual suitability, adequacy and effectiveness.

5.6.2 Review Input

A list of items relating to the Quality Management System (QMS) are required as an input for the review.

5.6.3 Review Output

A list of items is specified as a minimum as an output of the management review process.

Where is it in the ISO 9001 2015 – Standard:

Section 5.1.1 of the new standard contains subsections (b), (c) and (e) from the ISO 9001 2008 version.  – see also 4.4.1 (d) where resources availability is listed. Subsection (a) of the 9001 2008 version has emerged in two separate subsections of the ISO 9001 2015 new version – 5.1.1 (f) and 5.1.2 (a). Subsection (f) relates to communicating the importance of effective quality management and conforming to Quality Management System (QMS) requirements – one of which is communicating customer requirements within the organization. 5.1.2 (a) requires management to ensure customer and applicable regulatory requirements are determined, understood and consistently met.
Please click the link below to read more about "ISO 9001:2015 REQUIREMENTS (PART 2) MANAGEMENT RESPONSIBILITY (LEADERSHIP)"