Introduction
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 Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant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 Manual, Quality 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 a.com as well as our blog page:https://plus.google.com/u/0/b/100418610237055178555/+QisssoftwareQMSsoftware/posts/p/pub
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.
Subsection (d) of the ISO 9001 2008 version addressed conducting management reviews as a management commitment. Subsection (g) of the 2015 standard alludes to ensuring that the Quality Management System (QMS) achieves its intended results. The reader must infer the organization’s requirement to review its Quality Management System (QMS) and its functionality on a periodic basis. Section 9.3 of the new standard contains the requirements of conducting the management review and the required inputs/outputs of the review process.
Section 5.2 of the ISO 9001 2008 version discusses customer focus and requires that customer requirements are determined and are met with the focus on enhancing customer satisfaction. Section 5.1.2 of the 9001:2015 version captures this language in subsection (c).
Section 5.2.1 of the new ISO 9001 2015 standard deals with developing the quality policy. Subsections (a c, and e) of the 2008 version are contained in the new standard section. Subsection (d) of the ISO 9001 2008 version is now contained in 2015 version, section 5.2.2(b).
Section 6.2.1 of the new standard ISO 9001:2015 version deals with quality objectives and planning to achieve them. The 9001:2008 version of the standard had a simple paragraph outlining the necessary components related to quality objectives. These have been “spelled out” in the 2015 version into subsections that contain the aforementioned components.
Section 6.3 of the 9001:2015 version sets forth the requirements for planning and executing change of an organization’s Quality Management System (QMS). The requirements of the old standard ISO 9001:2008 version 5.2.4 are contained in the new version with a more detailed explanation of the required components.
Section 5.3 of the 9001:2015 standard contains the exact wording of the ISO 9001 2008 version Section 5.5.1 Responsibility and Authority.
Section 5.5.2 of the ISO 9001:2008 version sets forth the requirement of a Management Representative to be appointed to have responsibility and authority over all aspects of an organization’s Quality Management System (QMS). Section 5.3 of the 9001:2015 version of the ISO standard contains the required duty of responsibility and authority but DOES NOT requires the appointment of a designated representative, instead, management is charged with assigning the aforementioned responsibilities within the organization, as a whole, and not to one designated named individual.
Section 5.5.3 – Internal Communication is found in Section 7.4 of the ISO standard 9001: 2015. The new version is more detailed in defining the various; acceptable communications an organization is required to address in its Quality Management System (QMS) operations.
Section 5.6 (5.6.1, 5.6.2 & 5.6.3) – Management Review in the old version is completely contained in Section 9.3, et al of the 2015 version.
What is missing in ISO 9001:2015?
Section 5 of the old standard 9001:2008 does not have things missing as much as subsections or sentences that have been moved to another subsection in the ISO 9001:2015 version or have been re written for more definition or strategic emphasis. Direct reference to having a management representative is however missing, although the duties are still required to be done as assigned.
What is added/ changed?
More specificity has been added to the new standard ISO 9001:2015 in many subsections (ex. 6.2.1 lists the quality objective requirements and the planning on how to achieve same). However, some subsections (as will be discussed at a later time) have been written without any direct requirements of content or conduct, leaving the organization to determine for itself what would be necessary or required to meet the ISO standard for that conduct, process or action. Section 5.3 Organizational roles, responsibilities and authorities has been added. This addition assures that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization. Subsections (a e) delineate the requirements for undertaking these tasks assigned to organizational management.
Summary:
Management is now tasked with overall Quality Management System (QMS) management (not by a designated Management Representative). Quality Objectives have been given more detail and emphasis in the 2015 version than in the old. The detail expressed in section 6.2.1 evidences the importance of determining and managing objectives as a cornerstone of the Quality Management System (QMS) in the new ISO 9001 2015 standard.
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