Monday, December 21, 2015

ISO 9001:2015 REQUIREMENTS (PART 1) DOCUMENTATION


Preface
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  Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant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.

Quality Institute of America (QIA) is providing a series of articles to help people who wish to understand the new standard. These are divided into four groups: Group 1 provided an Introduction to the ISO 9001 2015 standard. This paper starts Group 2, subdivided into sub parts to handle the standard piece by piece. The series is aimed at readers who currently use theISO 9001:2008 version, and would like to know how to handle the ISO 9001 2015 version. Each of the sub parts in the Part 2 series will take a portion of the ISO 9001 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 2008version. 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.
We are presenting 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

START of REQUIREMENTS (Part 1)
Below is a refresher on the requirements related to Documentation in ISO 9001:2008

What is in ISO 9001 2008 – Section 4 Quality Management System (QMS)
Section 4.1 of the ISO 9001 2008 standard requires and organization to establish, document, implement, and maintain a Quality Management System (QMS), and continually improve its effectiveness. This needs to be achieved by determining the processes needed for the Quality Management System (QMS), their sequence and interaction, criteria and methods for operation and control of these processes, provide resources for these processes, and lastly: monitor, measure, analyze these processes and take actions to improve these processes.

Section 4.2.1 of the ISO 9001 2008 standard introduced the general requirements of the documentation needed for a Quality Management System (QMS). It speaks of the need to have a writtenQuality Policy, Quality Objectives, a Quality Manual (QM), specific documented procedures and the need for documents that would be necessary to ensure proper planning, operation and control of the organization’s processes. When compared to the version of ISO 9001 2015, the contrast is, at first, quite striking. (as discussed and contrasted below).

In section 4.2.2 of the ISO 9001 2008 standard, the three requirements related to the Quality Manual are discussed: scope of the Quality Management System (QMS), documented procedures and description of the interactions between processes.

Section 4.2.3 of the ISO 9001 2008, standard, Control of Documents, sets forth the requirement for a documented procedure to govern the control of documents.  Seven subsections articulated the needs to: approve, review, ensure changes, have relevant versions available, be legible, ensure external documents are identified and prevent the unintended use of obsolete documents.

Section 4.2.4 discusses the Control of Records. Records that are established or produced to provide evidence of requirement conformity and of the effectiveness of operation of the Quality Management System QMS shall be controlled.  Furthermore, the organization is required to produce and maintain a documented procedure to define the aforementioned controls.  All records are to remain legible, identifiable and retrievable.

Where is it in ISO 9001:2015?
ISO 9001 2015 – Sections 4.4.1, 4.4.2, 7.5.1, 7.5.2 and 7.5.3 (7.5.3.1 & 7.5.3.2)
The new version ISO 9001 2015 expands the documentation process into two sections (4.4 Quality Management System QMS and its Processes and 7.5 Documented Information).

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