Management Review Module of Quality Management Software

Management Review Module of Quality Management Software QISS coordinates all the activities related to Management Review Meeting within the organization. Management review committee members will be automatically notified whenever a meeting is scheduled. This module also meets requirements of ANSI/ASQ/ISO Q9001: 2008 clause 5.6 “Management Review”.

WHAT IS ISO 9001-2015 INTRODUCTION (PART-3 MAJOR CHANGES)

WHAT IS ISO 9001-2015 INTRODUCTION (PART-3 MAJOR CHANGES)

Structural and Philosophical Those of us who have been around these standards for a while might have the most difficulty with the changes. The reason could be two-fold. One is that the standard has had practically no change since 2000, or for the last 15 years, and we are used to the same standard for a long time. Even though it is all for the better- harmony with all other management standards, it is a change nevertheless, and major one. Perhaps the biggest change is that the standard has matured. With the publication of the new version, the standard is now 28 years old. Perhaps consequently, those of us accustomed to the standard prior to 2000 will have the most difficulty, since the familiar requirements/ restrictions/ admonitions seem to have disappeared. This has left many with the impression that the standard has been watered down. The fact is that not a single requirement has been eliminated. It just (may) seem that they have been. We will see why it seems that way when we get into the details of the new requirements, and the language/ style of presentation in the ISO-2015 version. In fact, there are net additions. Here again, some may argue that these were previously implied, and not really new. Regardless, now they are explicitly required. Following are synopses of some of the major additions: Context of the Organization Organizations are now required to determine external and internal issues that impact its purpose and strategic direction and ability to achieve goals of the Quality Management Standard. Understanding who are interested parties, and the requirements of these interested parties on the organization Risk Based Thinking Clause A.4 gives detail on this topic, but Clause 6 is likely one of the most clear in the requirement to make risk based thinking the foundation of a QMS complying with ISO 9001:2015   Management of Change Clause 6.3 requires the organization to carry out change in a planned manner, and address purpose of change, and risk associated so as to minimize it. Organizational Knowledge Organizations are now required to determine the knowledge necessary for the operation of its processes, and to achieve conformity of its product. This knowledge must be maintained, and made available as necessary. The above gives us a first look at the new ISO 9001:2015, and a peek at the more significant additions to requirements. The standard has matured; the language is much more subtle. You will find that the authors have done a tremendous job of presenting the original requirements in a much gentler fashion, with much fewer words. And yet, the size of the document has increased over the 2008 version.  That itself is a clue. Another clue is that we will have three years for the transition. Organizations are being expected to make decisions on their own regarding just how to effectively implement these requirements. We hope that you will stay with us over the next weeks/ months as we dig deep and mine some jewels.

WHAT IS ISO 9001-2015 INTRODUCTION (PART-2 MILESTONES)

WHAT IS ISO 9001-2015 INTRODUCTION (PART-2 MILESTONES)

The Quality Management Standards were born in the US military, during and after World War II, when a need was felt for systematizing manufacturing processes that were used to produce materiel purchased by the Department of Defense of the US Government. The military standard was called MIL-Q 9858. Q-9858 found its way into Europe through NATO, where it was called AQAP (Allied Quality Assurance Program). This was later adopted in the UK and transformed into a civilian standard, which was called BS 5750. Current ISO The current ISO standards are published by the International Organization for Standardization. ISO is Greek word, loosely translated to mean “standard”, and also serves as the informal synonym for the organization it comes from. The first Quality Management System (QMS) standards in 1987 and 1994 had three parts: ISO 9001, 9002, 9003. 9003 had only Inspection of product, 9002 had inspection and production, and 9001 and inspection, production and design. 9003 fit into 9002, and 9002 fit into 9001. 1987 and 1994 The 1987 version being a direct descendant of the (US) military standard had a command and control touch and feel to it. It was prescriptive. It was a rather small document. The 1994 version was essentially similar to the 1987 version, but had much more detail that was very helpful for implementing the requirements. The full version (ISO 9001) had 20 elements. 2000 and 2008 The 2000 version made a radical departure from previous versions. Quality Management System QMS standards till 2000 were quite blatantly focused on the manufacturing industry. The prevalent idea was that the pursuit of quality, and “quality control”, was applicable only to tangible products, typically produced in a factory with (usually) large teams of people involved. By far, the principal goal of aQuality Management System QMS was to ensure that (customer specified) requirements were met. The 2000 version expanded the goal of Quality Management System QMS to include “customer satisfaction” as the principal goal, and the pursuit of a “Process based approach” and “continual improvement” as a principal Modus Operandi.  The underlying look and feel of a manufacturing standard was erased as much as possible. Another significant change was the elimination of 9002 and 9003, but making the provision for taking exclusions as applicable. The general tone, look and feel was more relaxed, and organizations had much more explicit freedom to decide the details of their Quality Management System QMS. A major change was in the mandatory requirements for documented procedures. The 1987 and 1994 standards required documented procedure for almost all clauses. The 2000 version needed only six. The 2008 version of the standard had no significant changes from the 2000 version. ISO 9001:2015 The Draft International Standard (DIS) stage of the process was completed in May 2014, and the Final Draft International Standard (FDIS) was published last week on July 09, 2015. As expected, there were no significant material changes from the DIS to the FDIS. The final International Standard is expected in September/ October 2015, and there can be no material differences from the FDIS. The ISO 9001:2015 QMS standards can boast the most radical changes ever. The biggest change is of the structural and philosophical variety. The 2015 standard follows a harmonized structure that all management system standards will follow. This structure has 10 sections, in which all but one (section 8) apply uniformly to general management system requirements (quality, environment…et al). Section 8 (Operation) will apply to the specific discipline.

WHAT IS ISO 9001:2015 INTRODUCTION (PART 1)

WHAT IS ISO 9001:2015 INTRODUCTION (PART 1)

Perhaps the biggest change ever in Quality Management Systems is finally here. The Final Draft of Quality Management Standard (ISO 9001:2015) was released on July 09. This is still a draft, but there will be no material changes when the International Standard is released later this year. Contrary to many who thought that the standard has been watered down, and requirements reduced, careful reading will show that quite the opposite has occurred. There have been no reductions. In fact, there have been substantial additions of a philosophical nature. Despite the nature, the additions are not just feel-good cerebral exercises—they come with teeth, and can bite. This is the first in a series of articles that will be published on the Quality Institute of America (QIA) website www.qi-a.com and the Quality Management Software QISS software website http://www.qisssoftware.com/Quality-Management-Software-QHSE-Whitepaper/Whitepaper.aspx . The articles are written principally by Wali Alam with help from colleagues. Mr. Alam has been associated with the standards since 1990: implementing, auditing in the roles of certification, internal, second party auditor, and providing training in these standards. He is also the principal architect of the Quality Management Software QISS that helps people automate their systems. The purpose of these articles is to start a discussion on how to interpret the changes, and then how to deal with them. Mr. Alam and others at Quality Institute of America will start a line of thinking, and hopefully trigger discussions that will culminate in solid take-always for interpreting and implementing the new standard. Part 1 will introduce the reader to the history of the standard, and paint a 30,000 foot view of the requirements of the new standard. The discussions will typically be presented in the context of the fact that the 2015 standard is a major change from the current 2008 version. Subsequent parts of the article series will dig into details of the requirements in bite-size pieces so you can read them in one sitting of approximately an hour for reading, digesting, and contributing any thoughts and comments of your own through our blog page,https://plus.google.com/u/0/b/100418610237055178555/+QisssoftwareQMSsoftware/posts/p/pub We hope that you will enjoy this series, and have the time to contribute with your comments.