Home/Articles

ISO 9001:2015 NET ADDITIONS

by Quality Institute of America (QIA) | published on Feb 24, 2016

ISO 9001:2015 Articles Group 3

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.  Some people believe 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.


Quality Institute of America (QIA) has been providing a series of articles to help people who wish to understand the new standard. These are divided into five groups: Group 1 provided an Introduction to the ISO 9001-2015 standard. Group 2, provided a thorough understanding of the new standard by referencing the old version, and pointing out how the new standard essentially has the same requirement with a different twist and location in the new standard.


The ISO 9001:2015 version actually has net additions to the old (ISO 9001:2008) version. This article is the first in the Group 3, and introduces you to a summary of the additions. It will be followed by full length articles on the various additions.

Read More

ISO 9001:2015 REQUIREMENTS (PART 6) MEASUREMENT, ANALYSYS & IMPROVEMENT

by Quality Institute of America (QIA) | published on Sep 22, 2016

Introduction

This is a continuation of a series of articles.  If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 6.

 

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  Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant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

Read More

ISO 9001:2015 REQUIREMENTS (PART 5) PRODUCT REALIZATION

by Quality Institute of America (QIA) | published on Aug 11, 2016

Introduction

This is a continuation of a series of articles.  If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 6.

 

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.

Read More

ISO 9001:2015 REQUIREMENTS (PART 4) PRODUCT REALIZATION

by Quality Institute of America (QIA) | published on Jul 08, 2016

Introduction

This is a continuation of a series of articles.  If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 4.

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

Read More

ISO 9001:2015 REQUIREMENTS (PART 3) RESOURCE MANAGEMENT (PROVISION)

by Quality Institute of America (QIA) | published on May 14, 2016

Introduction

This is a continuation of a series of articles.  If you have read the earlier ones, you can skip this introduction and start reading after the underlined break, marked Start Requirements, Part 3.

The release of the Final Draft International Standard of ISO 9001:2015 has created a great deal o

Read More

ISO 9001:2015 REQUIREMENTS (PART 2) MANAGEMENT RESPONSIBILITY (LEADERSHIP)

by Quality Institute of America (QIA) | published on Apr 16, 2016

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 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.

Read More

ISO 9001:2015 REQUIREMENTS (PART 1) DOCUMENTATION

by Quality Institute of America (QIA) | published on Mar 25, 2016

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 Manual, Quality Objectives, or the six required procedures for their respective Quality Management SystemsReality: 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.

Read More

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

by Quality Institute of America (QIA) | published on Dec 21, 2015

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.

Read More

WHAT IS ISO 9001 2015 INTRODUCTION (PART 2 MILESTONES)

by Quality Institute of America (QIA) | published on Nov 04, 2015

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.

Read More

WHAT IS ISO 9001:2015 INTRODUCTION (PART 1)

by Quality Institute of America (QIA) | published on Oct 13, 2015

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.

Read More

KEY CONCEPTS IN UNDERSTANDING THE QUALITY MANAGEMENT STANDARDS

by Quality Institute of America (QIA) | published on Apr 05, 2017

Shall:
The word Shall in Quality Management Standard has been used in many places. We all know that in the English language the word Shall is used when an activity must be performed, therefore whenever you see word Shall, you must do what the Quality Management Standard demands if you desire certification to the Quality Management Standard. A popular exercise is to identify the places in the standard where "Shall" is used, and then address what follows that word. Some logical methods for "Engineering" the procedures needed to address the requirement can be derived from the "Shall" word, and will be offered soon in these blogs, articles and white papers.

Read More

HOW TO USE ISO 9001 TO RUN YOUR ORGANIZATION

by Quality Institute of America (QIA) | published on Mar 18, 2017

Apart from being just a politically correct statement, it is actually a fact that the ISO 9000 family of standards can help management run their companies better. It is also a fact that many companies who do have "Certified Systems" do not get the full benefit of ISO 9001.

This is the first in a series of articles aimed at providing some insight into how could someone use ISO 9001 to run their organizations better, and serve the needs of their customers. The series planned at this time will:

  • Give you a method for interpreting the standard at different levels, so you can choose the level you want to operate at.
  • Give you examples of interpretation at the different levels.
  • Discuss some options on how to use the different levels in a new and a mature system.
  • Investigate methods to automate a system so as to utilize a system to its fullest.
Read More

MANAGEMENT RESPONSIBILITY AND ISO CLAUSE 5

by Quality Institute of America (QIA) | published on Feb 10, 2017

Top Management of any organization has a tremendous influence on the success of that organization. This is a self-evident, and a simple fact. It would follow therefore, that the success of a project for an ISO Certification (certification of a Quality Management System- QMS to ISO 9001) would depend on how top management leads this project. The good news is that ISO 9001 provides simple rules which define the roles and responsibilities for top management. These rules ensure that not only is ISO certification achieved; the organization will also have a formal mechanism for success in whatever it chooses to do. You will find that the rules make powerful sense, and once organized, does contribute to overall organizational success.

Read More

COMPONENTS OF A MANAGEMENT SYSTEM

by Quality Institute of America (QIA) | published on Oct 08, 2016

There were several reasons why the craftsmen of the “good old days” made excellent products. Main reasons were: having been trained for decades, the products were quite simple, and the processes simple and stable. The most important reason was that most of the time, they operated as individuals. So, what is it about a lone ranger that gives him such an advantage?
Craftspeople were able to do everything in the business all by themselves. Their Central Nervous System governed everything that needed to be governed to get great quality. The challenge for modern enterprise is that they need to emulate the craftsman method of doing business. Rules that need to be followed are provided by ISO 9000 Quality Management Systems, and all the other related standards, like AS9100, API Q1, API Q2, TS 16949 and others, including non-quality standards like ISO 14000 and OHSAS 18000.

Read More

DEMYSTIFYING CORRECTIVE ACTIONS AND CORRECTIONS IN ISO 9001 AND RELATED MANAGEMENT STANDARDS

by Quality Institute of America (QIA) | published on Dec 08, 2015

Whether you are a first year post-graduate Quality Manager or a seasoned pro, with multiple years of ISO compliant, corporate experience, you probably face conflicts that arise from a misinterpretation or improper definition of a corrective action versus a correction. This can lead to faulty or incorrect management decisions, or worse, an incorrect application and/or approach to compliance that may cost a company financially and lead to audit troubles down the line.

Read More

CORRECTIVE ACTIONS & CORRECTIONS IN ISO

by Quality Institute of America (QIA) | published on Jan 22, 2016

Even though the ISO 9000 series of standards has been around for more than a quarter century, a fair amount of confusion or mystery still surrounds the topics of Corrective Actions and Corrections. Unfortunately, in the day-to-day usage of the terms, corrections and corrective actions are interpreted as synonyms, and this is one of the sources of the confusion. This confusion can result in designing management systems that are not as effective as they could be in ensuring that the organization always provide conforming product to customers. 

The key to understanding the difference is that Corrections are aimed at the Product (including service), and Corrective Actions are aimed at the Process (es) that produced the product. 

Read More

HOW TO SOLVE PROBLEM WITH CAPA

by Quality Institute of America (QIA) | published on Feb 21, 2016

Last month I talked about common problems seen with how companies handle the Corrective and Preventive Action (CAPA) part of their systems. This month I will talk about some ways on how to solve them.

Before I get into the problems stated last month, let me first set the stage by stating the requirements for CAPA in section 8.5.2 and 8.5.3.

A "30,000 foot" view of the standard shows a document that provides a model to help organizations to consistently produce conforming products. It also recognizes that nonconformities can occur. When they do, those must be handled according to section 8.3 to ensure that nonconformities are corrected, and the nonconforming product is not used as if it is conforming product.
Read More

COMPUTER ASSISTED CAPA/CPAR

by Quality Institute of America (QIA) | published on Jan 14, 2016

The first principle is to keep non-conformances (nc’s) and capa separate. There is a reason why they have been kept separate in ISO 9001 (8.3 and 8.5). With nc’s, we are solving (dispositioning) problems with the product and service that we are providing. With capa, we are solving problems with the process(es) that produce the product. Among several reasons for keeping them separate is that dispositioning every single nc is a must. CAPA, on the other hand, is discretionary, and depends on the severity of the nc. Some large customers give vendors forms that combine the two. What they are implying is that they consider the problem identified as serious enough to prevent in the future; and therefore they require both dispositioning and corrective actions.

Read More

DEMYSTIFYING CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS IN ISO 9001 AND RELATED MANAGEMENT STANDARDS

by Quality Institute of America (QIA) | published on Dec 08, 2015

As a Quality Assurance or Management professional, you are aware that ISO 9001 has been used by numerous other standards to provide a base for additional requirements relating to the particular industry or environment that the particular standard is written for.
The figure below has been reproduced from ISO 9001:2008 / ISO 9001:2015 standard. The figure distils the entire standard into one picture, proving once again that a "picture is worth a thousand words" (maybe many thousands of words). In my opinion, the figure also points to the real purpose of the use of the standard, and essence of all the requirements: the final requirement is that the management system must continually improve.

Read More

PROBLEMS WITH CAPA

by Quality Institute of America (QIA) | published on Aug 18, 2016

We have been conducting Quality Management ISO 9000 certification audits since 1992, and almost always, I find that the most misunderstood part of the ISO 9001 standard is the section: 8.5.2 & 8.5.3 on Corrective and Preventive Actions (CAPA), which is the engine for continual improvement, and consequently, growth. This is unfortunate for the client, since this the part of your management system that could actually make you a lot of money. There are several classes of misconceptions.

Read More

MAJOR CHANGES TO ISO 9001:2008 TO 9001:2015

by Quality Institute of America (QIA) | published on Oct 8, 2016

Now that we are solidly in the new 2015 year, we should start getting ready for the new ISO 9001:2015 standard that is currently under final construction. This is the first in a series of articles that will be published by the Quality Institute of America (QIA), aimed at helping organizations understand and implement the new standard.
ISO 9001 is one of ISO’s most well-known standards, with more than 1.1 million certificates worldwide. ISO 9001 is undergoing the periodic revision standards generally go through every 3 to 5 years to ensure they are relevant and up-to-date. The new edition, expected in 2015, will feature some important changes.

Read More

IT'S ALL ABOUT RISK!!

by Quality Institute of America (QIA) | published on Sep 23, 2016

Summary

Somebody finally got it right…Quality and Quality Systems is all about avoiding risks. Meeting Requirements, delighting customers, and other versions of the theme are but manifestations of the underlying desire to protect ourselves and our organizations from risks.  Building systems, processes, rules, and protocols to minimize risks brings a sharper focus on what and how to efficiently improve quality and productivity at all levels, from enterprise to an individual task. This article explains the role of Risk Based Thinking in the new ISO 9001:2015. The next one will show some tools and techniques to get the most out of the new mandate re risk.

Read More

TOOLS FOR RISK MANAGEMENT

by Quality Institute of America (QIA) | published on Nov 11, 2016

Summary

Although Risk Based Thinking is something new in the formal ISO 9001:2015. However, the concept has been the basis of Quality Management Systems since its inception in the US Military, and then brought into the civilian arena by the International Organization for Standardization (ISO Standard).

The base methodology for handling risks was also developed by the US Military in the 1950’s for reducing failures in equipment in the materiel. The core methodology was and is called Failure Mode and Effects Analysis (FMEA). Initially it was used by Reliability Engineers but was readily adopted by industries for improving Quality and Reliability.

Read More



  About

QIA offers a wide variety of professional services, such as, ISO 9001:2015 consulting and training to assist in transitioning from ISO 9001:2008 to the new 2015 standard. In addition, We offer consulting, Auditing and Training for a wide variety of standards.

  Quality Institute of America
  Headquarter

8951 Ruthby Street #15,
Houston, TX 77061, USA

Tel : (281) 335-7979
Fax : (832) 582-8504
E-mail : sales@qi-a.com,
      qisssupport@qi-a.com
Business Hours : 8:00 AM - 5:00 PM

  Asia Office

House# 14, Road# 1/A, Block# J,
Baridhara, Dhaka, Bangladesh

Tel : (880-2)-9854911
E-Mail : infobd@qi-a.com
Business Hours : 9:00 AM - 5:00 PM

Copyright © 2014 - QIA