by QIA
Posted on
30th Oct, 2018

I’m ISO 9001:2015 certified – what do I do now?

Our ISO 9001:2015 upgrade audit has been completed and we have been recommended for certification for ISO 9001:2015. Months of work and preparation has gone into re-writing and reorganizing our QMS into a compliant format for the new (i.e. required) additions of ISO 9001:2015 standard.

by QIA
Posted on
19th Sept, 2018

ISO 9001:2015 Risk Requirements

The table seen below explains the requirements of ISO 9001:2015 for risk and opportunity analysis within the organization. The concept of risks and opportunities, which emphasizes identifying potential problems as well as opportunities for improvement, needs to be applied to QMS processes, the conformity of products and services, and planning QMS objectives, including setting out actions for improvement plans and evaluating their effectiveness (i.e. Sections 7 & 8 of the ISO 9001:2015 standard).


by QIA
Posted on
24th Jun, 2018

Early Warning Indicators: Leading Indicators for Risk Management

A Management tool for assisting in Risk Assessment and Mitigation

With the advent of ISO 9001:2015, organization’s that are certified to that standard, as well as, multiple other standards have been tasked with the requirement of assessing and, if needed, mitigating risk factors from their operations and management systems.

For example, ISO 9001:2015, section 8.7 Control of Nonconforming Outputs requires that an organization shall insure that outputs that do not conform to their requirements are to be identified and controlled to prevent unintended use or delivery. (section 8.7.1). Furthermore, in section 10.2.1 (b), the organization is required to evaluate the need to eliminate the nonconformance by 1) reviewing and analyzing the nonconformance 2) determining its cause and 3) determine if similar nonconformities exist or could potentially occur.


by QIA
Posted on
24th Feb, 2016

ISO 9001:2015 NET ADDITIONS

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.


by QIA
Posted on
22th Sept, 2016

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

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 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.


by QIA
Posted on
11th Aug, 2016

ISO 9001:2015 REQUIREMENTS (PART 5) PRODUCT REALIZATION

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 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.


by QIA
Posted on
8th Jul, 2016

ISO 9001:2015 REQUIREMENTS (PART 4) PRODUCT REALIZATION

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


by QIA
Posted on
14th May, 2016

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

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


by QIA
Posted on
16th Apr, 2016

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

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.


by QIA
Posted on
25th Mar, 2016

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 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.


by QIA
Posted on
21th Dec, 2015

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.


by QIA
Posted on
04th Nov, 2015

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.


by QIA
Posted on
13th Oct, 2016

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.


by QIA
Posted on
05th Apr, 2017

KEY CONCEPTS IN UNDERSTANDING THE Quality Management StandardS

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.


by QIA
Posted on
10th Feb, 2016

MANAGEMENT RESPONSIBILITY AND ISO CLAUSE 5

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.


by QIA
Posted on
08th Oct, 2016

COMPONENTS OF A MANAGEMENT SYSTEM

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.


by QIA
Posted on
08th Dec, 2015

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

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.


by QIA
Posted on
22th Jan, 2016

CORRECTIVE ACTIONS & CORRECTIONS IN ISO

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.


by QIA
Posted on
21th Feb, 2016

HOW TO SOLVE PROBLEM WITH CAPA

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.


by QIA
Posted on
14th Jan, 2016

COMPUTER ASSISTED CAPA/CPAR

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.


by QIA
Posted on
08th Dec, 2015

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

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.


by QIA
Posted on
18th Aug, 2016

PROBLEMS WITH CAPA

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.


by QIA
Posted on
08th Oct, 2016

MAJOR CHANGES TO ISO 9001:2008 TO 9001:2015

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.


by QIA
Posted on
18th Mar, 2017

HOW TO USE ISO 9001 TO RUN YOUR ORGANIZATION

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.

by QIA
Posted on
23th Sept, 2016

IT'S ALL ABOUT RISK!!

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.


by QIA
Posted on
11th Nov, 2016

TOOLS FOR RISK MANAGEMENT

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.