Quality Institute of America: 2015

Monday, December 21, 2015

Quality Management Software for Training

TRAINING

This module can be used to ensure that the most important resource of an organization...its human resources is the best it can be. In other words, it provides the tool to ensure optimum competence of the personnel in an organization. This is achieved by ensuring that all requirements for competency are met:

Those that are required by the organization
Those that are required by the department the person works in
Those required by the job function/ title/
Those additional requirements from the person’s supervisor or the competence/ HR manager
Performance evaluations (supported by QISS)
Any others

A person’s current competencies are measured against the total requirements, and the deficit is flagged for correction through a variety of training and other programs like on-the job mentoring, self-acceptance and others, all supported by QISS.

QISS supports a library of training programs that can be offered through the software, as well as mechanisms to schedule and deliver live instructor led programs. The schedules could be unique, or could be driven by the individual training itself, such as fork-lift training that could be driven by periodic requirement.

https://www.youtube.com/watch?v=6MFK7qpQLVk

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 Furthermore, it has been replaced by an over worded document that doesn’t address the needed direction for an organization to follow in order to create and maintain a functioning and vibrant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

Start Requirements, Part 3

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 Resource Management in ISO 9001:2008

ISO 9001 2008 version Section 6 – Resource Management

Section 6.1 of ISO 9001 2008 discusses provision of resources. It is found, in total, in Section 7.1.1 of the ISO 9001 2015 version with the noted exception of subsection (b) enhancement of customer satisfaction by meeting customer requirements – this subsection is omitted in the new version. This omission is appears to be intentional because more detailed customer satisfaction explanation is found in Section 5.1.2 of the ISO 9001 2015 version – Customer Focus.

Section 6.2 of the old version – Human Resources is now found in Section 7.2 of the ISO 9001 2015 version – Competence. Section 6.2.1 of the ISO 9001 2008 version has been omitted but all of Section 6.2.2 has been included in the aforementioned Section 7.2 (a d).

Section 6.3 – Infrastructure is now found, in whole, in Section 7.1.3 of the ISO 9001 2015 version.

Section 6.4 – Work Environment is now found in Section 7.1.4 of the ISO 9001 2015 version. The ISO 9001 2008 version’s single paragraph has been replaced by more detailed requirements of compliance (a c) which speak to social, psychological and physical factors that impact an organization’s work environment.

What is missing in ISO 9001:2015?

Subsection (b) of the ISO 9001 2008 version has been omitted but appears in more detailed form in Section 5.1.2 of the ISO 9001 2015 version – Customer Focus.

Subsection 6.2.1 of the ISO 9001 2008 version has been omitted relating to Human Resources.

What is added/ changed?

Very little has changed. Sections 6.2, 6.3 and 6.4 have been retained in verbatim (with the aforementioned exceptions) and renumbered in the ISO 9001 2015 version of the standard.

Summary:

With very little changes (mostly cosmetic), the new sections of the ISO 9001 2015 version reflect those corresponding sections in the ISO 9001 2008 version.

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 “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.

Start Part 2 B:

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.

Please click the link below to read more about "ISO 9001:2015 REQUIREMENTS (PART 2) MANAGEMENT RESPONSIBILITY (LEADERSHIP)"

http://www.qi-a.com/Quality-Management-Software-QHSE-Whitepaper/Iso-9001-2015-Requirements-(Part-2)-Management-Responsibility-(Leadership).aspx

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.

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:

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.

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).

Click the below link to ready more about "ISO 9001:2015 REQUIREMENTS (PART 1) DOCUMENTATION"

http://www.qi-a.com/Quality-Management-Software-QHSE-Whitepaper/Iso-9001-2015-Requirements-(Part-1)-Documentation.aspx

Friday, December 18, 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.

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 Quality Management System 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)

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 a Quality 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 was published in October 2015, and there are 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 ISO 9001:2015 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…etc). Section 8 (Operation) will apply to the specific discipline.

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 qi-a.com/Articles.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.