In May 2008, a revision of ISO 9001, the world’s most popular standard for quality management systems (over one million certificates issued in 170 countries), was submitted for approval.

The International Organization for Standardization’s official press release (June 17, 2008) explained that “The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.”

The November 2008 issue of Quality Digest magazine said ISO 9001:2008 “clarifies requirements in outsourcing, document control, and customer relations ... Many of the changes are designed to bring about better compatibility between ISO 9001 and the ISO 14001 environmental management systems standard.”

For a document detailing ISO 9001:2008 requirements visit the International Organization for Standardization’s website.

Among the many regulations overseen by the Food and Drug Administration, there is one pertaining specifically to electronic records and signatures generated by computer systems - 21 CFR Part 11.  The FDA's purpose here is to ensure that electronic records and signatures are trustworthy, reliable and compatible with the FDA's mission of safeguarding public health.  Section 11.10 of the regulation requires procedures and controls to be put in place that "ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records".  Intelex offers a validation pack that is designed to test your system's compliance to these requirements. For more information, please contact an Intelex representative.

The Lahore Development Authority (Pakistan) has announced that they will be implementing quality control laboratories to assess the quality of road materials and construction procedures being used across their developments.  To kick off this new quality management initiative, the LDA "has issued orders to all contractors enlisted with LDA … [the contractors] have also been instructed to ensure submission of road materials to such 'Quality Control Laboratories' so that material could be screened in accordance with international standards" (Nation.com 2008).

I've blogged about the value of a quality management system before but I thought this story exemplified the point that quality control really can be applied to any industry, product, and service.

To read the complete story about LDA's quality control program visit www.Nation.com.

I recently picked up the April 2008 issue of Industry Week and read Brad Kenney's article "Whatever Happened to Quality?" In the past I've written posts about an increase in awareness regarding the importance of quality control, but what my previous posts didn't focus on and Mr. Kenney's article does, is the growing realization that quality management isn't just about manufacturing anymore.

In 2008, quality control has evolved to the point where it embraces an all-encompassing approach to process improvement. That is to say that it accounts not just for manufacturing, but also for services rendered, customer support, employee satisfaction, human resources development, senior leadership decisions,  etc.  As Kenney describes it, the evolved approach to quality goes "beyond the shop floor and into the front office."

As I see it, the new quality control is a complete quality management system. It's comprised of document control workflow, training management processes, supplier performance tracking procedures, corporate-wide quality policies, and internal & external communications tracking to name just a few components.

Check out Kenney's complete article at http://www.industryweek.com.

One of the challenges faced by organizations is showing the value derived from the management systems they have implemented.  It is often the case that an organization will implement a system such as ISO 9001:2000, OHSAS 18001 or ISO 14001 primarily to satisfy a client requirement.  When this occurs, the organization may not realize the potential value of the management system and could be wasting time and resources simply achieving the status quo.

At Intelex, we believe it is very important that organizations realize the true value of their management system approach.  Recently, Devon Ambrose, a key member of Intelex's Client Services Team, gave an informative presentation that highlighted the importance of maximizing the value of a management system by continually improving an organization.  The purpose of Devon's presentation was to explore the benefits of applying the Process Approach to a management system, thereby creating a 'Value Added Management System'.  A management system is the method in which an organization manages their processes and activities.  Devon's presentation underlined the opportunity for an organization to leverage their management system to drive continual improvement.  This opportunity is guided by the Process Approach that states that in order to facilitate meaningful decisions; a management system must consider all the variables involved in a process/activity.  Furthermore, we must understand how the processes within an organization are interrelated (referred to as the process links).

Essentially, the Process Approach creates a foundation for a Value Added Management System, by allowing for managers to pinpoint the use of resources, the overlap and interrelationship between processes (process links), and measure the effectiveness of the various contributions that make up processes.  This operational control over the processes that make up an organization's activities gives management and employees the necessary information to adjust and document activities to meet both operational and organizational objectives.

As Devon explained, this is the fundamental logic behind the Intelex system.  Consider for example an effective Quality Management System (QMS).  It must be able to track, analyze and report on all quality management initiatives from product defect tracking, to supplier management to document control.  Each process or sub-process is linked to another through variables such as inputs/outputs, resources, material, time, location and staff.  The Intelex QMS suite is structured so that interrelated processes are easily identified and accessible between modules.  If, for example, a nonconformance arises as a result of an audit, when the auditor records that nonconformance, it is also linked back to the audit record where it resulted from.  It is essential for a management solution to have continuity between its components that reflect the interrelationship between processes.  Thus, the Value Added Management System, guided by the principles of the Process Approach ensures organizations go beyond compliance to drive continual improvement.

View Devon's presentation

The task of staying up to date with Environmental, Quality, and Health & Safety (EQHS) management trends can be overwhelming.  When searching the internet, there seems to be an endless supply of information available.  As a way of helping industry professionals sift through this information, the Intelex Exchange has developed an EQHS tool shed full of valuable resources.

The Intelex Exchange's EQHS Tools brings together reference materials, training courses and helpful tools for environmental, quality, health & safety and general business performance management industry professionals.  It is a well organized and informative resource for accessing best practices, specific regulations, industry trends, tutorials, globally recognized management standards and much more!

Visit EQHS Tools

With an ever-changing series of governmental regulations, environmental, quality and health and safety compliance can be a formidable task.  Accordingly, the consequences of this task not being met can have catastrophic consequences.  Thus, many organizations have looked inward to meet these challenges.

Internal auditing, or self-auditing, is a tool that is increasingly used to address this challenge.  As the term "self-audit" indicates, compliance audits are performed by an organization's own personnel, or by an outside third-party retained on its behalf.  Self auditing is consistent with the notion that good decisions are made based on sound information.

For more information about the benefits of self auditing, an EH&S checklist, as well as a how-to-guide, please view the Basics of EH&S Self-Auditing, by Fred N. Rubel, available on www.environmental-expert.com