• ISO 9001 Overview
• ISO 9001:2008
• ISO 9001 Auditor
• ISO 9001 Lead Auditor
• ISO 9001 Business Strategy
• ISO 14001:2004
• ISO 14001:2004 Auditor
• ISO 14001 Lead Auditor
• ISO/TS 16949:2009
• ISO/TS 16949:2009 Auditor
• ISO 19011:2002 Auditor
• Good Laboratory Practices
• Six Sigma Overview
• Sarbanes-Oxley (SOX) Overview

A company (Fujitsu) now brings ISO to customers
In an industry first, a worldwide consortium and manufacturer announced that it has established a team of certified lead auditors and risk assessors who can implement and audit against international standards, ISO. Fujitsu has taken this initiative to address a shortfall in access to Caribbean organisations, but it may extend to other geographies with dramatic impact in the world of international standards and certifications. President and CEO of Fujitsu Caribbean, Mervyn Eyre said Fujitsu long-term strategy of investing in its staff and quality and service management systems is paying off in terms of increased customer satisfaction levels and "our ability to operate within complex customer environments".

"Having a team of industry certified Lead Auditors and Risk Assessors is a terrific milestone for both Fujitsu Caribbean and our customers. This initiative is consistent with our stated goal of continuing to utilise best practice in delivering IT and business solutions to our clients. Fujitsu Caribbean's customers will now directly benefit from this achievement through a greater employment of best practice and a rigorous risk assessment methodology in implementing solutions. We can now bring the benefits of good governance and compliant solutions to our customers ensuring that they can meet the challenges of an increasingly competitive global environment", said Frances Correia, EVP - Government Business of Fujitsu Caribbean.

Health and Safety. But this initiative may cut the middlemen (Registrars), which often compete for business by compromising the integrity of their audits. A manufacturer wanting to really have an assurance of the quality of its supply base may want to remove this unspoken conflict of interest that is often hurtful for the value of these certifications. The standards that Fujitsu can implement and audit include: ISO 9001 Quality Management System; ISO 14001 Environmental Management; and ISO 27001 Information Security and OHSAS 18001 Occupational

The position of Fujitsu is that customers will now see the benefits of this initiative through the use of these disciplines in the of existing systems and in the implementation of new systems - both of which will be positively impacted by the use of international best practice in quality, information security and risk management. ISO 9001 standard specifies Quality Management System (QMS) benchmarks focused on an organisation's ability to meet and improve upon customer satisfaction and quality requirements. Fujitsu Caribbean has a programme of Quality Management that emphasises continual improvement, teamwork and achievement of customer satisfaction. Its team of Lead Auditors and Risk Assessors will now be responsible for ensuring continual performance improvement in their tools and processes to consistently raise the bar in customer service quality and satisfaction on a regular, quantifiable, and demonstrable basis for Fujitsu Caribbean and its regional customer base.

More Stringent FDA Review Processes for Medical Devices on the Horizon
After years of scrutinzing the pharmaceutical industry for the safety and efficacy of pharmaceutical products prior to approval, the FDA is now focusing its attention to the medical device industry. On February 18, the agency held a meeting to address the 510(k) system, which it has used for more than 3 decades to review and clear medical devices to be sold in the US. 510(k) refers to the part of the Federal Food, Drug and Cosmetic Act that requires manufacturers of medical devices to notify the FDA of their intent to market a medical device at least 90 days in advance. It is also refrred to as the premarket notification. The 510k approval is intended to be applied to medical devices that are similar to products currently on the market.
As ever-more sophisticated HIGH_TECH medical devices are being developped, more "high risk" devices are slipping through the cracks and being approved under the 510k process, even though they may share only a marginal similarity with a device already on the market. Some 510k device reviews are processed through third-party reviewers. The Wall Street Journal (2/17/10) alluded to an internal FDA memo from December 22, 2009 in which the agency cited concerns that such reviewers may not have the xpertise to conduct a proper 510k assessment and may wrongly take a submission as valid instead conducting a thorough analysis. The FDA memo suggested that limitations may be placed on what devices will be eligible for third-party 510k approvals.
The 510k route to approval is popular among medical device manufacturers because it is faster and less expensive; products classified as wholly new must go through more rigorous testing as part of a new device application (NDA) for FDA 510k approval. Approximately 3,500 devices are approved, yearly, under the 510k approval process, compared to about 50 products approved as new devices. Dr. Larry Kessler, former Director of Science and Engineering for FDA's Device Center, was quoted by The New York Times as saying, "The device world codified by the Medical Device Amendments of 1976 was dramatically different than where we are today 35 years later. The pace of innovation has really ramped up and the 510k process has been used, and in some cases people would say misused, to clear very advanced technology." Although the FDA scrutiny of the pharmaceutical product review and approval process was prompted by Vioxx and other complaints, it is acting proactively now as it prepares to review and revise the 510k approval process. This change is viewed as one of the Obama administration¹s efforts to make medical-related products safer for consumers.

AS9100 Revision C is released. It incorporates changes to ISO 9001:2008, it expands scope to include land and sea based systems for defense applications. It also ensures alignment with IAQG strategy (on-time, on-quality performance), adopts new requirements based on stakeholder, and needs and improve existing requirements where stakeholders identified need for clarification.

ISO 9000:2008 is released. A new version of the standard, or actually amendments to ISO 9001 and revisions to ISO 9004 were released by the technical committee (TC 176). The changes are not major.

Medical Device Risk Management - ISO 14971:2007 The Medical Device Directive (MDD), and IEC 60601-1 3rd Edition have been revised and "now require you to demonstrate that you have a documented risk management system in place, no matter what the probability or the severity of the risk is, to show that your device is safe". So as part of your ISO 13485 program you will also need to comply with ISO 14971:2007. You can also be certified to it. This standard provides a framework that a medical device manufacturer can use to develop a risk management system. The standard requires the manufacturer to identify the hazards associated with their products, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of the standard apply at all stages of the product's life cycle -from concept through post-production - ultimately leading to reduced risk due to possible hazards with the product.

ISO 27001 replaces ISO 17799 as the newstandard for IT security Information ISO 27001 is the new international standard created by the International Standards Organization for Information Security Management Systems. Officially known as ISO/IEC 27001:2005, this standard, published last October, will replace the British BS7799-2 and the ISO 17799 standard; the latter may, however, be renumbered ISO 27002, but ISO has not made a final statement regarding ISO 17799 renumbering yet.
Internationalization of these standards will create a demand for a recognised ISMS certification. Clients in the future may ask whether your organization have achieved ISO 27001 certification. Besides providing "marketing" value, it helps IT managers create a framework, based on a "Plan-Do-Check-Act" approach.
If the Sarbanes-Oxley Act is relevant for your business, ISO 27001 could be your best way to get a framework. If SOX is not yet relevant -- if you live outside of the US, for instance -- you may be less interested in it.
Successful certification requires a methodical approach, careful consideration of scope, and a thorough understanding of your organization information security needs. Achieving the ISO 27001 certification mitigates the risk of human error, by having sound procedures and regulations. The certification process involves several visits from certified external auditors, who review documents and processes. Any non-compliance must be corrected before their next visit. The time the certification process takes can differ greatly, as no two organizations are alike.
There are clear relationships between ISO 27001 and the Sarbanes-Oxley Act's requirement to develop an information security management system that is integrated, comprehensive, and incorporates widely recognized best practices. ISO 27001 is a step toward effecting and demonstrating compliance with the SOX legislation. Getting the ISO 27001 certification also tells your clients that the requirements in SOX section 404 have been successfully passed.

What happened with Chiron?

It sent the Flu vaccination campaign into chaos after announcing it would not be providing 48 million doses because of quality problems (product quality, delivery dates, cost, etc).

The explanation is hard to give without a thorough analysis. But it most certainly lies in one or a combination of scenarios of companies that have quality management systems (QMS) that are registered to the applicable industry standards (ISO 13485, ISO 9001, AS 9100, TL 9000, etc) and compliant to regulatory standards of many countries, (FDA, CE, UL), and yet have serious recurring quality problems. How can that be?

Well, unfortunately you could ask the question: "Are you surprised?" and sound a lot more knowledgeable. Most companies with registered Quality Management Systems fall into one of the following categories.

1/ For companies in highly regulated industries such as pharmaceuticals, biomedical or aerospace, the QMS is often very bureaucratic and cumbersome. It is more designed to generate adequate records than produce quality products. The company will often operate outside or the QMS and backtrack quickly to sweep behind, and generate the adequate records and documentation to maintain compliance.

2/ Companies operate with a minimal QMS that enables them to pass a registration or surveillance audit and hardly meets the needs for managing quality of the product. Basically, all the employees do the bare minimum for ISO 9000, ISO 13485, GMP or ISO 16949 compliance, and the bulk of the working or control processes are kept outside of the QMS in order to have "maximum flexibility"

3/ The QMS is not aligned with business objectives. This scenario is very frequent with companies that have been in business for a while and the QMS has not been growing or living with the organization. So you end up with obsolete procedures and documented processes, and quality objectives such lead times, and defect levels that cannot be met given the business objectives such as sales volume and targeted growth.

4/ The QMS is well implemented but the work methodologies are inadequate. This is something that should be identified through adequate root-cause analysis as a result of quality problems. Unfortunately, this is often very difficult to accomplish without some expert analysis tools and process expertise. As a result, the company will accept a fairly high and disruptive level of quality problems as an industry reality, while process reengineering is what is really required.

Despite gloomy predictions, the transition to ISO 9001:2000 is further along than previously thought. (Quality Digest)

More than 43 percent of a Quality Digest survey respondents report that they¹ve finished the transition to ISO 9001:2000, 38 percent are in the process, 5 percent do not plan on transitioning and about 13 percent have never been registered to an ISO 9000 standard and are registering to ISO 9001:2000 for the first time......

.....In general, the overall value of the registration process is most positively perceived among those who have already completed registration, both first-time registrants and those that transitioned. Those who are in the process of transitioning were more reserved in their responses.

More than 50 percent of those who have completed the transition process agree that the transition was easy, compared to one-quarter of those still transitioning and one-third registered to ISO 9000 for the first time.

The cost of transition seems to be an issue mostly for those registering for the first time. About 44 percent of first-timers think registration is expensive, compared to the 22 percent that transitioned and the 33 percent that are still in the transition process.

There is a certain sense to this: The cost of registering for the first time tends to be more expensive than simply transitioning. Our survey shows that first-time registrants are much more likely to use consultants. They may also require more time from both consultants and registrars before they iron out all nonconformities. Organizations that already have experience with the standards are less likely to use consultants and, given prior knowledge of the standards, will be less likely to have problems with implementation. All this translates directly into dollars.

One of the most outstanding survey results was the perceived value of registration. More than 70 percent of first-time registrants agree or strongly agree that the quality of their products or services has improved as a result of registration, with 19 percent strongly agreeing that this is the case.

For those who have transitioned, about 30 to 40 percent agree or strongly agree that the new standard has improved products and services, and about one-quarter disagree or strongly disagree.