World of ISO standards and regulations

CMTC partnership is live

2012-02-19T09:40:00.000-08:00

CALISO's CMTC partnership in offering online course is live. CMTC is affiliated with the National Institute of Standards and Technology (NIST) and is part of the Hollings Manufacturing Extension Partnership (MEP) Program. The MEP Program contains 60 centers across the U.S. to serve the manufacturing community. Quarterly surveys ensure full accountability and a performance scorecard of certified value for our customers.

The MEP Program is an outgrowth of the U.S. Government policy to develop and deploy technology, management and technical expertise for improving the competitiveness of manufacturing for small and medium-sized companies. These companies are critical to California, representing 90% of job growth for high-paying jobs
having a 3-5 job multiplier effect in the economy. This means for every
new manufacturing job created or retained, there are 3-5 supporting jobs.

New FREE ISO 13485 TRAINING VIDEO

2012-01-23T11:39:00.000-08:00

click on the image to see the video

Incentive program for Southern California Manufacturers:

CALISO has entered into a partnership agreement with California Manufacturing Technology Consulting (CMTC). It provides for Southern California manufacturers financial incentives to improve competitiveness through training OR consulting on international standards and national regulations:

Southern California manufacturers can get a 25% discount for implementation projects for ISO 9001, ISO 13485, ISO 16949, GMP, HACCP, AS9100 AND ISO 14001

Please contact us should you need additional information at 1-800-306-1366 or at tiout@caliso9000.com

ISO Publishes new ISO 19011 standard

2011-12-25T09:48:00.000-08:00

ISO has just published an updated edition of the ISO 19011 auditing standard which will save money, time and resources by providing a uniform approach to multiple management system audits.

Many organizations incorporate a number of management systems, such as quality, environmental, IT services and information security. As a result, these organizations want to harmonize and, where possible, combine the auditing of these systems.

Compared to the first edition of the standard published in 2002 which applied only to ISO 9001 (quality) and ISO 14001 (environment),the new scope, Guidelines for auditing management systems, has been expanded to reflect current thinking and the complexities of auditing multiple management system standards (MSS).

It will help user organizations to optimize and facilitate the integration of their management systems and, in facilitating a single audit of its systems, will streamline the audit processes, reduce duplication of effort and decrease disruption of organizations being audited.

Specific attention is given to the implementation of the audit program. By fully applying these guidelines, the prerequisites are provided to make auditing a crucial tool for top management to achieve the objectives of the organization. ISO 19011:2011 provides guidance on the conduct of internal or external management system audits, as well as on the management of audit programmes. Intended users of this International Standard include auditors, audit team leaders, audit programme managers, organizations implementing management systems, and organizations needing to conduct audits of management systems for contractual or regulatory reasons.

Fish and Fishery Products Food Safety

2011-11-12T02:07:00.000-08:00

Food Safety is a major international concern. Many avenues and initiatives have been launched through the years to propose, implement and sometimes impose safety regulations or standards. Among them HACCP for food safety and the US FDA Food Code and the international Codex Alimentarius for Food Hygiene. Both the FDA Food Code and the Codex Alimentarius also provide guideline on how to implement HACCP in a generic fashion. Various USDA and FDA regulations have addressed Food Safety practices for some specific high risk food products like Meat and Poultry and Juices, and Fish and Fishery Products HACCP. ISO 22000:2009, the international standard, has now integrated all aspects in a food safety management system (FSMS), compatible with ISO 9001.

The bottom line for any organisation lies in the following:

Having first an effective Food Hygiene program in place,
Managing food safety aspects through an adapted HACCP Plan,
Processing and producing products that are safe for human consumption,

What are the key ingredients for this to happen: A strong and uncompromising commitment from top management to ensure safe food products are being produced at all stages of production from sourcing to consumption.

1/ Flowing down this commitment to the rest of the organisation, by providing an adapted food hygiene and food safety management system (procedures, SOPs, resources).
2/ Ensuring total buy-in, awareness, and compliance by all employees through systematic and comprehensive training.
3/ Continually monitoring the FSMS to improve it and maintain it current practice-wise and training-wise for employees. The saying "if you are not moving forward, you are moving backwards" cannot be more true for food safety management!

ISO publishes a standard based on Six Sigma

2011-10-31T07:17:00.000-07:00

The International Organisation for Standards just published ISO 13053.
The new standard, ISO 13053:2011, Quantitative methods in process improvement – Six Sigma, deals exclusively with the application of Six Sigma to ameliorate existing processes and is published in the following two parts:

-DMAIC methodology, describes the five-phased methodology DMAIC (Define, Measure, Analyse, Improve and Control), and recommends best practice, including on the roles, expertise and training of personnel involved in such projects.
-Tools and techniques, describes tools and techniques, illustrated by factsheets, to be used at each phase of the DMAIC approach. Both documents can be applied to all sectors and organizations.

Six Sigma was originally developed by Motorola in 1986 to improve manufacturing processes with the goal of 99.99966% of products free of defects. Today, the methodology is applied in many sectors of activity by organizations large and small for all types of process and services to:

Remove waste, defects and errors,
Drive process improvement and make statistically based decisions,
Measure business results with a level of reliance,
Prepare for uncertainty,
Combine high returns and benefits.

“Six Sigma can be used to effectively address serious chronic business issues,” says Dr. Michèle Boulanger, President of JISC-Statistics and co-chair of the subcommittee that developed the standard, “Organizations can deploy Six Sigma projects to increase customer satisfaction and become more competitive.”

“Although Six Sigma has existed for some time, bringing its best practice together under an ISO standard helps solidify and consolidate the methodology. The ISO brand is respected and recognized worldwide, and thus provides an added layer of confidence. Moreover, publication of Six Sigma methodology in an ISO standard will boost international uptake of the methodology in a coherent form, reduce fragmentation, and provide users with harmonized best practice,” concluded Dr. Boulanger.

Six Sigma projects follow a defined sequence of steps with quantified goals and financial targets (cost reduction & profit increase), and rely on statistical tools to deal with uncertainty. Implementation involves the establishment of an infrastructure with specific roles and responsibilities.

Source (www.iso.ch)

ISO 50001 is a success!!!

2011-09-01T06:48:00.000-07:00

Very few standards published by ISO in Geneva (Switzerland) have had the incredible rate of early adopters that ISO 50001, the Energy Management System standard is having. Several of the organizations are already reporting significant benefits and energy cost savings from their early ISO 50001 implementation. And that is probably the main reason for the immediate interest it is drawing:

-It provides actionable items that can yield immediate positive financial results through a planned and effective energy savings program.
-It yields to significant reductions in power consumption, carbon emissions and energy costs, and benefits to manufacturing plants, communities and the environment.
-It can integrate very easily with existing management systems such as ISO 9001, ISO 14001, ISO 13485, ISO 16949, ISO 22000 or AS9100. AND/OR leverage the management systems in place to quickly implement ISO 50001 and improve the bottomline.

Daryl Liao, Executive Vice-President of Delta Group’s China region provides the following feedback in an article published by ISO Focus:

“The Delta Dongguan factory is delighted about passing the evaluation for the ISO 50001 energy management system.... With the implementation of the ISO 50001 energy management system in the Dongguan region, and production capacity at an even level from January to May of this year, we have already reduced power consumption by 10.51 million KWH as compared to the same period in 2010. This is equivalent to a reduction of 10.2 thousand tons of carbon emissions and a saving of CNY 8 million. Power consumption was also reduced by 37 % as compared to the 74.3 thousand KWH/million USD production value in 2009. We are confident that our goal of 50 % reduction in 2014 is just around the corner.” Rock Huang, General Manager of Delta’s Dongguan factory, added.“

USAID launches grants for ISO 22000 safety standards

2011-08-17T07:39:00.000-07:00

The USAID Program for the Introduction of Food Safety (ISO 22000) and Quality Standards (ISO 9001), now in its third year, helps grantees meet other countries’ strict requirements for standardization and certification guaranteeing the quality and safety of food products.

Farmers, cooperatives, and small- and medium-sized businesses involved in agriculture and food processing can apply to the USAID Agribusiness Project for grants to obtain certification so they can export goods.v The Program for the Introduction of Food Safety and Quality Standards, now in its third year, helps grantees meet other countries’ strict requirements for standardization and certification guaranteeing the quality and safety of food products.

During the past two years, the USAID Agribusiness Project has disbursed nearly US$300,000 to 59 agribusinesses to help them meet international food safety and quality standards. These include ensuring that foods are organic, halal or kosher, and that they meet the criteria set by international organizations.

These include a group that sets standards to reduce chemical use, ensure worker safety, and minimize the environmental effects of farming; HACCP, a system that identifies hazards and their control to ensure food safety; ISO 22000, a management system to ensure safety in the food chain; and ISO 14001, standards to minimize farming’s negative effects on the environment.

Agribusinesses that produce or process fruits, vegetables, mushrooms, herbs, spices, meat or dairy products can qualify for the grants so they can export their products. Meeting these standards also improves production efficiency, decreases costs, assures compliance with environmental requirements, and protects consumers' health.

Is ISO 14001 Certification successfull?

2011-08-06T00:36:00.000-07:00

ISO 14001 was greeted by the words of a cynic and skeptic: "What does it mean to be certified?" he said, repeating my question rhetorically. "It means you can pollute to the ends of the earth, as long as it is well documented."
Needless to say, the statement was a sarcastic, since any polluter is at least held to account on legal and regulatory thresholds that affect the jurisdiction they operate within. But his remark highlighted a widespread perception of ISO 14001: Although it is capable of giving businesses a clear sense of where they're at in terms of environmental performance, no intrinsic "moral compass" of environmental responsibility is built into the standard.
Launched 15 years ago as a guideline for measuring and monitoring organizational activities that impact the environment, the ISO 14001 standard is today a widespread benchmark for thousands of organizations around the world that want to communicate to the public and stakeholders that they are environmentally responsible.
While a paltry 14,000 certifications were registered in 1999, the year the standard was launched, more than a quarter-million organizations are certified today.
In fact, the popularity of ISO 14001 has been so prolific the standard has achieved nearly the same notoriety and respect as its parent, ISO 9001, the go-to standard for organizations that want to communicate their commitment to quality management.
ISO 9001 essentially shaped the former (both were developed by the International Organization of Standardization) and the form and structural core of the two standards is fundamentally the same: Where an ISO 9001-conformant organization will retain the documentation supporting procedures and processes that impact product quality, ISO 14001-conformant organizations will retain documentation on procedures and processes that involve any sort of impact on the environment.
Think air, wastewater output, water use, energy use: essentially any aspect of business that can generate impacts upon the environment around us.
The widespread adoption rates and respect ISO 9001 achieved in the late '90s in many ways spelled the inevitable success of ISO 14001 as a widely sought-after standard. And while many prized the standard for the simple fact it mirrored the structure and form of ISO 9001, others criticized it on that very basis.

For just as ISO 9001-conformant procedures and processes do not guarantee high-quality products and performance, by virtue of its very implementation an ISO 14001 environmental management system in no way guarantees an organization is committed to improving environmental performance, nor does it provably suggest an organization is proactive and responsible in any of its environmental endeavors.

Certification is not a bad step. Any business that has taken the steps -- and they can be exhaustive -- of deploying an ISO 14001-conformant environmental management system and achieved certification is worthy of applause. Like 9001, it can be difficult to attain and maintain, and requires ongoing adherence to nuanced requirements through detailed documentation as well as the actualization of processes and procedures described within the associated documentation.
But the perception ISO 14001 certification cultivates -- the notion a certified organization is environmentally responsible -- is at odds with the fact a certified business might not actually be doing much to improve environmental performance.
An ISO 14001-conformant organization does not an environmentally responsible organization make.
As the cynic mentioned earlier might have elaborated, an ISO 14001-registered power plant can emit excessive air pollutants and discharge vast quantities of toxic wastewater, as long as the emissions and discharges are well measured and described.
So there's a discrepancy between what ISO 14001 implies, and what it actually does.
Given the fact many organizations invest in ISO 14001 certification simply to improve brand image -- that is, to boost the perception among stakeholders and the public at large it is committed to "green" business -- questions surrounding what certification actually means ought to arise: Are we improving environmental performance? Are we minimizing our negative environmental impacts? Are we green?
Certification does not mean anything without a commitment to the principles of continuous improvement and environmental stewardship. And these are cultural elements that go far beyond what any specifications standard can describe. However, ISO 14001 can be thought of as an excellent foundation for the "house" of an environmental program that leverages environmental metrics and KPIs to track, measure and analyze performance. In tandem, an ISO 14001 environmental management system with real-time environmental key performance indicators is a powerful combination.
Recall the term so central to quality guru W. Edwards Deming, a man who essentially fostered the whole premise behind quality management: Continuous Improvement. While it is bandied about all too often these days, the term describes something that is essential to all business operations: the simple fact that performance on all fronts ought to be improved, continuously.
Just as ISO 14001 was modeled after ISO 9001 -- a certification to which "continuous improvement" is such a central theme -- consider that it carries the same onus: Those who achieve ISO 14001 certification, those who monitor and measure the environmental impacts of their activities, are bound to the spirit of continuous improvement.
"Spirit" is key there, for while many organizations will secure ISO 14001 certification, many will present their certificate as a totem of their respect for the environment. Some, however, will actually honor the spirit of the standard and commit to continuously improving environmental performance: to minimizing negative impacts on the water we drink and the air we breathe.

ISO to improve international standards

2011-07-11T00:47:00.000-07:00

Leaders of the international groups of experts that develop ISO International Standards gathered in Geneva, Switzerland, for a two-day, highly interactive conference to improve even further the efficiency and usefulness of the solutions and benefits ISO 9001 and other standards offer to business, government and society.

ISO Secretary-General Rob Steele welcomed some 200 delegates representing 24 countries and explained the background to the Conference that opened in Geneva : “You have told us that we need to be faster, better and simpler. If we are not, we might as well pack up because we will be irrelevant.”

Rob Steele underlined the growing demand for ISO standards against a background of massive challenges, such as the global economic contraction and the expansion of social media. He added: “We need embrace change and think even more about our customers’ needs. If we are good, but too slow in meeting our customers’ needs, we are not relevant. If we are not using information and communication technologies to get the standards developed or to get faster to the market, we are not relevant.

New Registrar for AS9100

2011-06-12T09:14:00.001-07:00

The Society of Automotive Engineer (SAE) who created the aerospace standard AS9100, has now created a Registrar that can certify companies to this standard. The Registrar is called Performance Review Institute (PRI) and is based in Warrendale, Pennsylvania. So far the feedback in the industry has been very good as they are very competent and offer the most competitive pricing. It has been more and more difficult to find competent and inexpensive registrar, so this is extremely good news. Besides AS9100 certification, they also offer registration services for ISO 9001, ISO 14001 and other standards. So if you are frustrated with your current registrar give look them up we have only heard good things about them.

Did you know that Nasdaq is 9001 certified

2011-06-11T12:08:00.001-07:00

The Nasdaq was first US stock market to earn ISO 9001 certification. Its Chief Information Officer, Gregor Bailar, predicted registration might one day be required by the Securities and Exchange Commission (SEC) as a prerequisite to becoming listed: "You could see it being an SEC requirement some day....It is not far off being a possibility." On reports needed to compile Nasdaq annual SEC profile, "They [SEC] actually sent us back a note that said it was the best they have seen...For us, being a technology company, ISO 9000 was an inevitable goal. Frank Parrioti, director in the computer operations of Nasdaq, says that the company did not have to make significant changes to its procedures to accommodate the requirements of ISO 9001. We simply put them into compliance by the way of the standard," he says.

ISO 9001 training and your CV

2011-05-27T17:15:00.001-07:00

The tight job market has made certain types of training very valuable on any CV. One that is valuable across the board is training on ISO 9001. It is such a widely used standard in any industry or business and is also costly time-wise for organisations. So coming with strong familiarity with the ISO 9001 standard requirements and implementation is a big plus.

For any organization that has implemented an effective quality management system in compliance with ISO 9001 requirements, training is essential. There are 3 three types of training that are explicitly or implicitly required:

FDA slams Terumo Cardiovascular with $35 Million FDA f

2011-05-26T10:23:00.000-07:00

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Terumo Cardiovascular and its top executives have signed a consent decree of permanent injunction for several heart devices after violation of good manufacturing practice (Medical Device GMP) and FDA reporting violations. The decree, filed in the U.S. District Court in the Eastern District of Michigan, prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers. This is a serious blow for the company's credibility and profitability. It also restricts sales of these systems to existing customers until the company complies with the Fedral Drug Administration Good Manufacturiog Pratices and medical device reporting "MDR" requirements.

CALISO Signs Collaboration Agreement with SAE International

2011-05-07T21:59:00.000-07:00

WARRENDALE, Pa. (April 24, 2011) – CALISO Corp, announced that it has signed an Agreement with SAE International to present the CALISO online courses for international standards on quality, environmental standards and best practice.

“CALISO eLearning platform will provide members of SAE International with a curriculum of courses that has achieved tremendous recognition with over 20,000 courses sold worldwide. The courses selected by SAE International are the most relevant for its members and will bring valuable training that can be taken using a laptop or PC with an internet connection, at one’s own pace, and time availability.” according to Julie Santiago, CALISO Vice President of Regulatory and Training.

"We are pleased to partner with CALISO eLearning to present their online learning courses. Providing access to recognized courses on international management standards and best practices," says Kevin Perry, Manager, Professional Development, SAE International.

The courses offered include quality and environmental management standards such as ISO 9001, ISO 14001, and ISO/TS 16949. Courses for auditing to these standards, best practices for corporate governance, and business management strategy are also part of the collection.

CALISO Corp. is a privately-held Miami, Florida-based training and consulting company that focuses on developing web-based training courses on quality, environmental, safety and best industry practices. The advantages of the web-based course delivery has provided a cost-effective and convenience alternative to class course delivery for organizations and individuals. Our business model is 100% online delivery thus drastically reducing our overhead, and allowing us to offer the most widely sought industry training content at more than half the price compared to similar class courses.

For more information, please visit: www.caliso9000.com or email: training@caliso9000.com or CALISO Corp. - Miami, FL 33145, 800-306-1366

SAE International is a global association of more than 128,000 engineers and related technical experts in the aerospace, automotive and commercial-vehicle industries. SAE International's core competencies are life-long learning and voluntary consensus standards development. SAE International's charitable arm is the SAE Foundation, which supports many programs, including A World In Motion® and the Collegiate Design Series.

What type of Good Manufacturing Practice (GMP) training is required for Medical devices?

2011-04-17T05:51:00.000-07:00

There are several GMPs, commonly called cGMPs, which stands for "current" Good Manufacturing practices. The applicable GMP for the medical device or biomedical is 21CFR820, also called Quality System Requirements (QSR). It differs with the other industry-specific GMP in the sense that it is structured much like the ISO 9001:1994, and set quality system requirements rather than "industry practices".

The available Medical Device GMP Training differ than the training for pharmaceuticals and food GMP, and is required along with 510k or PMAs for medical devices to be authorized for sale by the FDA.

GMP regulations are issued by the FDA and are often adopted with some adaptation and applied worldwide in the biomedical industry

Why is ISO 13485 necessary for CE marking of medical devices?

2011-04-10T09:47:00.001-07:00

In order to obtain CE approval and being able to market medical devices in the EU manufacturers have to comply with the EU Medical Device Directive. The MDD sets safety and efficacy requirements for medical devices. Among the requirements manufacturers have to have an effective quality management system in place. ISO 13485 is the most commonly chosen path for companies to meet this requirement in Europe. Even in Canada, Japan, Australia and other countries local regulations make it the simplest way to achieve compliance. Implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada and Japan, ISO 13485:2003 is mandatory for most Class II, III and IV medical device manufacturers.

Contrarily to the US, where the FDA is the only regulatory organization, notified bodies in Europe can thus ensure and enforce the quality management requirement of the MDD.

The control structure of ISO 22000

2011-04-04T13:01:00.000-07:00

Compared to ISO 9001, ISO 22000 is focused on ensuring the safety of food products, while ISO 9001 is focused on ensuring customer satisfaction. Both require continual improvement of teh management, for a system that does not improve will regress. It is the law of entropy, a law of nature...

ISO 22000 relies on three layers of control:

-Prerequisite program that ensure hygiene and other standard practices in the industry are in place

-Operational prerequisite programs that address practices that will ensure safety of the food product during product realization through controls inherent in the processes.

-HACCP Critical Control points used to control steps in the process where a special control is required to ensure a criterio does not go over an established limit thus producing non-conforming product that is potentially dangerous for human use.

GO GREEN programs ISO 14001 compliance

2011-04-02T03:03:00.000-07:00

A GO GREEN program needs to be effective but also recognized by business and governmental organizations. ISO 14001 is a very effective way both implement GO GREEN and obtain the necessary recognition. ISO is a international environmental management system (EMS) standard that has worldwide recognition. It also provides a structured method to implement a GO GREEN program starting the creation of an Environmental Policy Statement declaring a policy to comply with all environmental laws and best practices appropriate to our business. ISO 14001 Training is provided to personnel assigned to specific duties within the EMS. The ISO 14001 standard expects that we improve on the prior year's performance by continued reduction in environmental

What facilities need Good Laboratory Practices (GLP)?

2011-03-27T02:13:00.000-07:00

The Food and Drug Administration GLP is applicable and is extremely helpful for Pharmaceutical, Medical Device, Human Food, Neutraceuticals, or a non-regulated industry test or research laboratory. It provides very sound techniques to operate a laboratory in a controlled fashion. It is not required for Clinical Laboratory studies, but some elements of it are very useful in a clinical research environment lab. The GLP contains a set of principles that provides a framework for planning, performing, monitoring, recording, reporting and archiving laboratory studies. GLP is also used to assure regulatory authorities that the data submitted can be relied upon when making risk/safety assessments and are a true reflection of the results obtained during the study. GLP Training should be provided to all the Laboratory staff that performs studies or generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents and so on.

Why is ISO 13485 necessary for CE marking of medical devices?

2011-03-21T09:51:00.001-07:00

Facilty registration with the FDA

2011-03-17T01:27:00.000-07:00

Manufacturers very often need to register with the FDA as medical device manufacturers to have a differential advantage that they can leverage to increase sales. They sometimes do not have the choice. Either:-They are manufacturing a medical device, or

-They are supplying a component to a manufacturer who makes a medical device, and their client wants them to register with the FDA to facilitate the FDA Approval of his own device. It is not that simple though. There are 3 scenarios:

1/ The device manufactured is simply NOT a medical device. So the manufacturer CANNOT register with the FDA.

2/ The device manufactured is considered as a low risk (Class 1) medical device. Then in this case the manufacturer of a Class I medical devices have the least amount of regulatory control because it presents minimal potential harm to the user. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples of Class I devices include tongue depressors, arm slings, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation. So the Manufacturer can self-declare and obtain a Device Manufacturer with the FDA

3/ The device manufactured is considered as a higher risk (Class 2 or 3), and in this case before being to obtain a facility registration, the manufacturer will need to obtain an FDA Clearance for the device through an FDA 510k approval process if similar devices exist already on the market (called predicate devices). Many controls are required such as compliance with the GMP, Special labeling requirements, Mandatory performance standards, both International and United States Postmarket surveillance, and FDA medical device specific guidance for Class III medical devices have most stringent regulatory controls. They devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Commonmy a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. And this precedes obtaining a facility registration by the manufacturer.

How do international standards based on ISO 9001 compare?

2011-03-13T13:56:00.000-07:00

Since its inception in 1987, ISO 9001 has become the most popular and successful management standard. It has been used worldwide by all industries and service organization. Even school districts, hospitals, and churches have pursued and achieved ISO 9001 certification. Some industries with specific needs have created "hybrid standards" based on ISO 9001. They basically kept the structure of this standard but added, removed or adjusted requirements to suit their needs. They also sometimes changed the intent or focus of this standard away from ensuring customer satisfaction and continual improvement. Some industries have been more successful than others at this hybridization. Here is a run-down:

1/ ISO 13485: This standard is specific to the medical device industry. Its focus is on medical device "safety and efficacy". It is a slick standard, that is widely used and is a must for companies wanted to sell their devices in the EU.

2/ ISO/TS 16949: This standard is specific to the automotive industry. It replaced the now defunct QS 9000. Even though, it is mandated by auto manufacturers to the supply chain, it is fairly cumbersome and bureaucratic.

3/ ISO 22000: This standard is specific to the food industry. It integrate well ISO 9001 and HACCP and has a primary focus for an organization part of the food chain is to establish a food safety management system, usually called FSMS, to ensure that food products do not cause adverse human health effects.

4/ TL 9000: This standard is specific to the Telecom industry and was developed by the QUEST Forum. It has not gained wide acceptance, because it is extremely prescriptive, bureaucratic and expensive to maintain.

5/ AS9100: This standard is specific to the aerospace industry and was developed by SAE. IT keeps all ISO 9001 requirements and has "additional" requirements that focus on safety and reliability across the supply chain. It is also intended for use by organizations that provide post-delivery support. This includes requirements for suppliers that provide maintenance, materials, or spare parts for their own products.

Which standard have been derived from the ISO 9001 QMS standard?

2011-03-10T08:03:00.000-08:00

The generic and original Quality Management System standard created was and is ISO 9001. It is applicable to all industries for product or services. Through the years various industries created their own versions of the standard, by usually keeping the overall structure of the ISO 9001 standard document, but adding their own specific requirements. There has been 2 approaches in creating these "hybrid" standards:

1/ Keep the original ISO 9001 document and adding ADDITIONAL requirements to it, that are specific to the particular industry. A good example of that is AS9100 the aerospace standard developed by SAE.

2/ Keep the structure of ISO 9001 but modify some parts to change the focus from ensuring total quality and continual improvement to:

-Ensuring safety and efficacy of medical devices for ISO 13485.

-Ensuring Food Safety through the supply chain for ISO 22000

In case 1 a company certified to that standard will also be certified to ISO 9001. In Case , it is not the case a separate certification has to be pursued, since some requirements differ.

What is the focus and benefits of ISO 9001, the international standard?

2011-03-07T14:50:00.000-08:00

The international standard ISO 9001 is a quality management standard used by businesses that implement it to keep the most important aspects of running their operations and aligning business objectives with quality objectives. A company and all who partake in the daily activities of running the business will benefit from implementing ISO 9001 to ensure that all the proper steps and regulations are followed in all the most important areas, such as Sales, Operations and Purchasing. This way, they can ensure that the business and its employees are getting the most done in the most proficient manner and in a way that makes the business more efficient: the end result being a more profitable venture and a well-balanced, organization.

Advantages of ISO 9001

The adoption of ISO 9001 by hundreds of thousands of companies worldwide is a good indicator on how advantageous it is to have ISO 9001. The number of certifications continues to grow and it is widely acknowledged that a QMS improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001 are also sound, and give the following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention

3. Reduce audits by customers

4. Enhance marketing ability

5. Improve employee motivation, awareness, and efficiency

6. Facilitate international trade

7. Increase profitability

8. Reduce nonconformities and increases productivity.

Is Lead Auditor Training required for ISO 9001 implementation?

2011-03-03T10:51:00.000-08:00

No, but it is highly recommended to have some key member within a company take this training so that they can manage and lead the required internal audits and eventually supplier audits. If the company chooses to outsource these activities, it is still a good idea to have ISO 9001 Lead Auditor training for the Quality Assurance Manager or QA Supervisor, so that he understands how to manage the internal audit program, and VERY IMPORTANT manage the 3rd party certification audits and surveillance audits by Registrars.

The ISO 9001 Lead Auditor training is also a very useful training for someone who wishes to drive the implementation of the international standard. The reason is that it gives useful insight on what auditors expects to find, it also takes the trainee through useful case studies that show all the different nuances in implementation for various industries whether they provide products or services.

Corruption and ISO 9001

2011-02-28T12:49:00.000-08:00

This subject has been eluded since the inception of this international management standard in 1987. The intent of the latter was and still is that compliant or certified organizations can systematically ensure customer satisfaction by supplying products and services that meet or exceed their expectations. And this of course in the wider sense of the term: quality, pricing, delivery, and customer service.

While many employees in ISO compliant organizations consistently express their cynicism at how their middle and upper-management act behind the scenes, while "preaching" the ISO thing to the world. With the cover of being periodically audited by a 3rd party organization that ensures processes and procedures are followed religiously and or improved continually to summarize the surveillance process.

Non-compliance is often easy to hide to auditors, who routinely audit companies and slowly adopt a non-engagement approach with their auditees, pointing to nonconformities but never digging very deep, hoping that the fix implemented by the auditee, will also get rid of the "tumor".

It is important to look at the question of corruption and ISO 9001. Is a company that is ISO 9001 certified less likely to engage in corruption practices in its interactions with the outside world? Does ISO 9001 certification provide an actual cover for illegal practices? Does it expose employees and partners to corrupt practices? Looking at it globally, does ISO 9001, ISO 22000 or ISO 13485 certification expose global business partners to the Foreign Corrupt Practice Act (FCPA) liability for US firms?

Well, it is so easy to say we are ISO certified so we abide by strict procedures and regulations. Or, we buy from ISO certified organizations so that ensures that they have sound and fair business practices. AND finally, we sell to ISO certified organizations so we know that they qualify their vendors in the strictest manner and will not engage with us if our own practices were not "by the book".

You see, how far this can be stretched... and it is being stretched day in and day out, in the dog eat dog business world. Organizations who promise or give bribes to secure sales are guilty of active bribery; organizations that receive bribes are guilty of passive bribery. Active bribery is the supply side, passive bribery the demand side. And this is where the requirements of ISO 9001 could be leveraged to combat this world disease; but can it?

From the supply side, ISO 9001 requires that organizations determine statutory and regulatory requirements applicable to the product.

What if the buyer from the organization requires a kickback, a bribe or a special favor to approve the order. Which requirement(s) is being violated? Well statutory or regulatory requirements of legal business practice are applicable to ALL products and services. But how is an auditor to find out that a Sales Order he is reviewing, is co-signed by the "corruption ghost"? One answer is to go audit the finance an accounting department, but it is out-of-scope for ISO 9001!

One way is to use audit investigative techniques by interviewing different players and cross-referencing the information and records. But even if the auditor have the physical time to do that and stumbles upon objective evidence of corruption practices what is he/her to do? Blow the whistle? The legal implications for him, and for his employers (the Registrars) who signed a Non-Disclosure Agreement could be catastrophic.Here, we have stop on the supply-side...

Let's move on to the demand side. ISO 9001 requires that organizations evaluate and select suppliers based on their ability to supply products in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation have to be established.So if out of a list of duly evaluated suppliers, with are often ISO certified themselves, one of them offers a bribe to the buyer to sweeten the deal, and he accepts. How would an ISO auditor uncover this? Knowing that most of the time, auditors take a sampling of suppliers and only verify that they are evaluated to begin with, and continuously monitored for their performance. They never have the time to look at comparative transactions in terms of quantities and financial amounts.

Again, the only effective way is to use audit investigative techniques by following and audit thread and cross-match information and records. If there is a finding that point to an illegal practice the problem will be exactly the same as for the supply chain.
So, in summary, ISO 9001, ISO 22000, or ISO 13485 do not offer any guarantee or protection against corruption practices. A company that is ISO 9001 certified may be just as likely to engage in corruption practices, ISO 9001 certification can provide a fallacious cover. Corruption will expose employees and partners to legal liability and with foreign transactions to the Foreign Corrupt Practices Act (FCPA).

Moreover, there are subtle techniques that can help an ISO auditor uncover illegal practices in a company that has an ISO 9001 certified Management System. But, even he does use them and uncover something; he will find himself between a rock and a hard place. I am sure a few colleagues conducting third party audits, where thrown off-track during certain audits with the moral question: "Should I call the FBI or the Police?"

How do you achieve ISO 9001 certification?

2011-02-28T00:56:00.001-08:00

It is often thought that each individual employee of a company needs to be certified. The reality is is that it is a company certification, a good number of employees are audit by a 3rd party registration body BUT it is the company the gets certified. Employees need to be trained on this international standard. ISO 9001 training should be dispensed to at least top and middle-management of an organization. Registration organizations will verify training records and compliance with the company processes, which in turn need to be compliant with the various requirements of the ISO 9001 international standard. The requirements are set in the ISO 9001 document and are preceded by the word "shall": i.e. "The organization shall establish and maintain a quality manual that includes....".

So in short an organization needs to train its employees, implement in its business practices all the necessary controls and process steps required by the standard, and then successfully pass an audit by a third party Registrar such as TUV, SGS, or UL.

What is the difference between the ISO 9000 and the ISO 9001 standards?

2011-02-26T07:03:00.000-08:00

Both names are often used meaning the same thing. In reality ISO 9000 refers to a family of standards: ISO 9000 (contains vocabulary and definitions), ISO 9001:2008 (contains the actual requirements that an organization has to comply with to become certified), and ISO 9004 (contains guidelines on how to improve a quality management system). ISO 9001, the latest version being 2008, is a standard for quality management and sets requirements for all aspect of the operation of an organization (Sales, Purchasing, Manufacturing, service delivery, etc...). Company will seek ISO 9001 certification to prove to the world that their total product quality meets this international standard. Areas that are not covered specifically by this standard are: accounting, finance and personnel. Human resources such as hiring and training are within the scopr of this standard developed by the International Organization for Standards The purpose of this standard is to ensure that your organization will consistently provide products or services that meet customer and applicable regulatory requirements, and that your organization will enhance customer satisfaction by being effective in your operation and continually improving them.