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Impact of Technology On The Field of Arts And Entertainment

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Nearly everyone enjoys the different types of entertainment, and some people enjoy even more being entertainers. They want to become actors, comedians, dancers, singers. We used to go inside theatres after a hard day’s work to relax and see our favorite plays. But only in the last hundred years have we been able to record sound and pictures and to broadcast them through air. These improvements have brought fun and entertainment to every corner of the world and into most of our homes.

Technology has indeed made it possible for us to see entertainment in a new light. For one, technology has made it also possible for us to store our memories. Actors and singers long dead seem to come to life again every time their films or records are played. We can store a seemingly countless number of these records and films in CDs, hard drives and other storing devices like our computer. This makes it possible for us to entertain ourselves almost anywhere- at home, at the office, at the park, the bus; as long as we bring our devices with us. One can actually live without TV these days as long as one has a computer device and internet connection.

The world of entertainment has grown tremendously, and it can teach us as well as entertain us. Today, broadcasting is the most important form of popular entertainment. But now it is challenged by still newer inventions. Video playback and recording equipments make it possible for home viewers to buy or record their favorite shows. Many classic movies are already available for home viewing. This new equipment may encourage many viewers to spend fewer hours watching network offerings of situation comedies and action dramas. And now, we can record, transfer, and produce our own videos using cellular phones.

At the same time, the internet has revolutionized viewing habits in another way. The internet provides information on a lot of sources for movies, music, and other forms of entertainment. With internet connection, people can bring programs directly into their computer by doing downloads and many of these downloads are offered for free. Not only does it provide entertainment but we can even do some transactions like when you want to buy stun guns online.

The internet offer entertainment on almost all particular interests- music, news, and special information such as stock markets, weather, and social networking. These sources are made available to us faster than ever, as fast as the stun gun effects.  We can update on news even before they get broadcasted on TV through the different websites on the internet.

Never in recorded history have Entertainment and arts been so important in the lives of so many people. Modern inventions such as the internet have put nearly every person within reach of music and drama all day, every day, at home, and away from home. The internet has also made it possible for people not just become viewers but also the performers themselves as they are able to upload their own videos on different sites. The future of entertainment and arts is taking shape through technology and the people themselves.

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Source by Joseph Pressley

Innovative Ideas in the Field of Technology

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Innovative ideas in the field of technology have simplified the work and helped our rapid development. These ideas contribute to the creation of innovative technologies over time. In order to create this innovative idea, it is necessary to have the knowledge, which is fundamental in this process.

Thus we get the scheme: knowledge, idea, technology.

To date, innovative technologies are traditionally divided into two segments: information technologies (technologies of automated information processing) and communication technologies (technologies for storage and transmission of information). For example, with the help of communication technologies, people can receive and transmit various contents, being in different corners of our world. International relations, including education, business negotiations and much more are now possible faster and more efficiently. If we recall the communication innovations in the field of education, first of all, it should be emphasized that people can enter higher education institutions and study remotely regardless of their location. Furthermore, every qualified pedagogue teaches something new and useful. Communication with representatives of other countries contributes to our self-development. All this eventually promotes the creation of qualified unique staff.

Information technologies allow:

– To automate certain labour-intensive operations;

– Automate and optimize production planning;

– Optimize individual business processes (for example, customer relations, asset management, document management, management decision-making), taking into account the specifics of various branches of economic activity. Information technology is used for large data processing systems, computing on a personal computer, in science and education, in management, computer-aided design and the creation of systems with artificial intelligence. Information technologies are the modern technological systems of immense strategic importance (political, defence, economic, social and cultural), which led to the formation of a new concept of the world order – “who owns the information, he owns the world.”

The spread of information and communication technologies play an important role in structural changes in all the areas of our life. For someone, it will be difficult to learn these technologies. Workers who will not be able to study will have to give way to the younger generation. Thus we are faced with a problem because, in order to use innovations in technologies and develop it, it is necessary to have a qualified youth. First and foremost there is the question of education. Anyway, only education can create a developed generation that will continue to strive for new knowledge and will meet the requirements of innovative technologies. In addition, I am convinced that innovative ideas in technologies have created a completely new life, which poses new challenges for our country. How we will cope with these tasks depends on the future of our country.

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Source by Emilia Orazova

Training is Key to German Success – ISO9001

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We have Clients in Germany and whenever I carry out audits for them or on their behalf at their suppliers, I am inevitably pleased to see how much more training is provided to workers than a similar company in the UK.

It seems that all workers receive a good level of product knowledge as well as quality and environmental awareness. Where hazardous goods are concerned the level of training is excellent. I also saw that a greater number of first aiders are trained.

There is of course always a downside, and on this occasion I did see a bottle in an eyewash station dated May 2006. The people in the department obviously ignored it but I firmly believe that the eyewash could have caused just as much damage to a person’s eye as the chemicals they were trying to dilute.

I don’t think that it would have been used as they also had a powerful water eye wash unit powered from the mains water, but the fact that it was there in the first place gives cause for concern. The bottle was consigned to the rubbish bin so no harm was done.

It was probably fortuitous that I carried out a vendor audit when I did rather than wait for a health inspector or even worse, an accident.

Rolls Royce cars are now produced by BMW and I am sure that training has played a big part in the success of German industry and although they are suffering in this recession they will come out of it strong and skilled.

The Benefits of ISO 9001 Certification in Business

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ISO 9001 is a business standard that is used by over a million organisations worldwide. It helps businesses achieve optimum operational efficiency by dealing with the fundamentals of quality management systems.

The requirements for ISO 9001 certification can be found in a 30 page document, when the organisation has implemented these requirements they are deemed fit to be issued with the certificate.

An ISO certificate is useful to businesses of any size. A recent survey conducted by QMS found that most of the respondents were from smaller companies of 1 – 49 employees, but they also found significant numbers in the medium category (50 – 499 employees) and that larger companies of over 500 employees had ISO 9001 certification. ISO Certificates also benefit both B2B and B2C organisations, the same survey found they were both 46% of respondents were B2B organisations, 45% were B2B and B2C, the remaining 9% were B2C.

Globally, the numbers of ISO 9001 is seeing a steady yearly increase as more and more companies receive the certification. In 2010 the top three countries that held the most certificates were China with almost 300,000, Italy with 139,000 and Russia with 62,000 certificates. This increase in popularity is because it can offer the following advantages:

– Gain new customers and more business

– Increased customer satisfaction and more effective customer communication

– Improved quality management processes

– More effective management reviews

– Improved supplier performance and increased profits

– Reduced waste and increased productivity

In addition to these benefits, companies also seek ISO 9001 certification to gain a competitive advantage and to help enhance operations internally. Clients are also increasingly expecting their suppliers to have the certification, so organisations often seek the ISO 9001 to meet client demand and tender requirement.

The survey also found that once company’s invested in an ISO 9001 they tend to renew the certificate. This demonstrates that businesses value the certificate and willing to regularly reinvest. The results found that more than half of the organisations had held their certificates for over five years and a huge fifth of respondents held the ISO 9001 for over 10 years and more.

Most organisations hold their ISO 9001 certification in very high regard, this is reinforced by the fact that over 75% of the companies questioned in the survey believe that the certificate should be officially recommended by their trade or industry.

What If ISO 9001 is No Longer Providing Value?

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This is a loaded question when you consider that I am in the business of selling ISO 9001 consulting services. So why would I even broach this topic and shoot myself in the foot? My main objective is to inform you of ISO 9001 in plain English and in an unbiased manner. That’s the whole point of this blog (soon to be a website…assuming the web developers ever get around to finishing the job…but that’s another story). If I am fortunate enough to earn someone’s business as a result of what I am conveying on this site, wonderful. Obviously I want to make a living based on my expertise and interpretation of ISO 9001. Let’s analyze this loaded question in more detail.

The topic came to my attention today in speaking to someone who works for a very large, global pharmaceutical company. Essentially, this company no longer saw value in maintaining ISO 9001 certification so they dropped it. The company operates in a very heavily regulated industry. They have audits for regulation A one day, audits for regulation B the next and audits for regulation C the next day after that. Senior management felt ISO 9001 audits were getting in the way and actually became counter-productive. They felt confident in maintaining compliance to other industry regulations and I can understand why. [NOTE: I can tell you that ISO 9001 clearly served a purpose for several years and greatly benefitted the company. Unless an organization has poorly implemented ISO 9001, I can guarantee you they will always come out ahead. And remember, if you have a poorly implemented ISO 9001 quality management system, you are not going to pass your annual audit by the 3rd party registrar].

When I think further on this conversation, I have to wonder if senior management might have mismanaged ISO 9001. Did their ISO consultant drop the ball and/or was the Management Representative asleep at the wheel? What of the fact that this company operated in a highly regulated environment? Who is to say that regulation A, B or C aren’t outdated, unnecessary, redundant, poorly designed and ISO 9001 took the bullet?

I also wonder about who is measuring and defining “value”? In the opinion of this company, was the value derived from ISO 9001 a quantitative measure or a gut feel? Personally, I believe it is a best practice and the obligation of any company to quantitatively measure their key performance indicators using balanced scorecards in order to illustrate if the company improved from implementing ISO 9001. But the reality is a brain freeze or lack of understanding or misunderstanding on behalf of senior management is enough to kill ISO 9001 sponsorship and certification (as well as any other voluntary initiative for that matter).

It is important to remember that ISO 9001:2008 registration is optional and you need to pay for the annual audits conducted by the 3rd party registrar. However, there is no cost for being compliant to ISO 9001. That is, you can act or operate your business in a manner that is demonstrative of what ISO 9001:2008 preaches but whether or not you choose to pass the litmus test and get audited so that you can get the certificate and proverbial stamp of approval is up to you. I would not force any of my clients to become ISO 9001:2008 registered. The choice is theirs.

ISO 9001 Vs Six Sigma

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I won’t get into the history and background of each process management approach. You only have to Google “Six Sigma” or “ISO 9001” to get your fair share of information. This article will go for the jugular on a topic that has been on my mind for some time. I am not trained in Six Sigma but I have always respected the program from afar and I have researched enough on this topic to give a fairly educated opinion. I can appreciate its call to action and I understand there is a strong group of supporters but I honestly feel like Six Sigma is yesterday’s fad. It has been touted in best-selling business books but that was 10 years ago.

Before I get off-topic, let’s jump straight into a bullet list that lists the problems with Six Sigma:

1. 3M, GE, Home Depot, Ford and other major companies are pulling back on Six Sigma because research shows that customer satisfaction and employee morale has suffered

a. On the other hand, customer Satisfaction is a major theme of ISO 9001 as Customer Focus is one of the eight ISO 9001 management principles.

2. Over analyzing

a. On the other hand, ISO 9001 simply suggests that your business should take a Factual Approach to Decision Making. This means making informed decisions and ensuring data and information are sufficiently accurate and reliable and accessible to those who need it. ISO 9001 wants you to use the facts but to also balance it with experience and intuition.

3. Six Sigma and innovation do not co-exist in the same world

a. Another major theme of ISO 9001 is Continual Improvement. Unlike Six Sigma, ISO 9001 puts innovation squarely on the roadmap for organizational success.

4. It’s all about numbers and not about customers

a. Again, ISO 9001 makes it abundantly clear throughout the standard that Customer Focus is a key element to business success.

5. Six Sigma = cost cutting. Surely, your business exists do to more than just cut costs?

a. ISO 9001 reminds us that in addition to cutting costs, we also have to focus on Mutually Beneficial Supplier Relationships, Leadership, Involvement of People and more.

6. Six Sigma = micromanaging

a. ISO 9001 is anything but micromanaging if it is well-implemented by an experienced consultant. The standard only required six documented procedures. A smooth-running ISO 9001 certified company is one that operates on its own positive, organic momentum.

7. It is elitist. Since when should a company only take direction from Black Belts? Whatever happened to everyone in a company acting as a process improver?

a. Not the case with ISO 9001. Only one central role of Management Representative needs to be assigned. As for the rest of the employees, everyone is encouraged to play their part.

8. It does not incorporate information technology – a huge force that can impact processes

a. There isn’t anything specifically written into ISO 9001 speaking to Information Technology. However, several sections of the standard allow ample opportunity for IT to shine and play a central role.

9. It espouses incremental improvement, not radical breakthroughs

a. One of my personal favorite Management Principles of ISO 9001 is Continual Improvement.

10. Read any article about Six Sigma and you are bound to find a disclaimer section addressing concerns or issues with it.

a. ISO 9001 does not generate the same kind of backlash Six Sigma is getting

11. A Fortune 500 article stated that “of 58 large companies that have announced Six Sigma programs, 91% have trailed the S&P 500 since”

a. On the other hand, a Harvard Business School Working Paper by David I. Levine and Michael W. Toffel published on January 18, 2010 concludes that ISO 9001 delivers value, is not a fad, increases sales by roughly 10%, and more. The authors mention “…the strength and consistency of our findings leads us to shift our own priors in favor of the hypothesis that ISO 9001 adoption is more beneficial than we had anticipated.”

12. It is based on arbitrary standards

a. 3.4 defects per million opportunities sounds great for some industries assuming their products are life-threatening or simply cannot endure any margin of error. But would you apply the same strict standard to your typical contact centre or service provider? Why does it need to be six standard deviations? This is not explained. Also, Six Sigma operates on the assumption that process data always conforms to a normal distribution model.

Hopefully this helps shed more light on the controversial subject of comparing Six Sigma to ISO 9001.

ISO 9001:2008 – A Primer

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Perhaps while investigating an organization you’ve run across this claim: ISO 9001:2008 certified. Certification, well, that sounds good, but what exactly does this combination of letters and numbers mean? Read on to find out what ISO 9001:2008 certification entails and what it says about the organization that has earned such a designation.

What is ISO 9001:2008?

ISO is short for International Organization for Standardization. This certifying body develops and publishes international standards that must be met before a business is presented with certification. The 9001: 2008 aspect of the name positions the certification into two different standard levels. The 9001 makes it part of the ISO 9000 Quality Management collection, which is designed for any company or organization that is looking to implement a quality management system.

Meanwhile the 2008 part of the name drills down further to specify, according to the ISO, the “requirements for a quality management system.”

What does ISO 9001: 2008 certification mean?

In order to be ISO 9001: 2008 certified, an organization must fulfill two obligations. First, it must demonstrate that it can “consistently provide product that meets customer and applicable statutory and regulatory requirements.”

ISO 9001: 2008 certification is generic and can apply to organizations that manufacture a wide range of products. However, the product consistency stipulation that is inherent to the certification process applies to the specific product being produced by the organization seeking the designation. So, for instance, a manufacturer of high temperature wire and cable for commercial and automotive industries must provide the wire industry with wire and cable that consistently meets all of the wire industry’s statutory and regulatory requirements.

The second obligation the certified holder of an ISO 9001: 2008 must meet is an aim to “enhance customer satisfaction through the effective application of the system.” In other words, customer satisfaction is a main benchmark for certification. To demonstrate customer satisfaction priority, the certificate seeker must show that it has implemented into its system “processes for continual improvement.” And as was the case in the first obligation, it must also provide “assurance of conformity to customer and applicable statutory and regulatory requirement.”

Using a manufacturer of high temperature wire and cable for commercial and automotive industries once again as an example, the manufacturing system being used by the organization must improve the satisfaction of the end users of the wire and cable.

What does ISO 9001: 2008 certification say about an organization that possesses it?

Because of the requirements that must be met to achieve it. ISO 9001: 2008 certification can add to the credibility of an organization. More specifically, it shows that the products being manufactured or the services being offered by the organization meet the expectations of the customers who use them.

The ISO points out, “For some industries, certification is a legal or contractual requirement,” but in cases where it is not, ISO 9001: 2008 certification provides further peace of mind that an organization is willing to go above and beyond to prove that it treats its customers’ satisfaction with the utmost priority.

ISO 9001 Consulting – How to Benefit From Using an ISO 9001 Consultant

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ISO 9001 Consulting has been available ever since the ISO 9001 quality management system standards were first published in 1979. At present, nearly a million companies worldwide have been certified to one ISO business management standard or another. These include ISO 9001, ISO 14001, AS 9100, ISO / TS 16949, etc. The statistics that have been accumulated to date indicate that while a number of companies went about implementing ISO standards using internal resources, those that used outside ISO 9001 consulting services benefited the most in terms of speed of implementation, effectiveness and payback.

ISO 9001 Consulting firms offer a number of services. Let us check out some of these so that you can determine what selection of services would best suit your company:

Standard Interpretation

The ISO 9001: 2015 quality management system standard can be a hard document to understand. It is written in quasi-legal language and points out requirements in very general terms. This is certainly so, as it is meant to be applicable to all types of business activity. Quite a few companies have issues interpreting it to their specific business processes. An experienced ISO 9001 consultant can help you apply the standard to your specific business activities.

Gap Audit

Before applying the ISO 9001: 2015 standard to your business, you need to know whats missing between your existing business practices and controls relative to ISO 9001. Engaging ISO 9001 consulting services, you can have a review done of your current management system practices, controls and documentation, to establish the amount to which you conform to ISO 9001 requirements. The consultant will give you a detailed audit report indicating the gaps in your company, along with their recommendations. This will help in putting together your ISO 9001 project implementation plan to achieve full conformity.

Project Planning and Organization

Depending on the size and complexity of your company, an ISO 9001: 2015 implementation project can take anywhere from six to eighteen months to complete. Your ISO project needs to be well-planned in terms of how much time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be a valuable aid in assisting your business deal with this important activity.

Business Process Identification and Documentation

ISO 9001: 2015 looks at business processes as the key point of control. These include internal as well as outsourced processes. Some companies have concerns distinguishing between processes, departments and functional activities. ISO 9001 consulting experts can help you identify and properly document all organizational processes relating to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.

System Development and Implementation

The main emphasis of the ISO 9001: 2015 standard is on effective planning, operation and control of all relevant quality management system processes. This is likely the most time-consuming and difficult part of any ISO implementation project. Many issues may arrise as to what processes should be controlled, what makes for an effective control, how best to communicate and implement it, interaction between processes, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide required focus and facilitation implementation.

Management System Documentation

The latest ISO 9001: 2015 standard has significantly reduced attention on documentation and maximized its attention on effective planning and control. Sufficient documentation is however needed for many business processes in order to ensure consistent application of effective controls. Many organizations have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.

Pre-assessment

ISO 9001 Registrars (also referred to as Certification Bodies) perform their certification audit in two stages. In stage 1, they review how ready your business is (which includes your planning, documentation and internal review activities) and in stage 2 that audit your management system for effective implementation of planned controls, in both cases the review is done against the ISO 9001 standard. After spending several months of implementation, you consider your company ready for the certification audit, it may be useful to use external consulting to do a once-over to determine if you are really ready, identify any shortcomings and help you take appropriate corrective action, prior to the Registrar audit.

Training

ISO 9001 consultancy services often offer a variety of training options. These include

– ISO 9001: 2015 awareness training to employees at all levels

– An executive overview of the ISO standard for top management

– Process identification, mapping, analysis and improvement

– ISO project management

– ISO documentation and implementation

– Internal audit

– Use of problem-solving tools

Based on the extensive internal expertise within your organization, you may wish to have an external ISO 9001 consulting service to provide some or all of this training.

Develop and Maintain your Internal Audit Program

To be certified and remain so, the ISO 9001: 2015 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, many organizations are short on resources, internal audit expertise and employee availability, so they outsource the upkeep of internal internal audit programs to ISO 9001 consulting firms, who do it far more effectively than most internal auditors.

Improvement Process

The ISO 9001: 2015 standard expects your quality management system to be dynamic and work towards continuously improving the effectiveness and efficiency of your organization and also enhance customer satisfaction. Many ISO 9001 consulting firms have diversified skills and experience in continuous improvement strategies and methods. These could include problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can greatly increase your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.

ISO 9001-2008 Vs ISO 9001-2000 – The New Requirements and a Comparison Between Them

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Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001: 2000 and the new born ISO 9001: 2008. I also included my comments regarding my experience and my perspective of things.

At the end of it I will summon the new requirements from the new ISO 9001: 2008 standard.

Paragraph number 0.1 – Changes here are a statement about whom and where the standard includes any statutory requirements. Statutory requirement (of any kind) has the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.

Paragraph number 0.4 – There is a comment that state that the new standard is made due consideration to ISO 14001: 2004.

My comment – Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is required to implement the ISO 14001 standard to implement also the ISO 9001 standard. There is a big correlation between the two. They actually support one another. It would be easier for organization to obtain the ISO standard 14001 requirements if it has been already certified for ISO 9001.

Paragraph number 1.1 & 1.2 – Statutory requirements had been referred in relation with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

My comment – After so many years of auditions the long last debt had been settled. Statutory legal requirements and regulatory requirements are applicable to the purchasing processes as well. It was always an open area that no one had the exact answer: Does your supplier must follow the law or not? Almost yes.

Paragraph number 2 – Normative reference – the ISO 9000 is now replaced by ISO 9000: 2005.

Paragraph number 3 – The explanations about what is a customer and what is an organization and what is a supplier had been removed.

Paragraph number 4.1 – Clause a – The word "determine" replaces the word "identify". A note had been added stating that a purchased processes are considered as purchasing products. Another note had been added demanding that these processes would be controlled as well as products.

My comment – When identifying, you are required to search and find something according to the requirement. When determining, the responsibility of the results is in your hands …

It was obvious before …. Sometimes they feel a need to state the obvious.

Paragraph number 4.2.1 – Slight change of words, but when you examine the change you realize the meaning remains same.

Note 2 was changed: A single document may include requirements for more than one procedure. Requirements of one procedure may appear in more than one document.

My comment – It's about time. A lot of headaches are filed to be save. If your auditor was one of the old schools and demanded everything by the book, you had problems. Now you may document two quality requirements on one document: Job description and trainings, for example. Or you can split one record into two documents. However it is suitable for you as long as you achieve the requirements.

A good example is that it is possible to combine the corrective and the preventive procedures together. As long as you maintain the requirements …

Paragraph number 4.2.3 – Paragraph f – A clarification that external documentation is considered while it is part of the quality management system.

My comment – When an external document is part of your quality management system, it is required to be included under the quality procedures: documents control and records control.

Paragraph number 5.1 – Clause a – the word "statutory" had been added.

Paragraph number 5.5.2 – An additional requirement that the management representative would have been a member of the organization's management.

My comment – That addition puts all external consultants at risk – you can no longer be the management representative. That sets a whole new line of form and documentation for you to develop in order that the external consultants would have considered as a management representative. All external consultants would have to be creative on this one.

Paragraph number 6.2 – Change of words from "affecting product quality" to "affecting conformity to product requirements"

Paragraph number 6.2.2 – Clause b – "provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competency"

Clause c – you must ensure that the training is with competence rather than if it was an effective training.

My comment – It all goes back to defining. You defined what is necessary now you must provide it – nothing is new. On one hand it is an improvement. The training must be reviewed before for its competency to the requirements. But we are still on this one. We think: instead of testing your employees if they got anything out of the training you must now review the training itself before or maybe both …. Only time will tell …

Paragraph number 6.3 – Clause c – information systems are included.

My comment – They are totally right!

Paragraph number 6.4 – A new note: noise, humidity, temperatures are part of a working environment.

My comment – That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard …

Paragraph number 7.1 – Clause c – measurement had been added to the product acceptance activities.

Paragraph number 7.2.1 – Clause a – change of words – not of the meaning.

Clause c – the word 'applicable' replacements 'related'. Change of words – not of the meaning.

Clause d – change of words – not of meaning.

A note had been added to explain the meaning of "post delivery activities".

My comment – I agree with the "post delivery activities" – it was not clear enough for our opinion.

Paragraph number 7.3.1 – A note had been added clarifying that design review, verification and validation are separated processes but they may be connected together.

Paragraph number 7.3.3 – A change of words. A note had been added clarifying the inclusion of "preservation of product".

My comment – The preservation of the product is to be included now in the design and development developments.

Paragraph number 7.5.3 – A requirement had been added regarding the measurements and test status must be identified through the product realization.

My comment – This requirement so far was required in standards such as ISO 13485 Standard for medical devices and the ISO / TS 16949 for the automotive industry. The requirement assures you that the inspection activities are defined maintained and registered and so is the product's status.

Paragraph number 7.5.4 – A change of words in the requirement to inform the customer of any problem regarding his property.

The note had been amended that also personal data is included as customer's property.

Paragraph number 7.5.5 – A change of words:

"devices" in the title was changed to "equipment"

"conformity of" to "in order to maintain conformity to requirements".

Reference to paragraph 7.1 was removed

Paragraph number 7.6 – A change of words:

from "devices" to "equipment".

The reference to paragraph 7.2.1 had been removed.

Clause c – from "be identified to enable the"

to "identification to enable theirs".

Changes in the notes:

Note 1 – the reference to ISO 100012-2 had been removed.

Note 3 – explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.

My comment – That means that from now on, a computers that provides any kind of measurements services, is considered as a monitoring and measuring device. And when the computer configuration has been changed – the software is required to be calibrated again.

How can one calibrate a computer? Ask your supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done and present evidences.

Paragraph number 8.2.1 – A note had been added to suggest some means of conducting customer satisfaction evaluation.

Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.

Requirements for the management responsibility had been added – The management is responsible for ensuring preventive and corrective action to be taken.

The reference to the ISO 10011 is changed to ISO 19011.

My comment – As I see it, that means an addition within the Management Responsibility procedure or the Internal audit procedure concerning management ensuring that preventive and corrective actions would be taken according to the results and decisions of the internal audit and a reference to the validation and verification.

Take a look at the next web site that provides you with prepared solutions for internal audit procedure the9000store.com.

Paragraph number 8.2.3 – A change of words:

"to ensure conformity of the product" had been removed.

A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how this effect would affect the quality management system.

Paragraph number 8.2.4 – A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.

Paragraph number 8.3 – An addition: Clause d – specify how to deal with a nonconforming product that was discovered after delivery – but actually there is nothing new only that they moved it to a new clause.

So, what are the new requirements of the new standard?

  • Statutory requirements are given scale as any other legal or customer's requirements.
  • The statutory requirements include the suppliers as well.
  • A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality management system.
  • You may include two quality processes in one document and split one process into two documents.
  • The management representative must be a member of the top management.
  • A requirement to ensure that trainings are suitable for the product in advance and not to exam wherever the training was effective after it was taken.
  • Information system is now specifically considered as a substructure.
  • Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
  • Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product through the realization processes.
  • The product realization process shall include references to the inspection activities and the status of the product through the realization processes.
  • Software configuration is a reason for re-calibrating the software.
  • The management is now responsible for preventive and corrective actions regarding nonconformities that were disclosed during internal audits.
  • The organization should determine the type of monitoring and measuring according to the processes and indicate how this would affect the quality management system.

Summary

Most of the changes made here are really minor and are assistance for understanding open issues. I accepted a bit more of new standard but I am satisfied. The objective was not to create any earth qaukes in the quality industry but to keep update with changes in technology and to update the feedbacks and responses that were collected over the last years. I am lucky. I already thought that all my articles in our website should be changed …

Itay Abuahv Eng.

ISO 9001 Lead Auditor Training Course – FAQ

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The ISO 9001: 2008 Lead Auditor Training course is a intensive and formal course provided by accredited Registrars and training organizations. It lectures course participants to perform ISO 9001 quality management system audits from different perspectives and how to build an effective Quality Management System.

Who Should Take This Course?

– Those that want to pursue a career as a professional third party auditor, conducting certification audits for Registrars or Certification Bodies.
– Consultants that want to hone their knowledge and improve the quality of their services
– Quality Management and Auditing personnel of larger organizations that perform internal and supplier audits.
– Other professionals in related fields wishing to diversify their credentials.

What You Should Find Out Before Taking This Course?

– Check whether the course is accredited by RAB / QSA, UKAS or simply recognized accreditation body.
– Check whether the course provider is accredited by these same bodies.
– Find out the location, schedule and cost of the course
– Ask if they provide any special discounts for – groups, handicaps, on-site, or other. If the course is provided by your registrar, you may be able to negotiate a better price.
– Check if they have any special arrangements for travel and accommodations.
– Ask for a course syllabus or outline.
– Check wherever you are expected to stay at the venue where the course is held if you are from out of town.
– Ask about their cancellation policy and course attendance requirements

What Background Should You Have To Take This Course?

– You should have a good understanding of the ISO 9001: 2008 standard, even though it is covered in-depth in the course.
– You should have some prior exposure to auditing.
– You should have some experience in a managerial or supervision role in an organization
– You should have at least a high school certificate and preferably a degree.

What Is The Typical Course Structure And Format?

– The ISO 9000 Lead Auditor training has 40 hours of in-class time spread over 5 days. This is not counting time you spend after class reviewing each days material.
– Roughly half that time is devoted to theory covering the ISO 9001 standard and auditing concepts, principles and practice as per the ISO 19011: 2002 Auditing Guidelines for quality and environmental management systems.
– The remaining time is directed towards in-class case studies, audit role-playing, team exercises, practice exams and open discussions.
– The course typically ends with a two hour written exam covering a variety of questions from multiple choice, true / false, short and long essay and case situations.

How Will Course Participants Be Evaluated?

Most course providers will use some combination of the following evaluation techniques:

– Daily and continuous assessment of student participation, interaction, leadership and time-management skills.
– Daily exercises and quizzes – audit role playing; interviewing; situation handling; etc.
– Presentation exercises – oral and written
– Opening and Closing meeting role play exercises
– Case study Audit Report
– Written examination

What Can One Expect To Learn From The ISO 9001: 2008 Lead Auditor Training Course?

– Understand the concepts, principles, terminology and benefits of a Quality Management System based on ISO 9001: 2008 Standard.
– Understand the requirements of the ISO 9001: 2008 Standard and how to implement and audit a Quality Management System.
– Understand the purpose, content, and interrelationships of related standards such as ISO 9000, ISO 9001, ISO 9004, and ISO 19011.
– Learn the knowledge and skills required to manage and conduct internal, second-party (Supplier / Vendor) and third-party Quality Management System audits.
– Be able to facilitate and manage quality audits performed by Accredited Certification Bodies or Registrars.

Does Taking And Passing This Course Make Me An ISO 9001: 2008 Lead Auditor?

Taking and passing this course (both exam and other evaluation requirements) is just the first step. Other requirements to become a formally recognized Lead Auditor includes applying to an Auditor Certification Body like RAB / QSA or IRCA for Lead Auditor certification and meeting their specific requirements for:

– Education – minimum requirement is a high school certificate. The higher your education, the less will be required of you for the other requirements
– Work experience – four or more years of work experience.
– Quality experience – at least two years of your work experience should be quality related.
– Auditing experience – perform sufficient first, second or third part audits to meet their requirements.
– Managing audits – Manage (lead) sufficient number of the above audits to meet their requirements.
– Maintenance of profitability – Once you satisfy the above requirements and submit your application and appropriate fees, you will then get your formal card as a Lead Auditor. After that you must continue to "professionally develop" yourself to some combination of the above requirements, again based on the requirements established by body that you certified (RAB / QSA or IRCA).