Friday, November 26, 2010

ISO 9001 auditor

Who is ISO 9001 Auditor?

Internal Audit is a mandatory requirement according to ISO 9001 Standards.

An ISO 9001 Auditor must participate in a training course about internal audit and must be certified with auditor certificate by authorized training organization.

There are two kinds of auditor:

1. Normal Auditor; and

2. Lead Auditor
Basic Content of a training course on ISO 9001 Internal Audit

A training course about ISO 9001 will help participants understand the basic principles and necessary practical skills to perform an internal audit and make an effective report on the implementation and maintenance of quality management system in an organization.

1. General Introduction to Quality and quality management;

2. Introduction to 8 principles in quality management;

3. Introduction to and explanation of ISO 9001:2008 Standards;

Continue reading at: ISO 9001 auditor

Thursday, November 25, 2010

ISO 9001 audit report

ISO 9001 Audit Report

Audit Report isn’t necessary to be long but must be general and objective on the current condition of the audited organization. The report must address good practices that should be recognized, visible risks and identified problems.

An audit report should involve the following contents:

1. The Date of the Audit

When was the Audit performed? This is a proof that the audit has been performed according to a planned schedule. If the managers want to know about the use of personnel for the audit or timeline of the audit, it is good to mention them in the Audit. All of these will help answer the question “How much time and money have been spent on internal audit activity?”

2. Audited areas

This is very important, especially when the organization has got many operation offices.

3. Applied Standards

When performing an audit on a third party, audit standards to be applied should be those on quality management system such as ISO 9001, ISO 14001, etc. In internal audit, auditing standards are often a list of documents relating to the audited activities such as procedure, guidance, or forms, etc.

Continue reading at: ISO 9001 audit report

Wednesday, November 24, 2010

ISO 9001 2008 requirements

ISO 9001:2008 requirements are available at ISO 9001 standard such as:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus
5.3. Quality policy

Continue reading at: ISO 9001 2008 requirements

Tuesday, November 23, 2010

ISO 9001:2008 changes

Some new points in ISO 9001:2008

On 14th January 2008, International Standard Organization officially published ISO 9001:2008 standards, which is the latest version of Quality Management System applied in 175 countries all over the World.

ISO 9001:2008 remains the same in structure with little change in accordance with ISO 9001:2000. It includes the following sections:
Standard structure

1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

However, in content, there are some new points as below:

1. Identify in the quality system approach and method of controlling external processes;

2. Clearer details on the control of external processes;

3. Change in document structure in quality management; the importance of files increases in equal to procedures;

4. Emphasis on analysis and improvement of processes;

5. Clearer representation of procedures; one procedure may involve many processes or many procedures represent a process;


Continue reading at: ISO 9001 quality manual

Monday, November 22, 2010

ISO 9001 questions

Auditors may use the following method to ask questions in an ISO 9001 internal audit. Following are some tips that need consideration:

1. Remember that the audited individuals are not recruited to answer the auditor’s questions

They are paid to do their jobs. Therefore, they are not likely to tell you exactly what you expect to hear, but instead, they will describe their own working processes in their understanding and experience which shows that they are qualified for the jobs.

2. Ask open-ended questions instead of close-ended questions

Let the audited employees explain their own performance. One will be more likely to give the most sufficient response if he or she is not subjectively suggested of the answer by the auditors.

3. Ask the audited employees how their jobs are performed

An auditor will not only want to know which tasks were done but also how correctly they were done in conformity with procedures. A non-conformance report will help the auditor know the wrong actions, but the audit may also be good to help identify which the root cause to wrong actions is.

Continue reading at: ISO 9001 implementation

Sunday, November 21, 2010

ISO 9001 quality policy

ABC Corporation strives to become the leading company in XYZ market in the areas of manufacturing engineering and construction services in the following commitments:

• ABC Company is ready to meet satisfactorily all the requirements of the customer contract has been signed as well as statutory requirements and regulatory.

• Applying scientific advances and new technologies in production and installation to:
– Ensure quality of mechanical products and construction services.
– Optimization of costs to achieve a competitive price.
Transactions and convenient delivery.


Continue reading at: ISO 9001 history

Saturday, November 20, 2010

ISO 9001 quality manual

An ISO 9001 quality manual must follow structure of ISO 9001 standard. So that you can ref more information for ISO 9001 quality manual at table of contents as follows:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus

Continue reading at: ISO 9001 certification bodies

Friday, November 19, 2010

ISO 9001 implementation

Steps to apply ISO 9001:2000

a professional support organization with the knowledge, skills and business experience will help a lot in advance to shorten the time of certification, to help businesses track and avoid the negative effects due process operation of the waste and inefficiency

ISO 9001:2000 applies to an organization will be conducted in 9 steps:

Step 1:
Learn the criteria and determine the scope of application. Leaders need to understand the meaning of ISO 9000 in organizational development and orientation activities, identify goals and specific conditions apply

Step 2:
Project steering ISO 9000. The application of ISO 9000 is a big project, so it needs a steering committee of ISO 9000 in the enterprise, including leaders and representatives of the departments represented in the scope of ISO 9000. The representative should be appointed leader instead of quality leadership in directing the application of ISO 9000 management system and responsible leadership on quality activities.

Step 3:
Assessment of business situation compared with the standard requirements. Should review the activity-oriented process, to consider any applicable requirements and meet the current level of activity in the enterprise. This assessment as the basis for determining the activities to change or supplement so that the implementation plan details

Step 4:
System design and establish the quality system documents. The documentation must be built and completed to meet the requirements of standards and operating requirements of the business including:
- Quality Manual
- The processes and procedures related
- The work instructions, rules and regulations necessary

Continue reading at: ISO 9001 auditor

Thursday, November 18, 2010

ISO 9001 history

ISO 9001 History
Overview

ISO 9001 Quality Management System, as know as ISO 9001, is one of ISO 9000 standards. This system sets up requirements for organizations those design, develop, manufacture, assemble or supply any kind of product or service and want to apply that system to improve their product and service quality.
ISO 9000

ISO 9000 Standards include many standards, in which the main standard is ISO 9001: Quality Management System which sets up requirements that organizations have to meet with their quality system. Besides, there are additional and guide standards which are:

1. ISO 9000: Terms and Definitions

2. ISO 9004: Guidelines for Performance of Management System Assessment

3. ISO 19011: Guidelines on principles of auditing a management system
ISO 9001 Versions

4. ISO 9001:1987 – Quality Systems
Quality management – quality management models in design/implementation, manufacturing, installment and technical service


Continue reading at: ISO 9001 audit report

Wednesday, November 17, 2010

ISO 9001 certification bodies

ISO 9001:2008 requirements are available at ISO 9001 standard such as:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus
5.3. Quality policy
5.4. Quality system planning
5.5. Organization and communication
5.6. Management review


Continue reading at: ISO 9001 2008 requirements

Friday, October 22, 2010

ISO 9001 Vs Six Sigma

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.


Source: http://ezinearticles.com/

Thursday, October 21, 2010

Your Guide to Auditor Training and OHSAS 18001 Certification

The practice of auditing provides objective assurance to an organization about its state of affairs. Auditing can help organizations attain their goals and objectives with systematic, accurate evaluation. Internal auditors are always a part of the organization that is being evaluated. It is important that the auditors understand the various aspects of their job well. Incidentally, internal auditor training can be very beneficial.

Internal auditor course is highly knowledgeable and interactive. It provides both practical skills and technical knowledge required to become a competent lead auditor. The course content covers introductions and objectives, ISO 9001:2008- outline philosophy and principles, impact on established management systems and certification, ISO 9001:2008- impact of the update on auditors and interpretation of the update. The purpose of the training is to ensure that both Quality managers and auditors are aware of the changes to ISO 9001:2008 and understand the kind of impact they will have on the quality management system. They will also learn to interpret changes when undertaking audits. The lead auditor course is highly recommended.

Internal auditing is a lucrative career option. Internal auditors are in great demand everywhere. An auditor's job requires practical and technical expertise. They need to determine the efficiency, accuracy and effectiveness of the systems in place for internal control. They are also required to review the integrity and reliability of the management and ensure compliance with laws, policies and procedures. They help protect the assets of the business. They need to be in complete control of a company's computer system to ensure the reliability and integrity of the data. Internal auditor training can help you gain in-depth knowledge about the same. It can help you understand the intricacies of your job.

Thanks to the advent of the Internet, a wide range of courses can be learned online. Other than internal auditor and lead auditor course, there are other courses like occupational health and safety courses that are popular. More and more people are educating themselves on OHSAS 18001 certification. This kind of certification is a must for companies having a large work force, operating in a high risk environment. Companies proactively protecting the health and safety of their stakeholders and employees are certificated under OHSAS 18001. There are many advantages of this kind of certification. It reduces accidents. It ensures better control over hazards at workplace. It focuses on safety of employees and improves a company's image. It promotes international competitiveness.

ISO 14001 also deserves a mention. You can download the course details online. It is mainly concerned with environmental management. It basically refers to what an organization can do to reduce harmful effects on the environment. A company gains a lot from being ISO 14001 certified. It gives a company a 'green' policy. It helps a company show responsibility towards the environment. ISO 14001 is a process based standard. The focus is on establishing internal policies, targets, objectives and procedures.


Source: http://ezinearticles.com/

Wednesday, October 20, 2010

What If ISO 9001 is No Longer Providing Value?

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.


Source: http://ezinearticles.com/

Saturday, October 16, 2010

Iso 9001 lead auditor training

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