Tag: iso 9000

How To Acquire ISO 9000 Standards

Companies dream of achieving success and recognition in their respective fields. That is why a lot of companies aim for certification of their management systems. Certification often gives companies an edge in their field, and the needed push for consumers to select their product or service.  While this article covers the basics of getting ISO 9000 certification, you can learn much more about how to get this certification and how it benefits your business by taking relevantcourses in business management.  If you don’t have time to attend a traditional school, consider online universities - they’re convenient and cost-effective!

ISO 9000 is a certification body that assesses a company’s quality management system against set standards. If a certain company passes their criteria, ISO grantsthem a certification that they have passed internationally recognized ISO standards. ISO 9000 is divided into 3 levels: ISO 9001, ISO 9002, and ISO 9003.

How do you go about acquiring this type of certification? Here are some steps to guide you in organizing an ISO 9000 certification.

Study the quality of your management systems. Preparation for an ISO certification with an evaluation of your own company’s management systems, procedures and standards. It is important to tap people from within the company to first make a realistic evaluation of the quality of management, procedures, and service that your business is offering.

Compare these with the ISO standards. Once you have completed your own evaluation, the next step is comparing it to the standards set by ISO 9000, according to the level you may want to apply for. It is crucial that your company takes important notice of the different things that need to be addressed in their system, may it be management procedures, regulations, or company practices.

Make the necessary adjustments. Upon recognizing the needed adjustments, then take the necessary actions to align your management systems and procedures to agree with the standards set by the ISO. Have these steps implemented and practiced, so that the changes can be adapted to gradually.

Have your quality management system evaluated. Once the needed changes have been realized, then it is time to request an outside audit by the registrar of the ISO certification body. An audit of your management systems will begin, and once approved, then you are certified to have met ISO’s requirements. ISO will then give you the certification, once they have approved the quality of your management system.

It’s also important to note that a company may opt not to get certification from ISO, but still use this standard to their advantage. Instead of requesting a certification from ISO, the company or business may form an ISO compliant management system and simply market your company as compliant with the ISO 9000 standard of choice.

High quality standards and procedures are key for any business or company. They promote a culture of excellence and hard work. And in return, this practice can improve company performance and sales. ISO accreditation will affirm the quality for which you want your company to be known.  You can also keep company standards high by regularly taking continuing education courses in business.

Read more on ISO 9000 Standards at http://www.iso9000-standards.com


How To Obtain ISO 9000 Certification In Business

ISO 9000 is a group of internationally recognized standards regarding quality management systems, laid down by the International Standard Organization. Previously divided into different standards like ISO 9001, ISO 9002, ISO 9003, they are now revised and combined into one simplified standard which covers all aspects, known as ISO 9001:2000. Another review is in process, but according to experts not many changes are expected.

Viability for your Business:
How important is ISO 9001 for your business? Or do you really need ISO certification? The answer to these questions depends on your nature of business and future plans. ISO certification can prove to be very helpful and is quite necessary if you are planning to go global. It provides your business with much needed credibility and improves your company’s overall impression. If you are operating in a highly competitive market, ISO certification can be a competitive advantage. However, acquiring ISO 9001 certification is very expensive and it all depends on your business nature, needs and more importantly the availability of funds.

Will it improve your product’s quality?
ISO 9001 certification has no direct affect on product’s quality; it mainly deals with quality management systems. Although implementing these standards may improve the final product quality and reduce cost, it should not be used to measure a product’s quality or business’s profitability.

Obtaining ISO 9001 certification:
After the management has decided that having an ISO certificate can be fruitful for the business. Some senior person, who is well informed of ISO standards, should be made in charge of all this process. ISO certification requires businesses to write down all procedures, job descriptions, different department functions, etc in accordance with ISO standards. Next step is the implementation. Start with educating the employees; tell them about the importance and significance of ISO certification, once motivated, they should be directed on how they can help in acquiring certification? Perform internal audits frequently to check if everybody is following the procedures. Make corrective actions when some error is found. If needed, you can hire an advisory service as well.

Issuance of Certificate:
International standard organization (ISO) doesn’t provide any certification itself. These certifications are issued by registered bodies that are entitled to do so. After some business has taken all necessary steps and their quality management system is in accordance with ISO guidelines, they can apply for the certification. Some representative from these registration bodies will visit the workplace or factory and observe the procedures. If satisfied, they will provide an ISO certification which is valid for three years.

Read more on ISO 9001 Standards at http://www.iso-9001-store.com


The Goals and Principles Of ISO 9001 Standards

The ISO 9001:2008 revision was released in a digital format on November 14, 2008 and the printed version on November 25th. The revisions are explanatory and editorial in nature. The requirements remain principally intact from the 2000 revision. You can find an in depth review of the changes on our website.

The goals and principles of ISO 9000 still apply. There are eight goals/principles that were initially enumerated in the 2000 release of ISO 9000 that set the temperament and focus of today’s quality management techniques and application.

ISO 9000 addresses process quality standards, not product quality standards. It does not involve inspection to see if a part meets a specification. It addresses examining the process and the controls used during its manufacture. The concept is that if everything in the process is good, it will produce a good product.

The requirements in ISO 9001 do not call for any specific type of product inspection. It does state that if an organization includes product inspection in their production plans they must carry out the inspections as planned.

It’s important that we always keep in mind these goals and principles and focus our efforts on attaining them.

The Eight Goals/Principles of ISO 9000 are:

1) Customer Focused Organization

Take care of the customer first. Companies that focus their energies on customers outperform those that are inwardly focused. Customers don’t reward their suppliers for simply following a procedure. You depend on your customers. You should understand their requirements and expectations and work to exceed them.

2) Leadership

Top management should be leaders. Continual improvement and increased customer satisfaction are attainable when led by top management. Leaders provide direction and make sure everyone is steering the same course.

3) Involvement of people

People make quality a reality. The folks that do the work must know what their customer expects. And, everyone works toward the same goal … the customer’s satisfaction.

4) Process Approach

Plan and setup work the way it naturally flows. When operations and departments work together toward the same goals there is a structure for managing and improving. The whole must be greater than the sum of its parts.

5) System Approach to Management

A company will be more effective if they manage a system of interacting processes. Managing each process as stand alone operations causes conflicts among processes because they work toward individual goals and not what the customer wants.

6) Continual Improvement

Being world class isn’t achieved by accepting the status quo. Small improvements made on an ongoing basis makes world class a reality.

7) Factual Approach to Decision Making

Decisions about change are based on empirical information. Wishing something better doesn’t work. You have heard it before and it’s worth repeating “If you don’t measure it, you can’t manage it”.

8) Mutually Beneficial Supplier Relationships

Make suppliers partners in your efforts and theirs. You depend on suppliers so you should work toward win-win outcomes. They are the experts in their chosen area and product. Everybody prospers.

Bonus Goal

9) Defect Prevention

Controlling the input to processes through goal # 4 emphasizes the importance of good input resulting in good output. Thereby, theoretically reducing the need to rely on defect detection methods such as inspection. Defect prevention is cheaper than defect detection and correction. In reality the total absence of inspection in manufacturing seems impossible. However, an ongoing endeavor to reduce inspections to a minimum is truly continuous improvement.


Identification of processes In ISO 9001

Identiication Of Processes In ISO 9001 Standards

1. Distinguishing between the concepts of a process and an activity
If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) and definition ((3.4.1) in ISO 9000 as background information. The auditor must be able to adapt to the auditee’s situation. It is the auditor’s responsibility to understand the auditee’s systems and approach.
During the audit, the auditor should determine whether there is a problem of difference of terminology only, or whether there is a lack of real implementation of the process approach by the auditee. There may be a need to issue an NCR if the auditee is not fully implementing the requirements stated in ISO 9001, Clause 4.1. If this is simply a terminology problem, there should be no need to issue an NCR, if all the requirements of in Clause 4.1 are satisfied.
The auditee has the right to use its own terminology, provided the requirements of the standard are met. The auditor should mentally develop a cross-reference list to ensure consistency and better understanding.
2. A process has defined objective(s), input(s), output(s), activities, and  resources If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..
This should help the auditor to establish whether the processes (as per ISO 9001) are already defined, have clear inputs, outputs, objectives and so on.
3. Processes should be analysed, monitored and/or measured, and improved
If after applying the audit techniques outlined above, there is an absence of any records or other proof to demonstrate that the processes are analysed, and/or monitored, and/or measured, and/or improved, there would appear to be non-conformity with part of ISO 9001 Clause 4.1.
4. The auditee/auditor considers that each clause or sub-clause of ISO 9001
must be defined as a separate process If the auditor considers this as the right approach, he should refer to relevant ISO documents,
(notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package:
Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary.
If the auditee considers this as the right approach, it is recommended that the techniques outlined
in section 2 (above) should be used.
5. Is the process approach as described in the ‘Introduction’ to ISO 9001 a requirement of the standard?
The description of the process approach in the ‘Introduction’ to ISO 9001 is purely informative and does not introduce a set of additional requirements by itself. Clause 4.1 specifies the steps necessary to implement a process approach with regard to quality management system processes, the Notes to clause 4.1 providing examples of processes needed for the quality
management system. Audit methodologies must be oriented, accordingly, towards analyzing the processes of the organization.

Integrating Management Systems Within The ISO Standards

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8?700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)


Risk Management In ISO 9000 Standard

Risk Management In ISO 9000 Standard

In each human endeavour there is an element of risk; personal, project or financial, or a combination of them all. The job of the responsible individual is to identify the risk and act accordingly. We all do these ‘risky’ things, almost daily, aware that we are taking a risk. Rather than staying away from the risk we become adept at identifying it and having a strategy for dealing with it if the risk materialises. This is what risk management is about, and is an ability that is important in virtually every endeavour.

The popular misconception that risk management is difficult or complicated stems from the bureaucratic methodology of some system-oriented organisations and managers. It is neither complicated or bureaucratic, and need not be. Risk management is basically a simple proposition with a complexity dictated by the nature of the situation to which it applies – usually a project, and the parties involved. In its basic form risk management involves:

1. Identifying risk – Looking for anything that threatens the successful completion of the project against the original requirement. Risks can be environmental, organisational, technical, legal, economic or commercial.

2. Counteracting risk – Taking action to remove or reduce the probability of a risk being realised. The response depends on the nature or seriousness of the risk.

3. Acting when the risk event occurs – Invoking whatever contingency measures were devised for the risk that has materialised.

And for this to happen needs:

4. Monitoring at all stages – This typically means documenting a risk assessment in a profile that identifies the risk, the probability of its occurrence, and the impact if it does materialise. Factors that score paramount are those that require the greatest attention and monitoring. A good risk manager will devise contingency plans that reduce either the probability or the impact of these occurrences, and so remove them from the scene.

Working within a formal structured management system similar to that defined by ISO 9000 requires the application of risk assessment practices to satisfy the requirements of the Standard. Auditors of such systems may not find specific references to risk management in these areas even though the identification of potential failure (8.5.3) is wholly concerned with a topic that is nothing less than risk management.

Well managed risk taking is an essential feature of any forward thinking enterprise, since risk is an element of any progression or advancement. It is the adoption of effective risk management in conjunction with the continuing need to drive forward from a comfortable position that leads to progress and advancement. Doing what we always do purely because the risks appear to be negligible or are well known is to be ‘risk averse’, and for progressive organisations cannot be acceptable. Neither is it acceptable to pursue new ideas without an understanding of their potential benefit, proper planning, a clear idea of the threats to these benefits being achieved , and a strategy for dealing with them should they materialise. We need to manage in a manner that is neither predictable or reckless. Risk assessment is an essential tool to support this strategy.


ISO 9000 CERTIFICATION IS AN APPRAISAL TO COMPANY

ISO 9000 CERTIFICATION IS AN APPRAISAL TO COMPANY

During World WarII, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. According to Seddon, “In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000.”

ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004.. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is deliberately planning the next release as an amendment rather than a formal revision. The difference is that an “amendment” is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

  • a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • facilitating continual improvement

ADVANTAGES OF ISO 9000 CERTIFICATION:

It is widely acknowledged that proper quality management 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, according to Wade, and Barnes, who says “ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.” Barnes also cites a survey by Lloyd’s Register Quality Assurance which indicated that ISO 9001 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:

  1. Create a more efficient, effective operation
  2. Increase customer satisfaction and retention
  3. Reduce audits
  4. Enhance marketing
  5. Improve employee motivation, awareness, and morale
  6. Promote international trade
  7. Increases profit
  8. Reduce waste and increases productivity

In today’s service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.


Review In ISO 9000 Standards

If you have your own business and now you are looking for ISO 9000 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.


Six Sigma Vs ISO 9000

Six Sigma Vs ISO 9000

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma – A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the “belts” to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the “belts” to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is “how to” rather than “what to” deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.


ISO’s logo

ISO’s logo

ISO will not authorize the use of its logo in connection with material publicizing an ISO 9000 or ISO 14000 certification –some examples of such uses are in company letterheads, marketing leaflets, advertisements, and so on. The ISO logo is a registered trademark. ISO does not authorize its logo to be used, either by quality system certification bodies, or by the companies to which the latter issue ISO 9000 certificates. The same applies to ISO 14000 certifications, as these become more widespread. Allowing the ISO logo to be used would give the false impression that ISO carries out certification activities, or has approved or authorized the organization using its logo. These activities are not business functions of ISO.

ISO is not an auditor, assessor, registrar, or certifier of either quality systems or environmental management systems – or, for that matter, of materials, products and services – nor does it endorse any such activities performed by other parties. ISO develops International Standards but, at present, operates no scheme for assessing conformance with them.

Allowing the use of our logo in advertisements or other publicity material would give the impression that ISO has “approved” such a certification – or even carried it out. For the reasons given above, such an impression would be totally misleading.


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