ISO 9001 Documents

ISO 9001 Standard - ISO 9001 Standards

2012-01-03T04:43:00.000-08:00

ISO 9001 Standard - ISO 9001 Standards

Corrective and Preventive Actions In ISO 9001 Standard

2011-10-01T06:44:00.001-07:00

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) andEngineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

Document Control Procedure In ISO 9001 Standards

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The ISO 9001:2008 quality management standard requires the implementation of six mandatory procedures. One of these mandatory procedures is the document control procedure (4.2.3) and the other is the record control procedure (4.2.4). The first step in implementing these procedures requires an understanding of the difference between the words `document’ and `record’, as well as the standard’s intent behind their application.

Defining Documents

ISO 9000:2005 Fundamentals and Vocabulary defines a document as being information, such as specifications or procedures and its supporting medium e.g. paper or electronic. The implication is that documents change and naturally evolve as new data replenishes existing data and it is this evolution and distribution that the document control procedure must effectively manage. Remember; information is an organizational asset.

The procedure must state how the following requirements are to be realised: – How documents are approved for suitability prior to use – How documents are reviewed and updated – How to identify the correct versions of documents – How the correct versions of documents will be accessed – How legibility is ensured – How external documents are controlled and distributed – How to prevent unintended use

Defining Records

A record, on the other hand is static as its primary purpose is to capture historical information which does not undergo change. Records capture the results of activities performed in support of the quality management system; including, among others, the outputs from the product realisation process, measurement analysis and improvement processes. They should be considered as a primary source of evidence that proves whether an activity was undertaken in accordance the necessary requirements.

The record control procedure must define the controls needed to:

- Identify and access records

- How records are stored and for how long

- How records are protected in order remain legible

- How records are retrieved for use

- How records should be disposed of

The Document Control Procedure and the Certification Process

Having understood the difference between records and documents, the next important point to keep in mind is the importance of the procedure and its relationship to the ISO 9001 certification process. To understand the relationship and the need for a document control procedure, it is important to remember that the last step in the ISO 9001 certification process is the certification body audit. So, what is audited? Obviously, it is the records and documents themselves that are audited. Hence organizations which have made the effort to preserve records and to manage documents will have already taken some vital steps in their certification journey.

The Implementation Steps Of ISO 9001 Standard Certification

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The Implementation Steps Of ISO 9001 Standard Certification

ISO 9001 implementation steps, and prerequisites for a successful ISO certification success of ISO 9001 quality management system depends on the entire implementation was carried out. The implementation steps for ISO 9001 Standards are as below:

(1) with a well-defined awareness training program started. You have to separate awareness training programs for top management, middle management and lower management. You need to the quality management, ISO 9001requirements and how quality management is to discuss making a difference in your organization. You can hire an outside consultant / trainer for the confidence in a professional manner.

(2) The next step is to perform a gap analysis. Gap analysis is a detailed and complete study of the current business processes of your organization vs. the request of the ISO 9001 standard. This is the most important and crucial stage during the entire ISO 9001 implementation process. Whether you are a manufacturer or a service organization, you need to benchmark your current business processes with ISO 9001 requirements. Results of the gap analysis study was created generating a gap analysis, you need to be circulated to all process owners and department heads. It is always advisable that you appoint a reputable and experienced consultants to carry out gap analysis of your company as an external consultant as a management consultant.

(3) gap analysis, you must complete workshop for the derivation of quality policy and quality objectives as process. These tasks will be the driving force behind the organization to improve performance and measurement.

(4) Based on the gap analysis and process as quality goals, you need to develop various documents such as quality manual, functional Procedures (SOP), formats, instructions, systems and checklists .

(5) is being developed by the Documentation, Procedures should owners officially approved and issued by a board representative. You need to training for the employees of your organization have to provide documents and it’s effective implementation.

(6) Process owners are required together with department heads and representatives of management to monitor effective implementation of the ISO 9001 system of organization and their processes / departments. Type help / assistance to users on the new system and ISO 9001 requirement if necessary to facilitate the proper implementation of ISO 9001 in the organization.

(7) Choose to be a team of employees trained as internal auditors. Talk to your consultant or trainer for the implementation of a comprehensive quality internal auditor training. This training allows your employees Auditing skills to understand process-oriented approach to the implementation of audit according to ISO 9001 clauses and requirements.

(8) Plan an internal audit and ensure that ISO 9001 internal audit is carried out according to schedule. If you wish, to facilitate wire in an external consultant will first round of internal audit. MR and auditors should ensure coordination with the auditee that the non-conformities are found during the audit is closed and the corrective measures are effective in nature.

(9) to discuss organizing management review meeting several points such as quality and objectives of the audit results, supplier performance, customer complaints and their redressal, customer feedback, and it is analysis, customer requests and their status, education, and it is the effectiveness, change in process or QMS, etc. Agenda and minutes of MRM is to be worked out with an action plan.

(10) Select a CA depending on your budget and your specific requirements. They have a practical experience of your advisor in selecting the most appropriate certification body.

(11) It is advisable to do a pre-assessment test before the final certification audit. Under the supervision of the results of the preliminary examination of the final exam schedule and communicate to everyone in the organization.

(12) Get out of the final certification audit and ensure that you close all non-matches (if any) in the stipulated time.

(13) you get a recommendation for ISO 9001 quality management system and you will receive a certificate as an ISO 9001 certified company

ISO 9001 Standards For Small Medium Enterprise

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There are some companies out there as small as two people that are ISO 9000 certified. In terms of size, companies range from the very small, to under 100 employees, to between 200 ? 300 employees. In terms of revenue, companies can range from one hundred thousand to multi-million dollar companies. They provide a variety of products or services including testing and assembly, manufacturing metal stampings, electronic components, paper products, printing, or different kinds of machinery. Other companies include banks, food industries, and chemical plants. There are also service companies that do recruitment, consulting, and engineering. Any industry in the world can be ISO 9000 registered, and it doesn’t matter what size they are or what they do.

ISO certification can help small business by slimming down your business operation system and make it more effective. Basically, when you first build your ISO 9000 system, it looks like a paper giant to you. In actuality, once it’s done, you’ve completed your audit, and are now running your system, you are able to more effectively utilize the people you work with.

You could have four different processes that you actually could work into one. Now one person can handle completing a particular process instead of four different ones. You’ve been able to consolidate multiple actions/processes into one. This will save time, which is money in the long run. Corrective and preventive actions help you as well. If you catch a product defect prior to its being completed or shipped, you save yourself money and an impact on your company’s reputation. There are a lot of cost effective ways that employee input can also help being ISO registered.

This process will save your business money down the road, even if you may not see it in the front end. You’ve got to run the system. Then as it is running and you are using it, you start consolidating areas of your business that are inefficient or are contributing to loss of materials, labor, etc?. The money isn’t always cash coming back all the time. You will get some cash in some workplaces if you’re getting a lot of scrap and re-work, but YOU ARE going to see it come back in savings of time, and we all know TIME is MONEY.

Obviously where people are working more efficiently, they are making more product in less time, so you are saving money and making money at the same time. In the long run it will balance out, and you’ll help your company into the next level. Also, you can put the ISO on your website. You can use it for your marketing because suppliers recognize it, not only in the United States, but around the world. You’ll probably get more calls, because of your ISO registration.

Many companies look to see if potential suppliers are ISO registered prior to contacting them. Potential customers will know that through effective and efficient management of your system you are assuring them that they get a quality product. It’s going to open up more doors for potential customers because they are going to understand what you’re doing. Some companies will not even look at clients or other companies unless they are ISO registered. It’s similar to the idea that, in the job market, a lot of companies won’t look at a candidate unless they have a college degree. In this case your ISO certificate is your degree.

Another way that ISO registration can save small businesses money is by eliminating the need for vendor audits. In the past, companies would conduct these audits to verify the quality of potential suppliers? products, or they would purchase the product and hope that it was what they wanted. Now you can verify just by asking for a copy of their certificate and verifying with the registrar. You would not have to send someone in to do a vendor audit. This is an extremely strong benefit.

Committing to becoming ISO certified is not a small decision. It takes time, dedication, and it can be expensive. However, the benefits for small businesses far outweigh these costs. Becoming ISO certified can help you small business grow!

ISO Certification – A Standard For a Quality Business

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ISO certification is accepted as the worldwide stamp of approval for business wanting to demonstrate compliance to quality systems. It is an organization working across 161 countries around the world looking to established standards for quality of materials, products, process, etc. It provided unique identification and goodwill to the organization to conduct business with any other, to deal in a global market.

The importance of ISO certification is that it provides assurance of Quality management which gives assurance to the customers. ISO Standard assessment and certification is recognized worldwide for giving your business the competitive edge, client confidence and market place leverage.

ISO provides the necessary tools to improve and unite work force of a business to increased profit margins, work efficiency, improved accuracy and customer base right through business operations. So although the process seems daunting and time consuming, the benefits of taking the time and putting the initial hard work into certification is well worth it for the long term benefit achieved. The process also includes regular internal audits of a company, to identify any nonconformity in procedures or documentation. By this it is easy catch small errors in processes or procedures before they become costly problems.

There are many ISO Companies that provides ISO Certification, Quality management, ISO standards, ISO 9001, ISO 9000, ISO 14001, ISO 27001, ISO 17025, ohsas, ohsas 18001 etc. It helps to ensure and keep the organization focus in terms of standard and quality. This is made possible in the course of certification. The organization will be given standards to work with and other training or enlightenments. The organization is to continue to follow if it must remain in the good book of the ISO. It helps in building customers trust and confidence in the company and its products. All an all ISO certification is very important for the growth and trust of customer on the business.

ISO 9001 Standards – Quality Policy and Objectives

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A ISO 9001 Standards quality policy and its corresponding quality objectives are established to direct the organization towards two specific goals of a quality management system:

-Provision of products – goods and services – that meet customer and applicable legal requirements, and

- Enhancement of customer satisfaction

The quality policy and the objectives are also a means of controlling the quality management system’s processes. Simply, if you want to control a process, assign an objective to it (or more) and make sure it is aligned to the quality policy, then monitor and measure the process’ performance against the assigned objective. You need to provide adequate resources to the process to ensure that it is capable of achieving the objective. You continually improve the whole process by upgrading the objective, make corrective and preventive actions or introduce innovation to it. Corrective action addresses an undesirable situation’s cause in order to prevent its recurrence. Preventive action, by contrast, addresses the probable cause of a potentially undesirable situation. This is what the quality policy and objectives are supposed to do. They provide focus, direction and control.

The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties. When an organization has established a quality policy and a set of operational objectives, this means the only thing left to do is to design or plan the necessary processes or tasks that can realize those objectives. Therefore, the processes determine if the objectives will be met in full, partially or not at all. This is where the ISO 9001 standard play a critical role in specifying the required processes and the operating criteria. This is what ISO 9001 is all about. It even specifies criteria for the policy and the objectives.

A quality policy needs to satisfy the following requirements:

It is appropriate to the purpose of the organization,
It includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
It provides a framework for establishing and reviewing quality objectives,
It is communicated and understood within the organization, and
It is reviewed for continuing suitability

Quality objectives must be established in order to enable the organization to comply with requirements and continually improve the effectiveness of the quality management system. Quality objectives must achieve four things:

Enable the organization to meet customer requirements
Enable the organization to enhance customer satisfaction
Enable the organization to comply with all legal requirements applicable to the product
Continually contribute to the effectiveness of the quality management system

Therefore, when you are in the meeting room with your management brainstorming on the appropriate objectives, have these four points in mind.

ISO 9001:2000 requires that management periodically review changes to both the policy and objectives. An organization’s objectives must be measurable and its processes designed to meet those objectives. An organization’s overall business goals, quality objectives and quality policy are all interrelated and must work together to achieve business improvement. To do this, it’s necessary to understand which processes are key to achieving business goals and align those processes with the quality objectives. It means aligning business goals, quality objectives and process measures to create real improvement. And it means using process mapping. Process mapping involves more than just flow charting. Among other things, it can manage and improve processes by illustrating process measures as well as process flows and interactions. One process-mapping method begins by involving the people who work in the process. Another entails mapping the process as is, taking action to improve it and then preparing a final map of the improved process.

Process owners are directly responsible for the attainment of the objectives. They must be given adequate resources, including competent human resources. They need to review the objectives periodically to ensure the key performance indicators are heading towards their objectives on schedule. If not, they need to initiate corrective actions and if the risks of non-achievement are visible, take preventive actions to control them and steer the KPI’s back on course.

Examples of quality objectives:

Production rejects <>
Machine breakdown <>
Returned products = 0/mth
Purchasing >95% on-time delivery
Inventory damage = 0/mth

Conclusion: ISO 9001 requires that the quality management system achieves its objectives in order to realize the quality policy.

Read more on ISO 9001 standards at http://www.iso9001store.com

IMPLEMENTATION OF ISO 9001 STANDARD IN EDUCATION

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international standards pertaining to ISO 9000 (1987) family. The implementation of this last standard grows continuously, either in Europe or in the world. In the period from 2001 to 2003, there was a slight stagnation, which was the consequence of the organisations having to adapt to the requests of ISO 9001:2000 edition of the standard. Croatia also actively participates in this trend, which show that at the end of 2004, organisations were certified, of which 970 of them were from Croatia.

The economy has already met with various endeavours and concepts to build aneffective quality management system. From the historical point of view, the most importantones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) andinternational standards pertaining to ISO 9000 (1987) family. The implementation of thislast standard grows continuously, either in Europe or in the world, as shown in the picture1. In the period from 2001 to 2003, there was a slight stagnation, which was theconsequence of the organisations having to adapt to the requests of ISO 9001:2008 editionof the standard. Croatia also actively participates in this trend, as illustrated by figures fromthe table 2, which show that at the end of 2004, 670,399 organisations were certified, ofwhich 970 of them were from Croatia.

The implementation of the stated standard in educational activities took a somewhat slower pace. Trends in Croatia do not completely follow the World ones . The 2002 and 2003 stagnation, which, as already mentioned, was mainly caused by transfer from one issue of the standard to the next one, had no particular impact to Croatia, partially because the data for Croatia includes standards from both the previous and the new issue of the ISO 9001 standard.

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Aligning At ISO 9001 Standard Requirements

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In conformity with the explanations of international series of standards elaborated in the 2008 year, the

implementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be done

in every kind of organization, indifferent of its field of activity , size or number of personnel. This means that

SMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to their

limited resources. The success of this action depends on more elements, mainly, the following ones:

· Strong commitment and decision of top management;

· Adopting an organization structure accordingly both with business plan of SME, and with the

requirements and guides of standards from quality management field, too.

This means that SME (sector in continuously development in Romania starting from 1990) can align to

these requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources.

The success of this demarche depends on several elements, mainly, the following:

· The decision and the strong commitment of the top management ;

· Adopting an organizational structure according to the business plan of SMEs, but also with the
requirements and the directions of the norm/standards in the quality management field.

· Accurate planning of the implementation project of a quality management system

· Allocation of the m a t erial, financial and human resources necessary for developing and

maintaining of the system;

· Suitable training of the personnel of the organization for the documentation and implementation of the system, but also for its supervising;

· Maintaining of an efficient communication and collaboration with business partners, first, with the

suppliers and the clients of SMEs, but also with other interested parts, including their own

personnel;

And one more remark: the success of a quality management system in a SME depends on endowment degree and on technological level of the equipments and working and controlling installation of the processes.

In conformity with the explanations of international series of standards elaborated in the 2000 year, theimplementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be donein every kind of organization, indifferent of its field of activity , size or number of personnel. This means thatSMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to theirlimited resources. The success of this action depends on more elements, mainly, the following ones:· Strong commitment and decision of top management;· Adopting an organization structure accordingly both with business plan of SME, and with therequirements and guides of standards from quality management field, too.This means that SME (sector in continuously development in Romania starting from 1990) can align tothese requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources. Thesuccess of this demarche depends on several elements, mainly, the following:· The decision and the strong commitment of the top management ;· Adopting an organizational structure according to the business plan of SMEs, but also with therequirements and the directions of the norm/standards in the quality management field.· Accurate planning of the implementation project of a quality management system· Allocation of the m a t erial, financial and human resources necessary for developing andmaintaining of the system;· Suitable training of the personnel of the organization for the documentation and implementation ofthe system, but also for its supervising;· Maintaining of an efficient communication and collaboration with business partners, first, with thesuppliers and the clients of SMEs, but also with other interested parts, including their ownpersonnel;And one more remark: the success of a quality management system in a SME depends on endowmentdegree and on technological level of the equipments and working and controlling installation of the processes.

A transparent quality management system, well conceived and applied, with adequate trained and motivated personnel, will be efficient and if technological level of endowments (working, supervising, measuring and monitoring equipments of the processes and product, working environment and infrastructure) will be comparable with the level of endowment of the top firms in the same activity area, as of the organization we refer to.

So, adopting a quality management system based on the requirements of the ISO 9001 standard is a strategic decision of the top management of an organization, much more for the management of SME that first of all has to analyse very well all the necessary resources, to put in balance both the necessary costs of the implementation and sustaining in function of a quality management system and the benefits brought, then to decide advisedly. Developing a quality management system gives both direct benefits and a contribution at the cost and risk management, being important not only for organization but also for the satisfaction of its clients and other interested parts.

The decision of designing and implementation of a quality management system in SME is influenced by proposed objectives, by the demand of the market, by products and services offered, as well as by objectives tendency of developing and the continuously improving of the performances of the processes of any organization.

A quality management system contains two essential elements. First, the most critical, refers to human resources and the other necessary resources for constant delivery of the adequate products and services to the client. Second refers to the existence of “documented quality management system” that is, usually, defined by documented policies, objectives, plans, processes, procedures and fabrication standards. The documented quality management system has to reflect the planning and carrying on the activities, made by SME. Both for the audit reported to the ISO 9001 standard’s requirements but also for improving activities, will need to generate adequate registrations to document the effective performance and to demonstrate the concordance.

Top management of SME has to be aware that the implementation of a quality management system according to this standard has to be approached as a project, to which are assigned resources and which has to be managed by a defined schedule.

First step is represented by defining the objectives of the schedule with an accent on those that will bring benefits for SME. For each objective must be defined the way in which will be measured his achievement, as well as the reference level. Schedule must also establish:

· An identification, documentation and continue improving system of SME’s processes;

· Stages that must be carried out for achieving the objectives regarding to the quality of the product and for long-term improving of a quality management system of SME;

After establishing the objectives, the next decision of the top management of SME refers to the type of approaching that will appeal to [3].

There are two ways of approaching:

a) to design the whole quality management system and then to be implemented;

b) to evaluate the processes and to appeal to improving techniques to build the system step by step, starting from existing elements.

The advantage of designing the whole quality management system is represented by obtaining a distinct structure, the main disadvantage being the tendency of a theoretical approach, separated from the realities and practices of SMEs. The performances of the personnel can also suffer because of the necessity to apply simultaneous a great number of new procedures.

The essential advantage of step by step approach is that if through evaluation of processes are determined both the adequate practices and the less acceptable, the efforts can be focused on those areas that ensure a maximum benefit. This approach has the disadvantage of the tendency to achieve a quality management system that is not so well structured and so is more difficult to understand and to apply by the personnel of SME.

The optimum approach represents a combination of the two variants. So, initially it is good to be established a general structure of the quality management system and then to be established frame models for documentation of the processes. Implementation activities will have in view identification and solving the problems and then the improving key processes of SME.

Indifferent the approaching way, top management of SME can decide if the conceiving and implementation project of the quality management system will be carried out through internal forces, or will be carried out external appealing to a specialised advising. In case they appeal to an advising firm, must exist an abiding collaboration between the two firm and a well tuned up contract to which will be affixed a plain schedule, with responsibilities and achievement terms.

Designing and implementation project of the quality management system cannot ensure solving all the problems. Changing the culture of an organization takes time and patience. Project must be accomplished through a well defined series of phases, with well established terms and with objectives that can be reached.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Active Implication Of The Implementation Of Quality Management System

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Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.

The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.

To achieve such a desideratum, top management must consider the following actions:

· defining the visions, policies and strategic objectives of SME;

· direct participation of the management to improving projects;

· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;

· developing an environment that encourages the involving of the personnel;

· ensuring the necessary resources for achieving the objectives.

Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.

These methods must allow the evaluation:

· financial performances of SME;

· performances of the processes of SME;

· client’s satisfaction, personnel’s and other interested parts’ satisfaction;

· other success factors identified by management.

Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving

the performances of SME.

In this way, top management can demonstrate its commitment through:

· understanding the necessities and present expectations and client’s perspective;

· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;

· adopting the principle of continue improving as a base principle for the processes of SME.

· Rigorous planning of all processes of SME and to operate the changes;

· ensuring an adequate background to satisfy the requirements of the interested parts.

Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.

The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:

· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;

· ensuring that incoming and outgoing elements are obvious defined and are kept under control;

· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;

· identification and administrate the risks and to turn to account the opportunities of improving

performances;

· doing the analysis of the information for continuously improving of the processes;

· designating the responsible of the processes;

· ensuring that every process is managed so that it allows the achievement of the established objectives;

· defining the necessities and expectations of the interested parts.

Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:

· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;

· defining the policy and objectives regarding the quality;

· managing the analysis of the quality management system;

· ensuring the necessary resources for the achievement of the objectives.

One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:

· getting client’s satisfaction as a main goal;

· clarifying the way in which it is ensured the quality of the products and services of SME;

· explicit commitment of the management regarding continue improving of the quality;

· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.

Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.

When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

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Why do organizations implement ISO 9000 systems?

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More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000 Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000 requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.

Read more on ISO 9001 Standards at http://www.iso9001store.com

What Is ISO 9000 Registration?

2011-06-22T05:32:00.000-07:00

Registration is documented and objective evidence that an organization’s quality system meets the requirements of ISO 9000. Certification is a term often used interchangeably with registration. In the context of ISO 9000, they mean the same thing. Registration is the technically correct term for verification of compliance to standards of quality systems. Certification usually applies to verification of the quality of products (as opposed to quality systems).

Registration is carried out by independent companies called registrars. These companies are:

_ Wholly independent.

_ Accredited by a recognized international accreditation body.

_ Selected, and paid, by you.

Registration can cover:

_ The sole location of a single-location organization.

_ Multiple locations of a multilocation organization.

_ Only certain parts of a multilocation organization (under certain conditions).

_ Separate locations under separate certificates. (This is a more costly approach.)

The registration body audits your quality system against the requirements of ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances. Major noncompliances must be closed out prior to official registration.

When this has been done, the registration body:

Lists the organization’s name in its book of registered companies— in effect, registers the organization in its book.

Issues a certificate to the registered organization. This registration includes:

— Identity of the organization.

— Location(s) covered by the registration.

— A list of products/services supplied by the registered locations.

— Revision date of the Standard.

— Registration effective dates.

— Name and location of registrar.

Most registrars limit registrations to three years. After that, you must renew your registration by undergoing another complete systems audit. Some registrars do not use the renewal approach. They simply keep checking the system via surveillance audits. Whichever the scheme, the organization, to keep registration, must undergo a surveillance assessment every so often. Six months is the typical interval. Some registrars offer annual surveillance schemes (not recommended except for firms with exceptionally well-implemented quality management systems). Surveillance assessments are scheduled events (there is no such thing as a “surprise” surveillance audit). Only part of the quality system is checked at each surveillance. Usually, the registrar does not disclose what part will be assessed until the day of the assessment, although some registrars will tell you everything up front.

The entire quality system is usually checked via surveillance audits over the course of three years. There is no way to “fail” a surveillance assessment, just as there is no way to “fail” a registration audit except by refusing to implement corrective action required by the registrar. Normally, registrars allow adequate time, but corrective actions must be done in a timely and agreed upon manner to keep registration.

One final note: As mentioned, each registrar publishes a list of the firms it has registered to ISO 9000. A comprehensive list of ISO 9000 registered firms is available from Irwin Professional Publishing (703-591-9008).

Read more on ISO 9001 Standards at http://www.iso9001store.com

Process Approach In ISO 9001 Standards

2011-05-24T06:14:00.000-07:00

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.

Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of

approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for managementsystems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance(ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

ISO 9001 Standards & ISO 14001 Standards

2011-02-05T04:45:00.001-08:00

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

Audit Of Electronic Documents In ISO 9001 Standards

2011-02-05T04:44:00.000-08:00

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

How To Prepare ISO 9001 Standards Audit Check List

2011-02-05T04:43:00.002-08:00

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA). This PDCA concept is applied at the Quality Management System and the process levels.

2. Convert the question to requirement raised by QMR or the QMS Committee which derived from theISO 9001 standards. In this case, several questions can lead to one single requirement.

3. To edit those questions to suit the process that is to be audited. For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise. There is no better way to do that than by developing the audit questions with them.

ISO 9001 Standards – Risks and opportunities

2011-02-05T04:43:00.001-08:00

The first things to consider when we want to change a people intensive process are:

• What do the people involved fear? These are the risks – things that we must prevent.

• What do people hope for? These are the opportunities – things that we must strive to obtain.

In order to better understand risks and opportunities, we used a two-step approach. We started by interviewing two developers and one manager. The interviews were semi-structured in that we had a set of questions that we needed answers to but in

addition, we used follow-up questions to gain a better understanding of the answers to the predefined questions. The focus of the interview was on what they expected would happen if the company implemented an ISO 9001 certified process. Two typical examples of what came out of the interviews are shown below – one from a developer and one from a manger.

Manager: Implementing ISO 9001 will cost quite a lot. At the same time, the company will get a better overview of its competence, its experience and its document templates. ISO certification is an investment. We are, however, unsure of how long we have to wait before we can reap the benefits.

Developer: Some of the developers may have a negative attitude towards ISO certification because they are afraid it will hurt creativity. This is not only true for ISO 9001 standards but holds also for coding standards and other rules and regulations. Rules

and standards can take away all the fun from the job. In many ways this is the same attitude as we saw when we started to reuse components – many developers were afraid that they would not be allowed to develop things but just had to use “toy bricks”.

After the interviews we found that:

A. Everybody in the company – both mangers and developers – filled in the questionnaire.

The items in the questionnaire that got an average score of 5.0 or more were considered for risk and opportunity analysis. This gave us the following items:

• When we get ISO certified, we will have to generate more documents for each development project.

• It is important that all employees participate actively in the introduction of new processes, standards and procedures. This is consistent with e.g. Trittmann et al’s observation

• Active management participation is important in order to make the introduction of an ISO certified process a success.

• Active management support is important in order to make the introduction of ISO certification a success.

• An ISO certified process will lead to better working practices in the company in general.

Based on our findings, we identified the following risks that needed to be controlled throughout the implementation of the ISO 9001 certified process:

Risk 1: The introduction of new documents or additions to existing documents.

We decided that we should not make new documents except if absolutely needed.

Risk 2: Developer participation. The developers must be included at all steps in

the process. Their experiences and advices are important input to the new processes and procedures.

Risk 3: Management participation and support. Management must show their commitment by allocating money and time to the ISO implementation activities.

Opportunity 1: Better working practices. The changes in the development process must be considered to be improvements by the developers.

Management and developers are in agreement in the sense that everything the developers found important also was ranked high by management. There were, however, some cases where the two groups disagreed strongly – average score difference greater than 2.0. In all cases, management ranked these items higher than the developers.

The points are:

• Introducing an ISO certified process will cost a lot but will be a good investment – developers 3.3 vs. mangers 6.0

• Introducing an ISO certified process will give the company a better control over the order situation – developers 3.0 vs. mangers 6.0

• Introducing an ISO certified process will give us more satisfied customers already after one year – developers 3.2 vs. mangers 6.0

Management is more optimistic than the developers when it comes to business related issues such as order situation and customer satisfaction.

Extreme Programming For ICT In ISO 9001 Standards

2011-02-05T04:42:00.000-08:00

Extreme Programming represents a new wave in software development known as the approach. Tom de Marco, the father of structural analysis, calls Extreme Programming the most important movement in software engineering. The strong points of Extreme Programming in the ICT context are as follows:

– Risk minimization. ICT is developing very fast. To catch up with current developments it is necessary to make investments in new technologies and try new tools out. On the other hand, new tools and technologies are immature and one cannot depend on them. The best approach is to make some (preferably small) investment now and after some time invest more or give up, depending on the developments (it is like buying an option on the stock exchange). Extreme Programming is based on incremental software development and its suites the strategy very well.

– Customer orientation. In Extreme Programming all the business decisions are made by the customer and he has the full control over the development process.

– Lack of excessive paperwork. In Extreme Programming programmers concentrate on programming, not on writing documentation. The only artifacts they have to produce are test cases and code.

– Quality assurance through intensive testing. In XP programmers first create test cases then they write code. Automated tests and integration are performed several times a day and they drive the development process.

– Lack of overtime. Short releases and increments allow to gain experience very fast. This makes planning easier and more dependable. As a result programmer do not have to (always) work overtime.

Extreme Programming has also weak points. The most important are problems with software maintenance.

Since the only artifacts are test cases and code, after some time it can be very difficult to maintain the software. It would be also the problem from the ISO 9001 point of view. In the remaining part of the paper we propose how to solve that problem.

How To Implement ISO 9001 Standards Using Template & Softwares

2010-12-31T06:08:00.001-08:00

There are few ways of implementing the ISO 9000 in a particular organization. One of the easy way is hiring a ISO 9000 consultant in a turn key project basis. This definitely will incur cost. However, some of the organization will appoiint an employee to start up the ISO 9000, by learning thru seminar, preparing the ISO 9000 Quality Manual, Procedure & Form by using some of the ISO 9000 Template sell at internet. Some of the provider such as http://www.iso-consults.com & http://www.quality-template.com are providing such services.

Normally, the template provide will provides the ISO 9000 Quality Manual Template, Standand Procedure & also sample form for the ISO 9000 implementation. One of the provider like http://www.e-wia.com give a very complete set of the ISO 9000 Templates, which will help an organization to implement the ISO 9000 easily.

There are also some ISO 9000 Softwares which helps the organization in the ISO 9000 implementation. Some of the ISO 9000 Software are listed below:

a. Document Control Software – Software which Helps the organization to keep track & control of the ISO 9000 Documents.

b. Audit Control Software – Software which helps the organization to keep track of internal & external audit events.

c. Training Record Management Software – Software which helps the organization to keep track of Training records in a system.

d. Calibration Software – Software to maintain the calibration records for tool & machinery.

More Sites on ISO 9001 Standards Template & Softwares are as below:

http://www.iso9001store.com

http://www.iso14000store.com

Hidden Businees Opportunities

2010-12-31T06:07:00.001-08:00

The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let me dispel any anxiety about the November 15, 2008 official “2008” release. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications. The changes to the ISO 9001 amendment, however, will have considerable benefit.
As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System. It is the world’s most recognized business management standard. And it makes a strong business case. It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement. That translates to improved business results and a sustainable competitive advantage.

Overview of the Changes

The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.
Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility betweenISO 9001 and ISO 14001.
The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.
With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.

ISO 9000 AND THE CONSTRUCTION INDUSTRY

2010-10-27T06:14:00.000-07:00

ISO 9000 AND THE CONSTRUCTION INDUSTRY

formal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business. Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems are

difficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which are

recognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization and

flexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers,whose requirement for quality is essential for doing business. Most of the construction organizations will not enterinto the cost and allocation of resources to implement a quality management system unless they will becompensated. There is a general movement towards making implementation of a quality management system acontractual requirement. Small to medium sized organizations can always argue that they ‘operate to a qualitysystem’ although this is not formalized.

However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standardsthat are applicable to all organizations irrespective of size or nature of business. ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization todevelop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably themost prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question thestandards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

ISO 9001 and occupational health and safety

2010-10-27T06:13:00.002-07:00

ISO 9001 and occupational health and safety

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

2010-10-27T06:13:00.001-07:00

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

Six Sigma Vs ISO 9000

2010-10-27T06:12:00.001-07:00

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 9001 Standards & ISO 14001 Standards

2010-10-27T06:11:00.000-07:00