Saturday, October 1, 2011

Corrective and Preventive Actions In ISO 9001 Standard


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

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

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

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


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.