Friday, December 10, 2010

How To Get ISO 9001 Certified


How To Get ISO 9001 Certified

The ISO 9001 accreditation is part of the International Organization for Standardization 9000 standards. They are awarded to businesses for quality. The ISO 9001 is recognized worldwide as an award for a company’s internal quality management or actions that the company takes to ensure the product or service they provide is of the highest quality. Customer satisfaction is a major factor in whether a company will be awarded an ISO 9001 accreditation. The International Organization for Standardization in Geneva, Switzerland publishes thousands of international standards to help companies throughout the world more efficiently do business with one another. The 27 page ISO 9001 standard is focused on defining minimum business practices for the production and delivery of a company’s products and services through the implementation of a formal “quality management system”, or QMS. An ISO QMS is made up of certain processes, documentation and other formal practices that control internal company operations to ensure customer requirements are consistently met. To pass an audit, an organization must follow these guidelines: Develop a Quality Management System (QMS) manual. Develop the procedures required by the ISO 9001 Standard. Determine the additional processes and procedures that are needed by the organization to perform work and satisfy the requirements in the ISO Standard. Operate in accordance with the organization’s documented QMS. Provide evidence that the organization is operating according to the QMS. The achievement of an ISO 9001 certification is a milestone in demonstrating to your customers that you have implemented a reliable system of producing and delivering your products and services. The focus of this “system” is twofold: providing consistent products and services; and continual improvement in your processes leading to better results. The ISO 9001 certification is granted by a third-party auditing firm called a Registrar who specializes in quality system auditing. There are a wide variety of Registrars located in every ISO participating country. Some firms have offices internationally; others have a more regional focus. The selection of your Registrar is one of the more important decisions you will make to ensure the best alignment with your type of business, your location(s) and overall cost of maintaining the certification. The initial certification audit is conducted in two parts. The Stage 1 audit is a general review of your QMS documentation to ensure you have addressed all of the requirements of the ISO 9001 standard. Depending upon the size of your business, this can be conducted in a one to two day visit to your facility or virtually via phone. Any discrepancies noted during the Stage 1 audit will be documented in a formal report and must be corrected before the Stage 2 audit. The main part of the ISO audit is the Stage 2 audit which is always conducted onsite at your location(s) and will be focused on the implementation and effectiveness of your QMS. During this audit which can take 1 day (for very small companies) to several days, the auditor(s) will tour your company, speak to managers and employees, and review documentation and records (along with any Stage 1 discrepancies) to ensure that your system is fully implemented. If nonconformances are found, they will be documented in a formal report for correction. Following the Stage 2 audit, you are generally given thirty (30) days to submit corrective action plans for all audit nonconformances. Once corrective actions are received, your certification is complete and your certificate is issued. In order to maintain the certification, you will participate in an annual surveillance audit from your Registrar where they confirm that you are maintaining your QMS. Every third year, a more comprehensive re-certification audit is conducted, similar to the initial certification audit.

ISO 9001 Standard Quality Manual Template


ISO 9001 Standard Quality Manual Template

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

Thursday, November 25, 2010

The Most Common Mistakes Made with ISO 9001


The Most Common Mistakes Made with ISO 9001
Some very common mistakes often happen when companies try for ISO 9001. Usually they:
Don’t really know what they want from their system
Don’t make the system work for them
Don’t keep it simple
Don’t understand the Standard, let alone how to apply it to what they do
Don’t know or use a ‘systems approach’
Don’t get the documentation right (the dreaded ‘quality manual’)
Don’t get their people involved
Don’t actually know what they mean by ‘quality’.
Then there’s the biggest one of all.
They don’t follow their own system. Is it any wonder?
Perhaps you’ve already looked into getting ISO 9001. If you’ve read it, you’ll probably agree it doesn’t make great reading. But it does talk about a ‘quality manual’, so presumably you have to write lots of documents.

The Most Common Mistakes Made with ISO 9001


The Most Common Mistakes Made with ISO 9001
Some very common mistakes often happen when companies try for ISO 9001. Usually they:
Don’t really know what they want from their system
Don’t make the system work for them
Don’t keep it simple
Don’t understand the Standard, let alone how to apply it to what they do
Don’t know or use a ‘systems approach’
Don’t get the documentation right (the dreaded ‘quality manual’)
Don’t get their people involved
Don’t actually know what they mean by ‘quality’.
Then there’s the biggest one of all.
They don’t follow their own system. Is it any wonder?
Perhaps you’ve already looked into getting ISO 9001. If you’ve read it, you’ll probably agree it doesn’t make great reading. But it does talk about a ‘quality manual’, so presumably you have to write lots of documents.

Who Is ISO 9001 Consultant?


Who Is ISO 9001 Consultant?
ISO 9001 Consulting has been available ever since the ISO management system standards were initially published in the late 1970′s. As of now, nearly a million business companies internationally have been certified to one or more of several ISO business standards. These include ISO 9001, ISO 14001, AS9100, ISO/TS 16949, etc. The statistics that have been accumulated to date indicate that while many organizations deployed ISO standards using internal know-how, those that used outside ISO 9001 consulting services profited the most in terms of speed of implementation, effectiveness and return on investment.
ISO 9001 Consultancy firms provide a numberof services. Let’s take a look at some of these so that you can determine what collection of services would best suit your company:
How To Interpret The ISO 9001 Standard?
The ISO 9001 quality management system standard can be a hard document to understand. It is written in semi-legal language and specifies requirements in in a very general sense. This is deliberately so, as it is meant to consider just about any type of business activity. Many companies have problems relating it to their specific organizations. An experienced ISO 9001 consultant can show you exactly how to apply the standard to your specific business processes.
ISO 9001 Gap Evaluation
Prior to implementing the ISO standard within your organization, you need to know the gap between your existing business practices and controls relative to ISO 9001. Using ISO 9001 consulting services, you can have an evaluation done of your current management system practices, controls and documentation, to determine to what extent you comply to ISO 9001 requirements. The consultant will give you a detailed audit report listing the gaps in your company, along with their recommendations. This will assist in developing your ISO 9001 project implementation plan to accomplish full compliance.
ISO 9001 Project Planning and Organization
Depending size and complexity of your business, an ISO 9001 implementation project can take as few as 4 months to over 18 months to complete. Your ISO project needs to well-planned in terms of time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be an invaluable resource in assisting a business address with this important activity.
ISO 9001 Business Process Identification and Documentation
ISO 9001 views business processes as the main point of control. These include internal as well as outsourced processes. Quite a few companies have issues differentiationg between processes, departments and functional activities. ISO 9001 consulting experts can assist you identify and effectively document all organizational processes pertaining to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.
ISO 9001 System Development and Implementation
The main thrust of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the most time-consuming and difficult aspect of any ISO implementation project. Many questions may arise as to what processes must be be controlled, what should be an effective control, how best to communicate and implement it, the inter-process impact, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide focus and speed up implementation.
ISO 9001 Management System Documentation
The latest ISO 9001:2008 standard minimizes the emphasis on documentation and maximizes its attention on effective planning and control. Adequate documentation is however needed for many business processes in order to establish consistent application of effective controls. Some business have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.
ISO 9001 Pre-assessment
ISO 9001 Registrars (also referred to as Certification Bodies) conduct their certification audit in two stages. In stage 1, they determine your state of readiness (which includes your planning, documentation and internal review activities) and in stage 2 they evaluate your management system for effective implementation of planned controls, in both cases relative to the ISO 9001 standard. After spending several months of implementation, you feel your company ready for the certification audit, it might be useful to use external consulting to do an assessment to determine if you are truly ready, identify any issues and help you take appropriate corrective action, prior to the Registrar audit.
ISO 9001 Training
ISO 9001 Consultancy services generally provide a number of training alternatives. These include
- ISO 9001 awareness training to employees at all levels
- An executive summary of the ISO standard to senior management
- Process identification, mapping, analysis and improvement
- ISO project management
- ISO documentation and implementation
- Internal audit
- Use of problem-solving tools
Based on the amount of internal expertise inside your organization, you may want to have an external ISO 9001 consulting service provide some or all of this training.
Develop and Maintain your ISO 9001 Internal Audit Program
To be certified and maintain your certification, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, some comapnies are short on resources, internal audit expertise and personnel availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.
ISO 9001 Continual Improvement Process
The ISO 9001 standard requires your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Some ISO 9001 consulting firms have diversified skills and experience in continual improvement strategies and methods. These mayinclude problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can significantly accelerate your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.

Who Is ISO 9001 Consultant?

ISO 9001 Consulting has been available ever since the ISO management system standards were initially published in the late 1970′s. As of now, nearly a million business companies internationally have been certified to one or more of several ISO business standards. These include ISO 9001, ISO 14001, AS9100, ISO/TS 16949, etc. The statistics that have been accumulated to date indicate that while many organizations deployed ISO standards using internal know-how, those that used outside ISO 9001 consulting services profited the most in terms of speed of implementation, effectiveness and return on investment.

ISO 9001 Consultancy firms provide a numberof services. Let’s take a look at some of these so that you can determine what collection of services would best suit your company:

How To Interpret The ISO 9001 Standard?

The ISO 9001 quality management system standard can be a hard document to understand. It is written in semi-legal language and specifies requirements in in a very general sense. This is deliberately so, as it is meant to consider just about any type of business activity. Many companies have problems relating it to their specific organizations. An experienced ISO 9001 consultant can show you exactly how to apply the standard to your specific business processes.

ISO 9001 Gap Evaluation

Prior to implementing the ISO standard within your organization, you need to know the gap between your existing business practices and controls relative to ISO 9001. Using ISO 9001 consulting services, you can have an evaluation done of your current management system practices, controls and documentation, to determine to what extent you comply to ISO 9001 requirements. The consultant will give you a detailed audit report listing the gaps in your company, along with their recommendations. This will assist in developing your ISO 9001 project implementation plan to accomplish full compliance.

ISO 9001 Project Planning and Organization

Depending size and complexity of your business, an ISO 9001 implementation project can take as few as 4 months to over 18 months to complete. Your ISO project needs to well-planned in terms of time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be an invaluable resource in assisting a business address with this important activity.

ISO 9001 Business Process Identification and Documentation

ISO 9001 views business processes as the main point of control. These include internal as well as outsourced processes. Quite a few companies have issues differentiationg between processes, departments and functional activities. ISO 9001 consulting experts can assist you identify and effectively document all organizational processes pertaining to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.

ISO 9001 System Development and Implementation

The main thrust of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the most time-consuming and difficult aspect of any ISO implementation project. Many questions may arise as to what processes must be be controlled, what should be an effective control, how best to communicate and implement it, the inter-process impact, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide focus and speed up implementation.

ISO 9001 Management System Documentation

The latest ISO 9001:2008 standard minimizes the emphasis on documentation and maximizes its attention on effective planning and control. Adequate documentation is however needed for many business processes in order to establish consistent application of effective controls. Some business have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.

ISO 9001 Pre-assessment

ISO 9001 Registrars (also referred to as Certification Bodies) conduct their certification audit in two stages. In stage 1, they determine your state of readiness (which includes your planning, documentation and internal review activities) and in stage 2 they evaluate your management system for effective implementation of planned controls, in both cases relative to the ISO 9001 standard. After spending several months of implementation, you feel your company ready for the certification audit, it might be useful to use external consulting to do an assessment to determine if you are truly ready, identify any issues and help you take appropriate corrective action, prior to the Registrar audit.

ISO 9001 Training

ISO 9001 Consultancy services generally provide a number of training alternatives. These include

- ISO 9001 awareness training to employees at all levels

- An executive summary of the ISO standard to senior management

- Process identification, mapping, analysis and improvement

- ISO project management

- ISO documentation and implementation

- Internal audit

- Use of problem-solving tools

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

Develop and Maintain your ISO 9001 Internal Audit Program

To be certified and maintain your certification, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, some comapnies are short on resources, internal audit expertise and personnel availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.

ISO 9001 Continual Improvement Process

The ISO 9001 standard requires your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Some ISO 9001 consulting firms have diversified skills and experience in continual improvement strategies and methods. These mayinclude problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can significantly accelerate your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.

ISO 9001 Standards Quality Management System


ISO 9001 Standards Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.
The process of implementing ISO 9000 depends on:
???? a. The sophistication of your existing quality program,
???? b. The size of your organization, and
???? c. The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement

Saturday, June 12, 2010

ISO 9000 family of standards and SMEs


ISO 9000 family of standards and SMEs

The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.

It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.

The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.

The new standard has included a provision for deciding on the applicability of

certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.

It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.