Monday, March 5, 2012

ISO 9001 Standard - ISO 9001 Standards



Tuesday, November 15, 2011

Why Some Implementation Of ISO 9001 Standards Fail?

Some times it is because they have not put in the required effort, others just do not read the requirements of the ISO 9001 standard or misinterpreted its requirements. This is why it is always best to employ a consultant who has been through the process many, many times before. A consultant will guide you through the process avoiding the numerous pitfalls like over-documentation or insufficient coverage of the ISO 9001 Standard.
Would you go for a driving test without having read the highway code? Of course not.
As a Senior lead auditor with the UK’s largest certification body for many years I would estimate that one in ten organisations visited did not have a copy of the appropriate ISO 9001 standard for which they were seeking registration, some had a copy but openly admitted that they had never read it, others had read it, didn’t understand it, and just did what they believed to be in the standard. Many businesses just forget to carry out internal audits or carry out the ISO 9001 standard training of their employees to give them a basic understanding of what ISO 9001 is all about.
When these applicants failed their initial registration audit they seemed shell shocked and could not understand how they could fail. Quite simple, it is rather like turning up for an “A” level exam having not read the syllabus, failed to do any home or course work and expecting to pass. A good consultant will ensure that your business does not fall into any of these traps.
The U.K. British Standards Institute, estimates that 45% of the companies who fail to achieve certification do so because of documentation deficiencies. The ISO 9001 is very specific about what documents have to be produced and which records have to be kept.
The remaining 55% of failures are in-part related to documentation in areas such as policies and procedures for process, inspection, testing and measurement. Employing a consultant would have prevented failure and the additional costs of a full registration body re-assessment.
The ISO 9001 standard is very specific about what documents must be controlled and in general you will find that they fall into the following three areas
Documents which describe the Quality Management System within your organisation
Documents of external origin which you use in the process of producing your product or service such as ISO standards, drawings, specifications etc.
Records which you must keep are generally recorded on forms, in books or in electronic format, all of which must be controlled.
If documentation control is an issue that concerns you then take a look at the Easy ISO 9001 software, it will take care of this for you and much more.
Based on our experience, we believe that ISO 9000 certification will become increasingly important, particularly if companies are to remain competitive in the global economy.

How To Meet ISO 9001 Quality Standards?

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.
The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.
Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.
Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.
Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continuous improvement
7. Factual Approach to Decision-Making
8. Mutually Beneficial Supplier Relationship
ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.
In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.
On the way to certification, a business can meet its ISO needs by:
1. Using well-defined processes and procedures to build stable processes
2. Training in the audit and certification process
3. Continuously improving with ISO 9001 standards
With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.
Read more on ISO 9001 Standards at http://www.iso9001store.com

Quality Management System To Improve Business Performance

The intent of the Quality Management Standard is to encourage the adoption of the process approach to manage an organisation.
A process is any activity or set of activities that uses resources to transform inputs to outputs. For organisations to function effectively, they have to identify and manage numerous interrelated and interacting processes. The “Process Approach” is the systematic identification and management of the processes employed within an organisation and particularly the interactions between such processes.
In order to lead and operate an organisation successfully, it is necessary to manage in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested parties.
Eight quality management principles that can be used by management in order to lead the organisation towards improved performance are outlined below:
Customer focus
Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
Leadership
Leaders establish the purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.
Involvement of people
People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the benefit of the organisation.
Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
System approach to management
An organisation’s effectiveness and efficiency in achieving its objectives is attributed to the identifying, understanding and managing interrelated processes.
Continual improvement
Continual improvement of the organisation’s overall performance should be a permanent objective of the organisation.
Factual approach to decision making
Effective decisions are based on the analysis of data and information.
Mutually beneficial supplier relationships
An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
These eight quality management principles form the basis for the quality management system standards within the ISO 9000 family.
More information on Quality Management, please go to http://www.iso9001store.com

Sunday, August 21, 2011

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Softwarewere designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.

Certification Of ISO 14001

Certification Of ISO 14001

International Organization for Standardization (ISO) is functioning from Geneva in Switzerland as a worldwide federation of national standards organizations. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing corporation in the spheres of intellectual, scientific, technological and economic activity. ISO’s works result in international agreements which are published as international agreements which are published as international standards.

ISO 9000

Previous version of ISO 9000 (1994) emphasize on documents and document control. But as per new standard the extent of documentation can differ from company to company in a simplified manner.

ISO 9000 system requires records at relevant stages which provide data for continual improvement and can be used for legacy as a data bank.

ISO 14000

ISO 14000, the environmental management system family of standards, was formally published by the International Organization for Standardization (ISO) on September 2, 1996. ISO 14001 is the conformance standard within the ISO 14000 series. After extensive groundwork, the revised version of ISO 14001 was released on 15th of November 2004. ISO 14001:2004 will replace ISO 14001:1996 after a transition period of 18 months, ending on 14th May 2006, and will become the basis for the certification procedure for environmental management. All ISO 14001:1996 certificates will be rendered invalid on 15th May 2006

Since 1996 the ISO 14001 has formed the basis for structuring, implementation, review and further development of environmental management systems. It lays down the applicable demands for organizations of all kinds and sizes as well as for diverse geographical, cultural and social conditions. The overall objective is to promote environmental protection and the prevention of environmental stress in harmony with economic, social and political requirements.

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks (OH&S). The importance of managing Occupational Health and Safety is recognized by all interested parties – employers, employees, customers, suppliers, insurers,shareholders, the community, contractors, and regulatory agencies. It enables an organization to control occupational health and safety risks risks and to improve performance.

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.