ISO 9001 Standard – Document Control Video at http://www.youtube.com/watch?v=A8scypx7cy4&feature=mfu_in_order&list=UL
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 9000Quality 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.
Read more on ISO 9001 Standard at http://www.iso9001-standard.us
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.
This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.
Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.
Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.
The ISO 14000 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit
on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio
Summit generated a commitment to protection of the environment across the world. The environmental field has
seen a steady growth of national and regional standards.
The British Standards Institution has BS 7750, the Canadian Standards Association has environmental management,
auditing, eco-labeling and other standards, the European Union has all of these plus the eco-management and audit
requlations, and many other countries (e.g. USA, Germany and Japan) have introduced eco-labeling programs.
After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, ISO assessed
the need for international environmental management standards. They formed the Strategic Advisory Group on the
Environment (SAGE) in 1991, to consider whether such standards could serve to:
· Promote a common approach to environmental
· management similar to quality management
· Enhance organizations’ ability to attain and measure improvements in environmental performance; and
· Facilitate trade and remove trade barriers.
In 1992, SAGE’s recommendations created a new committee, TC 207, for international environmental management standards. The committee, and its subcommittees include representatives from industry, standards organizations, government and environmental organizations from many countries.
ISO 14004 and ISO 14001—were published in September and October 1996, respectively. The ISO 14000 family
consists of standards and guidelines relating to environmental management systems and supporting standards, terminology and specific tools, such as auditing.
Essentially, the standards are concerned with what an organization does to minimize harmful effects on the environment caused by its activities: either during production or disposal, either by pollution or by depleting natural resources.
Any effective quality management system (including the subsystems) works as a control process, which has the ability to detect deviations and nonconforming products and assures that the corrective and preventive action measures are effective. The regulatory auditor should check that all subsystems and processes of the quality management system are structured as self-regulating control processes. For example Deming’s PDCA cycle demonstrates such a process with the following components:
i) Plan – Has the manufacturer established the objectives and processes to enable the quality system to deliver the results in accordance with the regulatory requirements?
ii) Do – Has the manufacturer implemented the quality system and the processes?
iii) Check – Has the manufacturer checked process monitoring and measurement results against the objectives and the regulatory requirements? Does the manufacturer evaluate the effectiveness of thequality system periodically through internal audits and management reviews?
iv) Act – Has the manufacturer implemented effective corrective and preventive actions? Confirm that the company is committed to providing high quality safe and effective medical devices, and that the company is conforming with applicable laws and regulations.
In our business we often need to describe our policy and practice regarding quality of service, responsibility towards environment and employees health to our clients. There are three set standards i.e. ISO 9001, ISO 14001 and OHSAS 18001 accepted globally.
ISO 9001 is the internationally recognised Quality Management Standard for all types of organisations. It’s all about managing your processes and continually improving the way you do things. It doesn’t require you to change any of your operating procedures or do anything that isn’t good practice. It simply asks you to “Say what you do, and do what you say”.
ISO 9001 is by far the world’s most established quality framework, currently being used by over ¾ million organizations in 161 countries, and sets the standard not only for quality management systems, but management systems in general.
Having ISO 9001 certification demonstrates that your organisation is well managed, knows where it is going and has a plan to get there. Also, having a plan means you are far more likely to succeed.
Certification to the ISO 14001 Standard demonstrates your ‘Green’ credentials to the world at large and your customers in particular. It gives them the confidence to know that behind the certificate there is an organisation that is aware of its environmental responsibilities and is doing everything it can to minimise any adverse impact.
ISO 14001 standard is applicable to any organization that wishes to:
- implement, maintain and improve an environmental management system
- assure itself of its conformance with its own stated environmental policy (those policy commitments
- of course must be made)
- demonstrate conformance
- ensure compliance with environmental laws and regulations
- seek certification of its environmental management system by an external third party organization
- make a self-determination of conformance
OHSAS18001 sets out the requirements for an Occupational Health & safety Management system that enables organisations to control physical, work related risk, protect employees’ health and improve business performance. It requires the creation of a relevant Management System and has been developed to promote best practice in this field.
Obtaining OHSAS 18001 demonstrates that you have:
· procedures for risk assessment, risk control and hazard identification
· structured health and safety training and required competences
· emergency procedures and response mechanisms
· formal communication channels for disseminating health and safety information
· performance measures and improvement plans
Achieving ISO compliance and certification can take significant amounts of time but should prove valuable for companies interested in successful global networking and high levels of customer satisfaction.
What Is ISO 9001 Standard?
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the companys products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
It’s always a good time to line up for a session with an ISO 14001 consultant. For most companies, this is really a good way of looking better. In reality though, certification can do so much more than polish company image. It is also the best way to make sure that a company has such strong values that its systems are structured in such a way as to limit negative environmental impact.
For a lot of businesses, general objectives revolve mainly around making more profits. These days though, it is hardly feasible or wise to maintain only this single-minded drive. Nearly every business, regardless of type or size can have an impact on the environment. Whatever you do can either worsen environmental degradation or help in preservation. It is now therefore, every business owner’s responsibility to strike a balance between making profits and promoting environmental responsibility. This is where becoming ISO 14001 certified becomes important.
To be exact, certification is a form of acknowledgement. Certified companies are recognized as holders and users of comprehensive environment management systems. What the 14001 standards really seek to provide are generic standards. This can’t be helped. Specific points are difficult to come up with since businesses aren’t all the same. This isn’t exactly a negative aspect though. After all, there are many general terms and standards that are applicable and even necessary to companies that belong to different sectors.
Certification is beneficial in a number of ways. First of all, a company that passes ISO 14001 certification comes out as automatically compliant with legal requirements. What partly keeps you in business other than customer satisfaction is compliance with government standards.
Legal compliance or going beyond this is advantageous in other ways. It is for example a good business image boost. With certification under your belt, you are able to build a great reputation for yourself, your company and your brand. This can then lead to attracting more customers and getting more sales conversions.
Naturally though, the top benefit of all is achieving control over how your processes affect the environment. By helping preserve the environment, you get the extra perks of power and cost conservation, thereby reducing your operational expenses.
An ISO 14001 certified system is important because it is what gives structure to your processes. With a solid structure on your side, you can be certain that your bid to make more profits and your commitment to preserving the environment are both on the same playing field.
Companies can perform self audits to prepare for the process of certification. Some business owners however immediately hire consultants to help with the preparations. Consultants do charge high fees but great service providers can actually help you save more in the long run. Specialists typically assess the system already in place, recommend changes for improvement and provide suggestions for staff training and documentation. It’s generally a good idea to tap expert help if you are a bit lost on where to begin. If you aren’t even yet compliant with mandatory requirements, getting help is a must.
Read more on ISO 9001 Standards at http://www.iso9001store.com
ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.
- Provide resources needed to support process operations, monitoring and the management review process.
- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.
- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.
- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.
- Keep a record of the review process. This includes corrective and preventive action procedures.
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