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.
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.
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.
Kindly go to http://www.e-wia.com for more information.
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by
— its business environment, changes in that environment, or risks associated with that environment,
— its varying needs,
— its particular objectives,
— the products it provides,
— the processes it employs,
— its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.