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  COMPLIANCE ACCELERATED  White Paper: ISO 9001:2000 Standards:  Automating Quality Systems If you like our white papers, you’ll love our products. See what our customers say about MasterControl products.Using MasterControl for ISO Compliance   White Paper  COMPLIANCE ACCELERATED 2 ISO 9001:2000 Standards: Automating Quality Systems PLEASE NOTE: MasterControl has another white paper that covers the latest standards, ISO 9001:2008. If you would like to know more, please download the following white paper:Meeting ISO 9001:2008 - Standards with Automated Tools Introduction Adhering to ISO 9000 quality standards have helped companies improve product quality and production efciency. Will your electronic quality management system capabilities meet the challenge? If you are using MasterControl, the worlds leading quality management solution, there is no worry about nonconformance. Be assured, you will not only meet, but will exceed the new standards. The following describes how MasterControl helps with ISO9001:2000 requirements specic to document control:   RequirementHow MasterControl helps with…4.1 GENERAL REQUIREMENTS 4.1.1Establishes a document control system that stores and manages documents relating to implementing, maintaining and continually improving a Quality Management System in accordance with ISO 9001:2000. RequirementHow MasterControl helps with…4.2 GENERAL DOCUMENTATION REQUIREMENTS 4.2.1Stores and manages documented procedures for:Control of documents; ã Control of quality records; ã Internal Audit; ã Control of non-conformity; ã Corrective action; ã Preventive action. ã 4.2.2Helps the organization identify and control documents particularly those needed to ensure effective operation and control of its processes. Note: MasterControl is capable of storing documented procedures in virtually any medium (le format) type. RequirementHow MasterControl helps with…5.1 MANAGEMENT COMMITMENT 5.1.1Provides evidence of commitment by top management towards development and improvement of the Quality Management System by:Helping maintain awareness of regulatory and legal requirements.1. Helping maintain documentation of top management’s communications regarding meeting 2. customer requirements.Helping maintain top management reviews of resource requirements and storage of quality 3. data collection. Also helps demonstrate timely resources are provided to achieve quality objectives.Helping maintain documentation of Management Review of the Quality Management 4. System.   White Paper  COMPLIANCE ACCELERATED 3 ISO 9001:2000 Standards: Automating Quality Systems RequirementHow MasterControl helps with…5.2 CUSTOMER FOCUS top management store and manage documented methodologies to ensure that: Customer needs and expectations are determined, converted into requirements, and fullled with the aim of achieving customer satisfaction.Helps maintain documentation including legal and regulatory requirements. RequirementHow MasterControl helps with…5.3 QUALITY POLICY 5.3.1 a-g) Helps top management store, communicate, and control a Quality Policy. The Quality Policy can be made accessible to appropriate levels in the organization. RequirementHow MasterControl helps with…5.4 PLANNING, maintains, and communicates quality objectives to relevant functions and levels within the organization. Info Cards with objectives can be “linked” to the Quality Policy Info Card. an organization store and manage quality planning Documentation.Ensures changes to quality planning are managed in a controlled manner.Ensures the integrity of Quality Management System is maintained during the change process. RequirementHow MasterControl helps with…5.5 ADMINISTRATION Manages interface information (i.e. organizational charts, documentation) including routing and approval interrelationships, responsibilities, and authorities. the “Management Representative” by:Maintaining process documentation.1. Assisting with management reports on the performance of the Quality Management System.2. Promoting awareness of customer requirements throughout the organization.3. the organization with communication at various levels and functions regarding the  processes of Quality Management System and improves effectiveness by providing access to documents and through the routing and approval processes. and provides secure access to the Quality Manual.Maintains relationships and references to documented procedures through the Vault structure, Organizer, Linking, etc.Helps ensure the Quality Manual is controlled.   White Paper  COMPLIANCE ACCELERATED 4 ISO 9001:2000 Standards: Automating Quality Systems Establishes a system for controlling documents (including documents dened as Quality Records) required for the Quality Management System. Helps to ensure documents are:Approved for adequacy prior to issue;1. Reviewed, updated, as necessary and re-approved;2. Identied with current revision status; 3. Available at points of use;4. Legible, readily identiable and retrievable; 5. Identied and their distribution controlled if they are external documents; 6. Prevented from unintended use if they are obsolete documents, and have suitable 7. identication if they are retained for any purpose. Establishes a system for the identication, storage, retrieval, protection, retention time and disposition of quality records.Guarantees quality records are subjected to control.Ensures the following records are maintained: Results of management review (5.6);ã Records of education, experience, training and qualication (6.2.2);ã Results of review of product requirements and subsequent follow-up actions (7.2.2);ã Results of design and / or development review and subsequent follow-up actions (7.3.4);ã Results of design and / or development verication and subsequent follow-up actions (7.3.5);ã Results of design and / or development validation and subsequent follow-up actions (7.3.6);ã Results of design and / or development changes and subsequent follow-up actions (7.3.7);ã Results of supplier evaluations and follow-up actions (7.4.1);ã Unique identication of the product, when traceability is requirement (7.5.2).ã Results of calibration for measurement and monitoring devices (7.6).ã Authority responsible for release of the product (8.2.4).   ã Stores records for the following, as applicable:Customer property that is lost, damaged or otherwise unsuitable for use reported to the ã customer;Process validation records; ã Basis of calibration in the absence of traceable national or international standards; ã Results of corrective action taken; ã Results of preventive action taken. ã RequirementHow MasterControl helps with…5.6 MANAGEMENT REVIEW 5.6.1Maintains records of top management review of the Quality Management System. and manage records that include:Results of audits;1. Customer feedback;2. Process performance and product conformance;3. Status of corrective and preventive actions;4. Follow-up action from earlier management reviews;5. Changes that could affect Quality Management System6.
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