ISO 9000
Bold Technologies is commited to ISO 9000. We began the journey in 1986 with the review and development of our quality manual. The following implementation schedule outlines our roadmap and our progress through ISO implementation. We are commited to providing the highest quality products and services to our customers. ISO, GMP and Total Quality Management aid us in meeting our customers most stringent requirments.
Implementation of ISO 9001
MANAGEMENT RESPONSIBILITY
Define and document the Quality Policy Distribute draft Quality Policy to management for review and correction Edit the Quality Policy per revisions made by management Release Quality Policy as controlled document Train: Ensure policy is understood by whole company Create training session outline and materials for adopting Quality Policy company-wide Schedule training session "Hold training session, document training of attendees" Post Quality Policy in conspicuous places around the company "Define and document responsibility, authority, interrelation of quality personnel" Job descriptions for quality department personnel Revise Organizational Chart if necessary Create flowchart that illustrates how QA functions in our organization "Appoint Management Representative for ISO, Define his/her authority" Determine person best suited to fill this function Redefine the person's job description Notify all company personnel of the new appointment Conduct Management Review of Quality System "In a meeting, review ISO requirements, organization and resources to begin project" QUALITY SYSTEM
Document outline structure of quality system in quality manual Management reviews and corrects draft Quality System document Revise draft into formal document and release for use Develop procedures addressing requirements of ISO standard Identify specific ISO requirements applicable to Bold's operations "Using the Quality System outline, write the details of the ISO requirements" Develop procedures addressing requirements of Quality Manual Implement documented Quality System CONTRACT REVIEW
"Review contracts/orders, define customer requirements, resolve ambiguities" Verify capacity to meet contract or order requirements Define and document how contracts are amended and changes communicated to functions concerned DESIGN CONTROL
Plan design activities Define organizational and technical interfaces Assign qualified personnel "Identify, document and review the Design Input" Conduct formal Design Reviews "Document the Design Output, including acceptance criteria" Review and approve Design Output documents before release Verify design at appropriate stages to ensure that Design Output meets Design Input requirements Validate new designs for operating conditions of intended uses "Identify, document, review and approve Design Changes" DOCUMENT AND DATA CONTROL
Review and approve documents prior to issue "Identify documents with revision level, maintain master list with current revision status" Ensure current documents are available at all locations where needed Remove obsolete documents from point of use Identify retained historical copies of obsolete documents to preclude uninteded use Review and approve corrections in documents and reissues of revised documents "At distribution, highlight changes in revised documents" PURCHASING
Evaluate subcontractors and monitor their quality performance Maintain a list of approved subcontractors and records as evidence of quality capabilities and performance "Precisely and completely describe the ordered product, and review and approve purchasing documents prior to release" "When appropriate, verify purchased products at subcontractor's premises" "When appropriate, allow customer's to verify purchased products at our premises" CONTROL OF CUSTOMER SUPPLIED PRODUCT
"Verify, store and protect products received from customers" Notify customers in the event of loss or damage of customer supplied product PRODUCT IDENTIFICATION AND TRACEABILITY
"Identify materials, components and products during all stages of production" "If required, uniquely identify individual products and batches to ensure traceability" PROCESS CONTROL
Plan production activities and processes Provide personnel with work instructions and workmanship standards "Qualify, monitor, and control processes, especially those the results of which cannot be verified" Use suitable production equipment and maintain the equipment to ensure continuing process capability INSPECTION AND TESTING
Specify the required inspection and testing program in quality plans and procedures Inspect or verify received products and prevent them from being used or processed before they are accepted Inspect products at key production stages and hold until they pass specified in-process inspections Inspect finished products to complete the evidence of conformance "CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT"
"Calibrate and/or check measuring and test equipment, maintain calibration records" "Identify, maintain, and safeguard measuring and test equipment" "Define criteria for selecting appropriate measuring and test equipment regarding accuracy, precision, and environmental" INSPECTION AND TEST STATUS
"Identify inspection and test status of products, to ensure only conforming products are used or dispatched" CONTROL OF NONCONFORMING PRODUCT
"Identify, segregate, and document nonconforming products" "Review nonconforming products and decide if they should be accepted, regraded, reworked, repaired, or scrapped" CORRECTIVE AND PREVENTIVE ACTION
Establish a system for effective handling of customer complaints "Investigate causes of product, process, and quality system nonconformities and implement corrective actions" "Review process and quality records to identify potential causes of nonconformities, and implement preventive actions" "HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY"
Provide methods of handling products that prevent damage and deterioration Provide designated storage areas Control receipt and dispatch of products to and from storage areas Regularly assess the condition of products in stock Specify and control product packaging Apply appropriate methods of preservation and segregation of products "Protect the quality of finished products to include delivery, when specified in contract" CONTROL OF QUALITY RECORDS
Index and organize quality records to facilitate their retrieval Determine and document retention periods for quality records INTERNAL QUALITY AUDITS
Plan and schedule internal audits of the quality system Conduct internal audits using independent and qualified auditors Implement corrective actions to deal with identified deficiencies Record and report the results of internal audits TRAINING
Identify training needs for all personnel Provide for required training and maintain training records SERVICING
Apply all requirements of the standard to servicing operations and activities
STATISTICAL TECHNIQUES
Identify the need for and apply statistical techniques to process control and product verification
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