The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity. Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required. Quality Documentation The documentation and procedures shall be relevant or appropriate to the manufacturer’s production and process control used during manufacture of the product, and shall provide at least the following items: Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity; Procedures for specifying and verifying the raw materials and other constituent materials that will include having an updated list of materials of products, with documented specifications and ensuring they are in conformity with requirements production control and other techniques, processes and systematic Manufacturer’s actions that will be used; Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures; Procedures for handling, storage, packaging, marking and labelling the product; Procedures for all personnel to receive training in the activities affecting quality or conformity of the product A procedure that will specify how non-complying products shall be dealt with. Any event of this kind shall be recorded as they occur and these records shall be kept for the period defined in the written procedures. manufacturer’s A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence. A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results(see exclusion for very small companies in chapter 8) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly. A procedure for control over documentation that affects the FPC A procedure describing how to handle the measuring and production equipment that includes Identification of verified equipment, traceability of calibration records to national or international standards, a list of equipment and frequency of controls A procedure for informing the Certification Body on any changes in the certified products All records must be kept for at least 3 years. Inspection and testing General All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for the results of control, calibration,
The manufacturer shall establish and maintain procedures for the training (with a training plan and training records) of all personnel in activities affecting quality or product conformity. Personnel performing work affecting product conformity shall be qualified on the basis of appropriate education, training and/or experience, as required. Quality Documentation The manufacturer’s documentation and procedures shall be relevant or appropriate to the production and process control used during manufacture of the product, and shall provide at least the following items: Quality aims or policy, the organizational structure, responsibilities and authority of the management with regard to product conformity; Procedures for specifying and verifying the raw materials and other constituent materials that will include having an updated list of materials of products, with documented specifications and ensuring they are in conformity with requirements Manufacturer’s production control and other techniques, processes and systematic actions that will be used; Inspections and tests to be carried out before, during and after manufacture, together with their frequency and possible retest procedures; Procedures for handling, storage, packaging, marking and labelling the product; Procedures for all personnel to receive training in the activities affecting quality or conformity of the product A procedure that will specify how non-complying products shall be dealt with. Any event of this kind shall be recorded as they occur and these records shall be kept for the period defined in the manufacturer’s written procedures. A procedure for corrective actions that instigates action to eliminate the cause of non-conformities in order to prevent recurrence. A procedure shall be established to define the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results(see exclusion for very small companies in chapter 8) The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes and/or markings are inspected regularly. A procedure for control over documentation that affects the FPC A procedure describing how to handle the measuring and production equipment that includes Identification of verified equipment, traceability of calibration records to national or international standards, a list of equipment and frequency of controls A procedure for informing the Certification Body on any changes in the certified products All records must be kept for at least 3 years. Inspection and testing General All necessary facilities, equipment and personnel shall be available to carry out the inspections and tests. The manufacturer may employ, under contract, a subcontractor who has the facilities, equipment and personnel to carry out the inspection and tests on behalf of the manufacturer. The manufacturer shall be responsible for the results of control, calibration,
GSC_N0001C1.R5.docx