| Audit Findings |
| Yes |
No |
The management system documentation demonstrated conformity with the requirements of the audit standard and provide sufficient structure to support implementation and maintenance of the management system. |
| Yes |
No |
The organization has demonstrated effective implementation and maintenance / improvement of its management system. |
| Yes |
No |
The organization has demonstrated the establishment and tracking of appropriate key performance objectives and targets and monitored progress toward their achievements |
| Yes |
No |
The internal audit program has been fully implemented and demonstrates effectiveness as a tool for maintaining and improving the management system. |
| Yes |
No |
The management review process demonstrated capability to ensure the continuing suitability, adequacy and effectiveness of the management system. |
| Yes |
No |
Throughout the audit process, the management system demonstrated overall conformance with the requirements of the audit standard. |
| Yes |
No |
Certification claims are accurate. |
| Nonconformities |
| None |
| General Observations / Opportunities For Improvement |
| Management review records are excellent. EuroPlast top management reviews the organization's quality management system, at planned intervals, as defined in the EuroPlast documentation, to ensure its continuing suitability, adequacy and effectiveness. |
| Internal Audit records are excellent. EuroPlast conducts internal audits at planned intervals, as determined by documented procedures, to determine whether the quality management system conforms to the planned arrangements, to the requirements of this International Standard and to the Quality Management System requirements established by EuroPlast. |
| Corrective Action records are excellent. EuroPlast takes action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action activities are appropriate to the effects of the nonconformities encountered. A documented procedure is established to define requirements for reviewing nonconformities (including customer complaints), determining the causes of nonconformities. |
| EuroPlast determines: requirements specified by the customer, including the requirements for delivery and post-delivery activities, requirements not stated by the customer, but necessary for specified or intended use, where known, statutory and regulatory requirements related to the product, and any additional requirements determined by EuroPlast. |
| EuroPlast designs fixtures and tooling, through Apex Mold & Die Corporation, for the manufacture of customer designed product. EuroPlast plans and controls the design and developement of fixtures and tooling. |
| EuroPlast plans and develops and assigns / schedules the processes needed for product realization. Planning of product realization is consistent with the requirements of the customer, and other processes of the quality management system. |
| Consider documenting a sales and marketing plan based on your company business plan. |
| Audit Findings |
| Yes |
No |
The management system documentation demonstrated conformity with the requirements of the audit standard and provide sufficient structure to support implementation and maintenance of the management system. |
| Yes |
No |
The organization has demonstrated effective implementation and maintenance / improvement of its management system. |
| Yes |
No |
The organization has demonstrated the establishment and tracking of appropriate key performance objectives and targets and monitored progress toward their achievements |
| Yes |
No |
The internal audit program has been fully implemented and demonstrates effectiveness as a tool for maintaining and improving the management system. |
| Yes |
No |
The management review process demonstrated capability to ensure the continuing suitability, adequacy and effectiveness of the management system. |
| Yes |
No |
Throughout the audit process, the management system demonstrated overall conformance with the requirements of the audit standard. |
| Nonconformities |
| None |
| General Observations / Opportunities For Improvement |
| Management review records document that the management review meetings do not follow the standard requirements as defined in ISO 9001:2000, 5.6.2. The Management Review Meeting Plan needs to cover: results of audits, customer feedback, process performance and product conformity, status of preventative and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality management system, and recommendations for improvement. Consider using a management review agenda / record that covers the requirements of the standard. Procedure for Management Review does not address all of the standard requirements for inputs and outputs. The EuroPlast Ltd. Management System Review Record Issued 4/1/03 and revised 4/28/03 to revision #1 meets the standard requirements but is not being used. |
| Internal Audit planning records need to address: The audit criteria, scope, frequency and methods shall be defined taking into account results of previous audits, customer feedback, process performance and product conformity. Procedure epl-qrp-020 revision # 2, Procedure for Internal Audit Cycle is not being followed. EPL AUDIT009 Audit Planning Report is not being used. |
| Consider adding the part quantity to the CAR log. |
| Consider using corrective or preventive action to document die issues and resolutions. |
| Consider adding all customer supplied fixtures to your quality management documentation. |
| Consider establishing color matching for customer supplied materials, (pre-blends) or where no requirements are supplied by the customer. |
| Consider establishing quality acceptance standards for product where no such standard exists today. |
| DETAILS OF NON-CONFIRMITY |
| 1) Purchasing : The right of entry for EuroPlast and EuroPlast customers is not reserved through purchasing documents. This was resolved during the audit. |
| 2) Calibration : The procedure for calibration does not completely describe the method used to investigate the product produced when equipment is found out of calibration. |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) Management review records are legible, readily identifuable and retrievable. |
| 2) Consider using the standard as your basis for the management review agenda. You want to ensure that your review covers all standard requirements. You may have no discussion about each subject in which case the record will document inaction. |
| 3) Consider documenting management review action plans on your corrective / preventive action form. It may be easier to meet the action plan follow-up requirements with one document instead of many. |
| 4) You need to clarify your right of entry through purchase order documents. Terms and conditions are the usual format. |
| 5) Design of fixtures and tooling is accomplished through suppliers. EuroPlast is responsible for all fixture and tooling design that is sub-contracted. EuroPlast maintains detailed records of all design and design review and approval documents. |
| VERBAL COMMENTS DURING AUDIT |
| 1) Auditor has not seen a cleaner or neater facility. |
| 2) Auditor has not seen better documentation in any injection molding facility than EuroPlast." |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) The internal audits sampled demonstrate that they are capable of detecting system compliance and effectiveness. |
| 2) The management review and planning records demonstrate that management is fulfilling the requirements defined in ISO 9001:2000 sections 4 through 8. Planning, review and resource allocation are well documented. |
| 3) All Quality objectives defined by management are measured, analyzed and met. Objectives not met are subject to preventive action. |
| 4) All areas were extremely neat, clean and well organized. The latest and best equipment is supplied to all employees. |
| 5) EuroPlast exemplifies the best of the best in applying the ISO requirement to the injection molding business. |
| VERBAL COMMENTS DURING AUDIT |
| 1) EuroPlast shows inventiveness and puts a lot of effort into developing gauging and quality awareness to assure assembly operations. He has seen few companies that put so much time into this function. |
| 2) "EuroPlast is a very unique company." |
| 3) "As usual, everything was excellent and I don't see how it could get any better." |
| 4) "It looks better every time I come here." |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) This is a mature well managed system. |
| 2) All top management have an understanding of the standards' requirements and use the standard in the day to day operation of the business. |
| 3) All objective evidence sampled verifies that the EuroPlast quality management system is effective in producing customer satisfaction and continual improvement. |
| VERBAL COMMENTS DURING AUDIT |
| 1) For the size of the company and the industry type, EuroPlast has the best Quality Management System that he has audited. |
| 2) Recommendation to implement Management Review items into formal Preventive Action process to improve tracability. |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
1) Areas audited include Management Requirements, Internal Audits, Corrective and Preventative Action, Purchasing, and Design.
All areas audited met the intent of the standard. The Quality Management system continues to improve. |
| 2) EuroPlast's hands-on management team supports the quality management system daily. |
| 3) All top managers have a complete understanding of the standards requirements and use the standard as the company's management model. |
| 4) All system elements are designed to interact in support of EuroPlast's goals and objectives. |
| 5) All objective evidence sampled verifies that the EuroPlast quality management system is effective in producing satisfaction and continual improvement. |
| VERBAL COMMENTS DURING AUDIT |
| 1) The auditor viewed EuroPlast as being in the top 10% of those he has audited. |
| 2) The internal audit system is effectively implemented and maintained.. |
| 3) Suggestion to continue development of the internal audit system to include optimization of the processes audited. |
The scope of our registration has been greatly expanded as follows:
EuroPlast, Ltd. is a provider of contract manufacturing services that include:
- Thermoplastic Injection molded products
- Assembly, testing and decorating
- Design and manufacture of :
- Prototype and production injection molds
- Rapid prototype parts and tools
- Fixtures and ancillary equipment
|
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) All areas a systems sampled meet the intent of the ISO 9001:2000 standard. All areas are neat clean and well organized. The 4.1 a,b & c requirements are very well developed. An overall excellent transition to the new requirements. |
| VERBAL COMMENTS DURING AUDIT |
| 1) The structure and documentation of the transition to the revised standard is the best he has seen |
| 2) The development of the system exceeds that of the work most consultants have produced and that he has audited. |
| 3) The development of measures to meet the new standard is excellent. |
| 4) Top management has demonstrated a strong commitment to the development of the system. |
| 5) EuroPlast, Ltd.'s system is the best transition audit he has seen to date. |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) Internal audit system is well implemented. |
| 2) Corrective and Preventative Action is complete and comprehensive with good links to management review. |
| 3) Document system is updated continuously. |
| 4) Contact Review system meets standards. |
| 5) Inspection and Test system elements meet requirements. |
| 6) Nonconforming Products system meets requirements. |
| 7) HSPP&D (4.15) system demonstrates effectiveness if customer complaints or lack of complaints is the primary measure of effectiveness. |
| VERBAL COMMENTS DURING AUDIT |
| 1) Recommendations on how to improve the effectiveness of our control of visual samples in the calibration system and ways to improve our control over packaging and handling requirements of finished goods. |
| 2) Considerable time spent discussing how the ISO 9001:2000 standard would effect the areas audited. |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) Management review shows good attention to numerical goals. Good management systems, action plans, assigned responsibilities and completion dates are well documented. |
| 2) Product Identification shows good traceability from new material through finished product. |
| 3) Internal audits show good maturity and focus on effectiveness. |
| VERBAL COMMENTS DURING AUDIT |
| Mr. Uttke provided us with valuable insight into how the ISO 9001:2000 standard can, and will, be applied to our present system. |
| OBSERVATIONS / OPPORTUNITIES FOR IMPROVEMENT |
| 1) There were a number of open corrective actions. Corrective action requests could improve with a more timely closure. |
| VERBAL COMMENTS DURING AUDIT |
| 1) Management review process and records of action items could be enhanced with addition of documented assignment of responsibility, due date, and follow-up. |
| 2) Recommendation to analyze how and when we audit, when problems arise. |
| 3) Recommended our ISO system as a benchmark to another client. |
| 4) Commented that our plant was the cleanest injection molding facility he had ever seen. |
