ISO 9001: 2008 Requirements

Transcription

1 GENERAL QUESTIONNAIRE ISO 9001: 2008 Requirements Before you begin your ISO journey, it is important that you obtain a copy of the standard and that you read the whole thing. In addition to auditing your processes you must establish an overall quality management system for which the standard has some minimum requirements. Use this questionnaire as a guide to identifying key elements necessary for the basis of your quality management system. Again, begin by acquiring and becoming familiar with the standard, then use this guide to do a gap analysis Quality Management System Documents Is there a written quality manual that outlines the organizations approach to meeting ISO requirements? Is there a written quality policy and associated quality metrics? Are documented procedures and records established to ensure effective planning, operation and control of the business processes and quality management system? Control of Documents Is there a written procedure that describes the organizations document control system? Has a method been defined for approving for adequacy prior to issue? Is there a mechanism to review, update & reapprove as necessary? Is there a method to identified changes and revision status of?

2 Are relevant versions of applicable accessible at the point of use? Are maintained in such a way as to preserve legibility and identification? Is there a method to prevent unintended use of obsolete? If external are used in the organization, are they identified and distribution controlled to ensure applicable version is used? Control of Records Is there a written procedure to describe how records are managed? Are records maintained in such a way as to preserve legibility, identification? Have storage locations been defined for records that take into account the level of protection necessary to control access and/or changes? Are records retrievable within a reasonable time period? Is there a mechanism for determining the retention time for records? Are records disposed of once their retention time has passed?

3 5.3 Quality Policy Does the quality policy provide a framework for establishing and reviewing quality metrics? Does the quality policy include a commitment to continually improve the effectiveness of the management system? Is the quality policy communicated and understood throughout the organization? 5.5 Responsibility, Authority & Communication Has top management appointed a member of management to serve as the management representative? Does the management representative ensure that processes needed for the quality management system are established, implemented and maintained? Does the management representative promote awareness of customer requirements throughout the organization? Are communication processes established within the organization and does this include communication regarding the effectiveness of the management system? 5.6 Management Review Are management review meetings held at regular planned intervals? Is the Quality Policy & Quality Metrics reviewed as part of the Management Review process?

4 Are results of audits reviewed as part of the Management Review process? Are results of customer feedback reviewed as part of the Management Review Process? Are results of product & process metrics reviewed as part of the Management Review Process? Is the status of corrective & preventive actions reviewed as part of the Management Review Process? Is the status of action items from prior meetings reviewed as part of the Management Review Process? Are changes or recommendations for improvement in the quality management system reviewed as part of the Management Review Process? Are records maintained of Management Review Meetings that identify any decisions made, resource needs and action items? 6.2 Human Resources Has the organization determined the necessary competence for personnel on the basis of education, training, skills and experience? Does the organization provide training or take other actions to achieve the necessary competence? Does the organization evaluate the effectiveness of the activities taken to achieve competence?

5 Do personnel understand the relevance and importance of their activities with respect to achievement of quality metrics? Are records of education, training, skills and experience maintained? 6.3 Infrastructure Does the organization provide and maintain buildings, workspaces, and associated utilities needed to achieve conformity to product requirements? Does the organization provide and maintain the necessary process equipment (hardware and software) need to achiever conformity to product requirements? Does the organization provide and maintain supporting services (such as transport, communication, or information systems) needed to achieve conformity to product requirements? 6.4 Work Environment Does the organization manage the work environment (physical environment, noise, temperature, lighting, humidity, etc...) needed to achieve conformity to product requirements Internal Audit Is there a documented process for internal audits that defines requirements and responsibilities? Are audit criteria, scope and frequency defined?

6 Does the assignment of auditors ensure objectivity and impartiality? Are records of the audits maintained? When Nonconformities are identified, does business owner of the area take responsibility for determining the cause of the nonconformity and take corrective actions to prevent future nonconformities? Are all NC from prior internal audits closed out? Is follow-up conducted to ensure the corrective actions were completed and are effective? 8.3 Control of Nonconforming Product Is there a documented process for nonconforming events that defines requirements and responsibilities? Are records of nonconforming events maintained that include actions taken to resolve? When Nonconformities are identified, does business owner of the area take responsibility for determining the cause of the nonconformity and take corrective actions to prevent future nonconformities? Corrective Action Is there a documented process describing the approach used for corrective action?

7 Is the cause of a nonconformity leading to corrective action identified? Is an evaluation of the impact/ risk of the nonconformity performed to determine the need for action? Is there a record of actions taken to prevent recurrence? Is the effectiveness of the action evaluated? Preventive Action Is there a documented process describing the approach used for preventive action? Is an evaluation of the impact/ risk of potential nonconformities performed to determine the need for action? Is there a record of actions taken to prevent occurrence? Is the effectiveness of the action evaluated? 7.4 Purchasing Requirements Are criteria established for vendor selection when looking to purchases goods or services?

8 Are evaluations routinely conducted to assess vendor s ability to supply products/services in accordance with company requirements? Are records of these evaluations maintained? If a new product/process is being developed that requires the purchase of goods or services from outside organizations or subsidiaries: have requirements for the items/services to be purchased been defined and communicated to the vendor? If a new product is being developed are criteria defined for staff responsible for evaluation & approval of the purchased item/ services? When goods/services that impact the quality of products & services are delivered to the company, are they inspected or evaluated to ensure specific requirements are met prior to acceptance? 7.6 Control of Monitoring & Measurement Equipment Is measuring equipment calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? If no standards exist, the basis for calibration or verification shall be recorded. Is measuring equipment identified with respect to its calibration status? Is measuring equipment safeguarded from adjustments that would invalidate the measurement result? Is measuring equipment protected from damage or deterioration during handling, maintenance, and storage?

9 When measuring equipment is found not to confirm the requirements, does the organization assess and record the validity of previous measuring results? Is appropriate action taken on any equipment or product affected? Are records of calibration and verification maintained?