JEDEC JESD670A-2013 QUALITY SYSTEM ASSESSMENT.pdf

1、JEDEC STANDARD QUALITY SYSTEM ASSESSMENT JESD670A (Revision of EIA671, June 1997) OCTOBER 2013 JEDEC SOLID STATE TECHNOLOGY ASSOCIATION NOTICE JEDEC standards and publications contain material that has been prepared, reviewed, and approved through the JEDEC Board of Directors level and subsequently

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9、uite 240 South Arlington, VA 22201-2107 or refer to www.jedec.org under Standards-Documents/Copyright Information. JEDEC Standard No. 670A -i- Foreword This document is based on the quality management system requirements of the international standard ISO 9001:2008 (also documented as the US national

10、 standard ANSI / ISO / ASQ Q9001-2008). It contains an audit checklist that is expected to be beneficial for organizations looking for a guideline to help with self-assessments and an understanding of their compliance to the requirements of ISO 9001:2008. This checklist is intended to support the ev

11、aluation of quality management systems, but is not sufficient by itself to guarantee full compliance to the requirements of ISO9001:2008. Introduction This standard contains a set of questions that can be used to evaluate a quality management system to the requirements of ISO 9001:2008. Each of the

12、questions in this checklist is referenced to the applicable clause in the ISO document. In addition, the section headings in the evaluation matrix match the clause titles in the ISO 9001:2008 standard. This standard should be used with some amount of common sense. Utilizing checklists for the purpos

13、e of auditing can result in too much focus on the checklist at the expense of overlooking important items. It is expected that users of this document will add their own experience and knowledge to the audit process, which may lead to questions or areas of inquiry that diverge from the checklist in t

14、his standard. JEDEC Standard No. 670A -ii- JEDEC Standard No. 670A Page 1 QUALITY SYSTEM ASSESSMENT (From JEDEC Board Ballot JCB-13-31, formulated under the cognizance of the JC-14.4 Subcommittee on Quality Processes and Methods.) 1 Scope This checklist is intended as a tool to allow users to assess

15、 the level of compliance of a quality management system to the requirements ISO 9001:2008. The questions in this checklist are of a generic nature and intended to be applicable to all organizations, not just those involved in the electronics industry. It can be useful while performing self-assessmen

16、ts of the organization or other internal audit procedures. It is not intended for use by a contracted third party registrar during a formal audit to the requirements of ISO 9001:2008. 2 Normative Reference ISO 9001:2008, Quality Management Systems Requirements ISO 9000:2005, Quality Management Syste

17、ms Fundamentals and Vocabulary ANSI/ISO/ASQ Q9001-2008, Quality Management Systems Requirements 3 Terms and Definitions Organization: A group of people and facilities with an arrangement of responsibilities, authorities and relationships. Management System: A set of interrelated or interacting eleme

18、nts to establish policy and objectives and to achieve those objectives. Quality Management System: A management system to direct and control an organization with regard to quality. Process: A set of interrelated or interacting activities which transforms inputs into outputs. JEDEC Standard No. 670A

19、Page 2 4 General Requirements This checklist is provided in tabular format. A space is provided after each question to record the results of the evaluation and any applicable comments. The method of recording the results is a matter of preference and may be different for different users. The followi

20、ng is an example of how the results may be recorded: Compliant (C) Fully meets all requirements. Observation (O) Minor discrepancy noted, not expected to result in substandard product or service quality. Discrepant (D) Non-compliant to requirements, expected to result in substandard product or servi

21、ce quality. Not Applicable (NA) Not a part of the organizations quality management system. Not Observed (NO) This item was not observed during the evaluation. The results of the evaluation may be recorded in any other format that provides meaningful information to the checklist user. JEDEC Standard

22、No. 670A Page 3 ISO Clause Question Result Comments 4 Quality Management System 4.1 General Requirements Has a quality management system been established? Is the quality management system been documented, implemented and maintained? Is the effectiveness of the quality management system improved over

23、 time? Have the various processes necessary for implementation of the quality management system, including any that may be outsourced to an external organization, been identified? a) Do these processes include those that are associated with management activities, provision of resources, product real

24、ization, measurement, analysis and improvement? b) Has the deployment of these processes throughout the organization been determined? c) Is the sequence of these processes and the interaction between them defined? d) Are criteria and methods necessary to ensure effectiveness of both the operation an

25、d control of these processes defined? e) Are the resources and information necessary for effective operation and monitoring of these processes available? f) Are these processes monitored, measured and, where applicable, analyzed? g) Are actions necessary to achieve planned results and continual impr

26、ovement of these processes implemented and monitored? Are outsourced processes that affect conformance of product to requirements identified and controlled? Is the type and extent of control applied to these outsourced processes: a) Defined within the quality management system? b) Influenced by the

27、potential impact of the outsourced process on the capability to provide product that conforms to requirements? c) Influenced by the degree to which the control for the process is shared? d) Influenced by the capability of achieving the necessary control through the application of purchasing processe

28、s? JEDEC Standard No. 670A Page 4 4.2 Documentation Requirements 4.2.1 General Does the quality management system documentation include: a) Documented statements of a quality policy and quality objectives? b) A quality manual? c) Documented procedures and records required by ISO9001:2008? d) Documen

29、ts, including records, determined to be necessary to ensure the effective planning, operation and control of the quality management system processes? Is the extent of the quality management system documentation appropriate to: a) The size and type of the organization? b) The complexity and interacti

30、on of the processes? c) The competence of personnel? 4.2.2 Quality Manual Has a quality manual been established, documented, implemented and maintained that includes: a) The scope of quality management system, including details of, and justifications for, any exclusion? b) The documented procedures

31、established for the quality management system, or references to them? c) A description of the interaction between the processes of the quality management system? 4.2.3 Control of Documents Are documents and records required by the quality management system controlled? Has a documented procedure been

32、 established that defines the controls needed: a) To approve the adequacy of controlled documents prior to issue? b) To review, update (as necessary) and re-approve controlled documents? c) To ensure that changes to controlled documents are identified? d) To ensure that the current revision of each

33、controlled document is identified? e) To ensure that relevant versions of applicable documents are available at points of use? f) To ensure that documents remain legible and readily identifiable? g) To ensure that documents of external origin determined to be necessary for the planning and operation

34、 of the quality management system are identified and their distribution is controlled? h) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? JEDEC Standard No. 670A Page 5 4.2.4 Control of Quality Records Are record

35、s established to provide evidence of conformance to the requirements of the quality management system? Are records established to provide evidence of the effective operation of the quality management system? Are these records controlled? Has a documented procedure been established to define the nece

36、ssary controls for: a) Identification of records? b) Storage of records? c) Protection of records? d) Retrieval of records? e) Retention time of records? f) Disposition of records? Are records legible, readily identifiable and retrievable? 5 Management Responsibility 5.1 Management Commitment Has to

37、p management demonstrated its commitment to the development and implementation of the quality management system and continual improvement in its effectiveness through: a) Communicating to the organization the importance of meeting customer, statutory and regulatory requirements? b) Establishing the

38、quality policy? c) Ensuring that quality objectives are established? d) Conducting management reviews? e) Ensuring the availability of resources? 5.2 Customer Focus Does top management ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction? 5.3 Quali

39、ty Policy Has top management ensured that the quality policy: a) Is appropriate to the purpose of the organization? b) Includes a commitment to comply with requirements of the quality management system and to continually improve its effectiveness? c) Provides a framework for establishing and reviewi

40、ng quality objectives? d) Is communicated and understood within the organization? e) Is periodically reviewed for suitability? JEDEC Standard No. 670A Page 6 5.4 Planning 5.4.1 Quality Objectives Has top management ensured that quality objectives have been established at all relevant functions and l

41、evels within the organization? Do the quality objectives include those necessary to meet product requirements? Are the quality objectives measurable and consistent with the quality policy? 5.4.2 Quality Management System Planning Has top management ensured that: a) Planning of the quality management

42、 system is carried out in order to meet the requirements of ISO9001:2008 clause 4.1 as well as the quality objectives? b) The integrity of the quality management system is maintained when changes are planned and implemented? 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Au

43、thority Has top management defined and communicated the responsibilities and authorities within the organization? 5.5.2 Management Representative Has top management appointed a member of the organizations management to act as a representative and liaison with external parties who has the responsibil

44、ity and authority to: a) Ensure that processes necessary for the quality management system are established, implemented and maintained? b) Report to top management on the performance of the quality management system and any need for improvement? c) Ensure the promotion of customer requirements throu

45、ghout the organization? 5.5.3 Internal Communication Has top management established appropriate communications processes within the organization? Does appropriate communication take place within the organization regarding effectiveness of the quality management system? JEDEC Standard No. 670A Page 7

46、 5.6 Management Review 5.6.1 General Does top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness? Does this review include the assessment of opportunities for improvement and the need for changes to the quality man

47、agement system, including the quality policy and quality objectives? Are records of management reviews maintained? 5.6.2 Review Input Do inputs to the management review include information on: a) Results of audits? b) Customer feedback? c) Process performance and product conformity? d) Status of pre

48、ventive and corrective actions? e) Follow-up actions from previous management reviews? f) Changes that could affect the quality management system? g) Recommendations for improvement? 5.6.3 Review Output Do outputs from the management review include any decisions and actions related to: a) Improvemen

49、t of the effectiveness of the quality management system and its processes? b) Improvement of product related to customer requirements? c) Resource needs? 6 Resource Management 6.1 Provision of Resources Have necessary resources been determined and provided to: a) Implement and maintain the quality management system? b) Continually improve the effectiveness of the quality management system? c) Enhance customer satisfaction by meeting customer requirements? 6.2 Human Resources 6.2.1 General Are personnel who perform work that af