ISO 9001:2000 AUDIT CHECKLIST - Elsmar

1 iso 9001 : 2000 AUDIT Quality Management Requirements1 Has the organization established, documented,implemented and maintained a quality managementsystem in accordance with the requirements of iso 9001 ?2Is the effectiveness of the quality management systemcontinually improved?3 Has the organization:a)Identified the processes needed for the qualitymanagement system including their applicationsthroughout the organization?b)Determined the sequence and interaction of theseprocesses?c)Determined the criteria and methods needed toensure that both the operation and control of theseprocesses are effective?d)Ensured the availability of resources andinformation necessary to support the operation andmonitoring of these processes?e)Measured, monitored and analyzed theseprocesses?f)Implemented actions needed to achieveplanned results and continual improvement ofthese processes?4 Does the organization manage these processes inaccordance with the requirements of iso 9001 ?

2 5 Where processes that affect product conformity withrequirements are outsourced, are the controls forthese processes identified within the qualitymanagement system? Documentation General6 Does the quality management system documentationinclude:a)Documented statement of a quality policy andquality objectives?b)Quality Manual?c)Documented procedures required by iso 9001 ?d)Documents needed by the organization to ensurethe effective planning, operation and control of itsprocesses?e) Records required by iso 9001 ? Manual7 Has a quality manual been established and maintainedthat includes:a)The scope of the quality management system,including details of, and justification for anyexclusions? )Documented procedures established for the qualitymanagement system, or reference to them?c)Description of the interaction between theprocesses of the quality management system? of Documents8 Are documents required for the quality managementsystem controlled?

3 9 Has a documented procedure been establishedidentifying the following controls needed?a)Approval of documents for adequacy prior to issue?b)Review, update as necessary and re-approval ofdocuments?c)Ensure that changes and the current revision statusof documents are identified?d)Ensure that relevant versions of applicabledocuments are available at points of use?e)Ensure that documents remain legible andreadily )Ensure that documents of external origin areidentified and their distribution controlled?g)Preventing the unintended use of obsoletedocuments, and to apply suitable identification tothem if they are retained? of Records10 Have records been established and maintained to provideevidence of conformity to requirements and of theeffective operation of the quality management system?11 Has a documented procedure been established to definethe following controls needed?a)Identification?

4 B)Storage?c)Retrieval?d)Protection?e)Ret ention time?f)Disposition?5 Management Commitment1 Has top management provided evidence of itscommitment to the development and implementation ofthe quality management system and for the continualimprovement of its effectiveness by:a)Communicating to the organization theimportance of meeting customer as well asregulatory and legal requirements?b)Establishing the quality policy?c)Ensuring that quality objectives areestablished?d)Conducting management reviews? )Ensuring the availability of resources? Focus2 Has top management ensured that customerrequirements are determined and met with the aim ofenhancing customer satisfaction? Policy3 Has top management ensured that the quality policy:a)Is appropriate to the purpose of the organization?b)Includes a commitment to comply withrequirements and to continually improve theeffectiveness of the quality managementsystem?

5 C)Provides a framework for establishing andreviewing quality objectives?d)Is communicated and understood within theorganization?e)Is reviewed for continuing suitability? Objectives4 Has top management ensured that quality objectivesare established at relevant functions and levels withinthe organization?5 Have quality objectives needed to meet therequirements of the product been established?6 Are quality objectives measurable and consistent withthe quality policy? Management System Planning7 Has top management ensured that the resources neededto achieve the quality objectives are identified andplanned?8Is the output of the planning documented? ( , qualitymanual, procedures, work instructions, quality plans, etc.)9 Does top management ensure that the integrity of thequality management system is maintained whenchanges are planned and implemented? Responsibility, Authority and Authority10 Has top management ensured that responsibilities,authorities are defined and communicated within theorganization?

6 Representative11 Has top management appointed member(s) ofmanagement who have responsibility and authority for:a)Ensuring that processes are established,implemented and maintained?b)Reporting to top management on the performanceof the quality management system, for improvement?c)Promoting awareness of customerrequirements throughout the organization? Communication12 Has top management ensured that appropriatecommunication processes have been establishedwithin the organization?13 Does communication take place regarding theeffectiveness of the quality management system? the top management review the qualitymanagement system, at planned intervals, to ensure itscontinuing suitability, adequacy and effectiveness?15 Are opportunities for improvement and the need forchanges to the quality management system, includingquality policy and objectives, reviewed during thereview?16 Are records of management reviews maintained as qualityrecords?

7 Input17Do the inputs to management review include informationon:a)Results of audits?b)Customer feedback?c)Process performance and product conformity?d)Status of preventive and corrective actions?e)Follow-up actions from previous managementreviews?f)Planned changes that could affect the qualitymanagement system?g)Recommendations for improvement? Output18Do the outputs from the management review includethe decisions and actions related to:a)Improvement of the effectiveness of the qualitymanagement system and its processes?b)Improvement of the product related to customerrequirements?c)Resources needed?6 Resource Management6 Resource of Resources1 Have the resources been determined and ) Implementing and maintaining qualitymanagement system and continually improvingits effectiveness?b) Enhancing customer satisfaction by meetingcustomer requirements? competency for personnel who perform workaffecting product quality based on appropriateeducation, training, skills, and experience?

8 , awareness and training3 Has the organization:a)Determined the necessary competency forpersonnel performing work affecting productquality?b)Provided training or take other actions to satisfythese needs?c)Evaluated the effectiveness of the actionstaken?d)Ensured that employees are aware of therelevance and importance of their activities andhow they contribute to the achievement of thequality objectives?e)Maintained appropriate records of education,training, skills and achieve conformity of product, does the organizationidentify, provide, and maintain the facilities including:a)Buildings, Workspace and associated utilities?b)Process Equipment, hardware and software?c)Supporting services? Environment5 Has the environment needed to achieve conformity ofproduct requirements been determined andmanaged?7 Product Realization7 Product of Realization Process1Is planning of the organization s product realizationconsistent with the requirements of the other processes ofthe quality management system?

9 2 Are the following being determined when planning theproduct realization:a)Quality objectives and requirements for theproduct?b)The need to establish processes, documents, andprovide resources specific to the product? )Required verification, validation, monitoring,inspection and test activities specific to the productand criteria for product acceptance?d)Records needed to provide evidence that therealization processes and resulting product fulfillrequirements?3Is the planning output in a form that is suitable for theorganization s method of operation? of Requirements Relatedto the Product4 Has the organization determined:a) Requirements specified by the customer, includingthe requirements for delivery and post-deliveryactivities?b) Requirements not stated by the customer butnecessary for specified or intended use, whereknown?c) Statutory and regulatory requirements relatedto the product?

10 D) Any additional requirements determined by theorganization? of Requirements Related to theProduct5 Prior to the commitment to the customer ( submissionof tenders, acceptance of contracts or orders oracceptance of change orders) are requirements reviewedto ensure that:a)Product requirements are defined?b)Contract or order requirements differing from thosepreviously expressed are resolved?c)The organization has the ability to meet definedrequirements?6 Are results of reviews and actions arising from thesereviews recorded and maintained as records?7 Where the customer has not provided a documentedstatement of requirements, are customer requirementsconfirmed by the organization before acceptance?8 Where product requirements are changed, does theorganization ensure that relevant documentation isamended and relevant personnel are made aware of thechanged requirements? Communication9 Has the organization determined and implementedeffective arrangements for communicating withcustomers relating to:a) Product information?