Sheet14.2.3Control of documents Is there a documented procedure?4.2.3aAre documents reviewed, updated as necessary, and then re-approved?4.2.3bIs there a method that identifies the current version status of documents?4.2.3cAre documents (procedure, instructions) available at points of use (location where quality activities are performed)?4.2.3dAre documents legible and readily identifiable?4.2.3eAre external origin documents identifiable?4.2.3fAre external origin documents identified and distribution controlled?4.2.3gAre obsolete documents (retained for legal and/or knowledge purposes). Suitably identified to prevent unintended use.4.2.4Control of quality recordsIs there a documented procedure in use for identifying, storing, retrieval, retention time and disposing of quality records?Are the following records established and maintained? Management review (5.6.1) Personnel training (6.2.2e) Realization process & product V/S requirement (7.1d) Review of customer requirements(7.2.2) Supplier evaluation (7.4.1) Validation of special processes (7.5.2d) Product identification (7.5.3) Lost /damaged customer supplied product (7.4) Basis of non-standard calibration (7.6a) Result of calibration (7.6) Validity of previous measurement when equipment out of calibration (7.6) Result of internal audits (8.2.2) Verification that product passed tests (8.2.4) Nonconformance (8.3) Result of corrective action (8.5.2e) Result and preventive action (8.5.3d)5Management Responsibility5.1Management commitmentIs there evidence of top management commitment by:a) Communicating the importance of meeting customer and regulatory requirements.b) Establishing a quality policy and objectives. c) Conducting management reviews andd) Ensuring availability of resources.5.2Customer focusDoes top management ensure customer requirements are determined and fulfilled with an aim to enhancecustomer satisfaction?5.3Quality Policya) Is the policy appropriate for the purpose of the organization?b) Does the policy include commitment to comply with requirement and continually improve?c) Does the policy statement provide a framework for establishing/reviewing objectives?d) Has the quality policy been communicated, understood?5.4Planning5.4.1Quality objectives5.4.1-1Are objectives established at each relevant function and level/ Are the objectives measurable and consistent with the quality policy including a commitment to continual improvement/5.4.1-2Do objectives include those needed to meet requirement to products and /or services?5.4.2Quality planning5.4.2-1Is planning performed to meet the quality objective requirements of 4.1?5.4.2-2Does quality planning include: Process of the quality management system? Resources needed? Continual improvement?5.4.2-3Are organizational changes planned, controlled and is the integrity of the management system maintained during the change?5.5Responsibility, authority and communication5.5.1Responsibility and AuthorityHave responsibilities and authorities been defined and communicated?5.5.2Management representative5.5.2aHas top management appointed a member within the Management with the defined authority and responsibility to ensure quality management requirements are established, implemented and maintained?5.5.2bDoes the management rep. Have authority to report performance to management for review and improvement of the quality system.5.5.2cDoes the management rep. have the authority to ensure awareness of customer requirement throughout the organization.5.5.3Internal communications:Is information about quality management system effectiveness communicated to various levels and functions?5.6Management Review5.6.1General5.6.1-1Are management reviews conducted at planned intervals?5.6.1-2Does top management review the quality system to ensure its continuing suitability, adequacy and effectiveness?5.6.1-3Are opportunities for improvements and needed to changes to the quality management system policy objectives evaluated?5.6.1-4Are records maintained?5.6.2Review input5.6.2-1Does the review includea) Results of audits.b) Customer feedbackc) Process performance and product performance. d) Status of corrective and preventive action.e) Follow up from prior reviews.f) Changes that could affect the QMS and g) Recommendations for improvement6Resource management6.1Provision of ResourcesAre the resources determined and provided to:a) Implement, maintain and continually improve the QMS.b) Enhance customer satisfaction?6.2Human resources6.2-1GeneralAre personnel performing work affecting product quality competent (demonstrated the ability to apply knowledge and skills)? Is competency based on education, training skills and experience?6.2.2Competence, awareness and training6.2.2-1Does the organization1. Determine competency needs for those affecting product quality?2. Provide training or take other actions?3. Evaluate effectiveness of actions?6.2.2-2Ensure employees are aware of the importance of their activities and how they contribute to achievements of objectives?6.2.2-3Are training records of appropriate education training skills experience records maintained?6.3InfrastructureHas the organization determined, provided and maintained infrastructure to achieve conformity to product requirements? (building (workspace), process hardware/software and support services)?6.4Work EnvironmentHas the work environment, needed to achieve conformity to product requirements been determined and managed?7Product realization7.1Planning of realization processes7.1-1Are the process needed for the realization processesplanned and developed?7.1-2Has the following been determined:a) Objectives for the product project or contract.b) The need for establishing processes c) Verification, validation, monitoring inspection test and associated criteria for acceptabilityd) Records needed to establish requirements have been met.7.2Customer related processes7.2.1Determination of product requirements a) Customer specifiedb) Necessary but not customer stated c) Statutory & regulatoryd) Additional requirements by the organization7.2.2Review of product requirement7.2.2-1Are requirements (contracts, tender and orders) reviewed prior to commitment?7.2.2-2Are records of review and follow-up actions maintained?7.2.2-3Are product requirements clearly defined?7.2.2-4Are contracts or order requirements that differ from previous expressed (those in the tender or offer) resolved?7.2.2-5Are customer requirements reviewed to ensure the organization has the ability to meet them?7.2.2-6When requirements are not written, are they confirmed before acceptance?7.2.2-7Are relevant documents amended and personnel notified of order changes?7.2.3Customer CommunicationHas the organization defined communication requirements fora) Product/service informationb) Enquiry contracts order handling and amendmentsc) Customer feedback including customer complaints.7.3Design and/or development (Excluded)7.4Purchasing7.4.1Are there purchasing controls to ensure that incomingpurchased product/service conforms to requirement? Is the type and extent of control dependent on the effect on product realization or final product?7.4.1-2Are supplier evaluated and selected on the basis of their ability to supply product that meets organization requirements?7.4.1-3Are there established criteria for evaluation revaluation and selection?7.4.1-4Do supplier records show results of evaluation and necessary follow up actions?7.4.2Purchasing information7.4.2-1Does purchasing information (contracts and purchase order) describe the product ordered?7.4.2-2If requirements are appropriate for approval of product, procedures, processes and equipment described?7.4.2-3If appropriate, is requirement for qualification of personnel identified?