<p> ISO 9001:2015 Readiness Review</p><p>Readiness Status Evidence Where OK or Not Referenced Quality Documents: Quality Policy statement (5.2) Sequence and interaction of processes (4.4.1) Scope & list of exclusions (4.3) - Adequate documentation - QMS</p><p>Site to be certified – number of employees (regular & temps)</p><p>Supporting locations</p><p>Product design responsibility</p><p>Monitoring and reviewing of information relative to the internal and external issues relevant to strategic direction (4.1) is established</p><p>Monitoring and reviewing of information related to the interested parties and their requirements (4.2) </p><p>Scope of the QMS is based on the information from internal and external interested parties and is documented (4.3)</p><p>Processes – all sections of standard included? Metrics established for each process? (4.4.1)</p><p>Responsibility defined for all processes Responsibility for QMS (5.3a)</p><p>Responsibility for processes (b)</p><p>Responsibility for reporting performance of QMS (c) </p><p>Responsibility for customer focus (d)</p><p>Responsibility for ensuring integrity when changes (e)</p><p>11/16/15 Page 1 ISO 9001:2015 Readiness Review</p><p>Risks and opportunities have been determined and actions to address risks and opportunities have been planned and effectiveness of the actions evaluated (6.1) (for example risks associated with customer RFQs & POs; new product designs; organizational processes; and suppliers to the organization)</p><p>Quality Objectives (6.2) -documented objectives -goals (planned results) documented - action plan determined - progress being made toward objectives and action plan </p><p>Knowledge necessary for the operations determined and made available (7.1.6)</p><p>Internal audit results and action plans. (9.2) Audit program plan Auditor qualifications Audit plan for each audit Full system audit completed Corrective action taken</p><p>Management review results (9.3) Alignment with strategic direction Changes to external and internal issues relevant to the QMS Effectiveness of actions to address risks and opportunities Internal audit results included</p><p>Customer complaints and customer satisfaction status (9.1.2 & 10.2) ISO Concerns - which may lead to a not ready decisión by your organization and that must be addressed before Stage 2 audit </p><p>11/16/15 Page 2 ISO 9001:2015 Readiness Review</p><p>For each concern, list how the organization has addressed the concern and whether it has been successfully resolved. </p><p>Timing of Stage 2 – DO CONCERNS LISTED ABOVE AFFECT SCHEDULING OF THE STAGE 2 AUDIT </p><p>NOTE – Documented Information is expanded upon in Annex A1 and A6</p><p>Legend: Documented Information must be maintained (procedure, work instruction or form) = M Or retained (record) = R</p><p>4.4.2 Processes carried out as planned (R)</p><p>5.2.2 Quality Policy (M)</p><p>6.2.1 Quality Objectives (M)</p><p>7.1.5.1 Resources needed, fitness for purpose (R)</p><p>7.1.5.2a) Calibration/trace-NIST (R) </p><p>7.2d) Evidence of competency (R)</p><p>7.5.1a) Information related to QMS (R)</p><p>7.5.1b) Information determined by the organization (R)</p><p>7.5.3.1 Available/adequately protected (M/R)</p><p>7.5.3.2 Distribution, storage and retention (M/R)</p><p>8.1 Operations: keep documented information as necessary (M/R)</p><p>8.2.3.2 Customer information (R)</p><p>8.2.4 Changes – documented information </p><p>11/16/15 Page 3 ISO 9001:2015 Readiness Review</p><p> amended (M/R)</p><p>8.3.2 Design stages identified (M/R)</p><p>8.2.3.2 Retain documented customer information (M/R)</p><p>8.3.3 Design input (R)</p><p>8.3.4 Design stages met; verification and validation (R)</p><p>8.3.5 Design output (R)</p><p>8.3.6 Design changes (R)</p><p>8.4 External process controls (R)</p><p>8.5.1 Control of production (M/R)</p><p>8.5.2 Identify and traceability (R)</p><p>8.5.3 Lost/damage customer property (R) </p><p>8.5.6 Control of changes/results of change (R)</p><p>8.6 Release of product (R)</p><p>8.7.2 Non-conforming- action taken (R)</p><p>9.1.1 Monitoring & measurement results (R)</p><p>9.2.2 Internal audits- program implemented and audit results (R)</p><p>9.3.3 Management review (R)</p><p>10.2.2 Nature of NC and corrective action (R)</p><p>Areas of concern which could be nonconformities at the Stage 2 Audit </p><p>11/16/15 Page 4 ISO 9001:2015 Readiness Review</p><p>11/16/15 Page 5</p>