ISO 9001:2015 Readiness Review
Quality Documents:
Quality Policy statement (5.2)
Sequence and interaction of processes (4.4.1)
Scope & list of exclusions (4.3)
- Adequate documentation - QMS
Site to be certified – number of employees (regular & temps)
Supporting locations
Product design responsibility
Monitoring and reviewing of information relative to the internal and external issues relevant to strategic direction (4.1) is established
Monitoring and reviewing of information related to the interested parties and their requirements (4.2)
Scope of the QMS is based on the information from internal and external interested parties and is documented (4.3)
Processes – all sections of standard included? Metrics established for each process? (4.4.1)
Responsibility defined for all processes
Responsibility for QMS (5.3a)
Responsibility for processes (b)
Responsibility for reporting performance of QMS (c)
Responsibility for customer focus (d)
Responsibility for ensuring integrity when changes (e)
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)
Quality Objectives (6.2)
-documented objectives
-goals (planned results) documented
- action plan determined
- progress being made toward objectives and action plan
Knowledge necessary for the operations determined and made available (7.1.6)
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
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
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
For each concern, list how the organization has addressed the concern and whether it has been successfully resolved.
Timing of Stage 2 – DO CONCERNS LISTED ABOVE AFFECT SCHEDULING OF THE STAGE 2 AUDIT
NOTE – Documented Information is expanded upon in Annex A1 and A6
Legend: Documented Information must be maintained (procedure, work instruction or form) = M
Or retained (record) = R
4.4.2 Processes carried out as planned (R)
5.2.2 Quality Policy (M)
6.2.1 Quality Objectives (M)
7.1.5.1 Resources needed, fitness for purpose (R)
7.1.5.2a) Calibration/trace-NIST (R)
7.2d) Evidence of competency (R)
7.5.1a) Information related to QMS (R)
7.5.1b) Information determined by the organization (R)
7.5.3.1 Available/adequately protected (M/R)
7.5.3.2 Distribution, storage and retention (M/R)
8.1 Operations: keep documented information as necessary (M/R)
8.2.3.2 Customer information (R)
8.2.4 Changes – documented information amended (M/R)
8.3.2 Design stages identified (M/R)
8.2.3.2 Retain documented customer information (M/R)
8.3.3 Design input (R)
8.3.4 Design stages met; verification and validation (R)
8.3.5 Design output (R)
8.3.6 Design changes (R)
8.4 External process controls (R)
8.5.1 Control of production (M/R)
8.5.2 Identify and traceability (R)
8.5.3 Lost/damage customer property (R)
8.5.6 Control of changes/results of change (R)
8.6 Release of product (R)
8.7.2 Non-conforming- action taken (R)
9.1.1 Monitoring & measurement results
(R)
9.2.2 Internal audits- program implemented and audit results (R)
9.3.3 Management review (R)
10.2.2 Nature of NC and corrective action
(R)
Areas of concern which could be nonconformities at the Stage 2 Audit
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