A= Opportunity for improvement SQ=Supplementary Question Conformance Opportunity for Improvement (OFI) B=Minor Non-Conformance C=Major Non-conformance Adherence with the requirements of the standard. No major or minor non-conformance found A situation or condition of a management system that may be weak, cumbersome, redundant, overly complex, or in some other manner, may in the opinion of the auditing team, offer an opportunity for an organization to improve its current status. OFIs do not require any action on the part of the organization; however, the organization should give them serious consideration in view of the auditors’ knowledge and exposure to similar systems. An OFI may be an improvement of the management system or could prevent future problems Minor No-conformance A non-conformity that, based on the judgment and experience of the auditor, is not likely to result in the failure of the management system or reduce its ability to assure controlled processes or products. It may be either:  A failure in some part of supplier’s management system relative to a specified requirement.  A single observed lapse in following one item of a company’s management system Major Non-conformance The absence (omission, not addressed) or total breakdown (failure, not implemented) of a system to meet a specified requirement. A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus be considered a major non-conformity. Any non-compliance that would result in probable shipment of a non-conforming product. Conditions that may result in the failure of or materially reduce the usability of the products or services for their intended purpose. A no-compliance that, in the judgment and experience of the auditing team, is likely to either result in the failure of the management system or to materially reduce its ability to assure controlled processes and products. Question No Clause Ref. 1 4.2.3 2 4.2.4 3 5.1 4 5.3 5 5.4.1 Audit Question Did the company write new documents? YES Finding NO A B Does the quality policy help establish and review quality objectives? Are the product objectives included in the quality objectives, and are the objectives consistent with the quality policy? The company’s quality manual did not state whether they have written new documents.  What are the procedures that the company has in place in order to control their quality records? Does the company provide adequate resources? Audit Evidence C  The company has not stated any of the procedures that they have to control the quality records.  In this section of the manual, the company did not specify that adequate resources are provided.  There was no mention as to whether the quality policy helps to establish and review the quality objectives.  There was no information about whether the product objectives are included in the quality objectives or if the objectives are consistent with the quality policy. 6 5.4.2 7 5.5.2 8 5.6.2 Does the company have a plan for the quality system? Does the representative manager ensure that the quality management processes are established, implemented and maintained? Does the representative manager act as a liaison to the registration agency and other external organizations regarding the QMS? Does the company perform follow-up actions from previous reviews?  In this section of the manual, there is no information given about the planning of the quality management system. The missing information includes:  Top management ensures that the QMS plans include all the general requirements of the QMS described in section (4.1).  Top management ensures that the current QMS continues to work effectively while changes and improvements to it are being planned and carried out.  In this section of the manual, the company presented that the manager ensures that the quality management processes are stablished and implemented, but they did NOT specify that it is maintained. There is no information given regarding whether the manager acts as a liaison to the registration agency or other external organizations regarding the QMS.  There is no information given regarding follow-up actions from previous reviews.

1. Non-conformities Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Major Minor Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Major Minor Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Recommended action: Major Minor Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Major Minor Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Major Minor Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Major Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Minor Requirement: Non-conformity Major Minor Recommended action: Area Under Review: Document used for Audit: ISO 9001-2008 Clause Number: ISO-9001 Standard / Quality Manual Requirement: Non-conformity Recommended action: Major Minor