The purpose of an ISO Audit is to determine whether the Quality Management System conforms to the planned arrangements, conforms to requirements established by the organization, and is effectively implemented and maintained. Many Saint Louis companies put into motion Quality plans and strategies, yet do not have the time, expertise, or available personnel to perform the required ISO Internal Audits. The result: ISO audit findings for poor audit programs.
A Bizmanualz ISO Internal Audit anywhere in the St. Louis Missouri area can avoid such audit findings by providing contract auditing services. You will receive an objective assessment of the current state of your ISO QMS effectiveness. By conducting an on-site analysis at your facility, we’ll produce a required ISO audit record of your processes and your quality objectives.
Using Bizmanualz ISO Audit Services saves you from maintaining a trained ISO audit staff, saves you from traveling to St. Louis, MO for supplier audits, and saves your staff time. You will receive an objective perspective from highly trained ISO auditors that have seen ISO implementations in many different industries. Bizmanualz has been involved in ISO auditor training and building lean ISO Quality Management Systems for manufacturing, services, information technology, distribution, medical devices, and continuous process based companies since 1995. We have worked with the Baldrige criteria, Missouri Quality Award, ISO 9001, ISO 13485, ISO/TS 16949, AS9100, FDA 21 CFR 820, and Sarbanes Oxley audits.
All aspects of the ISO 9001:2008 requirements are evaluated. Required documents, ISO procedures, and records are evaluated for content and compliance with the standard. All information reviewed as part of an ISO audit is considered confidential and will be protected in accordance with the contract agreement.
An ISO Internal Audit consists of five activities
Activity 1: Audit Pre-planning and Desk Audit
Each Bizmanualz audit includes an agreed upon ISO audit plan that specifies the time, date, place, areas and people to be audited. The Principal Consultant will obtain background information prior to an on-site visit. We will request business documents that make up your current Quality Management System, including your Quality Manual, Organization Chart, Quality Policy, Procedures, and any other related documentation in order to perform a desk audit of your system.
Activity 2: Introductory Meeting
Your Auditor will meet with you to discuss the audit plan, methodology and deliverables to your top management on the first morning of the engagement.
Activity 3: Data Gathering
The audit methodology includes interviewing personnel, watching actual processes being performed, and reviewing management system documents and records against the assessment criteria. Observation, data analysis, and interviews will be conducted with a cross-section of your organization’s personnel in order to obtain the objective evidence to substantiate any audit findings or observations. All data collected will be captured in the auditor’s notes and provided back to you in case your registrar requests such supporting material.
Activity 4: Audit Report
The Principal Consultant will produce a detailed audit report (the required record you need for your ISO QMS) of all audit findings including objective evidence and audit notes shortly after the conclusion of Activity 3. Although the purpose of the internal audit is to generate adequate confidence in your Quality Management System, the process of conducting audits involves the examination of sample records and events to a degree that they may be considered representative of the performance of the Management System as a whole.
Activity 5: Concluding Meeting
The Principal Consultant will lead a presentation and discussion of the Audit findings and observations to your management. This is a good time to answer questions about the audit findings. Bizmanualz is happy to help and explain each audit finding. The concluding meeting ends the audit. Once the audit is complete, there will be no surprises in the audit report. The Audit Report will be written up and emailed back to you within the next few business days.