ISO Internal Audit

Fast ISO Audits

Speak of operations assessment, and we’ll hear its significant value. Speak of an audit, and we’ll run for the nearest emergency exit. There’s no difference between the two, yet that word audit chills us. But is an audit really designed to help us or hurt us?

PURPOSE OF ISO AUDITS

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.

CONTRACT AUDITING SERVICES

A Bizmanualz ISO Internal Audit anywhere in the St. Louis Missouri area can help you avoid such audit findings using our 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 an objective assessment and deliver the required ISO audit record of your processes and your quality objectives.

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.

Using Bizmanualz ISO Audit Services reduces the need for a trained ISO audit staff, eliminates travel to St. Louis, MO for your supplier audits, and provides you with an objective assessment of your ISO Quality Management System.

Why ISO Internal Auditing?

Problems most often arise from poor planning. Sometimes we’re uncertain if we’re tackling the correct issues and dealing with them the right way. However, we can improve our assumptions about processes and performance with more effective auditing.

OBJECTIVE RECORDS

The internal audit process is not intended to be a ‘gotcha’ game. Rather, auditing helps management understand and validate the planning element. By keeping an objective record of the process, we can learn to swim first and avoid that sinking feeling later.

INTERNAL AUDITOR TRAINING

Les Cornelius, Quality Assurance Coordinator at Lee BioSolutions, Inc., took a two-day Internal Auditor Skills Class for the knowledge of getting improved results.

“I have to stay updated on new and improved ways to design, assess and improve processes,” said Cornelius. “The checklists, planning an audit, designing an audit program and conducting an audit – all are very helpful in preparation for the ISO certification audit.”

BETTER QUALITY DECISIONS

By gathering objective evidence through observations, interviews and sampling of quality records, management can make better decisions. This will help:

  • Test organizational objectives and processes
  • Write factual audit reports that help improve the effectiveness of the management system
  • Suggest ways to verify the effectiveness of any corrective action to achieve the objectives

‘CHECK’ FOR QUALITY

Auditing is the third phase of the Plan, Do, Check, Act process approach – check. It is also one of the 8 quality principles of ISO, which allows managers to make better decisions based not on subjective opinion but objective fact.

The audit process is a valuable step for improvement. Auditor training will teach managers and executives how to improve the effectiveness of their management system, which is essential for ISO 9001 certification.

AUDIT TO HELP

To fully understand the requirements of ISO 9001 and to facilitate audit teams, business professionals can also take a five-day Lead Auditor course. After all, auditing is designed to help us, not hurt us.

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.

Bizmanualz ISO Audit Services

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.