Auditing

ISO and API Auditing Services

The ISO and API standards emphasize the importance of audits as a management tool for monitoring and verifying the effective implementation of an organizations’ management system, be it Quality, Environmental, Occupational Health and Safety, or Information Security management system.

Mireaux can help your organization perform successful audits that can add value to your business activities while ensuring that you meet the requirements of the standards you subscribe to.

Call Mireaux at 713-589-4680 and let us help you implement an audit program that is suitable to your organization and that can be carried out effectively and consistently. 

Mireaux’s Auditing Services encompass the following types of audits:

ISO & API Audit Criteria

Audit criteria is a set of policies, procedures, or requirements requirements that are used during the Audit to audit against.  Essentially, Auditors use the Audit Criteria to gauge whether the organization is conforming successfully to such criteria. Based on the required audit criteria, Mireaux approaches its audits somewhat different. Each criteria may require a different set of documentation, different angles of implementation, and Mireaux’s expert Auditors are aware of that. Mireaux has the capability to audit to any or all of the criteria presented below, however if your standard or specification is not listed, contact us and we will happy to discuss our capabilities.

Our Auditing Approach

A successful audit is the result of having competent Auditors following a structured audit approach. Mireaux’s Auditing processes are certified to the ISO 9001 and ISO 27001 standards and follow the ISO 19011:2018 Auditing Standard.

Mireaux’s Auditing approach may vary based on the type of audit being conducted. The following are general steps common to most types of audits:

review-documentation

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
audit-agenda

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
audit-execution

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
issue-report

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
nonconformitites

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
qms

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.

Frequently Asked Questions

What does planning for an audit involve?

Planning for the audit is essential in order to ensure the audit achieves the goals and objectives desired. Poor planning may turn the audit into wasted time and effort. Mireaux can assist your organization plan for the audit, by helping you determine the following:

  • Criteria: The standard(s) you would like your management system to be audited against.
  • Scope of the Audit: This involves the actual reach of the audit, in terms of locations, processes, shifts, etc.
  • Scope of the management system: This is the scope of your management system, as written in your manual or certification documents; including any exclusions you may have taken from the standard requirements.
  • Type of Audit: Internal Audit, Gap Analysis, Process Audit, Product Audit, or Supplier Audit.
  • Number of People: This information is useful when calculating the number of days for the audit.
What are the typical steps in an audit?

The steps involved in an audit depend on the type of audit being conducted. The following are general steps common to most types of audits:

1. Review of documentation:

This includes a review of pertinent documentation appropriate to the type of audit to be carried out, and the standard or audit criteria being used.  Typical documents include:

  • Management system Manual, such as Quality Manual, Environmental Manual, or Information Security Manual
  • Audit procedure
  • Audit Schedule
  • Prior Internal & External Audit reports.
2. Preparation of Audit Agenda

This includes preparing an agenda that outlines the start and end times for each audit day as well as the allocation of time for each process/area.  If multiple Auditors are involved, this will also include the name of the Auditor and the process/area each of them will audit and when.

Mireaux’s Audit Agenda is typically reviewed internally by 2 or 3 people before being sent to the Client for their review and approval.

For optimal results, the Audit Agenda should be issued and approved ahead of time and be distributed to all the parties involved, so everyone can prepare and plan for it. Mireaux typically sends the Audit agenda 2 weeks to 1 month in advance to allow our Clients to provide feedback and distribute as necessary.

3. Execution of the Audit

Executing the Audit means conducting the Audit as planned and agreed to in the Audit Agenda, and as required by the standard or criteria used. An audit usually has the following elements:

  • Opening and Closing meeting
  • Additional Site Opening or Closing meetings (for multi-site audits)
  • Tour of the facilities, to acquaint the Auditor with the organization’s premises
  • Time for interviewing of personnel
  • Periodic daily reviews (for multi-day audits)

Mireaux ensures all our Auditors are well qualified for the standard or criteria used, and makes the Auditors’ certifications available before the Audit. Mireaux is also very keen in ensuring that Auditors spend most of the time on the floor shop or interviewing personnel, rather than in an office filling out paperwork.

4. Issuing the Audit report

The Audit Report is perhaps the most important part of any Audit, as it is the only tangible deliverable that is generated from the auditing process. Regardless of how well the Audit was conducted, if the report is either late, poorly written, or lacking information; the organization may not fully benefit from the Audit.

In general, organizations that outsource their Audits to Mireaux see a higher degree of success in their External Audits. This could be attributed to the following:

  • Mireaux’s Internal Audit was thorough and uncovered most issues that needed attention, giving the organization time to fix them before the External Audit.
  • External Auditors see our Audit Reports and realize that the organization has already gone through exhaustive scrutiny.
  • Just like the Audit Agenda, Mireaux’s Audit Reports go through a series of 2 or 3 reviews before being sent to the Client. And our Audit Report turnaround time is 3 business days, part of our agreement and commitment to our Clients.
5. Following up with closure of nonconformities

Depending on the results of the Audit, Mireaux has the resources available to assist your organization with closure of the nonconformities issued during the Audit.  Using Root Cause Analysis techniques, we can facilitate sessions among process owners and stakeholders that can help with the following:

  • Find the root causes of the nonconformities.
  • Implement corrective actions that can address the nonconformities in a holistic manner, ensuring that similar issues will not surface at any other location or at any other time.
  • Draft appropriate responses that can be used as evidence of the actions taken.
6. Updating Web QMS

If your organization uses Mireaux’s Web QMS software, our staff can assist in publishing the following documents in your Web QMS’ Internal Audit module, in order to ensure your Internal Audits records are kept up to date:

  • Audit Plan or Schedule
  • Audit Agenda
  • Audit Report
  • Audit nonconformities or CIPs
What are benefits of oursourcing your internal audits to Mireaux?

When organizations outsource their Internal Audits to Mireaux, there are many benefits to enjoy.  Some of the benefits are listed below:

  1. Our Auditors are seasoned professionals with decades of experience in various industries.
  2. Our Auditors have been in different job positions, and have experience wearing different hats, such as:
    • Managers for organizations being audited
    • Conducting Internal Audits themselves
    • Running Audit Programs within their organizations
    • Being External Auditors for Accredited Registrars
  1. As opposed to your own employees who may only conduct audits once or twice per year, our Auditors conduct Audits on a weekly basis, which allows them to keep their auditing skills fresh and sharp-witted.
  2. Our staff will reach out to you ahead of time to plan for your audit.
  3. Timely provision of the Audit Agenda to help you get ready for the actual audit.
  4. Three-day turnaround on Audit Reports, to help you act quickly on the audit findings issued.
  5. Thorough, independent, and objective auditing reduces conflicts among members of your team, since the findings will come from “the Auditors” and not another employee.
  6. Less disruption of your internal resources.
  7. If you have our Web QMS software, our staff can input your audit findings on Web QMS.

Call Mireaux today at (713) 589-4680 to get a quote and let’s work together to schedule your next Audit.

What kind of nonconformities are issued during audits?

In general, Mireaux uses the following nomenclature for reporting its findings:

1. Noteworthy Efforts

These are strengths and positive attributes that help an organization comply with the standard over and above what may be considered normal or what is typically seen. These type of findings do not require a response.

2. Opportunities for Improvement

Opinions made by the Auditor, about activities that can be done more effectively based on experience and best practices. Since the requirements of the standard are being met, albeit not efficiently as seen by the Auditor elsewhere, these type of findings do not require a response.

3. Observations or Concerns

Views made by the Auditor regarding areas of the process or management system which could become nonconforming should objective evidence become available or the right conditions appear. These could be treated as “near misses” and while some registrars do not require a response to them, Mireaux does encourage its Clients to document these findings and treat them as Preventive Actions in order to proactively resolve or prevent any future problems.

4. Minor Nonconformance

An isolated lapse of either discipline or control during the implementation of a management system element or procedural requirements is considered a minor nonconformity. A minor nonconformity also must not indicate a management system breakdown, and must not raise doubt that products or intended services will meet requirements. Overall the management system requirements are defined, implemented, and effective.

5. Major Nonconformance

The absence or lack of implementation of one or more required management system elements or clauses constitutes a major nonconformity.  These encompass situations which indicate that:

  • Products or services will not meet specified requirements (ISO 9001, API Q1API Q2)
  • Environmental impact of disastrous effect cannot or has not been prevented (ISO 14001)
  • Human injury or fatal accident is imminent (ISO 45001)
  • An Information Security breach has or will occur, or the integrity or availability of information is compromised (ISO 27001)

A group of minor nonconformities indicating inadequate implementation or effectiveness of an element of the management system or the standard may also result in a major nonconformity.

Does the Gap Analysis interview people in the same way an Internal Audit does?

A Gap Analysis is an exhaustive exercise, in which every clause of the ISO or API standard is checked for compliance. While a thorough Gap Analysis includes verification of implementation by interviewing some employees, it is highly focused on reviewing required documentation and records– usually performed from a desk or meeting room. This is why Gap Analyses are also called “Desktop Audits”.

Testimonials

Product Description: Internal Audit against ISO 9001:2015 and API Q1 (2018).

Paul provided us with excellent feedback as we prepare for our audit next year. We appreciate his professionalism during this process and look forward to continuing our partnership with Mireaux into next year.

Eric H.
Chemjet Inernational

Chemjet International Internal Audit against ISO 9001:2015 and API Q1 (2018) February 28, 2019

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