Audit with Confidence. No Surprises.

We provide Independent ISO & API internal audits that identify risks early, reduce nonconformities, and prepare you for certification and surveillance audits.

Audits shouldn't feel like a trap.

Are you experiencing similar challenges?

We understand how stressful audits can be. A poorly executed audit can leave teams feeling exposed, frustrated, and uncertain about next steps. But with the right independent, objective audit team, audits become a tool for clarity and improvement—not fear. They identify gaps early, and explain findings clearly.

Audits Should Bring Clarity, Objectivity and a Path Forward

We Audit Against Set Criteria

We audit directly against ISO, API & your own requirements, using objective evidence and auditor guidance—not personal interpretation.

We Explain What We See, Clearly

Findings are discussed and explained clearly in real time, so your team understands what is required and why it matters.

We Identify Your Gaps Early

Our audits focus on uncovering weaknesses & risks before they turn into nonconformities, suspensions or even certificate withdrawal .

We Leave with Clear Next Steps

You receive structured reports with actionable findings—so you know exactly where you stand, what to address and how to move forward.

Types of Audits We Provide

Internal Audits

A complete, independent evaluation of your management system to determine conformity and effectiveness. We deliver:

Audit Agenda
In depth on-site or remote audit
Audit Report

Gap Analysis

Not sure where you stand today?
A gap analysis gives you a clear roadmap to certification revealing:

Missing processes
Missing or incomplete documentation
Weak areas in implementation

Supplier Audits

Ensure your suppliers meet requirements that impact your products, services, or API monogram licensing:

QMS compliance
Process controls
API & ISO requirements

Standards We Audit

We support these standards and more

ISO 9001: 2015

ISO 14001: 2015

ISO 45001: 2015

ISO 27001: 2015

API Q1 9th Edition

API Q2 2nd Edition

API Monograms

ISO 80079-34

ISO 9001 Quality Management System standard
API Q1 Quality Management System standard
API Q2 Quality Management System standard
ISO 14001 Environmental Management System standard
ISO 45001 Occupational Health & Safety Management System standard

ISO 50001 Energy Management System standard
ISO 27001 Information Security Management System standard
ISO 13485 Quality Management System standard
ISO 80079-34 Explosive Atmosphere Quality System
API Monogram Specifications

We can also support other ISO-based standards, Ask Us.

Why Choose Mireaux for Your Audits?

We don’t just point out gaps — we help you understand them.

Auditors with real ISO & API implementation as well as industry experience
Clear reporting with actionable insights
Two-week lead time on Audit Agendas and 3-day turn around on Audit Reports
Web QMS users-only: Audit Agendas, Reports, and Findings sent directly to Audits app on Web QMS
Flexible scheduling with on-site or remote options

Our Audit Approach

A successful ISO Audit is the result of having competent Auditors that follow a structured audit approach. As a certified ISO 9001 and ISO 27001 organization, Mireaux’s auditing processes follow a structure format.

We also count with a state-of-the-art auditing software to schedule, audit, report, and manage all our audits. And you get access to that whether you have our Web QMS or not.

In general, these are the general steps we follow for our audits.

1. Review of Documentation

This includes a review of pertinent documentation appropriate to the type of audit carried out, such as:

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 and multiple locations are involved, this will also include the name of the Auditor, the location and the process/area each of them will audit and when.

For optimal results, the Audit Agenda is issued 2 weeks in advance to allow sufficient time for review and distribution.

And if you are a Web QMS user, the agenda will be delivered directly into your own Web QMS’ Audits app, so you can prepare sooner.

3. Execution of the Audit

This is the hands-on auditing, according to the Audit Agenda, and as required by the standard or criteria used. An audit usually has the following elements:

Opening and Closing meeting
Tour of the facilities, to acquaint the Auditor with the organization’s premises
Interviewing of personnel, observation of activities, review of records
Periodic or daily reviews as necessary, especially for multi-site or multi-day audits

The goal of our Auditors is to spend most of their time on the shop floor 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.

Our goal is to have the report to you in 3-business days from the last day of the Audit. And if you are a Web QMS user, the report and findings will be delivered directly into your own Web QMS’ Audits app, thus leaving you with the task of assigning the findings for follow up -without the need to reentering all information.

What Auditors Are Really Looking For

In this video, we break down the questions that most often lead to confusion or findings—and how to prepare for them.

When your team knows what to expect, audits become structured conversations—not interrogations.

Let Us Help You Pass Your Audits With Confidence

Whether you need Internal Audit, Gap Analysis, or Supplier Audits, our experts are ready to support you.

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. We 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.Objectives
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 kind of nonconformities are issued during audits?

In general, we use the following nomenclature for reporting 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:

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”.

Can Mireaux conduct Audits remotely?

Yes, starting on April 1, 2020, we are able to conduct audits remotely. During remote audits, our Auditors review documentation or records made available electronically and conduct interviews via a Microsoft Teams.

How often should internal audits be conducted?

The expectation nowadays is that a full cycle of Internal Audits be conducted “every 12 months”. This may be seen as contrasting the various definitions the standards, may have:

PERIODIC: this may be interpreted as being able to conduct Internal Audits every 2 years for example.
ANNUAL: this may be interpreted as being able to conduct your Internal Audit in January this calendar year, while next calendar year you could conduct your Internal Audit in December for example. Both still took place on the “annual” year.
EVERY 12 MONTHS: This means that if this year you conducted your Internal Audit in January, next year your Internal Audit shall be conducted no later than January. Conducting it in February would put you a month late and therefore out of compliance.

Therefore, even though the language may not be consistent among standards, the expectation is that you will conduct a full cycle of Internal Audits, EVERY 12 MONTHS.

Your Audit Plan, Program, or Schedule should outline when you will conduct the Internal Audits. We recommend pinpointing the month and year, rather than just the year, as this may be seen as too broad and not a good plan.

What is a full cycle of internal audits?

A full cycle of Internal Audits signifies that you have audited all of the processes in your management system within the 12-month period. Whether you audit one or more process per month, or all processes at once, you have to audit all of the processes that are part of your management system.

A full cycle of Internal Audits also implies that you have conducted the actual audit, issued the findings, and closed out all nonconformities appropriately.

Depending on how your Internal Audit Schedule is setup, we can help you meet this requirement. For efficiency reasons, we usually propose Internal Audits be conducted all at once, meaning your processes are audited in the same timeframe one after another.

What happens if we don't conduct an internal audit?

There are a few consequences to be expected during your Registrar’s External Audit if you do not conduct your Internal Audit on time according to your Internal Audit schedule, or prior to your Registrar’s External Audit. Below are three possible outcomes based on your Internal Audit schedule’s modus operandi.

1. If you conduct one Internal Audit per year

If you only conduct one Internal Audit per year, meaning all of your processes are audited at once; missing an internal Audit should be cause for concern. More than likely, you will get a minor Nonconformity during your External Audit, which could possibly be a major nonconformity, especially if you do not even have it on the schedule.

2. If you conduct several Internal Audits per year

If you conduct several Internal Audits per year, each focusing on a few processes of your overall management system, then missing one Internal Audit may not be as serious. Nevertheless, expect a minor Nonconformity during your External Audit.

3. If this is your first Internal Audit

If you missed conducting an Internal Audit prior to your initial certification or Stage 2 Audit, then this is serious. Having an Internal Audit prior to your certification audit is a critical requirement and definitely a showstopper:

Is a Gap Analysis necessary?

A Gap Analysis is beneficial when an organization has implemented some elements of the ISO or API standard desired. In this case, a thorough Gap Analysis will provide a clear indication of how close or how far the organization’s management system is in relationship to the ISO or API standard being sought.

However, if the organization does not have any elements of a management system in place, and has not worked much towards meeting any of the requirements of the ISO or API standard desired; then a Gap Analysis is not recommended. In fact, having a Gap Analysis in this situation, is likely to yield a huge gap –as you are lacking just about everything – which may already be evident to your team. If this is your case, save your money and put it towards resources for implementation.

When should you conduct a Gap Analysis?

A Gap Analysis may be conducted once or twice while the organization prepares for their certification audit – to get reassurance that their implementation efforts are moving them closer to meeting all requirements of the ISO or API standards being sought.

Having a Gap Analysis at the onset of the certification journey is worthwhile. It should provide clear guidance on the direction to take and provide assurance that you are (or are not) in the right track.

If time and budget allows, a second Gap Analysis could also be helpful before the External Audit or Certification Audit. At this point, the results of the Gap Analysis should provide confirmation that the organization is indeed ready for certification. A type of audit called Pre-Assessment – often conducted by the Registrar or Certification Body themselves – can be equated to this Gap Analysis.

What are the advantages of having Mireaux conduct a Gap Analysis?

We can help your organization tremendously towards achieving your desired ISO or API goals, by conducting a thorough Gap Analysis that can provide a clear roadmap to certification. Having Mireaux conduct your Gap Analysis also provides a chance for your team to discuss face to face with an expert, areas that may need attention in order to close the gaps.

Additionally upon completion of the Gap Analysis, Mireaux issues a comprehensive Gap Analysis Report that contains a detailed clause-by-clause analysis of the ISO or API standards being sought, providing for each clause:

Details of the Gap
Recommended actions to close the Gap
Evaluation compliance on a scale of 1 to 5

Mireaux’s Gap Analysis Report also provides an overall percent of compliance, to give the organization a good idea of their “grade” and the road ahead.

When should I conduct supplier/vendor audits?

There are many reasons that can spark the need to conduct a Supplier/Vendor Audit. Among them are the following:

Your organization requires it for Supplier/Vendor approval
Your organization requires it for Supplier/Vendor re-approval
The Supplier/Vendor has shown a negative trend in the number of NCRs (product or service nonconformances)
The Supplier/Vendor has been issued a Corrective Action and you would like to verify implementation and effectiveness
A customer complaint was received, where the root cause was attributed to a failure or breakdown in the supplier/vendor processes
Your organization wants to give the Supplier/Vendor additional work and wants to verify capabilities and capacity
An information security incident, environmental impact, or safety incident occurred and it is evident that an error in the supplier/vendor’s processes, contributed to the problem.

In essence, reasons for conducting a Supplier/Vendor Audit abound. If your organization practices the ISO principle of “Relationship Management” formerly known as “Mutually beneficial Supplier Relationships”, then being able to audit your Supplier/Vendor should be welcomed as an opportunity for furthering the ties between you and your supplier/vendor.

Does ISO or API require supplier/vendor audits?

The ISO management system standards do not require Suppliers/Vendors Audits as part of the evaluation/reevaluation of supplier or vendors. API however, is more prescriptive in its requirements for Suppliers/Vendors’ initial evaluation and selection, as shown on the following API Q2 excerpt:

The requirement above is clear in that an assessment of the supplier needs to be done at their facility (the facility from where the supplier is providing their product or service); however, the assessment can be conducted by your organization, an organization you outsourced to, or a third-party. Whichever method you decide, it should be part of your supply chain program and be documented as part of your management system requirements.

Should you notify your supplier/vendor before showing up for an audit?

Audits should never be confrontational or offensive. If you have a management system in place that follows the ISO principle of “Relationship Management” formerly known as “Mutually beneficial Supplier Relationships”, then the relationship between you and your supplier/vendor should be one of mutual cooperation and improvement.

In general, Mireaux discourages use of surprise audits or similar scare tactics. We like to send Audit Agendas in advance and make sure that the organization is fully aware of our visit. However, if you truly believe that there are major discrepancies that need to be verified, it is up to your organization to bypass early notification and just show up.

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