The Essential Steps to Jumpstart your ISO/API Certification Journey!
These are the same steps our own Consultants use to successfully guide our clients to achieve ISO/API certification.
With our API Managed Services, you get flexible, expert support to keep your API management system compliant, current, and ready for audits year-round
Achieving API certification is only the first step. Maintaining API compliance requires continuous oversight, disciplined execution, and readiness for audits that leave little room for error.
Our API Managed Services help you protect your API monogram by maintaining your management system, addressing findings, managing corrective actions, and supporting surveillance and recertification audits.
From technical writing and data entry to acting as your API Coordinator or Management Representative, we fill critical gaps so your system remains compliant and audit-ready year-round.
Handling of all required activities, including coordinating audits, to ensure your system remains compliant and audit-ready year-round.
Expert ISO or API consulting available on an as-needed basis for specific tasks, questions, or fulfillment of requirements.
Assistance expanding your management system to include additional ISO or API management system standards.
Revisions or updates to your management system manual to reflect new requirements, processes, or organizational changes.
Hands-on assistance with document creation, revisions, formatting, approvals, and records management.
Creation or revision of your company Main Process Map or mapping of individual processes.
Creation or revision of procedures that meet ISO or API requirements while accurately reflecting your operations.
Develop job descriptions that accurately describe responsibilities, competencies, and that align with your management system.
Facilitation of Root Cause Analysis using proper RCA techniques on problems or nonconformities from internal, external or customer audits.
Assistance addressing nonconformities, including conducting root cause analysis, planning corrective actions, preparing a response up to implementation.
Review of root cause analysis, corrective actions, and evidence to determine whether your response is likely to satisfy an ISO or API auditor.
Facilitate risk assessments for ISO or API requirements, including risk or hazard identification, risk analysis, risk evaluation and formulation control strategies.
Assist with the creation of a legal register that includes legal, statutory, regulatory and other requirements. necessary to meet compliance obligations.
Formal review of legal and other applicable requirements, and factual verification that obligations are being met.
Get expert help only when you need it—no hiring, no long-term commitments required.
Our consultants function as part of your internal team, providing reliable support throughout the year.
We help ensure your management system remains compliant and audit-ready at all times.
Once certified, many companies rely on Managed Services to maintain and improve their systems year after year.
Whether it’s an NCR, a new customer requirement, or a needed update, we are available to support you quickly and professionally.
Get expert API support to safeguard your certification and monogram and stay prepared for high-stakes audits
Remaining certified entails not only following the processes and procedures that were established, but it also requires maintaining the integrity of the management system when changes occur. Updating your management system is part of the continual improvement principle all standards promote, therefore you have to handle them appropriately to remain in compliance.
While these responsibilities can be shared by everyone in the organization, duties related to updating of documentation, such as procedures and work instructions, are often relinquished to an employee with Document Control responsibilities. After years of experience, Mireaux strongly promotes a centralized Document Control function, as best practice. In fact Internal and External Audit results, often show Document Control as the main source of findings, which can easily be prevented with good Document Control preparation.
Therefore, while a Document Control person is not absolutely a requirement, we strongly recommend an employee or a team (depending on the size of your company) be appointed the responsibilities of maintaining control over documents updates, documents releases, etc.
Documentation can vary from organization to organization, based on the number of employees, complexity of the processes, and the standard or specification involved. Our team will provide support with creation, editing, updating, and publishing of documents.
For customer who use Web QMS, we can also send documents for review within the Master Documents application, post releases and send notifications to those affected.
Here are a few examples of documents Mireaux helps to update and maintain as part of its Document Control Services:
For organization who use our Web QMS software, Document Control activities may extend beyond updating items listed above, and include the updating, uploading, and creation of:
In essence, Mireaux ensures the availability of up to date information, allowing your organizations to keep its management system performing effectively.
Job descriptions per se are not required by any ISO or API standard, however they are often used to meet several critical requirements, related to responsibilities and authorities, competence, training and awareness.
Our goal is to provide Job Descriptions that outline a complete list of the duties and responsibilities of a given position within your organization while also satisfying other specific requirements of the ISO and API standards.
Job Descriptions are helpful for ISO and API compliance; however they are also an asset for your organization. The benefits of clearly defined and well-written Job Descriptions include:
1. Easier Hiring Process
Because the skills and educational background needed to fill a position are clearly defined in a Job Description, your Human Resources personnel can use the Job Descriptions to select those candidates that meet the requirements defined and approved in the Job Descriptions.
2. Clear Delineation of Responsibilities
Since the duties and responsibilities of each position are clearly defined in Job Descriptions, when employees read and sign off their Job Description, they are becoming aware of what is expected from them, and are agreeing to the responsibilities assigned.
3. Better understanding of qualifications needed to advance
Mireaux promotes open communication, and thus believes that Job Descriptions should be available to everyone. In fact, in our Web QMS software, Job Descriptions can be viewed by any user. This allows employees to see what additional skills, training, education, or experience is required to advanced; not to mention, learn what the duties of the new role entails.
Mireaux brings a fresh perspective to your documentation, helping you maintain up-to-date and accurate procedures and clarifying instructions for the right audience. Using process mapping and excellent procedure writing techniques, we can help your organization break your processes down and then build them back up into a format that employees can easily read, understand, follow, and most importantly feel their own.
Mireaux uses process mapping techniques to narrow down and identify core and support processes absolutely necessary for your organization.
Free Essential Guide
These are the same steps our own Consultants use to successfully guide our clients to achieve ISO/API certification.