Managed Services Offered by Mireaux
So what happens after you achieve certification?
It has been said that achieving certification is not the hard part, the hard part is maintaining certification! Luckily there is Mireaux Management Solutions! See below how Mireaux can help you with your management system’s needs.
On-Demand Document Control
Organizations without dedicated Document Control employees, are able to request Mireaux’s assistance when needed as needed to help with the creation, updating, and publishing of documents. Mireaux Associates are trained to process changes holistically, knowing that a change in a core procedure may spark updates in the Management System Manual, associated forms, or records. If your organization uses our Web QMS software, the process is even easier and faster, as we are able to make updates to your management system instantaneously.
Regardless of your location, management system certification, or software used, Mireaux’s Document Control services will ensure that your management system is kept updated at all times.
Process Mapping & Procedure Writing
Using process mapping and interviewing techniques perfected through the years, Mireaux can assist your organization create accurate procedures and work instructions that employees can easily read, understand, follow, and most importantly feel owners of.
If you are unsure what procedures or work instructions to start with, Mireaux will help you define your core and support processes that will serve as the roadmap for your documentation. We can also assist in defining document numbering, version and format if you do not have these established, or follow your existing Document Management System conventions.
Mireaux brings a fresh perspective to your documentation, as well as best practices and experience from multiple industries which will ensure that you end up with value added procedures with clear instructions for the right audience.
Assistance with Legal Register, Compliance Obligations and Evaluation of Compliance
- Review the company’s existing Compliance Obligations or Legal Register based on the industries and the locations the organization operates as well as the applicable ISO or API standard(s).
- Propose enhancements or updates to Compliance Obligations or Legal Register with all applicable Compliance Obligations, Legal Requirements and Other Requirements found.
- Conduct Evaluation of Compliance Obligations, Legal Requirements, and Other Requirements; listed on Legal Register or Compliance Obligations list.
- Issue Report including gaps, shortcomings, and recommendations for achieving full compliance.
Job Description Writing
Whether you need to create new Job Descriptions, or revamp existing ones, Mireaux can work with your team to ensure you obtain the right information to meet your needs.
Mireaux Associates will help design a suitable job description template to hold information such as responsibilities, education, training, skills, and/or experience; ensuring that the template meets applicable ISO, or API management system standard requirements, other legal requirements, and/or your own hiring and onboarding policies. Our team will conduct interviews with Human Resources staff, Managers, Supervisors, and other appropriate personnel; review existing processes, and procedures to gather responsibilities from different angles, and use information available in our library; to write comprehensive Job Descriptions for each job title as necessary.
Support and Maintenance of Management System
Mireaux can provide a dedicated Consultant and Technical Writer to support and maintain your management system when needed as needed.
Ongoing activities can be carried out throughout the year. Examples of these activities include:
- Update procedures, forms, job descriptions, org charts, Management System Manual and other documentation as necessary or as requested.
- Ensure Corrective Actions are initiated and closed out in a timely manner.
- Ensure Management of Change is taken place when required and are being closed out in a timely manner.
- Ensure new employees are being onboarded and trained on the Management System and exiting employees are being offboarded appropriately.
- Ensure Legal Requirements, External Documents, and Records are kept up to date.
- Ensure Calibration and Maintenance programs are up to date.
- Ensure Supplier Evaluation and Reevaluation is up to date. Assistance in the evaluation process.
- Ensure Objectives are updated as necessary and communicated to Employees.
- Ensure Customer Satisfaction surveys are sent, metrics are captured and analyzed as necessary.
Annual activities are critical to the success of your ISO or API certifications and need to be planned ahead. These activities may include the following:
- Assist with preparation & execution of Management Review meeting as well as the creation of meeting minutes.
- Assist in conducting Risk Assessment and ensuring that controls are put in place for significant risks.
- Schedule yearly Internal Audit and ensure nonconformities are addressed promptly.
Assistance with Answering of Nonconformities
If you have been issued nonconformities during your ISO or API Registrar audit, you have a limited time to respond to them and perhaps you would like another set of eyes to ensure that you have done your due diligence. Mireaux can help assure that you have answered the nonconformities adequately and that you have cross-checked all required elements.
Assistance answering nonconformities typically includes:
- Review and execution of Root Cause Analysis on required nonconformities.
- Facilitate meetings and discussions to help formulate well rounded responses.
- Assistance with implementation of actions and preparation of supporting documentation.
- Assistance entering and submitting nonconformities on API website. (API only)
Becoming ISO or API certified is just the beginning of a journey. Maintaining the certification is the most challenging aspect of the certification process.
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.
Documentation can vary from organization to organization, based on the number of employees, complexity of the processes, and the standard or specification involved.
Here are a few examples of documents Mireaux helps to update and maintain as part of its Document Control Services:
- Quality Manual
- Quality Policy
- Objectives, and Monitoring& Measuring tables/charts
- Customer Satisfaction survey results, tabulation or updating of charts
- Emergency plans
- Procedures, including process maps
- Work instructions
- Forms, checklists, templates
- Records Retention Matrix
- List of External Documents
- Approved Vendors List
- List of legal requirements, etc.
- Job Descriptions
- Training Plans
- Training Records
- Training tests
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:
- Management Review Agendas, Reports, Meeting Minutes, and Action Items
- Internal Audit Agendas, Reports, and Nonconformities or CIPs
- External Audit Agendas, Reports, and Nonconformities or CIPs
- Risk Assessment matrix and Contingency Plans
- Employee Certifications
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 in those standards, such as:
ISO standards requirements
- 5.3 Organizational Roles, Responsibilities, and Authorities
- 7.2 Competence
- 7.3 Awareness
API standards requirements
- 4.2.2 Responsibilities, and Authorities
- 18.104.22.168 Competence
- 22.214.171.124.d Training and Awareness
Mireaux’s goal is to provide Job Descriptions that outline a complete list of the duties and responsibilities of a given position within your organization. Job Descriptions written by Mireaux typically have the following sections to satisfy the requirements of the ISO and API standards:
- Duties & Responsibilities
- Physical and Safety Requirements
Mireaux promotes the creation of a Job Description for every job title within your organization. Therefore your first task should be to identify the job titles existing in your organization, which may come from your organizational charts, or procedures. Once that list is made, you will have a clear roadmap of Job Descriptions to create.
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.
In a typical manufacturing or service organization, core processes may encompass the following but not limited to:
- Manufacturing/Service Execution
- Quality Control
Support processes may entail the following, but not limited to:
- Supply Chain Management
- Human Resources
If your organization has already identified the processes in need of formal procedures, call Mireaux and let’s discuss how we can help accomplish your document writing goals.
Details that seem too obvious to include in your documentation present risk to your management system, such as:
- Knowledge may be lost when experienced employees leave
- Errors may be made by inexperienced employees, resulting in nonconforming products or services
- Processed may be accomplished inefficiently if important steps are skipped