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Since 2001, Mireaux has been serving organizations in various industries become ISO or API certified. Here are examples of industries we have helped in the past:
Although Mireaux has expanded to new sectors over the years and has amassed a great deal of expertise and knowledge on certain sectors, we always treat every organization as unique; ensuring that its own processes are taken into consideration when implementing the desired management system.
- We have 100% success rate in helping companies obtain ISO or API Certifications
- Our Proven Consulting Approach creates a real sense of ownership within your organization.
- Our Consultants have 10 years or more of prior industry experience in various industries
- Our consulting services paired with simultaneous deployment of your Web QMS will give you the best bang for your buck!
- Each consulting job gets assigned a team that includes a Consultant, a Technical Writer, an Auditor, and a Trainer to ensure a well-rounded implementation of your management system.
- Integrated Services: We provide consulting, internal audits, training, and our software Web QMS, all with the same winning approach.
Our Proven Consulting Approach and attitude are our best traits that help create a great rapport with our clients (see Google Reviews and client testimonials). We strive to look at things from the client’s perspective, ensuring we work smarter not harder. We understand that our assistance is limited, therefore we strive to help organizations build a management system that they will be able to sustain on their own for years to come.
Our attitude is always humble, never forgetting that the client is the expert in what they do and that we are just there to help them effectively achieve their certification and compliance goals.
By and large, most of Mireaux’s Certification Consultancy Services consist of turnkey jobs. A turnkey job means we assist your organization from the beginning of the project until your organization has achieved the desired ISO or API certifications and has the certificate in your hands.
We treat every job as a project. In this manner, we allocate resources, assign a timeline, and create tasks related to the certification being sought out. We then establish a project plan and use it to manage and control the job. Individual activities are based on the standard requirements, while time durations are based on experience. Final timelines are often dictated by the client and agreed with us.
With this approach, we guarantee the project will accomplish all required activities, meet established deadlines, and be successful. In fact, in our business trajectory, we have never requested our Clients to delay the project timeline, which is an achievement in itself!
There is no typical job, as every client has their own processes and idiosyncrasies, however in terms of steps to certification, we can summarize them as follows:
By ensuring all tasks on the project plan have been completed, Mireaux has high certainty that the first 3 steps above have been completed and that our client is ready for the Stage 1 and Stage 2 audits with the registrar or certification body.
Given the turnkey nature of our consulting projects, Mireaux can assist consulting clients. Depending on the standard being sought out and the organizations’ processes, this may entail procedures, work instructions, forms, or other specific documentation. In general, the scope of work includes the following documentation but not limited to:
- Manual (Quality, Environmental, etc.)
- Policy (Quality, Environmental, Information Security, etc.)
- Core procedures pertaining to the organization core competencies or core processes
- Support procedures such as Document Control, Training, Risk Assessment, etc. as necessary
- Internal Audit templates (checklists, reports, etc.)
- Management Review templates (presentation, minutes, etc.)
- Job Descriptions
- Statement of Applicability (SOA – Information Security)
- Conformity Matrix (All API standards)
In general, the majority of Mireaux’s Certification Consulting projects last between 5 to 8 months, depending on the organization’s size, and the certifications being sought out. We believe time to certification varies mainly due to the following factors:
1. Starting point
Organizations with a good foundation or with existing certifications may be somewhat easier to get certified or add a new certification to their already existing portfolio. However if the foundation is not solid, sometimes it is better to start from scratch vs. working with a broken system. Mireaux’s team of experts will help identify the best course to take when starting new projects.
Although ISO and API standards are aligned within its family of standards, each standard has its own set of requirements and some have more than others. In general, we allocate extra steps for API Q1 and API Q2 implementations, as well as for ISO 27001 and ISO 45001.
3. Number of personnel and locations
Naturally the larger the organization is, the longer the project may take. However, the rate of time increase is not necessarily linear. Using Mireaux’s Proven Consulting Approach, we can increase the level of resources in order to ensure that we remain within time and budget.
4. Organization’s Responsiveness
By far the largest obstacles we see within our Certification Consulting projects are our client’s responsiveness. Usually delays are encountered when the organization fails to complete certain tasks assigned. By using our project management and control tools, Mireaux works hard to help everyone stay on track and avoid delays in the project.
5. Number of processes
Aside from the Client’s responsiveness, the next large contributor to the certification timeline is naturally the number of processes, or services the organization has. Regardless of the number of personnel or locations, a company with several products or service lines, will require additional time compared to a company with a single product or service.
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.
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
When organizations outsource their Internal Audits to Mireaux, there are many benefits to enjoy. Some of the benefits are listed below:
- Our Auditors are seasoned professionals with decades of experience in various industries.
- 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
- 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.
- Our staff will reach out to you ahead of time to plan for your audit.
- Timely provision of the Audit Agenda to help you get ready for the actual audit.
- Three-day turnaround on Audit Reports, to help you act quickly on the audit findings issued.
- Thorough, independent, and objective auditing reduces conflicts among members of your team, since the findings will come from “the Auditors” and not another employee.
- Less disruption of your internal resources.
- 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.
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 Q1, API 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.
Mireaux provides 3 types of training:
- Public training
- On-site training
Please see below for a comparison:
|PUBLIC TRAINING||ON-SITE TRAINING||E-LEARNING|
|Held at Mireaux Training Center in Northwest Houston||Held at your own facilities or contracted facilities||Deployed through our Web QMS Software|
|Available to the general public||Available to any organization with at least 4 attendees||Available to organizations who use our Web QMS software|
|Provides instructor, printed material, food, and audiovisual equipment||Provides instructor, and printed material only||Provides instructional video only|
|Certificate provided after successful completion and test||Certificate provided after successful completion and test||Certificate available after successful completion and test. Online records updated.|
|Benefits: interact with other industries and learn from various perspectives||Benefits: focus on your organization and your issues||Benefits: save time, and be able to train large amount of employees|
|Charged per attendee||Charged per group, based on a set number of attendees||Charged per course|
|Register and pay online or complete our registration form and send to us.||Request a quote online or call us at (713)589-4680||Request a quote online or call us at (713) 589-4680|
Public courses available are as follows:
ISO SPECIFIC COURSES
API SPECIFIC COURSES
|Document Control Certification||Fundamentals||3|
|Advanced (Engineering and Project Management)||4|
|For Web QMS||5|
|Root Cause Analysis||1|
|Auditor Certification||Internal Auditing Techniques||1|
|API Auditor Fundamentals||2|
|API Lead Auditor||3|
Training courses available On-Site are the same as Public courses, however they can be customized to fit your organization needs.
Have you ever wonder if there is a ”right progression” to take our courses, yes there is! If you are thinking about a career in Quality, Auditing, or have the time and resources to take more than one course with Mireaux, below are some suggested tracks that may optimize your goals of furthering your career.
Quality Manager Track
Fundamentals of Document Control → ISO 9001 Internal Auditor → Risk Assessment → Root Cause Analysis → API Q1 or API Q2 Fundamentals
Information Security Manager or ISO 27001 Internal Auditor Track
Fundamentals of Document Control → Risk Assessment → ISO 27001 Internal Auditor → Root Cause Analysis
HSE Manager or ISO 14001 Internal Auditor Track
Fundamentals of Document Control → ISO 14001 Implementation → Internal Auditing Techniques → Risk Assessment → Root Cause Analysis
Safety Manager or ISO 45001 Internal Auditor Track
Fundamentals of Document Control → ISO 45001 Implementation → Internal Auditing Techniques → Risk Assessment → Root Cause Analysis
Document Controller Track
Fundamentals of Document Control → ISO 9001 Implementation (or Other ISO standard implementation) → Internal Auditing Techniques → Root Cause Analysis → Advanced Document Control → Document Control for Web QMS Users (if using Web QMS)
ISO 9001 or QMS Internal Auditor Track
Fundamentals of Document Control → ISO 9001 Internal Auditor → Root Cause Analysis
API Q1 Internal Auditor Track
Fundamentals of Document Control → ISO 9001 Implementation → API Q1 Fundamentals Practitioner → Root Cause Analysis
API Q2 Internal Auditor Track
Fundamentals of Document Control → ISO 9001 Implementation → API Q2 Fundamentals Practitioner → Root Cause Analysis
At the present time, all Mireaux public courses are taught in English.
For information on having on-site training in Spanish, please contact Mireaux’s office at (713) 589-4680.
Due to API requirements, all API training material cannot be translated, and can only be provided in English.
Definitely. You can go to our Web QMS Video Gallery page and watch a series of short, informative segments. We can also conduct a guided tour of Web QMS at your facility or through a web/video conference. A guided demonstration will ensure that you are shown the depth, navigation and functionality of each module and application part of Web QMS.
There are a myriad of benefits an organization gets when deploying a quality management system using Web QMS, for example having a centralized location for all ISO, API, OHSAS and SEMS related work (such as policies, procedures, etc), 24/7 visibility and accessibility across multiple locations, etc. For a full list of benefits please refer to the Web QMS page.
Mireaux’s Web QMS quality management system software is a full suite of software modules designed specifically to meet, in a very efficient manner, all requirements set forth by the latest ISO 9001, ISO 14001, OHSAS 18001, ISO 27001, API Spec Q1 9th Edition, API Spec Q2, and SEMS standards and to foster continual improvement.
The software resides on the company intranet, allowing all employees or appropriate users, full access to the management system, anytime, from any company location, or remotely through VPN or dial-up. The full system consists of modules and dynamic applications, which work seamlessly to provide users the information needed with minimal effort.
Click on the link to learn more about Web QMS.
Web QMS can be edited/updated by multiple people. You may want to have local admins at each company location, while also have a global admin at your headquarters. User security is structured in tiers, so that each tier may have specific access rights, thus ensuring that information is disseminated appropriately. The setting depends on your company hierarchy structure and the amount of resources you have.
That depends largely on your intranet, server capacity and speed. Web QMS has been designed especially for an intranet environment to allow multiple users see the contents and work with the applications simultaneously.
That is one of the strengths of Web QMS, helping small to large organizations meet the requirements of various ISO, API, OHSAS and SEMS standards. Web QMS is not a pre-packaged software, and therefore modules and applications are tailored to suit the company size and business model before it is deployed on the company intranet.
Implementation of Web QMS depends on whether you are already ISO 9001, ISO 14001, OHSAS 18001, ISO 27001, API Spec Q1 9th Edition, or API Spec Q2 certified. If you already hold any of these certifications, then implementing Web QMS is relatively simple and may take anywhere from 1 month to several months depending on various factors, such as the size of your company, the number of locations involved, whether each location has separate QMS, EMS or ISMS and whether you want to integrate the QMS, EMS, and ISMS into one.
If your organization is not yet certified to any standard, then the length of Web QMS implementation will probably go hand in hand with the certification timeframe given. In most cases, Web QMS reduces this timeframe because each development step serves as a placeholder, like putting the pieces to a puzzle. Mireaux Management Solutions will work with your organization to ensure that any deadlines are met.
Virtually minimal. While populating your Web QMS may take long hours, once everything is setup, the system takes care of itself. Updates to procedures are the most common task, and it can be done typically in a matter of minutes. Once approved, it is automatically posted on the intranet at the latest revision for all appropriate locations to view.
Web QMS applications also require little to no maintenance, except for taking care of the action items themselves. For example the Continual Improvement Program (CIP) Application may require input from the from employees involved in a corrective/preventive action. Built-in reminders and escalation features allow for the system itself to take care of outstanding corrective actions by e-mailing the appropriate employees.
The information you see on any module of Web QMS is real time. Unless a new revision is in the approval process, you should always see the latest revision of the documents, records, procedures, etc.
Web QMS applications store most of the data in SQL tables, which means all information is stored in a database. When reports or status are requested to the applications, the information is extracted from these tables and presented to the user in real time.
Web QMS is continuously updated to comply with the latest revision of most ISO and API standards, including: ISO 9001, ISO 14001, ISO 45001, ISO 27001, API Q1 and API Q2. If you have a specific requirement not being addressed, we will help you configure Web QMS to ensure your need is met.
Definitely! You can configure and use Web QMS for all standards your organization wishes to comply with. Whether you are already certified or not, with slight modifications, you can prep your management system to meet the requirements of standards you already comply with and those you wish to comply in the future. In this manner, you start getting everyone acquainted with the additional information/requirements with ease.
Most certainly! Web QMS comes with all modules and applications available for your use. If you want to use Web QMS beyond compliance to one management system standard, you can do that.
By all means, they can! In fact, Mireaux encourages its Consulting Clients who use Web QMS, to open it up for other locations to see and use; because as they use Web QMS, they are inherently and inadvertently adhering to your management system requirements. Therefore when it comes time to prepare them for certification, they would have a leg up on the process. For example let them add their calibration equipment on Web QMS, or have the employees at that location take the E-Learning courses. Not only are they taking advantage of these great tools, but they are already meeting the requirements of your management system!
If you are still printing evidence for the Auditor to see, then print no more. With Web QMS you should be able to provide the majority of evidence on the screen –obviously a good audit will also seek real input from employees, but a lot of the records, i.e. corrective actions, MOC, risk assessments, procedures, equipment PM, etc. will be at your and the Auditor’s fingertips.
We suggest you create a temporary account for the Auditor, and let them navigate themselves through your Web QMS. Not only will they be impressed at how organized your management system is, but they will be more relaxed –since you are not making them wait in order to view the records they ask for.
No, it does not, but the reason is based on our stance, which matches that of the ISO standards:
- A Corrective Action, is essentially a tool to find the root cause of a PROBLEM that HAPPENED. So this is not a suspected problem or near miss, this is basically a problem or nonconformity that materialized, and therefore a root cause analysis is conducted to find out what caused the problem. Part of the Corrective Action is establishing Short Term Action – to correct the problem immediately- and Long Term Actions – to PREVENT the problem from happening again. But despite these actions and the fact that Corrective Action does incorporate preventive measures, a Corrective Action can never change to be a Preventive Action because it was originated from a PROBLEM that actually happened.
- A Preventive Action on the other hand, is a tool to find the root cause of a PROBLEM that NEVER happened, in essence a POTENTIAL PROBLEM. This could be a near miss, as the problem never materialized. The root cause analysis entails finding out what could cause the POTENTIAL problem and establish actions to prevent this potential problem from ever materializing.
Think about this also, there is a clause for Corrective Action and a clause for Preventive Action, and both clauses exist separately in the API Q1 and API Q2 standards.
No you do not have to populate or use all areas of Web QMS. You can use Web QMS as you see fit to add value to your organization. To ensure compliance within Web QMS you will benefit from using all its modules and applications prescribed for the ISO or API standard you wish to comply with. However if you have other ways to take care of the ISO or API requirement, then not using a module or application on Web QMS is fine.
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
- 188.8.131.52 Competence
- 184.108.40.206.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.