IS 9001:2008

Do you need help deciding whether ISO 9001 is right for your IT/technology services-based organization? Want to become ISO 9001 certified but don’t know how to get there? Tired of speaking with quality consultants who focus on manufacturing and don’t understand your business or the language of IT professionals? Does your organization operate in a classified environment or with sensitive government customers?

Let Business Transformation Institute, Inc. (BTI) help…

BTI offers a wide range of ISO 9001 services. We employ seasoned staff who have “been there and done that” when it comes to ISO 9001. Moreover, BTI’s staff expertise is deep and broad so you won’t get a boilerplate solution from us, but one that is tailored to your specific quality needs, goals and objectives.

BTI’s value-added ISO 9001 service offerings:

ISO 9001:2008 Consulting – BTI’s experienced consultants work with key organizational stakeholders for QMS planning and implementation to achieve ISO 9001 compliance and, if desired, certification by an accredited external registrar. Our experts guide you through the process of planning and tailoring a quality management system specific to your organization and quality objectives. The following services are available ala carte or as a package of two or more offerings :

(click on a topic to expand the section and get more information)

Often treated as trivial tasks among the many things required to achieve ISO 9001 registration, the reality is that defining an organization’s scope of certification and selecting the right external registrar/auditor (when seeking a certification) are arguably the most critical activities you must do when establishing a QMS. The registrar is required to audit the “island” that you define in your scope statement, and no 2 registrars are exactly the same with respect to how they do that or in their accreditation and qualifications to understand your particular organization and line of business. BTI will help you formulate the appropriate “island” (i.e., scope) of certification commensurate with your organization’s quality goals and objectives, and assist in vetting the myriad of registrars from which to choose.

A popular ISO 9001 QMS rule of thumb is “Say what you do, do what you say, and show what you did.” Many times, organization’s starting along the ISO 9001 path don’t know where to start--a gap analysis can serve as a starting point. BTI determines the organization’s current state of readiness via site visit and artifact review, and prepares a detailed analysis of what it will take to fully comply with ISO 9001 requirements, the results of which can be used as a roadmap to implementing your QMS.

Mapping existing and “to-be” processes is a precursor to creating the necessary documentation to support an organization’s QMS. With sufficient detail, resulting process maps can be used as a substitute for lengthy procedures and work instructions. BTI guides your organization through the mapping process and ensures associated process diagrams and flow charts are complete and accurate.

ISO 9001 requires that a management representative be appointed by the organization to report on the status of its QMS, ensure ongoing compliance to ISO 9001 and QMS requirements and to serve as liaison with the external registration bodies. The ISO management representative’s duties often extend beyond these core responsibilities to include internal auditing, document and records control, and process development roles as well. Unfortunately, formal training for the management representative role is virtually non-existent. A BTI consultant with prior ISO management representative experience, works one-on-one with your management representative to ensure that all responsibilities are understood and effectively executed.

Although there is no single correct way to create quality procedures required by ISO 9001, experts and registrars alike, discourage the use of off-the-shelf/ready-made procedures available in the marketplace. These “cookie-cutter” solutions often lack the required specificity and “fit” to the organization to successfully maintain an ISO 9001 certification. BTI will review your organization’s QMS documentation to ensure it complies with ISO 9001 requirements and adequately reflects your actual operations.

An effective internal audit program is an essential part of any ISO 9001 QMS and is directly dependent upon the skill and training of its internal auditors. An auditor must possess a wide range of “tools” to be proficient, such as people skills, time management, attention to detail, ability to formulate audit questions and audit trails on the fly as the situation dictates, and many others. For a fledgling QMS, audit staff may not be as ready as they should be to conduct a thorough audit, identify associated nonconformities, and accurately word audit findings. BTI’s consultant have extensive auditing experience so they can observe and help the organization through its first series of audits. BTI will provide one-on-one guidance to audit staff where needed and make recommendations for improvement. BTI will verify the accuracy of audit findings and reports so that appropriate corrective action can be taken.

The pre-assessment is a thorough “stress test” of the QMS conducted prior to undergoing the actual certification audit. This event led by expert audit staff is designed to exercise the QMS in its entirety and disclose any previously unknown nonconformities and gaps in compliance. Unlike a certification audit where the auditor looks for evidence of compliance, the focus of the pre-assessment is to find everything that is “broken” so that the organization can take corrective action to resolve deficiencies prior to undergoing the certification audit main event. BTI’s experts ferret out weaknesses in your QMS so you can go into a certification audit confident of its success. The pre-assessment gives the organization a heads up of what the registrar will be looking for and reduce the anxiety associated with a registration audit.

ISO 9001 requires an effective corrective and preventive action program be implemented to correct deficiencies and effect continual improvement for the QMS. If root causes are not correctly identified and properly closed out problems are likely to recur. BTI’s process improvement and six sigma experts guide the organization on appropriate techniques for determining the true root cause of identified problems, designing robust corrective and preventive action, and verifying the effectiveness of those actions in a timely manner. Mentoring at this stage is most effective when done in conjunction with the internal audit process.

BTI’s Integrated Service Offerings

Verification and Alignment of your Processes – Statutory, regulatory, and organizational improvement mandates can have considerable impact on quality management system processes if not accounted and planned for. BTI can help you navigate the maze of requirements and fine tune your QMS for maximum effectiveness. BTI’s consultants can align your processes with SOX 404 requirements and best practices such as Lean Six Sigma and CMMI.

Business Process Automation with Metastorm® BPM – Processes are neither created equally nor remain static. Processes impacted by insufficient planning or that have undergone repeated organizational changes can devolve over time to include wasteful manual activities, redundant steps, obsolete gates, single points of failure, and stovepipe transactions. BTI’s seasoned team of Metastorm® BPM experts will work with you to transform your ineffective process to one that’s optimized and enhances the effectiveness of your QMS.