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Management System Documentation & Implementation

Oriel STAT A MATRIX has successfully assisted hundreds of organizations in attaining certification to ISO 9000 and related management standards like ISO 13485 and using our proven 14-Step Process.



Our 14-Step Process guides your organization through the development, implementation, and registration of your quality management system (QMS). This structured process ensures your project occurs in a timely and efficient manner. We combine planning, training, and follow-up consultation to ensure knowledge is transferred to your organization and activities are implemented successfully.

For organizations that are already certified, our Audit Services Practice can support you in administering and sustaining management system and regulatory protocols.

The process flowchart below illustrates the Oriel STAT A MATRIX Quality Management System Certification Program.

QMS Implementation Program

  • Management Orientation – Executive staff is introduced to standards, procedures, and certification/regulatory requirements as they apply to executive management and company/departmental processes and interactions.
    Deliverable: Management Understanding of Certification/Approval Process
  • Baseline Assessment– A baseline set of observations is generated to identify the gap between what is required for certification/compliance and where the organization stands. This is a macro-level analysis performed in a relatively short period of time by a team of two or more Oriel STAT A MATRIX auditors.
    Deliverable: Baseline Assessment Report
  • Management Planning – Oriel STAT A MATRIX and the executive staff walk through the results of the baseline assessment together, assessing the resources and allocations necessary for a successful program and developing an action plan for certification/compliance.
    Deliverable: Action Plan
  • Responsibility Matrix – The Oriel STAT A MATRIX Executive Management Consultant (EMC), together with the organizations senior management, prepare a responsibility matrix that defines each applicable clause of the standard and specifies the individual(s) with primary and secondary responsibility for accomplishing conformance with that clause.
    Deliverable: Responsibility Matrix
  • Form and Train the Steering Committee – Oriel STAT A MATRIX prepares selected executives and department heads to serve as the company’s steering committee. At this point, the organization’s ISO management representative is identified. The recommended follow-on training to members of the steering committee is decided on a case-by-case basis.
    Deliverable: Steering Committee Selection and Training
  • Macroflowcharting (Process Mapping) – In “war room” style, Oriel STAT A MATRIX and the organizations steering committee members and/or their delegates flowchart every function of the organizations operation, from the time a request for proposal or quotation arrives to the time the product or service is delivered. This flowchart, in its final form, allows the identification of all processes of the QMS, along with their sequence and interaction. It also aids both your personnel and the third-party auditors during the certification audit.
    Deliverable: Macroflowchart of Company Operations
  • Identify Specific System-Level Procedures (SLPs) – Using the applicable standard/regulation, the responsibility matrix, and the macroflowchart, the Oriel STAT A MATRIX team and the steering committee together identify procedures that must be documented to achieve certification.
    Deliverable: List of System-Level Procedures to Be Documented
  • Prepare System-Level Procedures (SLPs)

    Flowchart SLPs – Each system-level (cross-functional) procedure (SLP) identified in Step 7 must be fully flowcharted. Oriel STAT A MATRIX demonstrates and teaches the proper flowcharting techniques by working directly with various teams to fully flowchart selected SLPs. The customer’s teams then flowchart the remaining procedures.

    NOTE: The Oriel STAT A MATRIX philosophy is to use the certification process as a series of opportunities for improvement, and this is the phase where the organization can make the most significant improvements while aligning the QMS with business strategy. When flowcharting, we use and teach techniques to improve processes by identifying and eliminating redundancy, non-value-added activities, and superfluous paperwork.  

    Walk Through, Document, and Validate SLPs – Individuals responsible for each flowchart, as identified in the responsibility matrix, must then document the corresponding SLP.  To help prepare the procedures for audit review, Oriel STAT A MATRIX will help develop a company-specific documentation template for SLPs, read and review representative flowcharts and documented procedures, perform a walk-through of sample procedures to confirm accuracy and adequacy, provide suggestions for improving the documentation, based on the walk-through, repeat the process after corrections are made by the organization’s staff.
    Deliverable: Completed System-Level Procedures
  • Write Quality Policies– Oriel STAT A MATRIX assists management in establishing and documenting high-level policies that may be required in support of the SLPs.
    Deliverable: Draft of Quality Policies.
  • Flowchart, Improve, and Document Work Instructions – Oriel STAT A MATRIX briefs personnel in formatting, writing, and preparing work instructions. Your personnel then write the instructions, train other staff members in their use, and implement and audit the instructions. Oriel STAT A MATRIX consultants will review instructions and assist your personnel in preparing them, if needed.
    Deliverable: Work Instructions Writing and Training

    NOTE: If requested, Oriel STAT A MATRIX consultants/technical writers will help write and audit the instructions. However, we recommend that the customer undertake the bulk of this effort to demonstrate to the larger organization the level of management commitment. “Ownership” of the new or revised procedures is further reinforced by your personnel performing the training and auditing. Oriel STAT A MATRIX can review a selected sample of instructions to ensure that the process was fully understood and properly implemented.
  • Train Personnel and Conduct Internal Audits – Throughout the program, as new SLPs and work instructions are introduced into the system, Oriel STAT A MATRIX consultants can participate in initial internal audits. Oriel STAT A MATRIX can also help develop appropriate audit checklists and templates for records, and integrate the process into the master audit cycle. During this phase, the customer realizes numerous opportunities for systems improvements and simplification of documentation. The customer’s personnel should be trained in how to recognize systems/processes/functions that affect end-product or service quality, and how quality-related functions interact with and affect the organization’s overall quality system. The goal is to develop a smooth and coherent internal audit system, an initial set of audit records, and improved procedures and instructions.
    Deliverable: Documented and Validated Internal Audit System

    NOTE: To demonstrate management commitment, the customer should perform the bulk of this effort. In addition, ownership of the new internal audit system by your personnel reinforces buy-in at all employee levels during internal audits.
  • Perform Preassessment – Oriel STAT A MATRIX consultant staff members who have not participated in the prior steps conduct a preassessment prior to the certification audit that will be conducted by your Certification Body. The purpose of this independent assessment is to identify any areas that might require fine-tuning of corrective action prior to the certification audit, which will increase the probability of success. We then submit a formal report detailing our observations and required corrective actions.
    Deliverable: Preassessment Audit Report

    NOTE 1: Oriel STAT A MATRIX can provide advice for remedial action, while a Certification Body is prohibited from doing so. NOTE: Prior to the third-party certification audit, the system must have been fully implemented, with records available to provide evidence of compliance with the standard/regulation (e.g., records of internal audits).

    NOTE 2: Oriel STAT A MATRIX can assist in identifying a Certification Body according to your certification objectives and customer desires.

  • Take Corrective Action and Review Results – The customer corrects nonconformities and notifies Oriel STAT A MATRIX of actions taken and dates completed. Oriel STAT A MATRIX spends one day (or more, if necessary) confirming that nonconformities found during the preassessment audit were properly corrected as per certification requirements. If all items are corrected and no new nonconformities are uncovered, Oriel STAT A MATRIX then reviews the actions and signs off that the facility is ready for a certification audit.
    Deliverable: Corrective Action Review
  • Certification Audit – Oriel STAT A MATRIX can remain on-site during the certification audit to help answer questions and correct nonconformances before the registrar’s auditors leave.
    Deliverable: Assistance During Certification Audit


Provided below are a variety of practice related white papers, market updates and case studies.

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Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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