Change Management Consulting, Inc.

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ISO 9000 and 14000

Six Sigma and Lean

A fast, affordable turnkey approach to ISO 9001:2008 registration

Guaranteed Registration

The ISO 9000 Solution provides all the documentation, guidance, and training required for ISO 9001:2008 registration.  And it is custom tailored to meet your unique needs.  This comprehensive, yet flexible implementation program is designed for organizations in the early stages of the ISO 9001:2008 process.

CMC’s pragmatic approach to compliance and registration will speed you through the ISO 9000 journey - from start to finish - and in most cases have you ready for registration in six-to-nine months.  Mile markers include:

► Conduct Management Orientation (briefing)

Deliverable:  Management understanding of the ISO Standards, Quality Management System (QMS), procedures and the registration process, and their commitment to building a culture of continuous improvement.

► Perform Baseline Evaluation (gap analysis; includes documentation review and remediation of critical non-conformances)

Deliverable:  Baseline Evaluation Report that identifies non-conformances and opportunities for improvement; it compares the organization’s current QMS activities to ISO 9001 requirements.

► Facilitate Management Planning (assess resources and develop program objectives)

Deliverable:  Action Plan and Timeline, and selection of a management representative who has responsibility for QMS ongoing implementation (a part-time value-added responsibility).

► Develop Responsibility Matrix (fixes accountability)

Deliverable:  Responsibility Matrix that defines each applicable ISO 9001 element and specifies responsibility (links the QMS element with the process owner and delineates accountability).

► Develop Macro-Flowchart (process mapping at organization level)

Deliverable:  Macro-flowchart of company operations; this enables a thorough understanding of the sequence of events of all key business processes.

► Prepare Policy Documents (develop Quality Management System manual)

Deliverable:  Draft Quality Manual that that defines the approach and responsibility; it describes QMS policy, procedures, requirements, and objectives.

► Identify, Flowchart and Prepare System-Level Procedures (SLPs)

Deliverable:  Flowcharts of required SLP’s and completed procedures; SLP’s define the “who, what and when,” (activities typically at the department level).

► Coordinate Registrar Selection (third-party firm that audits the QMS)

Deliverable:  Selected registrar with the required accreditations to meet your organization’s unique requirements (initial registration audit, followed by annual surveillance audits).

► Review and Recommend Changes to Work Instructions and Forms

Deliverable:  Modified (streamlined) work instructions that describe how complex jobs are accomplished; you will probably find that you already have instructions for many of your critical operations.

► Conduct ISO 9001 Awareness Training (for staff beginning with senior management)

Deliverable:  Trained staff with clear understanding of ISO 9001 requirements, and their personal roles in the process; training also includes how to pass the registration audit.

► Implement Quality Management System (to ensure practice is consistent with procedure)

Deliverable:  A fully functioning, scalable, and practical QMS (includes procedures implementation to ensure conformity to the Standard; e.g. document control, preventive and corrective action, management review, etc.)

► Support the Preparation of Audit Procedures, Train Staff and Conduct Audits

Deliverable:  Documented and validated internal audit system (required to monitor the QMS implementation for conformity to the Standard; includes hands-on internal auditor training).

► Perform a Pre-Assessment Evaluation

Deliverable:  Audit report detailing observations and required corrective actions; CMC will also provide detailed remediation guidance addressing all non-conformances.

► Facilitate a Management Review Meeting

Deliverable:  Management Review Meeting minutes that includes corrective action implementation plan to eliminate non-conformities, current performance, and continual improvement opportunities.

► Provide Support During the Registration Audit (QMS, facilities and documentation)

Deliverable:  Continued assistance throughout the registration audit to ensure a smooth process, resulting in registration (CMC guarantees registration).

ISO 9001:2008 Turnkey Registration