ISO9000, ISO 13485, 21CFR820, Baldrige,
COSO Internal Controls, Enterprise Risk Management, Internal Audit
Outsourcing
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ISO9000, ISO 13485, 21CFR820, Baldrige,
COSO Internal Controls, Enterprise Risk Management, Internal Audit
Outsourcing
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Consulting Services Main Focus
QMS Implementation ISO 9001:2000 FDA 21CFR Part 820 ISO 13485:2003 Medical Devices BOS Implementation COSO Internal Control/ERM Malcolm Baldrige Assessments Gap Analyses - QMS/BOS Baldrige On-Line Internal Audit Outsourcing |
Standards, like ISO 9001:2000, FDA
21 CFR Part820, ISO 13485:2003,
etc., are considered Quality Standards
because their expressed purposes are to provide confidence to your customers (and to you)
that your Quality
Management System (QSM) is capable of delivering
products and services that fulfill your contractual agreements and
comply with applicable laws and regulations.
On the other hand, guidelines such as the COSO Integrated Framework of Internal Controls and the Malcolm Baldrige criteria are Business Operating System (BOS) "standards". Their scope extends well beyond the customer who buys or uses your products/services: it goes to every constituency that has a right to expect satisfaction from your enterpise or operation. Typically, that includes:
No two QMS/BOS implementations are exactly alike, because no two organizations are exactly alike. We guide, facilitate and support each customer through system implementation, based upon the unique needs of each one. Our methods allow us to provide meaningful, affordable, custom-crafted services to customers of all sizes. We structure every project to fit the unique needs and desires of each customer. Depending upon how closely your current practices meet the requirements of the standard you select and the urgency of your need, we can help you put your system in place in 6 to 12 months, on average. If you are planning to apply for certification to one of the international standards, reputable registrars will require at least 3 months of actual quality system operation before they will consent to conduct the certification audit. Gap Analyses - QMS/BOS A Gap Analysis is a systematic comparison of an organization's practices against a selected standard or model. Depending upion your needs, we offer three different approaches. 1. Desk Audit Gap Analysis We review your QMS/BOS documentaion to determine the level of your system's compliance with the requirements of the applicable standard or model. We deliver a written report that includes a completed Checklist, Scorecard and Bar Charts and an assessment of what needs to be done to close any gaps between your practices and the requirements. The Desk Audit is typically performed off site. The report is typically delivered in person, although it is not mandatory. 2. Walk-About Gap Analysis (with or without a complete Desk Audit of documentation) We tour your operation and interview managers and supervisors to obtain a first hand look at your activities and practices to determine the level of your system's compliance with the requirements. As above, we deliver a written report that includes a completed Checklist, Scorecard and Bar Charts and an assessment of what needs to be done to close any gaps between your practices and the standard's requirements. In this case, the report is made in person. 3. Team Gap Analysis - Style: Workshop We will guide your Implementation Team through an exhaustive checklist of requirements, item-by-item, reviewing what each one says, what each one means and why it is there (its intent). The Team will identify current practices and methods of control and, together, they will determine if any changes or augmentations may be needed to meet each requirement and to satisfy management's objectives. Where additional work is needed, we will discuss and provide examples of how other, similar organizations handle the requirement and will make recommendations that we feel make sense and are best suited to your business and methods of operation. In addition to identifying the gaps, the output of the Team Gap Analysis will be 1) a Gap Analysis Scorecard Report that details, quantifies and graphs the current level of system compliance, and 2) an implementation action plan and schedule which will be used to manage, monitor and report on the status of the implementation project. Benefits of the Team Gap Analysis: Combine requirements training of supervisors and managers with the Gap Analysis and implementation planning process. Greater ownership and buy-in of the gap analysis results is the biggest benefit of the Team Gap process. Rather than us telling you what the gaps are, you discover them yourself. Who should participate: A core group of "Process Owners" from each organization along with the individual charged with overall system implementation and the organization's designated "Audit Leader". (In most small organizations, it is typical to have one person perform several functions.) Baldrige On-Line These assessments are conducted by our associate, Robert Bitner. For complete information about the on-line assessment process, please visit his web site. www.robertbitner.com Internal Audit Outsourcing After a thorough review of your quality system practices and documentation, we conduct a complete, documented audit of the effectiveness of the quality system on your behalf. (This practice is universally accepted by most, if not all, registrars.) We deliver a detailed, written report including any findings of actual and/or potential nonconformance - fully detailed and supported to enable issuance of corrective/preventive action requests - observations and opportunities for improvement. Who should consider Audit Outsourcing
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