ISO 9000 GAP-ANALYSIS AUDIT

Who would ever begin traveling from one city to another without at least knowing where both cities were in relation to one another? Also called a Baseline Audit, the Gap-Analysis defines the relationship between the current quality management system and that described by ISO 9000. This is an initial audit performed by trained, qualified ISO auditors to determine the current extent of ISO 9000 compliance. It is performed in the same format as an actual Registration Audit and identifies the "Gap" (if any) between your current management system and the ISO 9000 requirements.

The Gap-Analysis report includes any Nonconformances or Observations issued, records of current system compliance, an audit schedule, and a matrix of the items reviewed in each functional department. The Gap-Analysis Audit and the Implementing ISO 9000 course are the two most powerful tools for beginning the organization's journey to ISO compliance.

PREREQUISITES: None.

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DOCUMENTING FOR ISO 9000 WORKSHOP

A workshop-style course teaching your staff (20 people maximum) about:

1. the typical documentation structure for ISO,
2. documentation required by ISO and to what extent,
3. proven methods of distribution and retrieval control,
4. documenting in various medias,
5. developing flow-charts/tables/visual aids as procedures,
6. creating procedures and work instructions that accurately reflect the process, and minimizing the amount of documentation needed by the company.

PREREQUISITES: Must have prior familiarity with the ISO 9000 requirements.

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ISO 9000 AWARENESS TRAINING

This course is often used to prepare employees for the upcoming Registration Audit or as preparation for the other ISO courses. It covers the importance of ISO 9000, the purpose and benefits of Third-Party Registration, the Registration Process, the requirements of the ISO 9000 standard, and what to expect during the actual audit.

Two hours to half-day interactive course is a lecture format with exercises which covers the requirements of the ISO 9000 standard. (50 students maximum)

Two-Day course is a workshop format in which students develop a detailed understanding of each ISO element and how it applies to their jobs. (20 students maximum)

PREREQUISITES: None.

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IMPLEMENTING ISO 9000 WORKSHOP

In-house workshop for the ISO Implementation Team(s) (10 to 20 people). The team:

1. Gains detailed understanding of the ISO 9000 standard and how to interpret it,
2. Determines gaps in the current system vs. ISO requirements,
3. Identifies existing activities and procedures which can be used for ISO, and
4. Develops Project Plan for Implementation (complete with due-dates & assigned responsibilities for completion).

This Implementation Team should be a cross-section of functional departments (purchasing, customer service/sales, production, engineering, etc.) and authority levels (managers, engineers, lead operators, etc.) to ensure a broad and detailed understanding of the current quality system and any limitations that must be addressed by the Implementation Plan.

Two-Day course is intended for implementation teams that already have some familiarity with ISO 9000 or that have had a 1-day ISO Awareness or ISO Understanding course.

Three-Day course is for those teams needing a more detailed training in the ISO standard, before assessing their organization's current gaps and developing corrective measures.

PREREQUISITES: Recommend Gap-Analysis Audit (for in-house presentation) before the workshop so that the Implementation Team may use the audit results in class.

Prior familiarity with ISO 9000 requirements is helpful for the participants in 2 day course.

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INTERNAL AUDITOR WORKSHOP

This workshop-style course covers the requirements of ISO 9000, and ISO 10011-1, -2, and -3 about Auditors, Auditing, and Audit Programs:

1. how to interpret the ISO standard,
2. the evidence required to demonstrate compliance,
3. the qualifications for an auditor,
4. audit scheduling and daily audit schedules,
5. audit planning - functional matrix, operational analysis, flow charts, creating checklists,
6. performing an audit - opening & closing meetings, sampling, interviewing techniques,
7. writing NCR reports, NCR follow-up and close-out, and audit reporting.

Two-Day course is a hands-on workshop, with case-study work. (20 students maximum)

Three-Day course adds a third day for "in-house" audit practice by the students, under the supervision of a Registered Auditor. This practice audit will utilize the organization's own procedures and instructions. (20 students maximum)

PREREQUISITES: Prior familiarity with ISO 9000 is helpful.

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ON-GOING CONSULTATION

Consulting visits are used to review implementation progress, help the implementation team over obstacles encountered, recommend solutions and tools, and provided perspective to the overall project.

PREREQUISITES: None.

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DOCUMENTATION REVIEW (ADEQUACY AUDIT)

Consultant/Auditor will review the company's Level I and Level II Documentation (Quality Manual and Procedures) for adequacy of coverage of the ISO 9000 requirements. Can be performed at the Company's facility or at Consultant's office. Includes a summary report by element of any gaps and what is required by ISO 9000 to close those gaps.

PREREQUISITES: None.

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AUDIT MEDIATION

Consultant/Auditor is on-site for the duration of the Registrar's visits (Pre-Assessment & Audit) to act as mediator on behalf of your company. The mediator ensures both that audit findings are clearly understood (stated in the company's language) and that all available evidence of conformance is presented to the audit team by the company (to preempt undeserved nonconformances and to mitigate the classification level of any actual findings). The Consultant also helps the company develop corrective action plans acceptable to the Registrar, thus closing-out most nonconformances before the audit's end.

PREREQUISITES: None.

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PRELIMINARY ASSESSMENT (AUDIT)

Usually performed near the end of the implementation project, the Preliminary Assessment provides an unbiased, qualified indication of the new quality management system's readiness for the actual Registration Audit. The Preliminary Audit is performed by trained, qualified auditors, and the audit report provides recommendations for corrective action based on the audit team's extensive experience. At your company's discretion, this assessment can be performed using the same number of audit days projected for the actual Registration Audit, or as "mini-audit" of approximately 70% of Registration Audit days.

PREREQUISITES: A Documentation Audit must be done prior to or in conjunction with the Preliminary Audit.

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THE REGISTERED LEAD AUDITOR TRAINING COURSE

This intensive course is the same one that Third-Party Registration Auditors must take and pass (includes 2 hour exam on last day). Imagine the advantage of having one or more staff members with the same level of training as the Registrar's audit team!

This course satisfies the formal training requirement for individuals seeking registration. It has a minimum of 4 students and a maximum of 20 (two instructors are required for class sizes of 11-20). This course is licensed by The Hartley Group through another provider.

PREREQUISITES: Class time (with required evening team work) is approximately 8 to 10 hours on Monday through Thursday, and concludes on Friday with an exam.  Students are graded on both class participation (Continual Assessment) and the Exam. Students are expected to have a comprehensive understanding of the content, application, and implementation of the ISO 9000 series of standards prior to the commencement of this course. Participation in any of the previously listed courses will satisfy this requirement for anyone having doubts about their comprehensive understanding.

Up to 10 students - One Instructor

Up to 20 students - Two Instructors