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We provide highly experienced consultants
for each of these standards:
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ISO Management
Systems Standards |
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ISO
9000 |
The general
Quality Management System (QMS) by which most others are based |
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TL 9000 |
Telecommunications
QMS |
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OSHAS |
Health and
Safety |
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ISO 17025 |
Inspection and
Laboratories |
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AS9100, AS9110,
AS9003, AS9120, AC7004 |
International
Aerospace QMS |
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QS-9000 |
Domestic
Automotive QMS |
| Automotive
Processes |
PPAP,
APQP, MSA, FMEA, SPC |
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TE-9000 |
QS-9000
Tooling &Equipment Supplement |
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ISO/TS 16949 |
International
Automotive QMS |
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EN 46000 |
European
Medical Devices QMS |
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ISO
13485
ISO
15189
ISO
14971 |
International
Medical Devices QMS, Medical Laboratories, Medical Risk Management |
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CMDCAS,
CMDR |
Canadian Medical
Devices QMS |
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IVD & Medical
Devices Technical Files, CD Mark, 510(k) |
Technical File
Standards for In-Vitro Diagnostics (IVD) and other Medical Devices |
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ISO
14001 |
Environmental
Management System |
| Nadcap |
US
Aerospace and Defense Contractor Accreditation Program |
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Key Steps to your ISO Management Systems
implementation
Planning Phase
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Kickoff
Session: an initial meeting with key process owners
to map out what documentation must be created or updated and how the project
will be rolled out over a 6-month timeline (range: 4 to 8 months, depending
on the standard). This sets the expectations
of the project, the roles and responsibilities of each participant, and
results in the creation of a Document Map.
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Document
Map: The Document Map
is a tool which lists all documentation to be created and states the
following information for each document: related requirement of the
standard, document control number, process owner, development status, and
comments. This tool is updated by ER frequently and distributed to all
interested participants.
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Project Plan:
ER will create a detail project plan
that will outline every milestone and its scheduled start and completion
dates. At any point in time, you will know if we are on time, behind
or ahead of schedule.
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Registrar Selection:
ER's consultants have
successful experience with the most reputable registrars in the
nation. If you haven't already selected a registrar, ER will create a
short-list of registrars for you. Each registrar will have experience
in your industry, have presence in your geographical sales areas to promote
name recognition, and meet any other requirements you feel are
important. We will draft and send a request for bid on your behalf and
review the quotations with you. The final choice is ultimately yours.
Development and Implementation Phase
Quality Manual (level 1):
As a
requirement of most management systems, your organization will require a
quality (or environmental) manual that summarizes how the organization is
managed. This manual includes your policies, an organizational chart,
and a review of your management procedures. Unlike most consulting
companies, ER customizes your manual to reflect your vision. ER
interviews your top management during a facilitated meeting to capture the
essence of the company while minimizing the business disruption of top
management. The quality manual can describe the organization in a way
that new employees or key clients can understand without reading all of your
procedures. The manual often addresses the requirements of management
standards directly and becomes the first level of documentation.

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Procedures (level 2):
The vast majority of your project will
be the creation, training and implementation of procedures. These
procedures are referenced in the quality manual and the document map.
Procedures explain Who should be doing What, When and Where. They are
the overall guiding management procedures that may be departmental, or cut
across many departments. The average organization will have 10 to 20
procedures, give or take a few based on the complexity of the organization
and the standard.
Work Instructions and Quality Records (level 3
& 4): Work
Instructions (level 3 documentation) often take the form of lists, logs,
forms, user manuals, diagrams, blue prints, travelers, change requests,
reports, schedules and charts. If referenced in a level 2 procedure,
ER will ensure that the document will be place under document control by
placing it on the document map. Typically, ER does not create work
instructions, although they may become a customized option. Level 4
documents are Quality
Records, which include forms, lists, travelers, reports and other documents that are
stored for historical reference (proof you did it right).
Training
Phase
Company-wide
Audit Preparation Introduction: ER provides a company-wide introduction to
all employees to explain the benefits of a management system, how a
management system will apply to their job, how to implement procedures, and
how to prepare for an audit of the management system. Sessions are
typically 2-hours provided in groups of 20 in either English or
Spanish. The training utilizes projection overheads and each
participant receives reference materials.
Internal
Auditor Training: ER will train up to 20 employees to
become your internal auditors. This two-day training session will
include an introduction to the entire management system standard, auditing
principles, case studies, sample auditing materials, and completion
certificates. The training utilizes projection overheads and each
participant receives reference materials.
Auditing
Phase
Internal
Auditor Mentoring: ER will provide valuable assistance
while mentoring your internal auditors through their first internal
audit. ER will make sure that the audit it thorough, that the proper
reports are made, and that each auditor is comfortable with the
process.
Pre-Audit
Preparation and Attendance: After the internal audit, ER
will assist your auditing team and key process owners to ensure that all
corrective actions have been made and that the entire organization is
prepared for the pre-audit (trial run with the registrar). ER attends
the pre-audit to review and interpret any findings with your organization.
Final
Audit Preparation and Attendance: ER will prepare your
organization for the final audit with the registrar. After preparing
for the audit, ER will attend the audit to ensure that the audit runs
smoothly and that any minor findings can be immediately corrected.
ER's consultants have a perfect success record.
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