| Expert
Resource specializes in all of these standards. Our consultants
provide comprehensive services including document development,
training, implementation and consulting. |
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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 |
ISO 13485
ISO 15189
ISO 14971 |
International Medical
Devices QMS, Medical Laboratories, Medical Risk Management |
| CMDCAS, CMDR |
Canadian Medical Devices
QMS |
| Medical Devices CE Mark 510(k) |
Technical File Standards
for In-Vitro Diagnostics (IVD) and other Medical Devices, European
Union, and FDA |
| AS9100, AS9110, AS9003, AS9120, AC7004 |
International Aerospace
QMS |
| Nadcap |
Aerospace and Defense
Contractor Accreditation Program |
| MedAccred | Medical Device Contractor Accreditation Program |
| ISO 14001 |
Environmental Management
System |
| IATF 16949 |
International Automotive
QMS |
| Automotive Processes |
PPAP, APQP, MSA, FMEA, SPC, CQI-9 |
| ISO 17025, AC7006 |
Inspection and
Calibration Laboratories QMS |
| TL 9000 |
Telecommunications QMS |
| OHSAS 18001 |
Health and Safety MS |
| ISO 22301 | Business Continuity Management System (BCM) | | ISO/IEC 27001 | Information Security Management (ISMS) |
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Key Steps to your ISO
Management Systems implementation
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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.
- Document Map: 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.
- Project Plan: ER
will create a detailed 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.
- 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.
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Development
and Implementation Phase
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- Document Control: ER
will create or update your document control system to comply with the
management standard. This includes the creation of the procedure and
training.
- 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.
Quality
Manual
Describes
the QMS |
Level Two
Procedures
Describes process steps for who is
doing what, where, when. This is
often the tribal knowledge that is
passed down but not documented. |
Level Three
Work Instructions
Detailed instructions: traveler, lists, logs, prints, forms,
diagrams, user manuals, ERP and MRP system |
Level Four
Quality Records
Detailed historical records to show evidence of completed work |
- 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 placed 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).
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Training
Phase
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- 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.
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Auditing
Phase
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- 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 is thorough, that the proper reports are made, and that
each auditor is comfortable with the process.
- Internal Audit Workbooks: As
an option, ER may provide specially designed internal audit workbooks
to help support the internal audit and also to measure the risk
associated with any of the elements of your Quality Management System.
- 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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