| 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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Benefits of ISO 9000 and Other Management ystems
Customer/Marketing
Benefits
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Greater focus on customer
requirements and customer service
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Conveys commitment to quality
and partnering
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Promotional credibility to an
international standard
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Provides access to markets and
bids
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Employees become more responsive
to customer needs and requirements
Internal Benefits
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Continuous Improvement Cycle of a management system results
in savings:*
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$117,000 in annual savings on
average (range: $25,000 - $500,000)
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plus $77,000 in additional
on-time savings in first year
*(survey
based on average North American registered company)
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Guarantees that new and existing
products and services satisfy customers
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Provides a universal approach to
quality and business
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Assists in establishing
operational baselines and enterprise alignment
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Operationalizes and
proceduralizes quality
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Encourages self-assessment and
maintains internal consistency
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Controls processes and systems and
establishes operational controls
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Makes internal operations more
efficient and effective
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Corporate walls come down;
people communicate better
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Ensures product development and
design changes are controlled
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Reduced customer quality audits
reduce your business disruptions
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Creates awareness of the need
for training and encourages operational problem solving
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Provides insights on
organizational interrelationships, encourages internal focus,
facilitates internal operational control, and assists employees in
understanding and improving operations
Customer-Supplier
Partnering Benefits
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Forms the basis for a common
language of quality
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Ensures a minimum level of
quality
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Facilitates development of
seamless operations
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Reduces supplier base and
assists in selecting suppliers
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Facilitates just-in-time delivery
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Assists in monitoring suppliers
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Internal Benefits |
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| Improves |
Reduces |
- Management efficiency
- Planning
- Problem-solving
- Supplier control
- Communications
- Ability to change
- Discipline
- Staff morale
- Employee training
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- Duplicate effort
- Rework
- Waste
- Costs
- Staff Turnover
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| External Benefits |
| Improves |
Reduces |
- Product and service quality
- Customer satisfaction
- Repeat sales
- Company image
- Marketability
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- Complaints
- Warranty claims
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