What is iso 9001

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					What is iso 9001

The Problem With How Consultants Implement ISO 9001 Quality Management

ISO 9001 requires that an organization identify and implement effective controls over its
quality management processes. Businesses will typically identify its processes under
typical categories such as operational processes, support processes and outsourced
processes. Collectively the controls exercised over these processes will make up their
quality management system (QMS). Many ISO 9001 Consultants and organizations go
about implementing QMS process controls in a very superficial manner resulting in a
system that does not provide any value to the organization and consequently any return
on the cost of its investment. The main reason they got certification was to satisfy a
customer contractual requirement.

But ISO 9001 can do a whole lot more for an organization if implemented the right way.
Effective risk management control over each QMS process and the interaction between
processes can result in huge improvements in an organizations productivity and bottom

The Solution: So how does an organization use risk management to control its

A process typically has inputs, outputs and value-adding activity. Each of these process
characteristics use various resources. These resources include manpower, materials,
machinery and equipment, facility and environment, methods, management, etc. These
resources are all variables and subject to risk in their use.

An organization must identify the nature and degree of such risk and implement
appropriate controls over them. Tools such as Fishbone analysis or FMEA's (Failure
Mode and Effects Analysis) may be used to perform this risk analysis. A discussion on
how to use these risk analysis tools will be left to another article.

Listed below are some of the controls an organization should consider for each of
the resources used in any QMS process.


- Inventory management

- Inspections & Tests

- Standards & Specifications
- Supplier Management

- Identification & Traceability

- Turnover & Preservation


- Capability, capacity and & technology

- Engineering & support

- Inspection, measuring & test equipment

- Tools, dies & fixtures

- Maintenance & supplies

- Equipment layout


- Skills, knowledge & experience

- Training

- Responsibility & Authority

- Empowerment, Motivation & Morale

- Adequate staffing

- Health & Safety


- Building & facilities

- Environment controls

- HVAC and other utilities

- Housekeeping, health & safety

- Lighting, air quality & noise
- Contingency/emergency measures


- Systems & Procedures

- Inspection & Tests

- Quality Plans & Checklists

- Work Instructions

- Bill of manufacture/assembly

- Technology/automation/robotics

- operational and administrative software

- Process flowcharts

- FMEA's & process controls

- Drawings & blueprints


- Objectives/tracking/review/improvement

- Standards/codes/regulations

- Specifications/tolerances/criteria/tolerances

- Operational data/statistics/SPC

- Efficiency & effectiveness

- Customer Satisfaction

- Bench-marking


- Leadership & Planning

- Policies & Objectives
- Commitment & involvement

- Organization & resources

- Follow-up & review

- Communication

How To Use These QMS Process Variables:

- Determine which of these resources variables apply to each process identified in your

- Determine which combination of controls apply to that process variable - process input,
output or value-adding activity.

- Implement the controls you have identified and verify their effectiveness.

This article provides a brief overview to using a risk management approach to effectively
implementing ISO 9001 in an organization. Keep in mind that ISO 9001 is a business
management tool. So the benefits you get from using it is directly related to how
effectively you use it. The risk management approach is a very powerful way to use ISO
9001 to effectively control your business and benefit significantly in terms of customer
satisfaction and profitability.

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