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ISO 9001-2000

Quality Management
System (QMS)

Paul Corona

ISO 9001


0 ORDER 8110-42
What are the ISO 9000 Standards?

The ISO standards are a series of international

quality management system standards which
adopt a process approach for developing and
improving the effectiveness of a quality system.

These standards can be applied to almost any

company from product manufactures to service
providers; they are not specific to any product or
What are the ISO 9000 Standards (Con’t)

The ISO 9000 Standards require documented

systems for controlling the processes we use to
develop and produce our products. These types
of standards are based on the idea that there are
certain elements every quality system must have
in place in order to ensure that quality products
and services are consistently produced and on
What are the ISO 9000 Standards (Con’t)

The ISO standards focus on the how you produce

a product rather then what you produce

The ISO 9000 series was developed and is

maintained by committees that include
representatives from 27 countries. It has been
adopted by over 70 countries around the world
as the accepted standard of quality management
systems requirements.
The Purpose of the ISO 9000
Standards is to ...

Provide a common basis for doing business

and managing quality.

Allow diverse companies to exchange

products and services with greater
The Objectives of the ISO 9000
Standards are to...
Achieve, sustain, and improve product/service
quality by managing the processes that create them

Give ourselves confidence that customer

requirements are being met

Give the customer confidence and satisfaction that

products and services are consistent
Provide or sustain market entry
ISO 9000 Isn’t ...
A Panacea. It alone won’t solve all problems related to quality

Prescriptive. It tells you What, not How

All we need to do. It only specifies minimum requirements for an

effective quality system.

The Ultimate Goal. Our competitive edge depends on our ability to

constantly improve and strive for excellence

Sufficient. It requires supplementation with more specific and detailed

customer and/or sector specific requirements
The Registration Process
Registration is provided by organizations know as
U.S. Registrars are certified by the Registrar
Accreditation Board (RAB)
About 70 Registrars in the U.S.
Registrars perform an “independent” (third-party) audit
of organization
Successful audit yields registration recommendation
Registration is maintained through periodic “surveillance”
ISO 9000 Status
270,000+ Companies Registered Worldwide

35,000+ Companies Registered in the U.S.

20,000+ U.S. Companies pursuing Registration

DoD, & many other “sectors”or industries have

adopted ISO 9000 based standards
Goals are Captured in the Quality
The quality policy was developed by top management
to ...

tell customers what Your Company’s quality goals are,

and to

tell all employees what they should strive for

Do you know Your Company’s quality policy?
“to provide error free products
and services on time ”
We are Adopting ISO 9000 to …
meet our customer requirement of demonstrating
compliance to the ISO 9000 standard. This will
maintain our status as a preferred supplier.

have a competitive advantage in developing future

business and customers.

Improve the many benefits and improvements that all

companies adopting ISO 9000 have reported.
What is a Quality Management
achieving desired results by

establishing policy and objectives and providing resources to
achieve them through a

set of interrelated or interacting processes
The Basis of a Quality System is to

say what you do,

do what you say,
record what you did,
check the results, and
act on the difference
Structure Comparison
ISO 9001-1994 to ISO 9001-2000
ISO 9000:2000 has abandoned the 20 clause structure.
Instead the new standard has 5 sections.
The new standard is more customer orientated. In
addition, it expects one to communicate with the
customer and to measure customer satisfaction.
The new standard also emphasizes the need to make
improvements. It requires us to evaluate the
effectiveness and suitability of the QMS and to identify
and make improvements
ISO 9001-2000 Structure

The new standard has five sections:

4.0 The Quality Management System

5.0 Management Responsibilities
6.0 Resources Management
7.0- Product Realization
8.0 Measurement Analysis and
Section 4.0
Quality Management System General
The organization shall establish, document, implement, and maintain a QMS and
continually improve its effectiveness in accordance with the requirements of the
standard; this includes:

- define processes to be managed (including out-sourced processes - which typically

include design, training, calibration, heat treat, etc.)

- define the sequence and interaction of these processes

- determine the criteria and methods needed to manage these processes and ensure their

- take actions to improve these processes.

Section 4.0
Quality Management System General
Documentation Requirements

- A quality manual
- Controlled Procedures and Work Instructions
- Records that provide evidence of conformity
Section 5.1
Management Commitment
Top management must demonstrate commitment to
development and implementation of the quality system
and continually improving its effectiveness through
specific activities:

- communicate importance of meeting customer (and

statutory/regulatory) requirements
- establish quality policy and objectives
- conduct management reviews
- ensure availability of necessary resources
Section 5.2
Customer Focus
Top management must:

- ensure customer needs and expectations are

determined, turned into requirements, and

- ensure customer requirements are met with the

aim of enhancing customer satisfaction (a
“perception” that must be measured.
Section 5.3
Quality Policy
Top management has established a quality policy that:

- is appropriate for the organization’s purpose,

- includes a commitment to meeting requirements and continual
improvement of the effectiveness of the QMS,
- provides a framework for establishing/reviewing measurable
quality objectives, and,
- is communicated and understood and implemented at
appropriate levels, and
- is periodically reviewed for continuing suitability
Section 5.4
Top management must establish quality objectives and
identify resources needed to meet them:

- 5.4.1 Quality objectives. First, measurable quality objectives

consistent with the quality policy must be established at relevant
functions and levels in the organization, including those needed to
meet product requirements; and

- 5.4.2 Quality management system planning. Secondly, resources

required to meet the objectives and carry out the processes (identified
per clause 4.1) must be identified and planned
Section 5.5 Responsibility, Authority and
Top management must establish clear responsibilities, authorities and
communication systems regarding the QMS:

- Responsibility and authority. First, responsibilities and authorities must be defined

and communicated with the organization.

- Management representative. Secondly, a management representative appointed by

top management must ensure the QMS is implemented, report to top management on
performance of the QMS, and promote awareness of customer requirements throughout
the organization

- Internal communication. Finally, internal communications regarding the effectiveness

of the quality system must be established
Section 5.6
Management Review
Top management must review the suitability, effectiveness, and
adequacy of the QMS at planned intervals; and must evaluate the need
for change, including changes to policy and objectives.

- Review input. Specific review inputs are required including current

performance and improvement opportunities related to audit results,
customer feedback, performance of product and processes, status of
actions, changes that could affect the QMS, and recommendations for

- Review output. Specific review outputs must be recorded including

actions and resources related to improvement of product, the QMS,
and QMS processes
Section 6
Resource Management
The organization shall determine and provide the resources needed:

- to implement and maintain the QMS and continually

improve its effectiveness;
- to enhance customer satisfaction by meeting customer
- ensure personnel performing work that effects quality
are competent in the basic skills required;
- infrastructure and a suitable environment shall be determined and
provided to achieve conformity to product requirements.
Section 7
Product Realization
This section deals with the product. In brief, when you
start out with an idea and interconnect a series of
processes to end up with a product, the overall process is
called product realization.

The individual processes are planning, determining

customer needs and requirements, review of the
requirements, customer communication, design and
development, purchasing, verification of purchase
products, production, production process validation,
identification and traceability, preservation and calibration.
Section 8
Measurement, Analysis and
The organization shall plan and implement the monitoring,
measurement, analysis and improvement of the processes

The organization shall monitor information relating to the


customers perception as to whether customer

requirements have been met.
Internal audits shall be conducted at planned intervals to

determine if the processes conform to the QMS, the ISO

standard and are effectively implemented and maintained.
Three Categories of Audits
External independent audits - 3rd party
conformity to a specific standard (across the organization)

Customer audits of suppliers - 2nd party

Conformance to customer requirements and customer’s special
interest items.

Internal audits - 1st party

Conformance to standards, customer requirements, internal policy and
systems, management expectations (whether documented or not), and
opportunity finding (beyond requirements)
The Audit Process

Audit Audit Leadership

planning execution checks

The Role of Internal Audits has

ISO Effectiveness
9001 Internal audit assessed in
1994 audit report

Internal audit Management

ISO Customer effectiveness by Management
9001 satisfaction analyzing all review
2000 available data
Other data and information
Audit Methodologies ...

Audit Planning

Evaluating QMS Documentation

Conducting Process Audits

Using Internal Audits to:

- Verify QMS Effectiveness

- Identify Opportunities for Improvement

Conducting Top Management

The expanded role of top management
requires more time be spent with them
during internal audits to collect evidence of
their commitment to:

Communicating importance of meeting


Establishing quality policy and objectives,

Conducting management reviews, and

Ensuring availability of necessary resources.

Conducting “Process Owners”

Process Owners are interviewed to collect
evidence that:
- Processes and improvement objectives are
documented and planned,

- Processes and needed resources are deployed,

- Processes are monitored and measured, and

- Actions are taken, as warranted by analysis of process

Section 8
Measurement, Analysis and
Improvement (Con’t)
The organization shall develop suitable methods for monitoring
and measuring the processes to the planned results. Where
planned results are not achieved, corrective and preventative
action shall be takes as appropriate to ensure conformity of the
The organization shall monitor and measure the characteristics of
the product to the product requirements. Evidence of conformity
with the acceptance criteria shall be maintained. Records shall
indicate the persons authorizing the release of the product.
Section 8
Measurement, Analysis and
Improvement (Con’t)
The organization shall control nonconforming material,
Records of the nature of the nonconformity, actions
taken including concessions shall be maintained
The organization shall determine, collect, and analize
appropriate data to demonstrate the suitability and
effectiveness of the QMS and to evaluate where
continuous improvement of the effectiveness of the QMS
can be made.
The organization shall continually improve, take action
to eliminate the cause of nonconformities and take
action to eliminate the causes of potential
We Need the Involvement of all the
People Within Our Organization

People at all levels are the essence of an organization,

- their full involvement enables their abilities to be used for

the organization’s benefit.
We Need To Develop a Systems

A system is a set of interrelated processes, and

- the output of one process is the input to one or more

subsequent processes, so ...

- It is critical to manage the “white space” (or interface)

between processes to ensure that the overall system is
We Need to Develop Develop a
Process Approach

We need to do more than simply monitor process
outputs, (typically through inspection activities)

- we must also control all process inputs, (people,

facilities/equipment, material and methods)

and, control the transformation activities,

and monitored the process to enable a continuous
improvement environment
Almost Everything Can Be Viewed
as a Process

The Business Cycle

Turning customer requirements (inputs)

Into customer satisfaction (outputs)

Manufacturing Functions
Viewed as a Process

Turning raw material (inputs)

Into products (outputs)

We Need To Continually Improve

Continual improvement of our overall performance should

be a permanent objective:

- improvement must be a planned activity if the

organization desires to improve overall performance and
We Need To Develop a Supplier
An organization and its suppliers are inter-dependent, and a
mutually beneficial relationship enhances the ability of both to create

Suppliers should be chosen based on their ability to provide their

products in a timely manner and to meet all quality requirements

Purchase documents must clearly and accurately state our

We Need To Document the QMS

Flow charts
Referencing with documents (quality manual,
procedures, work instructions
Written description
Any Combination of the above
How Do We Develop And Manage
A Process
Establish a team to map out the process.
Define the overall objective of the process.
Define the process inputs and outputs and evaluate the
accuracy to the original requirements.
Define the baseline measures of process effectiveness and
Establish improvement objectives and identify the actions
to achieve the desired results.
Monitor processes to ensure the desired results are
achieved or to identify new opportunities for improvement.
ISO 9001-2000 QMS Summary

The QMS is made up of many processes, and

these processes are interrelated by means of
many input-output relationships. These input-
output relationships turn a simple list of
processes into an integrated system.