Transcript ISO 9000:2000 Management Overview

Management Overview of
ISO 9001 : 2000
Revision: 8-Feb-2003
ISO9000:2000 Management
Overview
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Consolidation of the ISO 9000 Series
• ISO 9001, ISO 9002 and ISO 9003 are now integrated
into one certification standard, ISO 9001:2000.
• All organizations will now be ISO 9001 certified.
– The differentiation of design / no design will be done
through the scope statement on the ISO 9001 certificates.
• Exclusion of any activities (i.e. design) must be
stipulated and justified in the Quality Manual.
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Consolidation of the ISO 9000 series
Previous 20 standards now replaced by four:
• ISO 9000: QMS Fundamentals & vocabulary
• ISO 9001: QMS Requirements
• ISO 9004: Guidance for QMS performance improvement
• ISO 19011: Guidelines for auditing
To be further supported by technical reports (ISO 9000-2, ISO 9000-3, etc.)
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The Use of ISO 9004 as a
Management Tool
• ISO 9004 includes all of ISO 9001 plus additional
items to consider for improvement ideas.
• ISO 9004 should be regularly used throughout the
organization to lead beyond the basics of ISO 9001
and improve the QMS during:
–
–
–
–
QMS Development,
Internal Audits,
Preventive Action,
Management Reviews.
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New Structure & Focus
• The ISO 9001:1994 model for Quality Assurance and
the familiar 20 elements did not adequately achieve the
intent to ADD VALUE.
• The ISO 9k2k Standards are now modelled for Quality
Management with 5 Major clauses:
–
–
–
–
–
Quality Management System (QMS)
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis & Improvement
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New Structure & Focus
• Significantly less emphasis on
procedures and records.
• Significantly more emphasis on
management involvement and a
system that works to achieve the
goals of your business.
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Management Systems
BMS
Quality Management
Systems vs. Business
Management Systems:
Your BMS =
QMS+
FMS+
QMS
HS&EMS+
ERP+
HR
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Management Systems
Quality Management Systems vs. Business Management
Systems:
Your QMS is not something you do separately from your BMS
“because ISO requires it”!
QMS
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BMS
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New Structure & Focus
• ISO 9001 & 9004 are based on the 8
Management System Principles:
– customer focus
– leadership
– involvement of people
– process approach
– system approach
– continual improvement
– factual approach to decision making
– mutually beneficial supplier relationships
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New Structure & Focus
Food for Thought:
– Your business is a set of interactive processes, not
20 elements of ISO 9000...
– Your QMS is the means of controlling these
processes and ensuring that the desired output is
effectively and efficiently achieved...
– Why would you define and manage your QMS
based on 20 fragmented elements of a standard?
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The Process Approach
“A desired result is achieved
more efficiently when
activities and related resources
are managed as a process.”
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The Process Approach
Controls
(e.g. procedures, operators, gaging, tooling, maintenance, etc.)
Inputs
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Process
Activities
+
Resources
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Overview
Outputs
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The System Approach to
Management
“Identifying, understanding and
managing interrelated processes
as a system contributes to the
organization’s effectiveness and
efficiency in achieving its
objectives.”
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The System Approach
The organization must identify the sequence & interactions of the QMS
processes in the Quality Manual.
Process
A
Inputs
Outputs
Controls
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Process
C
Process
B
ISO9000:2000 Management
Overview
Process
D
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System Approach of ISO 9k2k
C
U
S
T
O
M
E
R
S
Continual Improvement of the
Quality Management System
R
e
q
u
I
r
e
m
e
n
t
s
Management
responsibility
Resource
management
Input
Measurement, analysis,
improvement
Product
C
U
S
T
O
M
E
R
S
S
a
t
I
s
f
a
c
t
I
o
n
Product
Output
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Customer Focus
“Organizations depend on their
customers and therefore should
understand current and future
customer needs, should meet
customer requirements and strive to
exceed customer expectations.”
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Customer Focus
• Information on Customer perception as to whether
the organization has met their requirements must
be collected, reviewed and appropriately acted
upon (8.2.1).
• The methods of doing this are not prescribed by the
standard but should be objective, representative of
the customer base, and ADD VALUE.
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Customer Focus
• The most common methods of collecting Customer
Satisfaction data are customer surveys and customer report
cards (when provided).
• Other methods include measuring repeat orders, market
share, industry benchmarking, capturing info. from sales
visits, focus groups, and hiring consulting firms.
• A good system will use multiple methods and compare data
from multiple sources to comprehensively understand
customer perceptions and balance out any potential biases.
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Customer Focus
Additionally, the organization must
demonstrate that effective
arrangements for communicating with
customers are in place in relation to:
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Customer Focus
Product Information (7.2.3-a):
– How well do you communicate your product
information to your customers?
– Consider the experiences of using your favorite
store Catalogue, or browsing Amazon.com or
ebay...
– Were you satisfied with these experiences?
– How do you know what your customers think about
your ability to communicate information that they
are looking for?
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Customer Focus
Enquiries, contracts, and order handling,
including changes (7.2.3-b):
– Now consider the “buying experience” with these
same companies and ask the same questions…
– How do you think your customers feel about the
ordering experience with your company? What
about your quoting and order amendment
processes?
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Customer Focus
Customer feedback, including complaints
(7.2.3-c)
– Consider that a customer can be more loyal when
you handle their problems to their satisfaction (or
delight) vs. them never having a problem at all.
– Your want to know whether your customers are
satisfied with how you handle their feedback (even
positive) and complaints.
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Factual Approach to Decision
Making
“Effective
decisions are
based on the analysis of
data and information.”
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Factual Approach to Decision
Making
Plan
Act
Do
Check
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Analysis of Data & Measurement
More Food for Thought:
• Consider all the records and data that you collect and
store in your company...
• How are each of these used for analysis, training,
and improvement purposes?
• If you can’t answer this question for nearly every
record you spend time and money collecting then
why do you do it?
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Comprehensive Measurement &
Improvement Model
Quality
Policy
Strategic QMS
Objectives /
CSAT Metrics
QMS Process / Departmental
Metrics and Objectives
Project / Product / Individual Metrics &
Objectives
Factual & Logical Approach to Decision Making
Identification, Collection & Analysis of Records / Data
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Analysis of Data & Measurement
• The Quality Policy must provide the
framework for establishing strategic objectives
(5.3).
• Measurable, documented, tactical objectives at
relevant functions and levels of the
organization must be established to support the
strategic objectives (5.4.1).
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Analysis of Data & Measurement
• The QMS Processes must be Monitored and/or
Measured (8.2.3).
• Product specific objectives must be established
(7.1-a).
• Customer Satisfaction must be measured (8.2.1).
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Continual Improvement
“Continual improvement of
the organization’s overall
performance should be a
permanent objective of the
organization.”
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Continual Improvement
• The organization shall implement actions
necessary to achieve planned results and
continual improvement of the QMS processes
(4.1-f).
• Top management shall provide evidence of its
commitment to the development and
implementation of the QMS and continually
improve its effectiveness (5.1).
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Continual Improvement
• (8.1) The organization shall continually improve
the effectiveness of the QMS through the use of
the…
–Quality Policy
–quality objectives
–internal audits
–analysis of data
–corrective and preventive actions
–management reviews
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Analysis of Data, Measurement &
Improvement
Plan
Act
Do
Check
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Analysis of Data, Measurement & Improvement
Strategic Quality Planning
Top Management shall ensure that:
• The planning of the QMS is carried out in order to meet
the requirements in 4.1. - NOTE: Take some time to
review 4.1!
• Plans are in place to achieve the quality objectives
(5.4.2-a).
• No requirement for plans to be documented - Caution:
verbal plans are only effective in certain situations.
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Analysis of Data, Measurement & Improvement
Tactical Quality Planning
Top Management shall ensure that:
• any changes to the business that affect the QMS are
identified and that planning occurs to ensure that the
integrity of the QMS is maintained (5.4.2-b).
• changes that could affect the QMS are identified in
Management Reviews (5.6.2-f).
– Examples: New IT/MRP systems, new / updated equipment,
new or changed products / processes, organizational
changes, etc.
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Leadership & Involvement of People
“Leaders establish unity of purpose and direction
of the organization. They should create and
maintain the internal environment in which
people can become fully involved in achieving the
organization’s objectives.”
“People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization’s
benefit.”
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Leadership & Involvement of People
• Top Management shall ensure that appropriate
communication processes are established within
the organization… (5.5.3)
• Specific requirements for communicating
information regarding the effectiveness of the
QMS and the importance of meeting customer
and regulatory requirements (5.5.3 & 5.1-a).
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Leadership & Involvement of People
• The organization shall ensure that all
personnel are aware of the relevance and
importance of their activities and how they
contribute to the achievement of the quality
objectives (6.2.2-d).
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Resource Management
• Management must determine and provide the
resources needed to implement, maintain and
continually improve the QMS, and to enhance
customer satisfaction (6.1).
• Top Management shall provide evidence of its
commitment by… ensuring the availability of
resources (5.1-e).
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Resource Management
• Resource needs are a required
Management Review item (5.6.3-c).
• Infrastructure (buildings, equipment,
utilities, IT, communications, etc.) needs
to ensure quality must also be determined
and provided (6.3).
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Resource Management
• A system to determine competency
needs and evaluate employee
competencies must be established.
• The effectiveness of any actions
taken to satisfy competency needs
must be evaluated (6.2.2-c).
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Evaluation of Competence
Competency requirements must be determined for
all positions / people that affect quality (6.2.2-a).
Examples – Qualification criteria in job descriptions, defined
in QMS procedures, project plans, performance reviews…
Appropriate records to demonstrate that competency
requirements have been met must be maintained
(6.2.2-e).
Examples – Employment applications, resumes, degrees,
professional certifications, training records, performance
reviews...
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Evaluation of Competence
Organizational Competency considerations:
• Future demands (customer, technology, market)
• Anticipated management and workforce
succession needs
• Changes in the processes and equipment
• Individual competencies needed
• Statutory and regulatory requirements, standards,
directives, etc.
(ISO 9004 :2000)
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Evaluation of Training Effectiveness
Consider Four Variables in the Training Equation:
1. The Trainee – Did they learn?
Controls – Qualification criteria, pre/post testing, trainer /
supervisor assessments, performance reviews…
2. The Trainer – Could they Teach?
Controls – Qualification criteria / training for trainers,
Trainee / management assessments of trainer performance,
course evaluations…
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Evaluation of Training Effectiveness
3. The Material – Did it adequately convey the
necessary information?
Controls – Trainee / Trainer assessments of materials,
internal audits, course evaluations, benchmarking…
Consider the ability of an interactive video to convey
information vs. pictures only vs. a written procedure only vs.
verbal instruction only vs. a combination of all?
4. The Environment – Was it conducive to learning
the material?
Controls – Defined environmental requirements and
monitoring (temperature, noise, lighting, distractions, etc.),
trainee evaluations…
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Comprehensive Measurement &
Improvement Model
Quality
Policy
Strategic QMS
Objectives /
CSAT Metrics
QMS Process / Departmental
Metrics and Objectives
Project / Product / Individual Metrics &
Objectives
Factual & Logical Approach to Decision Making
Identification, Collection & Analysis of Records / Data
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Comprehensive Measurement &
Improvement Model
On Time Delivery example
Contract
Review /
Lead time
management
Production
Planning &
scheduling
Inventory
Management
OTD
Supplier OTD
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Equipment
capacity &
Maintenance
In order to achieve any
improvement in OTD you must first
collect and analyze appropriate
data in order to understand the
primary causes of late deliveries
and establish realistic
improvement goals.
Metrics, improvement objectives,
plans and resource needs will then
be identified and communicated
throughout the organization.
By engaging the entire
organization in this process and
using the PDCA cycle you will
ultimately achieve your OTD goals
and increased customer
satisfaction and organizational
efficiency.
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Course Summary
Say what you do…
Do what you say…
And make sure that it works!
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Course Summary
The majority of the efforts
needed to demonstrate
compliance to ISO 9001:2000
lie with the management
team.
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Course Summary
Run properly, by
management, your QMS
will help you achieve
your business goals.
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