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Overview of Quality Management Systems and ISO 9001

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Title: Overview of Quality Management Systems and ISO 9001


1
Overview of Quality Management Systems and ISO
9001
2
  • Why is ISO 9001 so popular?
  • The scope of the Standard specifies requirements
    intended to
  • demonstrate organizations ability to
    consistently provide product meeting customer
    applicable regulatory requirements
  • enhance customers satisfaction through effective
    application of the system including processes for
    its continual improvement and assurance of
    conformity to customer and applicable regulatory
    requirements

3
New Structure Focus
  • Why is ISO 9001 so popular?
  • 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.

4
  • The ISO 9000 Family
  • ISO 90002005 Quality management - Fundamentals
    and vocabulary
  • ISO 90012000 Quality management systems -
    Requirements
  • ISO 90042000 Quality management systems -
    Guidelines for performance improvements
  • ISO 100062003 Quality management - Guidelines
    for quality management in projects
  • ISO 100072003 Quality management systems -
    Guidelines for configuration management
  • ISO 100122003 Measurement management systems -
    Requirements for measurement processes and
    measuring equipment
  • ISO 190112002 Guidelines for quality and/or
    environmental management systems auditing

5
  • Relationship with ISO 9004
  • ISO 9001 ISO 9004 - consistent pair
  • Designed to complement each other
  • Different scope - same structure
  • ISO 9001 can apply for certification or
    contractual purposes and focuses on effectiveness
  • ISO 9004 aims on improving performance and
    efficiency

6
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.
  • There is a possibility that we may offer ISO 9004
    certification for clients seeking to achieve
    results beyond ISO 9001

7
New Structure Focus
  • The ISO 9001 Standard is modelled for Quality
    Management with 5 Major clauses
  • Quality Management System (QMS)
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis Improvement

8
System Approach of ISO 9k2k
C U S T O M E R S
C U S T O M E R S
Continual Improvement of the Quality Management
System
S a t I s f a c t I o n
Management responsibility
R e q u I r e m e n t s
Resource management
Measurement, analysis, improvement
Product
Product
Input
Output
9
The Deming Cycle
10
The Deming Cycle for improvement is the
cornerstone of all Management Systems
11
  1. PLAN Design or revise business process
    components to improve results
  2. DO Implement the plan and measure its
    performance
  3. CHECK / STUDY Assess the measurements and report
    the results to decision makers
  4. ACT Decide on changes needed to improve the
    process

12
Every organizations management systems are
comprised of various processes, each with their
own set of metrics, goals, targets and
initiatives. The key is to align each process
PDCA cycle with the overall strategic effort of
the organization.
13
As your Management Systems mature, effective use
of the Deming Cycle will ensure continual
improvement
14
System Approach of ISO 9k2k
C U S T O M E R S
C U S T O M E R S
Continual Improvement of the Quality Management
System
S a t I s f a c t I o n
Management responsibility
R e q u I r e m e n t s
Resource management
Measurement, analysis, improvement
Product
Product
Input
Output
15
THE VALUE ADDED AUDITING APPROACH
PROCESS AUDITS
16
8 Management Principles
17
New Structure Focus
  • The intent of ISO 9001 is based on the 8
    Management System Principles described in ISO
    9004
  • customer focus
  • leadership
  • involvement of people
  • process approach
  • system approach
  • continual improvement
  • factual approach to decision making
  • mutually beneficial supplier relationships

18
Customer Focus
19
Customer Focus
  • 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.

20
System Approach of ISO 9k2k
C U S T O M E R S
C U S T O M E R S
Continual Improvement of the Quality Management
System
S a t I s f a c t I o n
Management responsibility
R e q u I r e m e n t s
Resource management
Measurement, analysis, improvement
Product
Product
Input
Output
21
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.

22
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.

23
Customer Focus
  • Additionally, the organization must demonstrate
    that effective arrangements for communicating
    with customers are in place in relation to

24
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?

25
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?

26
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.

27
Process and System Approach
28
The Process Approach
Process Approach A desired result is achieved
more efficiently when activities and related
resources are managed as a process.
29
The System Approach to Management
System Approach Identifying, understanding and
managing interrelated processes as a system
contributes to the organizations effectiveness
and efficiency in achieving its objectives.
30
ISO 9000 2.4 The Process Approach Any
activity, or set of activities, that uses
resources to transform inputs to outputs can be
considered as a process. For organizations to
function effectively, they have to identify and
manage numerous interrelated and interacting
processes. Often, the output from one process
will directly form the input into the next
process. The systematic identification and
management of the processes employed within an
organization and particularly the interactions
between such processes is referred to as the
process approach.
31
ISO 9000 2.8.1 Evaluating processes within the
quality management system When evaluating quality
management systems, there are four basic
questions that should be asked in relation to
every process being evaluated. a) Is the process
identified and appropriately defined? b) Are
responsibilities assigned? c) Are the procedures
implemented and maintained? d) Is the process
effective in achieving the required results? The
collective answers to the above questions can
determine the result of the evaluation.
32
Process InteractionsInputs and Outputs
33
Controls (procedures, inspections, training,
etc.)
Process Activities Resources
Inputs
Outputs
34
Management Systems must define the sequence and
interactions of processes
35
A Quality Management System is focussed on
meeting customer requirements.
Customer requirements
Customer Satisfaction
36
Other Management Systems (Environmental, Safety,
SOX, etc.) are mainly focussed on meeting
regulatory requirements.
Regulatory requirements
Regulatory Compliance
The Process Approach can be used for all
Management Systems!
37
Ultimately every Management System must be seen
by Top Management as an effective method for
ensuring financial performance (even though its
not a requirement).
Investment
Profitability
38
  • Compatibility with other management systems
  • Standard is intended to be compatible with other
    systems
  • It is aligned with ISO 14001 and 18001 to enhance
    compatibility
  • Standard does not include requirements for other
    management systems such as EMS, OHSM, or
    financial management
  • Integration of management systems is possible

39
  • The ultimate goal of any organization is to fully
    integrate all
  • customer
  • shareholder
  • regulatory
  • and any other requirements? (discuss)
  • into ONE Business Management System.

40
  • Ideal scenario
  • Our clients Quality, Health Safety and
    Environmental Management Systems operate within
    their Business Management System
  • Their BMS
  • QMS
  • FMS
  • OHSM
  • EMS
  • ERP
  • HR

41
All too common scenario that we need to help
change Their QMS, OHSMS and EMS are seen as the
ISO systems and operate mostly outside of their
BMS. Management does not see the value of these.
Its something that we have to do for ISO
42
This example clearly defines the sequence of
processes but does it clearly define their
interactions?How should process interactions be
defined?
Sequence versus Interactions
43
Interaction of Processes
  • Interaction should be defined using inputs and
    outputs
  • Graphical representations such as process maps /
    flowcharts are perhaps the most easily
    understandable methods of describing interaction
    between processes, however not a specific
    requirement.
  • Interaction can be described with words if
    desired
  • At a minimum, the processes of the organization
    need to be identified as per 4.1a and their
    interaction needs to be clearly defined in the
    manual as per 4.2.2c.

44
  • Common methods used to define process
    interactions
  • Flowcharting
  • SIPOC diagrams (Six Sigma method)
  • Process Turtles (ISO 9001 method)
  • Value Stream Mapping (Lean Manufacturing method)
  • NOTE How many times have your processes been
    defined in how many ways? Are all process
    definitions linked and do they complement each
    other (no redundancy)?

45
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46
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47
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48
Most importantly, does Top Management use their
process definitions to effectively manage their
business (not just for audits)?
49
Every process has an owner.The process outputs
are their job description!The process measures
are their performance review!
50
  • Evidence to find and communicate
  • Organization charts are process based and show
    clear process ownership
  • Business metrics are process based and ensure
    transparent accountability for process
    performance
  • Facility floor plans can be linked to processes
  • Business plans and budgets align with their
    process definitions.
  • Management reviews of process performance
    include ALL processes at some frequency

51
  • Quality Manual
  • ISO 9001, clause 4.2.2 requires
  • The organization shall establish and maintain a
    quality manual that includes
  • A) the scope of the quality management system,
    including any details of and justification for
    any exclusions
  • B) the documented procedures established for the
    QMS, or reference to them
  • C) a description of the interaction between the
    processes of the QMS

52
  • Quality Manual
  • A QM that simply regurgitates the ISO clauses is
    not acceptable!
  • A QM that includes a process map showing sequence
    only is not acceptable!
  • The QM must define the process interactions
    (outputs inputs)!

53
  • Quality Manual potential uses
  • To manage the business as a key input to
    organizational planning, resource allocation,
    goal setting, problem solving, etc.
  • The training material for employee orientation,
    especially managers!
  • A communication tool for external parties
    (customers, corporate management, board of
    directors, regulatory bodies, etc.)

54
Process Measurementand Objective Deployment
55
Factual Approach to Decision Making
  • Factual Approach to Decision Making
  • Effective decisions are based on the analysis of
    data and information.

56
Analysis of Data Measurement
  • 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 cant answer this question for nearly
    every record you spend time and money collecting
    then why do you do it?

57
Analysis of Data Measurement
  • 8.4 - The organization shall determine, collect
    and analyze appropriate data to demonstrate the
    suitability and effectiveness of the quality
    management system and to evaluate where continual
    improvement of the effectiveness of the quality
    management system can be made. This shall
    include data generated as a result of monitoring
    and measurement and from other relevant sources.
  • The analysis of data shall provide information
    relating to
  • customer satisfaction (see 8.2.1),
  • conformity to product requirements (see 7.2.1),
  • characteristics and trends of processes and
    products including opportunities for preventive
    action, and
  • suppliers.

58
Continual Improvement
  • Continual Improvement
  • Continual improvement of the organizations
    overall performance should be a permanent
    objective of the organization.

59
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).

60
ISO 9000 2.11 Quality management systems and
other management system focuses The quality
management system is that part of the
organization's management system that focuses on
the achievement of results, in relation to the
quality objectives, to satisfy the needs,
expectations and requirements of interested
parties, as appropriate.
61
ISO 9000 - 2.8.2 Auditing the quality management
system Audit findings are used to assess the
effectiveness of the quality management system
and to identify opportunities for improvement.
62
THE VALUE ADDED AUDITING APPROACH
PROCESS AUDIT
63
Process Monitoring and Measurement
64
  • Processes must be monitored and measured -
  • Measurement categories that need to be considered
    are
  • Quality Does the process consistently produce
    desired outputs?
  • Delivery Does the process consistently deliver
    the outputs on time?
  • Efficiency Does the process produce and deliver
    the outputs using the least amount of resources
    necessary
  • Others such as Cost, Safety, Regulatory
    Compliance, etc.
  • Too often only one of these categories is applied
    and that misleads management into thinking that
    everything is alright.

65
How does a company implement their BUSINESS
PLAN? The process approach is one of the best
methods to implement a business plan
66
Top Management
Effective policy deployment through measurement
is required by all ISO 9001 based standards.
Top Management
Process Owners
Effective Planning and Communication
Operators
67
We try to focus our audits on The linkage of
the measures and objectives to customer
satisfaction and business results The planning
and resource allocation activities that are
necessary to achieve any improvement
objective The leadership and communications
activities that engage the entire organization in
this process The effective use of the PDCA
cycle in every process that is focused on company
objectives
68
  • Policy Defect free product, on time to the
    customer at a reasonable price and continually
    improving all processes in accordance with the
    requirements.
  • Organizational objective 98 on time to
    customer promise date
  • Process objectives established to meet
    organizational goal
  • Order review processes all orders processed
    within 2 days of receipt
  • Warehouse process 100 compliance with FIFO, 18
    inventory turns
  • Maintenance Process 97 uptime, no past due
    scheduled items
  • Purchasing process 95 of tier 1 suppliers on
    time and within window
  • Production Scheduling all shop routers
    completed within 1 day of receipt and all orders
    scheduled to be completed 2 days prior to
    required ship date

69
Management Communicationand Employee Awareness
70
Leadership Involvement of People
  • Leadership and 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
    organizations objectives.
  • People at all levels are the essence of an
    organization and their full involvement enables
    their abilities to be used for the organizations
    benefit.

71
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).

72
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).

73
Imagine the power of an organization that has
truly achieved Unity of Purpose?
74
Is this enough information to ensure that
everyone clearly understands what must be done to
achieve the improvement goal?
75
  • Too often management only communicates partial
    information. To understand the complete path to
    improvement everyone needs to know the following
  • Where are we now (measure) and where do we want
    to be (goal)?
  • Why are we here (causes of failure)?
  • What are we doing to improve (plan)?
  • How am I personally involved?

76
Plan for Improvement
Tasks Resp. Due Contribution Status
Increase PM frequencies on key machines Joe K. 2/23/08 50 75 complete, Need more resources
Increase buffer inventories of critical parts Janice Q. 4/1/08 30 50 complete, no issues
77
  • EFFECTIVE Communication
  • Too often management only communicates in one way
    (think - quarterly all employee meeting)
  • Does this communication effectively reach
    everyone (think - kids in the back of the room)?
  • To truly achieve unity of purpose shouldnt there
    be multiple communication methods happening all
    the time?
  • Will management have to adjust their
    communication methods and frequencies or do they
    normally achieve perfection on the first try?
  • Can management communication be considered a
    process with clear outputs (employee
    understanding, satisfaction, unity of purpose,
    etc.) and measures?

78
Summary
79
What is the role of an auditor? Especially 3rd
party pros
80
  • To make sure that an organization is doing the
    right things, the right ways, all the time.
  • To find evidence that what the organization does
    is conforming, effective and efficient.
  • To add value by
  • Identifying potential problems before they happen
  • Helping to solve existing problems, and
  • Identifying opportunities for improvement.

81
Hierarchy of Quality
Advanced Auditing covers QA and QM more
effectively
Basic conformance auditing covers QC level
82
Course Summary
  • Its not about the paperwork
  • Its all about if it works!

83
Course Summary
  • The majority of the efforts needed to demonstrate
    conformance to ISO 9001
  • lie with Top Management.

84
Course Summary
  • Run properly, by management, your QMS will help
    you achieve your business goals.
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