Overview of Quality Management Systems and ISO 9001

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Overview of Quality Management Systems and ISO
9001
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• 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

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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.

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• 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

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• 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

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

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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

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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
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The Deming Cycle
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The Deming Cycle for improvement is the
cornerstone of all Management Systems
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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

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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.
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As your Management Systems mature, effective use
of the Deming Cycle will ensure continual
improvement
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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
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THE VALUE ADDED AUDITING APPROACH
PROCESS AUDITS
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8 Management Principles
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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

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Customer Focus
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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.

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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
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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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Process and System Approach
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The Process Approach
Process Approach A desired result is achieved
more efficiently when activities and related
resources are managed as a process.
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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.
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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.
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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.
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Process InteractionsInputs and Outputs
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Controls (procedures, inspections, training,
etc.)
Process Activities Resources
Inputs
Outputs
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Management Systems must define the sequence and
interactions of processes
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A Quality Management System is focussed on
meeting customer requirements.
Customer requirements
Customer Satisfaction
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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!
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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
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• 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

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

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• 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

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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
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This example clearly defines the sequence of
processes but does it clearly define their
interactions?How should process interactions be
defined?
Sequence versus Interactions
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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.

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• 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)?

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Most importantly, does Top Management use their
process definitions to effectively manage their
business (not just for audits)?
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Every process has an owner.The process outputs
are their job description!The process measures
are their performance review!
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• 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

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• 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

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• 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)!

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• 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.)

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Process Measurementand Objective Deployment
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Factual Approach to Decision Making

• Factual Approach to Decision Making
• Effective decisions are based on the analysis of
  data and information.

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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?

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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.

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Continual Improvement

• Continual Improvement
• Continual improvement of the organizations
  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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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.
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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.
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THE VALUE ADDED AUDITING APPROACH
PROCESS AUDIT
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Process Monitoring and Measurement
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• 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.

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How does a company implement their BUSINESS
PLAN? The process approach is one of the best
methods to implement a business plan
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Top Management
Effective policy deployment through measurement
is required by all ISO 9001 based standards.
Top Management
Process Owners
Effective Planning and Communication
Operators
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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
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• 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

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Management Communicationand Employee Awareness
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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.

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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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Imagine the power of an organization that has
truly achieved Unity of Purpose?
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Is this enough information to ensure that
everyone clearly understands what must be done to
achieve the improvement goal?
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• 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?

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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
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• 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?

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Summary
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What is the role of an auditor? Especially 3rd
party pros
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• 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.

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Hierarchy of Quality
Advanced Auditing covers QA and QM more
effectively
Basic conformance auditing covers QC level
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Course Summary

• Its not about the paperwork
• Its all about if it works!

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Course Summary

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

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Course Summary

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