2. What is a QMS?
The short answer:
Say what you do (documentation)
Do what you say (implementation)
Prove what you do (records)
Review and improve (continuous improvement)
3. QMS Definitions
A Quality Management System is:
System for managing the quality of an
organization
Includes everything in the organization that
relates to quality:
Products and services
Processes
Operations
Customer Satisfaction
4. QMS Description
As required by ISO 9000:
The Quality System is well documented,
implemented, understood, maintained and
continually improved
Emphasis is placed on problem prevention rather
than inspection
Quality planning is required
The PROCESS APPROACH to management is
encouraged
5. QMS Description
Quality Standard or
Regulation
ISO 9001:2015
Process Verified
ISO Guide 65
Quality System
Assessment Program
National Organic
Program
Product or Service
Consistent quality feed
Identity Preserved
livestock or grain
Consulting Service
Organic Certification
and Organic
Production
Beef Export Verification
(BEV)
6. What makes it so special?
Process Approach to management
Integration of processes into a System/
Interrelation of all activities
Continual Improvement at all levels
Communication among all employees and
management that leads to full utilization of
everyone’s talents
7. DEFINITION
“A desired result is achieved more efficiently when
activities and related resources are managed as a
process.”
PROCESS – collection of interrelated activities
that transform inputs into outputs
8. DEFINITION
“Identifying, understanding, and managing
interrelated processes as a system contributes to
the organization’s effectiveness and efficiency in
achieving its objective.”
SYSTEM – a collection of interrelated
processes with a common set of objectives and
outputs.
9. Yes, more DEFINITIONS
PROCESS CHAMPION – member of top
management who has interest in promoting the
control and improvement of a specific process.
PROCESS OWNER – the head of one of the
key functions involved in the actual operation of
the process and is responsible for ensuring that
the process is understood, documented,
implemented, controlled, and improved.
10. Last of the DEFINITIONS
VERIFICATION – the confirmation that
specified requirements have been met
VALIDATION – confirmation through
the provision of objective evidence that
the requirements for a specific intended
use or application have been fulfilled
11. Process – making coffee
INPUTS
MANUFACTURE
OUTPUT
VERIFY
MEASURE
Sub-process
17. Vertical Management Style
Focus on end product
Customer satisfaction only relevant to
complaints
Communication on a “need to know” basis
Improvement on an “as needed” basis
Responsibility not established until
something goes wrong!
18. ISO 9000 QM System
Customers
Customers
Resource
Management
Measurement,
Analysis and
Improvement
Management
Responsibility
Product
Realization
Continuous Improvement of the
QMS
Requirements
Input
Output
Satisfaction
Product
19. Quality Management Style
Focus on the entire system
Customer is main concern
Communication at all levels
Continuous Improvement
Responsibility assigned
20. Why Implement a QMS?
(ISO 9001)
Ensure Customer Satisfaction
Improve Quality System
Enhance Control of Resources
Improve Suppliers Performance
22. ISO 9001 Requirements
1. SCOPE covers why the standard is used
2. APPLICATION states that the standard
is generic and there can be exclusions
from section 7
3. TERMS AND DEFINITIONS
reference ISO 9000 and 9001 vocabulary
23. ISO 9001 Elements
4. General Requirements (Documentation
requirements covered in earlier training)
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and
Improvement
24. Just a Refresher
Documentation – The information used to
provide a description of your operation and to
record its activities
Quality Manual, Work Instructions, Sales Invoices
Documents – work papers used for activities.
They will change over time (living)
Procedures, Forms, Policies
Records – historical material that will not
change, but will be retained for reference (dead)
Meeting minutes, Completed forms, Reports
25. ISO 9001 Element 4
General ( Documentation)
Covered in “Creating and Documenting a
Quality Management System”
Managers and supervisors most likely would
write or participate in writing documents:
procedures
forms
work instructions
Managers and supervisors provide oversight of
record creation, preservation, and retention
26. ISO 9001 Element 5
Management Responsibility
Management Commitment
Customer Focus
Planning (Objectives & QMS)
Responsibility, Authority and Communication
(Management Representative)
Management Review
27. ISO 9001 Element 5
Management Responsibility
Top Management is responsible for Meeting
Customer Requirements, Policy, Objectives,
Planning, Management Review, and
Management Representative
Mid-level Managers and Supervisors are
responsible for supporting Top Management’s
Objectives, Fostering Communication at ALL
Levels, and Building Enthusiasm for the QMS
Throughout the Company
28. ISO 9000 Element 6
Resource Management
(Human, Infrastructure and Environment)
Provision of Resources
Human Resources
General
Competence, Awareness, and Training
Infrastructure
Work Environment
29. ISO 9001 Element 6
Resource Management
(Human, Infrastructure and Environment)
Mid-level Managers and Supervisors must:
Ensure that all employees are competent to do their
jobs; strive for performance improvement
Be observant of buildings, machinery and property;
make recommendations as appropriate
Follow all safety rules and make certain employees
follow your example; make working conditions as
comfortable as possible – including both physical and
emotional comfort
30. ISO 9001 Element 7
Product Realization
7.1 Planning
7.2 Customer-Related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring
Devices
31. ISO 9000 Element 7.1
Product Realization
Planning of Product Realization
Plan and Develop Process
Planning Consistent with other processes must
determine:
Quality Objectives and Requirements
New processes, documents and resources
Verification, validation, monitoring, inspection
and testing
Records
Suitability
32. ISO 9000 Element 7.2
Product Realization
Customer-Related Processes
Determination of requirements related to
the product
Review requirements related to the product
Customer communication
33. ISO 9001 Element 7.3
Product Realization
Design and Development
Planning
Inputs
Outputs
Review
Verification
Validation
Control of changes
34. ISO 9001 Element 7.4
Product Realization
Purchasing
Purchasing Process
Purchasing Information
Verification of Purchased Product
35. ISO 9001 Element 7.5
Product Realization
Production and Service Provision
Control of Production and Service
Provision
Validation of Processes
Identification and Traceability
Customer Property
Preservation of Product
36. ISO 9001 Element 7.6
Product Realization
Control of Monitoring and Measuring Devices
Determine the monitoring and measurement needed
and the devices to be used
Establish processes to ensure that monitoring and
measurement can be carried out
Ensure that equipment is calibrated correctly,
identified, safeguarded, protected and keep records
Asses validity of previous measuring results when
equipment is faulty/take appropriate action/record
Confirm intended use of computer software
37. ISO 9001 Element 8
General
Monitoring and Measurement
Control of Nonconforming Product
Analysis of Data
Improvement
Measurement, Analysis and Improvement
38. ISO 9001 Element 8.1 & 8.2
8.1 General
8.2 Measurement
Customer Satisfaction
Internal Audit
Monitoring and Measurement of Process
Monitoring and Measurement of Product
Measurement, Analysis and Improvement
39. ISO 9001 Element 8.3 & 8.4
8.3 Control of Nonconforming Product
8.4 Analysis of Data
Measurement, Analysis and Improvement
40. ISO 9001 Element 8.5
Improvement
Continual Improvement
Corrective Action
Preventive Action
Measurement, Analysis and Improvement
41. ISO 9001 QM System
Customers
Customers
Resource
Management
Measurement,
Analysis and
Improvement
Management
Responsibility
Product
Realization
Continuous Improvement of the
QMS
Requirements
Input
Output
Satisfaction
Product
43. What are ISO 9000 Principles?
Fundamental beliefs that form the foundation of
the ISO requirements
Lead to quality excellence by following them
Are based on practical application
Can be applied at any level of the quality pyramid
Quality Control (QC)
Quality Management (QM)
Total Quality Management (TQM)
44. ISO 9001 Principles
Customer Focus
Leadership
Involvement of
People
Process Approach
Systems Approach
to Management
Continual
Improvement
Factual Approach
to Decision Making
Mutually beneficial
supplier
relationship
45. ISO 9001 Principles
1. Customer Focus
QC -- understand and meet basic
requirements; little or no knowledge of
customer perceptions
QM – better understanding of overall
requirements; customer satisfaction tracked
TQM – customer information collected
systematically throughout the company;
knowledge of customer perception; ability
to offer preferred products
46. ISO 9001 Principles
2. Leadership
QC – management provides resources
sufficient for quality control
QM – management establishes policy,
objectives and environment to control
processes that ensure quality
TQM – managers provide personal
examples that create customer
satisfaction; quality is a strategic issue
47. ISO 9001 Principles
3. Involvement of people
QC – people must create and operate basic
process; does not draw on full talents
QM – processes defined and personnel
qualified; employees contribute to
improvement
TQM – employees fully engaged & entirely
involved; high level of communication
between leaders and employees
48. ISO 9001 Principles
4. Process Approach
QC – inspection and testing are common;
controlled processes provide feedback
QM – movement from control of only process
outputs to control of the process itself ;
additional processes such as management review,
corrective actions, etc.
TQM – optimizes resources, continually improves,
uses process measures
49. ISO 9001 Principles
5. System Approach to Management
QC – inspection and control systems work
together but not integrated with the rest of
the organization
QM – moved to integrate the process for
creating the product with verification of the
final product; focus on customer
satisfaction
TQM – fully understands the interaction
among the processes; continually improves
50. ISO 9001 Principles
6. Continual Improvement
QC – focus on improvements to ensure
that the customer does not receive
defective products
QM – focus on improving the
effectiveness and efficiency of the QMS;
mature corrective/preventive loop
TQM – focus on efficiently meeting
customer needs through the QMS;
leaders involved in improvement process
51. ISO 9001 Principles
7. Factual Approach to Decision Making
QC – uses data to distinguish nonconformities;
statistical data ensure requirements are met;
little use of data to measure trends
QM – facts and data used to make decisions
regarding the QMS; focus on improvement
TQM – analysis used to improve market
position; information gathered from all
members of the organization
52. ISO 9001 Principles
8. Mutually Beneficial Supplier Relationship
QC – some validation of the suppliers product
QM – processes to define and document,
review and evaluate; well developed and
defined validation process
TQM – focus changes with established strategic
alliances or partnerships; mutual commitment
to customer satisfaction; focus on continual
improvement becomes common
