This document provides an overview and introduction to ISO 9001:2015 Quality Management Systems (QMS). It begins with defining ISO and its purpose in facilitating international standards. It then discusses the benefits of implementing an ISO 9001 QMS such as improved operational efficiency, international recognition, and competitive advantage. The document outlines the key clauses of ISO 9001:2015 including management responsibility, risk-based thinking, documentation requirements, internal audits, corrective actions, and continual improvement. It provides examples of typical QMS documentation and processes. The overall summary is that this document serves as an introductory training on ISO 9001:2015 QMS requirements and implementation.

1. IMSM
Introduction to
ISO 9001:2015 QMS
Trainer:

2. Content
 Introduction to ISO
 Benefits of ISO
 How to start
 ISO9001: 2015
 Objectives
 Management Review
 Internal Audit
 Continual Improvement
 Who is IMSM
 Questions

3. 3
• In 1946, delegates from 25 countries met in London and decided
to create a new international organization, of which the object
would be "to facilitate the international coordination and
unification of industrial standards".
• And so the “International Organization for Standardization” or ISO
was born. It is now based in Geneva, Switzerland with over 100
member countries.
• ISO's purpose is to facilitate international trade, their Technical
Committees define internationally recognized standards for goods
and services that people everywhere would recognize and respect.
What is ISO?

5. 5
• Standards can be broadly sub-divided into three categories
namely; 1. Product, 2. Process and 3. Management system
standards.
• The first two refer to characteristics related to the quality and
safety of the product and process and refer to the conditions
under which products and services are to be produced, packaged
or refined.
• Management system standards assist organizations to
manage their operations. They are often used to help create a
framework that then allows the organization to consistently
achieve the requirements that are set out in product and process
standards.
Categorization

7. 7
• Benefits include operational efficiency, whether that
means increasing market share, driving down costs,
managing risk more effectively or improving
customer satisfaction.
• A Platform for Success – Great organization tool for
a small business
• ISO 9001 is by far the world’s most established quality
framework, a quality management system gives your
organization the framework they need to monitor and
improve performance in any areas you choose.
A million+ certifications worldwide
ISO 9001

8. 8
Some of the key benefits include:
• International Recognition: ISO is a recognized
mark of quality.
• Streamlined Internal Processes: Improving
efficiency, accountability and traceability while
maintaining expenses and savings.
• Employee Replacement Costs: Documents
created that detail job processes
The Benefits of Implementing ISO 9001

9. Benefits of Implementing
ISO9001
• Improved Staff Motivation : Teams
are motivated to succeed due to time and
resources being spent on what really
matters to the business.
• Quality at the Forefront : Regular
reviews ensures quality is consistently at
the forefront of the business.
• Competitive Advantage: Achieving an
ISO standard shows prospective clients
that your processes adhere to
international standards.

10. • Registration to ISO 9001 by a certification body
shows commitment to quality, customers,
and a willingness to work towards improving
efficiency.
• It demonstrates the existence of an effective
quality management system that satisfies the
rigors of an independent external audit.
• An ISO 9001 certificate enhances company image
in the eyes of customers, employees and
shareholders alike.
The Benefits of Implementing ISO9001

11. 11
• Planning & designing
• Describing
• Implementing
• Improving
• Identify the requirements of ISO9001 and how
they apply your business
• Establish quality objectives and how they fit into
the operation of the business
How do you start to implement ISO 9001?

12. 12
• Produce a documented quality policy indicating how
these requirements are satisfied.
• Communicate them throughout the organization
• Evaluate the quality policy, its stated objectives and
then prioritize requirements to ensure they are met.
• Identify the boundaries of the management system and
produce documented procedures as required.
• Ensure these procedures are suitable and adhered to
and once developed, internal audits are needed to
ensure the system carries on working.
How do you start to implement ISO 9001?

13. ISO 9001:2015 adopts a PROCESS APPROACH:
• A process is the transformation of inputs into outputs
• Organizations have to determine and manage numerous
linked activities (a system of processes) Example: From
receipt of materials to invoicing
• Output from one process often forms the input to next
ISO 9001:2015
Process Approach

15. Process Approach

16. Plan Do Check Act

17. ISO 9001:2015
PDCA – Plan, Do, Check, Act
• Plan: Establish objectives and processes to meet
customer requirements and the organization’s policies.
Identify and address risks and opportunities
• Do: Implement what was planned
• Check: Monitor and measure processes and product
against policies, objectives and requirements for the
product/service and report the results
• Act: Take actions to improve performance

18. ISO 9001:2015
Management Principles
• Customer focus
• Leadership
• Engagement of people
• Process approach

19. • Management Principles
• Improvement
• Evidence based decision making
• Relationship management

20. ISO 9001:2015
Risk-Based Thinking
Organizations need to plan and implement actions to
address risks and opportunities:
• Basis for increasing effectiveness of the QMS
• Risks - Preventing negative effects Example:
Identifying risks associated with insufficient
resources; supplier reliability; customer payments,
failure to adhere to the national and state regs., etc.
• Opportunities - Achieving improved results
Example: Attracting customers; reducing waste;
improving productivity

21. ISO 9001:2015
Some new definitions
• Interested Party – person or organization that can
affect or be affected by a decision or activity
• Competence – ability to apply knowledge and skills to
achieve intended results
• Documented Information – information required to
be retained by the organization
• Performance – measurable result
• Monitoring – determining the status of a system,
process or activity

22. ISO 9001:2015 -
A brief review of the clauses
4:1 Context of the organization

23. 4.1 Understanding the organization and its
context:
• Determine external and internal issues
(positive and negative factors)
• External context: legal; technological;
competitive; market; cultural; social and
economic issues
• Internal context: values; culture;
knowledge and performance of the
organization
Context of the Organization

24. ISO 9001:2015 -
A brief review of the clauses
4 Context of the organization
4.2 Understanding the needs and expectations of
interested parties.
The organization must determine, monitor and review:
• Interested parties relevant to the QMS
• The requirements of these interested parties

25. Interested Parties

26. Example: Insurance Terms
Chattel - Movable or immovable personal property. Chattel
does not include real estate or structures attached to the real
estate.
Claim adjuster - Person employed by or acting on behalf of
an insurance company to evaluate and settle insurance
claims; the adjuster must determine the cause of loss,
whether the loss is covered by the policy, the value of the loss,
and the amount of loss payable by the policy.
Claims-made form - Commercial general liability coverage
form that pays for BI or PD losses for which a claim was first
made against the insured during the policy period.
Class rates - Rates developed and "ready to use" before the
individual risk is even presented to the insurance carrier.
Normative Terms

27. ISO 9001:2015 -
A brief review of the clauses
4 Context of the organization
4.3 Determining the scope of the QMS
• External and Internal issues (4.1)
• Requirements of relevant interested parties (4.2)
• Products and services of the organization
• Scope must be available, documented and
maintained

28. ISO 9001:2015 -
A brief review of the clauses
4 Context of the organization
4.4 QMS and its processes
• The organization shall establish, implement, maintain
and continually improve the QMS
4.4.2 The organization shall
a) Maintain documented information to support the
operation of its processes
b) Retain documented information to ensure processes
are being carried out as planned – Post Process

29. ISO 9001:2015 -
A brief review of the clauses
5 Leadership
5.1 Leadership and commitment
• Top management must demonstrate leadership and
commitment with respect to the QMS
5.1.2 Customer focus
a) Customer, statutory and regulatory requirements are
determined, understood and met
b) Risks and opportunities are determined and addressed
c) Focus on enhancing customer satisfaction is maintained

30. Company Policy Manual
 Equal Opportunity Act
 HIPPA
 Immediate Termination Policy
 Illness, Sick Leave, Maternity, Bereavement
 Vacation, PTO policy
 Benefits – Insurance, 401K and Education
 Reviews, Merit Increases
 Expense Reimbursement

31. Company Policy Manual
Mission Statement:
Example: Local Police: To serve and protect
Marketing Services: To deliver a cutting edge,
current group of marketing tools and
messages that grow business for our
customers.
Vision Statement: To grow the company’s
market share in the Austin SMSA to a first
place position by the year 2022.

32. ISO 9001:2015 -
A brief review of the clauses
5 Leadership
5.2 Policy
5.2.1 Top management must establish, implement and
maintain the quality policy
5.2.2 Document and communicate the quality policy
5.3 Organizational roles, responsibilities and authorities
“Top management shall ensure that the
responsibilities and authorities for relevant roles are
assigned, communicated and understood within the
organization.”

33. ISO 9001:2015 -
A brief review of the clauses
6 Planning
6.1 Actions to address risks and opportunities in
relation to
a) Assurance that the QMS can achieve intended
results
b) Enhance desirable effects
c) Prevent or reduce undesired effects
d) Achieve improvement

34. ISO 9001:2015 -
A brief review of the clauses
6 Planning
6.2 Quality objectives must be documented
a) Consistent with the Policy
b) Measurable
c) Take into account applicable requirements
d) Relevant
e) Monitored
f) Communicated
g) Updated

35. ISO 9001:2015 -
A brief review of the clauses
6 Planning
6.2.2 When planning how to achieve objectives the
organization must determine:
a) What will be done – Documented steps
b) Required resources – Personnel, money
c) Responsibilities - Accountability
d) Completion date – Power of a deadline
e) How results will be evaluated –
Measurable/Benchmarks/Pre and Post Steps

36. ISO 9001:2015 -
A brief review of the clauses
6 Planning
6.3 Planning of changes – the organization must
consider:
a) Purpose of changes and potential consequences
b) The integrity of the QMS
c) Availability of Resources
d) Allocation of responsibilities and authorities

37. ISO 9001:2015 -
A brief review of the clauses
7 Support
7.1 Resources
Establishing, implementing, maintaining and
continually improving the QMS
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes – a
combination of human and physical factors

38. Resources

39. ISO 9001:2015 -
A brief review of the clauses
7 Support
7.1.5 Monitoring and measuring resources
Resources required to verify conformity of products and
services to requirements
Documented information required
7.1.5.2 Measurement and traceability
Measuring equipment must be identified, safe-guarded and
calibrated / verified at specified intervals (traceable to
international / national standards where required)

40. Measurement and Traceability

41. Traceability

42. Calibration Example

43. ISO 9001:2015 -
A brief review of the clauses
7 Support
7.1.6 Organizational knowledge
Knowledge specific to the organization
Generally gained by experience; is used and shared to
achieve the organization’s objectives
Organizational knowledge can be based on:
• Internal sources e.g. intellectual property, experience,
licenses, certifications, education, etc.
• External sources e.g. standards, academia, customers
and external providers etc.

44. ISO 9001:2015 -
A brief review of the clauses
7 Support
7.2 Competence – education, training and experience
7.3 Awareness – policy, objectives and QMS
7.4 Communication – internal and external relevant to
QMS – Training requirements for staff and production
7.5 Documented information:
Required by the standard and the effectiveness of
the QMS
Appropriate identification, formatting, review and
approval
Internal & external sourced documentation must be
controlled , available & protected from unintended
alterations

45. 45
QUALITY MANUAL
Policy, objectives, organisation,
outline of quality system
PROCESS DOCUMENTS
AND PROCEDURES
INSTRUCTIONS
FORMS
Processes, practices,
responsibilities,
interfaces
Detailed instructions
on how to carry out
specific tasks
Quality
records
Design IT Support Installation Training
Typical QMS Structure

46. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.1 Operational planning and control
Plan, implement and control the QMS processes to meet
the requirements for the provision of products and
services
Documented information must be maintained to
demonstrate:
• That processes have been carried out as planned
• To demonstrate conformity of products and services
Changes must be controlled and reviewed
Outsourced processes must be controlled

47. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.2 Requirements for products and services
8.2.1 Customer communication
a) Product and service information
b) Enquiries, contracts / orders and changes
c) Customer feedback and complaints
d) Customer property
e) Contingency actions when relevant

48. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.2.2 Determining the requirements for products and
services
Define:
1. Applicable statutory and regulatory requirements
2. Requirements considered necessary by the
organization
The organization must ensure that it can meet the
claims for the products and services it offers

50. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.2.3 Review of the requirements for products and
services
a) Customer requirements including delivery & post-
delivery
b) Requirements not specified by the customer
c) Requirements specified by the organization
d) Applicable statutory and regulatory requirements
e) Any changed contract or order requirements
Customer requirements to be confirmed before
acceptance of the contract / order
Documented information on change & review to

51. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.3 Design and development of products and services
The organization must establish, implement and maintain a
design and development process
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes

52. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.4 Control externally provided processes, products / services
The organization must retain documented information
pertaining to criteria for evaluation, selection, monitoring of
performance and re-evaluation of external providers
8.4.2 Type and extent of control
8.4.3 Information for external providers
Includes products / services, methods, processes, equipment,
release and competence / qualifications of personnel if
required

53. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.5.1 Control of production and service provision
a) Documented information - product / service /
activities
b) Monitoring and measuring resources
c) Acceptance criteria
d) Infrastructure and environment
e) Competency requirements
f) Validation where output cannot be subsequently
verified
g) Actions to prevent human error
h) Release, delivery and post-delivery activities

54. Process Example
The Linkedin Prospecting Process
 Reconstruct your bio to reflect your business.
Not a personal resume.
Answer the questions: What we do? What do we
deliver? Enhance with written person references
for every product offering or job.
 Have a professional headshot posted.

55. Process Example
Linkedin Prospecting
 Vendor / Manager obtains your e-mail and login for
Linkedin
 Vendor / Manager joins groups where your prospects
are members
 Vendor /Manager searches for the correct job titles
within those groups / in a geographic area and writes a
personal note inviting them to connect

56. Process Example
Linkedin Prospecting
 Vendor / Manager should be posting in
Linkedin at least three times a week
 Upon connection a personal thank you
response is generated
 New Linkedin connections are added to a
CRM for sales management

57. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external
providers
8.5.4 Preservation
• Identification, handling, contamination control,
packaging, storage, transportation and protection
8.5.5 Post-delivery activities
• Warranties / guarantees; maintenance services;
recycling / final disposal
8.5.6 Control of changes (retain documented
information)

58. ISO 9001:2015 -
A brief review of the clauses
8 Operation
8.6 Release of products and services
Documented information must be retained:
a) Evidence of conformity with the acceptance criteria
b) Traceability to the person(s) authorising release
8.7 Control of nonconforming outputs
Documented information must be retained:
Description of the nonconformity; the actions taken;
concessions and the authority deciding any actions in
respect of the nonconformity

59. Standards - Nonconformance

61. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
Documented information must be retained of the results of
evaluation of the performance and effectiveness of the QMS
9.1.2 Customer satisfaction – monitoring customer’s
perception e.g. surveys, feedback on delivered products and
services, meetings with customers, market – share analysis,
compliments, warranty claims and dealer reports
9.1.3 Analysis and evaluation
Can include statistical techniques

62. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.2 Internal Audit
9.2.1 Planned intervals – to provide information:
• Determine whether the QMS conforms to:
• The organization’s own requirements for its QMS
• The requirements of the ISO 9001:2015 standard
• Is the QMS effectively implemented and maintained?

63. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.2 Internal Audit
9.2.2 The organization must:
a) Plan, establish, implement and maintain an audit
program that takes into account:
• The importance of the processes concerned
• Changes affecting the organization
• The results of previous audits
b) Define the audit criteria and scope for each
audit
c) Objectivity and impartiality of the audit process

64. Process Auditing Example
With what?
• Order processing
system
With who?
• Customers
• Competent sales and
processing staff
What results?
• Order processing
time
• Number or orders
• Value of orders
• Contract accuracy
Outputs
Production/Service
Delivery
Inputs
• Customer
requirements
• Sales staff
How done?
• IT system
• Processing system
• Terms and conditions
• Contract review procedure
Contract
Review

66. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.2 Internal Audit
9.2.2 (continued) The organization must:
d) Results of audits reported to relevant personnel
e) Take appropriate correction and corrective actions
without undue delay
f) Retain documented information:
• Evidence of implementation of Audit Program
• Audit results
[ISO 19011 guidelines for management systems
auditing]

67. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.3 Management Review
9.3.1 Top management must review the QMS at
planned intervals to ensure:
• Continuing suitability, adequacy,
effectiveness
• Alignment with strategic direction of
organization

68. Management Reputation

69. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.3 Management Review
9.3.2 Management Review Inputs:
a) Actions from previous management reviews
b) Changes – internal and external relevant to QMS
c) Analysis of performance & effectiveness of QMS
d) Resources
e) Risks and opportunities
f) Opportunities for improvement

70. ISO 9001:2015 -
A brief review of the clauses
9 Performance evaluation
9.3 Management Review
9.3.3 Management Review Outputs:
Decisions and actions related to:
a) Opportunities for improvement
b) Changes to QMS
c) Resource needs
Documented information must be retained

71. ISO 9001:2015 -
A brief review of the clauses
10 Improvement
Determine opportunities for improvement
Implement actions to meet customer requirements
Enhance customer satisfaction.
a) Improving products and services to meet
requirements. Address future needs and
expectations
b) Correcting / preventing / reducing undesired effects
c) Improving performance and effectiveness of QMS

72. ISO 9001:2015 -
A brief review of the clauses
10 Improvement
10.2 Nonconformity and corrective action
When a nonconformity occurs e.g. Customer complaint:
a) React, control and manage the nonconformity
b) Eliminate the cause of the nonconformity
c) Implement action needed
d) Review effectiveness of corrective actions taken
e) Review risks and opportunities - update if
required
f) Make changes to the QMS if necessary
Documented information must be retained

73. ISO 9001:2015 -
A brief review of the clauses
10 Improvement
10.3 Continual Improvement
The organization shall continually improve the
suitability, adequacy and effectiveness of the QMS by
considering:
• The results of analysis and evaluation
• Outputs from management reviews
Are there any needs / opportunities requiring
action as part of continual improvement?

74. 74
• Identify Key Performance Indicators (KPIs)
• Set measurable targets
• Collect information and compare with targets
• Initiate action if targets are not met
• Review targets (suitability, practicality)
Setting objectives & measuring
performance

75. 75
• Specific
• Measurable
• Agreed
• Realistic
• Time Oriented
SMART Objectives

76. 76
• The Management Review meeting is the
core of the whole process.
• It must be held regularly and must review:
- Quality policy and objectives
- Improvement
- Non-conformance and customer
complaints
- Corrective and preventive action
- Internal and external audits.
- Planning and future resource requirements
- Training
- Supplier performance
- Customer satisfaction
Significance of Management Review

77. Typical Audit Activities
Initialing the Audit
Conducting Document Review
Preparing, Approving, Distributing Audit Report
Completing the Audit
Conducting Audit Follow-up
Preparing for On-site Activities
Conducting for On-site Activities

78. Internal Audit
Unlocking organizational potential
Internal Audit plays a pivotal role in the Continuous
Improvement cycle of the QMS:
• No longer only about the pursuit and detection of
non-conforming product and service
• Effective and efficient Auditing focusses on
conformance – positive approach to Internal
Auditing

79. Internal Audit
Unlocking Organizational Potential
• Auditing for conformance will still identify
non-conformance but will add value to the
process
• Internal Audit – a key methodology for the
‘check’ part of the PDCA cycle
• Proactive search for ‘Opportunities For
Improvement’

80. Internal Audit –
Key Aims and Objectives
• Establish, check and test whether the organization’s
QMS, procedures and working practices meets
the requirements of ISO 9001:2015
• Ensure that the organization is working to its own
documented / established internal procedures
• Highlight areas for attention before they
become non-conforming or problematic
• Identify opportunities to improve procedures and
working practice (continuous improvement
initiatives)

81. 81
• It is a requirement that the Quality
Management System be continually
improved
• Improvements can be made to any of the
company’s activities, including:
• Customer requirements
• Design
• Planning
• Procurement
• Process control – Example – Manufacturing
processes
• Storage, shipping, handling
Continual Improvement

82. 82
• Internal and external communications,
customer relations
• Documentation and records
• Software
• Facilities and equipment
• Recruitment, retention, training, personal
development, etc.
Initiatives for improvement can come from,
for example:
• Feedback from customers
• Feedback from staff
• Evaluation of the competition
• Questionnaires or surveys
• Review of equipment in use, etc.
Continual Improvement

83.  Established in 1994, IMSM supports organizations
around the world in gaining ISO certification and new
business opportunities. An ISO certification is a
recognized mark of quality, improving your business by
producing consistent standards of quality to meet
customer’s requirements.
 IMSM have won numerous awards over the years
including being awarded ‘Recognized for Excellence 5*’
for the second time running, as a result of on-going
commitment to business excellence and quality, the
highest an organization can achieve.
International Management
Standards Marketing

84. International Management
Standards Marketing
 International Management Systems Marketing
Limited wishes to be an organization that puts the
needs of the customer first. Our staff are committed to
providing a responsive, caring and professional service.
 IMSM has helped over 20,000 organizations achieve an
ISO9001 Certification
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