ISO 9001 2015 QMS Awareness Training Module

ISO 9001:2015
AWARENESS
Training
PHILIPPINE TRADE TRAINING
CENTER
by
Romeo M. Ramirez
Transforming Organizations Towards Excellence
OBJECTIVES
To enable participants to:
• Understand the benefits, key
concepts and requirements of
ISO 9001:2015;
• Apply the principles and
requirements to their
respective organizations.
All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

1
Course Outline
Section 1 – Introduction: ISO 9001 and its Benefits
Section 2 – Concepts and Management Principles
Section 3 – Review of ISO 9001:2015 Requirements
- Clause 4 – Context of the Organization
- Clause 5 – Leadership
- Clause 6 – Planning
- Clause 7 – Support
- Clause 8 – Operation
- Clause 9 – Performance Evaluation
- Clause 10 – Improvement
Conclusion

SECTION 1:
Introduction

2
ISO
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ü Independent, non-governmental organization founded Feb. 23, 1947
ü Consists of 164-member National Standards Bodies (NSBs)
Ø Philippines’ NSB: Bureau of Philippine Standards (BPS)
ü Headquarters: Geneva, Switzerland
ü Official Languages: English, French, Russian
ü Develops and publishes International Standards
Source: ISO Website

ISO 9001
ü Most popular standard issued by ISO
ü Sets out the criteria for a quality management system (QMS)
ü Can be used by any organization of any size, location and nature of
economic activity
ü Current version: 2015
ü Previous versions: 1987, 1994, 2000, 2008

3
Benefits of ISO 9001
• Enhanced Customer • Legal compliance
satisfaction • Improved stakeholder
• Better operational efficiency relationship
• Improved risk management • Positive image
• Robust operations • Certification may allow access
to new customers and markets
• Enhanced effectiveness
Quality enhances the value of an organization!

ISO 9001 Family of

Standards
ISO 9000:2015 FUNDAMENTALS AND VOCABULARY
ISO 9001:2015 QUALITY MANAGEMENT SYSTEM REQUIREMENTS
ISO 9004:2018 GUIDANCE TO ACHIEVE SUSTAINED SUCCESS
Note: Only ISO 9001:2015 can be audited for certification purposes.

4
Quality
Some definitions
• Fitness for use (or purpose) - Joseph Juran
• Conformance to requirements; Doing right the first time! (DRIFT) - Philip Crosby
• Standard of something as measured against other things of a similar kind;

Degree of excellence of something - Oxford
• A standard: How good or bad something is
We are what we repeatedly do! Excellence, then, is not an act, but a habit. - Aristotle

Quality
• Degree to which a set of inherent characteristics of
an object fulfils requirements.
Requirements - main basis for judging quality is the specified requirements.
ü “Inherent” – existing in something
ü “Characteristics” – distinguishing feature
Ø Adjectives related to QUALITY: Poor, Good, Excellent
If you cannot do great things, do small things in a great way. - Napoleon Hill

10
5
Management System
• Set of interrelated or interacting elements of
an organization to establish policies and
objectives and processes to achieve those
objectives
A Management System is a network of various elements of an organization.

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Quality Management System

ISO 9000:2015
• Part of a management system with regard, to
quality
A Quality Management system is formal version of a business system.

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6
SECTION 2:
Concepts and Quality
Management Principles

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ISO 9001:2015 Concepts
PROCESS
Start End
Set of interrelated or Receiver of

Sources of Inputs Inputs Activities Outputs
interacting activities Outputs
that use inputs to Predecessor Subsequent

processes processes
deliver intended results.
Note: The output of a process is

called product (generally
tangible) or service.

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7
Process Approach
Management of interrelated
processes and their interaction
which contribute to an
organization’s effectiveness and
efficiency in achieving its intended
results.

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PDCA Cycle
Plan – Define goals and provide
resources, evaluate risks and
opportunities
Do – Implement what was planned
Check – Monitor, measure and
evaluate the results
Act – Pursue improvement
Ref. ISO 9001:2015

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8
Risk-based Thinking
A systematic approach to risk
where the QMS determines
and provides preventive
controls to factors that can
cause deviation from its
planned results to minimize
negative effects and maximize
opportunities.
All rights reserved 2021| CRR (Cynthia & Romeo Ramirez)

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ISO 9001:2015 Business Model

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9
Quality Management Principles
1 - Customer Focus
2 - Leadership
3 - Engagement of People
4 - Process Approach
5 – Improvement
6 - Evidence-based decision-making
7 - Relationship Management

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SECTION 3:
Understanding the
Requirements of ISO
9001:2015

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10
Non-auditable Clauses
Clause 1 – Scope
Clause 2 – Normative References
Clause 3 – Terms and Definitions
The above clauses comprise the introductory part of the standard. No

responses or actions are expected from an organization!

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Auditable Clauses
Requirements
4 - CONTEXT 5 - LEADERSHIP 6 – PLANNING 7 – SUPPORT
8 - OPERATIONS 9 - PERFORMANCE EVALUATION 10 - IMPROVEMENT

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11
CLAUSE 4:
Context of the
Organization

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Clause 4 – Context of the

Organization
4.1 Understanding the Organization and its Context
Determine issues – relevant to purpose and strategic direction

- affects intended results of the QMS USEFUL HARMFUL
• External issues
Internal
Factors
• Internal issues
Monitor and review this information

External
Factors

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12
Organization
4.2 Understanding interested Parties
IDENTIFY DETERMINE REVIEW

INTERESTED IP’s NEEDS & IP-RELATED -Relevant to
PARTY EXPECTATIONS INFORMATION QMS:
(Stakeholder)
Affects products
and services;
MONITOR: New IPs, IP requirements Legal compliance

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Organization
4.3 Determining the Scope of QMS
Establish scope of the QMS

• Determine:
o Boundaries of QMS
o Applicability of all standard requirements
• Consider:
ü Internal and external issues
ü Requirements of relevant interested parties
ü Products and services of the organization

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13
Organization
4.4 QMS and its Processes
• Establish, implement, maintain and
continually improve the QMS
• Determine the processes needed
• Maintain documented information (DI) to support the
QMS processes
• Retain DI to prove QMS processes are implemented as
planned

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Organization
4.4 QMS and its Processes
Requirements for QMS processes:
ü Process inputs required and outputs expected
ü Process sequence and interactions
ü Operations and control criteria and methods
ü Resources needed
ü Responsibilities and authorities
ü Actions addressing risks and opportunities
ü Process evaluation, including changes needed to achieve
planned results
ü Process improvement

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14
CLAUSE 5:
Leadership

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Clause 5 – Leadership
5.1 Leadership and Commitment
vision
Leadership - The art of motivating a group of people to act toward
achieving a common goal (The Balance Small Business) management
Top Management – person or group of people who directs and controls an strategy improvement
organization at the highest level (ISO 9000:2015)
objective
Roles in the QMS: motivation
resources
ü Takes accountability for QMS effectiveness responsibility

ü Establishes quality policy and quality objectives authority
ü Ensures QMS is integrated into business process

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ü Promotes process approach and risk-based thinking
ü Ensures availability of resources
ü Communicates importance of QMS conformance
and effectiveness;
ü Ensures QMS achieves its intended results;
ü Engages, directs, supports persons to contribute to
QMS effectiveness;
ü Promotes improvement
ü Supports other relevant management roles

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Roles to demonstrate ‘Customer Focus’:
ü Ensure to consistently meet customer and
applicable statutory and regulatory
requirements
ü Determine and address risks and
opportunities
ü Enhance customer satisfaction

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5.2 Policy
Establish the Quality Policy (criteria): QUALITY
ü Appropriate to the organization POLICY
ü Framework for setting objectives
ü Expresses commitments to satisfy requirements and
pursue continual improvement
Communicate the Quality Policy:

ü Available as documented information
ü Communicated, understood, and applied
ü Available to relevant interested parties

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5.3 Organizational Roles, Responsibilities and Authorities
Assign and communicate roles, responsibilities and

authorities across the organization, and ensure that:
ü QMS conforms to requirements
ü Processes deliver intended results
ü Customer focus is promoted
ü Integrity of QMS is maintained during changes
ü Performance of QMS and opportunities for
improvement are reported

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17
CLAUSE 6:
Planning

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Clause 6 – Planning
6.1 Actions to address risks and opportunities
Determine the risks and opportunities to be

addressed:
ü Consider 4.1 (issues) and 4.2 (interested parties)
ü Ensure QMS achieves intended results
ü Enhance desirable effects
ü Prevent, or reduce, undesired effects
ü Achieve improvement

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Plan actions to:
ü Address risks and opportunities
ü Integrate and implement the actions to its QMS
ü Evaluate the effectiveness of actions taken
Actions to address risks: Actions to address opportunities:
ü Adopt new practices

ü Avoid risk ü Launch new products
ü Take risk to pursue opportunity ü Open new markets
ü Eliminate risk source ü Address new customers
ü Change likelihood or consequence ü Build partnerships
ü Share risk ü Use new technology
ü Retain risk by informed decision ü Pursue other desirable / viable
possibilities

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6.2 Quality objectives and planning to achieve them
Establish the Quality Objectives (criteria):

• Consistent with quality policy
• Measurable
• Consider applicable requirements
• Monitor, communicate, update
Plan how to achieve Quality Objectives

• Actions
• Responsibilities
• Resources
• Timelines

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6.3 Planning of changes
a) Determine need for changes

b) Carry out changes in a planned manner
Consider:
ü Purpose
ü Potential consequences
ü Integrity of the QMS
ü Available resources
ü Responsibilities and authorities

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CLAUSE 7:
Support

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Clause 7 – Support
7.1 Resources
GENERAL
GENERAL: Determine and provide resources
• Financial, personnel, material, equipment, facilities, etc.) PEOPLE
RESOURCES
Consider: INFRA
ü Capabilities and constraints
ü What to be obtained from external providers ENVIRONMENT
PEOPLE: M&M RESOURCES

• Determine and provide the persons (human resources)
ORG. KNOWLEDGE
necessary for the QMS

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7.1 Resources
INFRASTRUCTURE: Determine, provide, and maintain:

• Buildings, associated utilities
• Equipment including hardware and software,
• Transportation services
• Information and communication technology)
Consider relevant preventive, corrective, and if necessary, predictive maintenance

processes / activities to ensure that infrastructures are working properly!

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21
ENVIRONMENT FOR THE OPERATION OF PROCESSES:

• Determine, provide and maintain suitable environment necessary
for the operation of processes
• Purpose: To achieve conformity of products and services.

• Work environments
ü Social (non-discriminatory, calm, non-confrontational)
ü Psychological (e.g. stress-reducing, burnout prevention,
emotionally protective)
ü Physical (e.g. temperature, heat, humidity, light, airflow, hygiene,
noise)

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MONITORING AND MEASURING RESOURCES:
Determine and provide the resources needed to ensure valid and reliable results
• Suitable and maintained monitoring and measuring resources
• Maintained and fit for purpose
Measurement traceability
Measuring equipment is:
• Calibrated or verified, or both
• Identified to determine status
• Safeguarded from adjustments, damage or deterioration that would
invalidate the calibration status and subsequent measurement results.

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22
ORGANIZATIONAL KNOWLEDGE:
Determine the knowledge necessary for:
• Operations of processes
• Achieving product / service conformity
Maintain / make available organizational knowledge.
Acquire or access additional knowledge and required

updates.
Organizational knowledge can be based on:

a) Internal sources (e.g. intellectual property)
b) External sources (e.g. standards)

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7.2 Competence
Competence – Ability to apply knowledge and skills to achieve intended
results (ISO 9000:2015)
• Determine the necessary competence required

• Ensure persons are competent (education, training or
experience)
• Take action to acquire the necessary competence (e.g.
Provision of training, Mentoring, Reassigning, Hiring or
contracting of competent persons)
• Evaluate effectiveness of actions taken
• Retain documented information (records)

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7.3 Awareness
Awareness – Knowledge or perception of a situation or fact (Oxford)
Persons under organization’s control are aware of:

ü Quality Policy
ü Relevant quality objectives
ü Contribution to QMS effectiveness, including benefits of
improved performance
ü Implications of not conforming with the QMS
requirements

51
7.4 Communication
Determine:
COMMUNICATION ü What to communicate
ü When to communicate
ü With whom to communicate
INTERNAL EXTERNAL ü How to communicate
ü Who communicates

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7.5 Documented Information (DI)
DI - Information required to be controlled by the organization and the medium
on which it is contained; can be in any format (ISO 9000:2015)
QMS includes documented information:

• Required by the standard
• Determined as necessary for the
effectiveness of the QMS

53
7.5 Documented Information (DI)
Creating and updating of Documented Information:
ü Identification and description
ü Format and media
ü Review and approval
Control of Documented Information:

ü Available, suitable for use
ü Protected (e.g. from loss of confidentiality, improper use
and loss of integrity)

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Controls needed for documented information:
ü Distribution, access, retrieval and use;
ü Storage and preservation, legibility;
ü Control of changes;
ü Retention and disposition
ü Control documented information of external origin
ü Protect retained documented information from
unintended alterations

55
CLAUSE 8:
Operations
ramirez_cynthia09@yahoo.com;
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0917-867-5956/57; 0927-077-2744
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Clause 8 – Operations
8.1 Operational Planning and Control
Plan, implement and control processes needed to:
ü Provide products and services
ü Implement actions from 6.1
a) Control planned changes and unintended changes

b) Control outsourced processes (8.4)
The planning output must be suitable for the

organization’s operations

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Planning and control activities:
ü Determine requirements for products and services;
ü Establish processes and product acceptance criteria
ü Determine needed resources
ü Implement control of the processes
ü Determine, maintain and retain documented information
Ø to prove processes are done as planned and products conform to requirements.
Contract Design Purchasing Operations Inspection Delivery Post-Delivery

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8.2 Requirements for products and services
Customer communication
Customer feedback, Contingency action

Information on Handling/controlling
including complaint customer property when relevant
Products and Services

64
Determining requirements for products and services:
Define requirements clearly
a) Define requirements
ü Applicable statutory and regulatory requirements
ü Those considered necessary by the organization
b) Ensure ability to fulfill claims for products/services

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Review of requirements for products and services
a) Before committing, review ability to meet requirements:
ü Specified by customer, including delivery and post-delivery
ü Not stated by customer but known as necessary for intended use
ü Specified by the organization
ü Statutory/ regulatory requirements applicable to the product
b) Resolve contract/order variations from previously defined
c) Confirm customer requirements before acceptance (if no documented
statement is provided)
d) Retain documented information on results of review and any new
product requirements.

66
Changes to requirements for products and services
a) Amend relevant documented information

b) Make aware / inform relevant persons of changed
requirements

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8.3 Design and Development
• Process: Establish, implement, maintain design & development

process
• Design & development planning: Define stages and controls
• Design & development inputs: Define requirements
Design and
• Design & development controls: Conduct review, verification,
Develop-
validation, and act on problems encountered ment
• Design & development outputs: Meet inputs; suitable for
provision of products and services
• Design & development changes: Identify, review, control
changes

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8.4 Control of externally provided processes,
products and services P
a) Ensure requirements (process, products, services) are conformed to
P
b) Determine and apply controls
c) Determine and apply criteria for external providers on:

ü Evaluation
ü Selection
ü Monitoring of Performance
ü Re-evaluation

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Type and extent of control:
ü Outsourced processes remain within control of QMS

ü Controls defined for external providers and outputs
ü Potential impact to customer requirements and legal
compliance
ü Verification and other activities to ensure conformity to
requirements

70
Information for external providers:
a) Requirements are adequately defined

b) Requirements are communicated to providers:
ü What needs to be provided
ü Approval criteria
ü Competence or qualification of personnel
ü Mode of interaction
ü Control and monitoring of performance
ü Verification / validation to be carried out in
provider’s premises

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8.5 Production and service provision
Control of production and service provision
Implement production and service provision under controlled conditions

• Documented information for • Suitable infrastructure
• Competent persons
products/services and results to be
• Validation of processes whose output
achieved
not verifiable by
• Suitable monitoring and monitoring/measurement
measuring resources • Prevention of human error
• Monitoring and measurement • Release, delivery and post delivery
activities activities

72
Identification and traceability
Purpose: To ensure conformity of products
Requirements:
• Suitable means to identify outputs
• Identify status of outputs with regard to monitoring
and measurement requirements
• When required, unique identification of output for
traceability
• Retain documented information

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Property belonging to customers or external providers
ü Exercise care (e.g. in handling, storage, use, etc.)
ü Identify, verify, protect and safeguard
ü Report and record when lost, damaged or found unsuitable for use
Examples of customer or external provider’s property:
ü Materials,
ü Components, tools and equipment
ü Premises
ü Intellectual property
ü Personal data

74
Preservation
To ensure conformity to requirements
Preserve outputs during production and service provision
Examples: identification, handling, contamination control,

packaging, storage, transmission or transportation, and
protection.

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Post-delivery activities
Meet requirements for post-delivery
Determine:
ü Statutory and regulatory requirements
ü Undesired consequences with products / services
ü Nature, use, lifetime of products / services
ü Customer requirements
ü Customer feedback
Examples: Warranty provisions, contractual obligation such as

maintenance, supplementary services like recycling.

76
Control of changes
Review and control changes for production/service

provision
Retain documented information:

ü Results of the review of changes
ü Person(s) authorizing the change
ü Any necessary action arising from the review

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8.6 Release of products and services
Verify product and service requirements at appropriate

stages
Release products / services if planned arrangements
are satisfactorily completed, unless approved by
authority or customer.
Retain documented information:
ü As evidence of conformity with acceptance criteria
ü Traceability to person authorizing the release.

78
8.7 Control of non-conforming (NC) outputs
Identify and control NC outputs to prevent unintended use

or delivery.
Take appropriate action based on nature of nonconformity
and effect to products and services.
ü Apply also to delivered NC products, during or after
provision of services.
Verify conformity to requirements when NC outputs are
corrected.

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Possible actions to deal with NC outputs:
Correction:
ü Segregation, containment, return or suspension of provision
of products and services
ü Informing the customer
ü Obtaining authorization for acceptance under concession.
Retain documented information: describe the nonconformity, action

taken, concessions obtained, deciding authority for the NC.

80
CLAUSE 9:
Performance
Evaluation

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Clause 9 – Performance
Evaluation
9.1 Monitoring, measurement, analysis and evaluation
General:
Determine:
ü What and when to monitor and measure
ü What methods to use to ensure valid results
ü When to analyze and evaluate results
Evaluate performance and effectiveness of the QMS.

Retain documented information as evidence.

82
Evaluation
Customer satisfaction
Monitor:
ü Customer’s perception of degree of fulfillment of needs
and expectations
ü Determine methods for obtaining, monitoring and
reviewing customer perception
Examples: Customer surveys, customer feedback on delivered

products and services, meetings with customers, market-share
analysis, compliments, warranty claims and dealer reports.

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Evaluation
Analysis and evaluation
Analyze and evaluate data and information:

ü Conformity of products and services
ü Degree of customer satisfaction
ü QMS performance and effectiveness
ü If planning is effectively implemented
ü Effectiveness of actions for risks and opportunities
ü Performance of external providers
ü Needs for improvements to the QMS

84
Evaluation
9.2 Internal Audit
Internal audit – conducted by, or on behalf of, the organization itself for
management review and other internal purpose, and can form the basis
for an organization’s declaration of conformity of conformity.
Conduct internal audits at planned intervals:

- To provide information on QMS implementation and
conformance to requirements

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Evaluation
9.2 Internal Audit
ü Plan, establish, implement an audit program

ü Define audit criteria and scope
ü Select (and train) auditors
ü Report results to relevant management
ü Take correction and corrective action without
delay

86
Evaluation
9.3 Management Review
Conducted by top management at planned intervals

- To ensure continuing QMS suitability, adequacy,
effectiveness and alignment with the strategic direction.
Management review inputs:

a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant
to the quality management system;

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39
Evaluation
c) information on QMS performance and effectiveness, including trends in:
ü customer satisfaction and feedback from relevant interested parties
ü extent quality objectives were met
ü process performance and product/service conformity
ü nonconformities and corrective actions
ü monitoring and measurement results
ü audit results
ü performance of external providers
d) adequacy of resources
e) effectiveness of actions taken to address risks and opportunities
f) opportunities for improvement.

88
Evaluation
Management review outputs:
-Include decisions and actions related to:
a) opportunities for improvement
b) any need for changes to the quality management
system
c) resource needs
Retain documented information of management reviews

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CLAUSE 10:
Improvement

90
Clause 10 – Improvement
10.1 General
a) Determine and select opportunities for improvement

b) Implement necessary action to meet customer
requirement and enhance customer
ü Improve products and services
ü Correcting, preventing or reducing undesired effects
ü Improving performance and effectiveness of the QMS.
Examples of improvement: correction, corrective action,

continual improvement, breakthrough change, innovation
and re-organization.

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10.2 Nonconformity and Corrective Action
Nonconformity – nonfulfillment of a requirement (ISO 9000:2015)
Corrective Action – action to eliminate cause of nonconformity (ISO
9000:2015)
When nonconformity (NC) occurs, including arising from complaints:

ü React to the nonconformity (correct it; deal with consequences)
ü Evaluate need for action to eliminate cause of NC so it does
not recur or occur elsewhere
ü Implement action needed

92
10.2 Nonconformity and Corrective Action
• Update risks and opportunities determined during planning

• Make changes to the QMS, if necessary
• Retain documented information as evidence of:
ü Nature of nonconformity
ü Actions taken
ü Results of corrective action
Corrective actions shall be appropriate to the effects

of the nonconformities

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10.3 Continual Improvement
Continually improve the suitability, adequacy and effectiveness of the

QMS.
Basis:
ü Results of analysis and evaluation
ü Outputs from Management Review

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CONCLUSION
ISO 9001 is a management tool for:
• Quality products and services
• Legal compliance
• Managing risks and opportunities
• Consistent performance
• Customer satisfaction
• Continual improvement
• Organizational excellence

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Our Services
CONSULTING SERVICES TRAINING SERVICES related to Consulting: For single
• Management System (MS) Gap Analysis or integrated management system (IMS)
• MS Scoping: Defining the boundaries and • Management System (MS) Standard Awareness:
applicability Concepts, Requirements and Application
• MS Strategic and Operational Planning • MS Documentation
• MS Design, Development • Effective Control of Maintained and Retained
• Establishing MS Documentation Documented Information (Document and Records
• MS Performance Evaluation & Improvement Control)
• MS Internal Auditing • MS Planning and Setting Objectives
• MS Management review technical assistance • MS Risk Analysis, Evaluation and Control
• Integrated Management System Development • MS Effective Internal Auditing (on-site and remote)
• Process Improvement and Streamlining • MS Effective Audit Report Writing
• MS Pre-Certification Review and Preparation • Nonconformity, Root Cause Analysis & Corrective Action
• Roles and functions of an effective Management
Representative
• Emergency Preparedness and Response
Examples of MS – ISO 9001, ISO 14001, ISO 22001/FSSC, GMP/HACCP, ISO/TS 16949, ISO 45001, ISO 50001
and other standards
Cynthia R. Ramirez - 0917-867-5956 ramirez_cynthia09@yahoo.com

Romeo M. Ramirez – 0917-867-5957; 0927-077-2744 romy_m_ramirez@yahoo.com
96
OPEN FORUM!!!!
FOR YOUR ATTENTION and

COOPERATION!

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ISO 9001:2015

Transforming Organizations Towards Excellence

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

Quality enhances the value of an organization!

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

ISO 9001 Family of

ISO 9001:2015 QUALITY MANAGEMENT SYSTEM REQUIREMENTS

ISO 9004:2018 GUIDANCE TO ACHIEVE SUSTAINED SUCCESS

Note: Only ISO 9001:2015 can be audited for certification purposes.

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

• Standard of something as measured against other things of a similar kind;

• A standard: How good or bad something is

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

Ø Adjectives related to QUALITY: Poor, Good, Excellent

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A Management System is a network of various elements of an organization.

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Quality Management System

A Quality Management system is formal version of a business system.

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

All rights reserved 2021 | CRR (Cynthia & Romeo Ramirez)

ISO 9001:2015 Concepts

Set of interrelated or Receiver of

that use inputs to Predecessor Subsequent

Note: The output of a process is

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ISO 9001:2015 Concepts

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ISO 9001:2015 Business Model

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The above clauses comprise the introductory part of the standard. No

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4 - CONTEXT 5 - LEADERSHIP 6 – PLANNING 7 – SUPPORT

8 - OPERATIONS 9 - PERFORMANCE EVALUATION 10 - IMPROVEMENT

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Clause 4 – Context of the

Determine issues – relevant to purpose and strategic direction

Monitor and review this information

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IDENTIFY DETERMINE REVIEW

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Clause 4 – Context of the

Establish scope of the QMS

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Clause 4 – Context of the

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ü Takes accountability for QMS effectiveness responsibility

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Communicate the Quality Policy:

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Assign and communicate roles, responsibilities and