1. finance
2. accounting and auditing

UNDERSTANDING INTERNATIONAL
QUALITY MANAGEMENT STANDARDS
KNUST SUMMER SCHOOL 2
Presented by: ABENA SAFOA OSEI, M.Phil
IRCA Registered Quality Auditor
Food Safety Expert
PRESENTATION
OUTLINE
History and Introduction to Quality
Management Systems and Standards
 The PDCA Cycle
 The Process Approach to Management
 The Eight Quality Management Principles
 Benefits of Quality Management Systems
 Overview of Quality Management Standards and
their Implementation
 ISO 9001: 2008 – Summary of Requirements

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SESSION 1
QUALITY MANAGEMENT
SYSTEMS STANDARDS



History and Introduction
PDCA and the Eight Principles
Benefits of Quality Management Systems Standards
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HISTORY
OF QUALITY MANAGEMENT
SYSTEMS (QMS)
 MIDDLE AGES:


The Guilds regulated various trades – the craftsman was
his own quality inspector and maintained direct relations
with the client
LATE 18TH CENTURY:

The Guilds disappeared, the industrialization age began
with vague or no rules on quality
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HISTORY

19TH CENTURY:


Fraud became more widespread – and some sort of
inspections took hold
EARLY 20TH CENTURY
Various laws on inspection activities were produced
 Statistical methods and monitoring systems began between
1940 – 1955

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HISTORY

Quality assurance systems were defined in various
systems:
1954 – in the American Military Systems
 1969 – American Nuclear Systems
 1984 – British System, NATO Programme and AFNOR
standards in France
 1987 – the first ISO International Standard for Quality
Management System

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INTRODUCTION TO
MANAGEMENT SYSTEMS


A management system is a Set of interrelated or
interacting elements to establish policy and objectives
and to achieve those objectives
To ensure capability and consistency of the
organization to meet customer as well as statutory/
regulatory requirements
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INTRODUCTION TO
MANAGEMENT SYSTEMS

A Management System can also be described as a set
of activities an organisation carries out to manage its
processes in order to meet set objectives such as:
Satisfying customer requirement
 Complying with regulations or
 Meeting environmental requirements

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INTRODUCTION TO
MANAGEMENT SYSTEMS


Organisations have recognised the costs of poor quality
(rework & frequent complaints) and the need to have
control over their processes
Organisations gradually opted for the Quality
Approach to management
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INTRODUCTION TO
MANAGEMENT SYSTEMS


Quality is achieved through planning and
communication to prevent problems
It is cheaper and more effective to run preventive
systems than to run inspection based systems
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QUALITY MISCONCEPTIONS

The Quality approach has gradually dismissed
the general misconceptions of quality. The
misconceptions include:





Quality means expensive
Quality systems are expensive “nice to haves”
Good quality is high specifications
Quality control is testing and checking
Quality comes from inspection only
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QUALITY APPROACH


Preventive measures include planning activities
and processes, analysing inputs and outputs,
training, writing and implementing procedures
or plans and auditing the activities
The Quality Approach also includes monitoring
and continual improvement
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INTRODUCTION TO
MANAGEMENT SYSTEMS


Management System standards set up the model to
follow in setting up and operating a management
system
The ISO 9001 is an example of a management system
standard
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ISO MANAGEMENT STANDARDS
Quality management systems (QMS) (ISO 9001)
 Environmental management systems (EMS)
(ISO
14001)
 Informational security management systems (ISM)
(ISO/IEC 27001)


Food safety management systems (FSMS) (ISO 22000)
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


QMS – Ensures quality of products and services
EMS – To ensure organization complying to legal &
statutory requirements for environment
FSMS – To ensure organization complying with food
safety requirements
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

OHSMS - To ensure organization complying to legal &
statutory requirements for safety & health of the
employees
The ISO 9001 is an integral part of all the other
management standards
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ISO 9001 STANDARD FOR QMS




ISO first published the standard on Quality Management
Systems in 1987
The latest edition was revised in 2008
ISO 9001 is a generic standard and can be implemented by
any type of organization, manufacturing, service providers,
etc
In 2007, and International Working Agreement developed
and Guidance for the implementation of ISO 9001 in
Educational Organizations (IWA 2: 2007)
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THE ISO 9000 SERIES




ISO 9000:2005 - Quality Management Systems –
Fundamentals and Vocabulary
ISO 9001:2008 – Quality Management Systems –
Requirements
ISO 9004:2009 - Managing for the sustained success
of an organisation – A Quality Management Approach
ISO 19011:2011 – Guidelines for Auditing
Management Systems
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The PDCA CYCLE
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


The major operating principle underlying the ISO
Management Standards is the PDCA Cycle
Cycle – also known as Deming Cycle was first
introduced by Deming
PDCA is a pro-active approach to management
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

Proactive approach – all problems are anticipated
and measures are taken to prevent them in order to
ensure a continually improving system.
The measures put in place are constantly monitored.
You plan, do, act and check – with your results you
plan again…..
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THE “P-D-C-A” CYCLE
Plan – establish
objectives and
make plans
 Do – implement
plans
 Check – measure
results
 Act – correct and
improve plans &
how they are put
into practice

Check
Plan
Do
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Act
THE PDCA AND ISO 9001

They must characterize all your activities in
order to achieve your set objectives
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
This operating principle runs through all the
clauses of the ISO 9001 standard
The Process
Approach To
Management
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THE PROCESS APPROACH



Process – a set of interrelated or interacting activities
which transforms inputs into outputs
Product – Result of process (service) - The Educational
Service
Output of one process may the input of another process
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THE PROCESS APPROACH
The systematic identification and management of the
processes and interactions between such processes is
referred to as the “Process Approach”.
Control of process inputs ensures that outputs meets
specified requirements
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CONTROL OF PROCESSES
•
–
–
–
–
–
People - by training
Materials
– control of suppliers and
specifications
Methods - by procedures and standards
Machines
- by maintenance systems
Environment – by organisation and care
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Processes are controlled by controlling the inputs
into the processes rather than inspecting the
output:
PROCESS APPROACH
consistent inputs produce consistent outputs
 Quality must be built in as a chain of event by
linking the processes – this is referred to as the
system approach to management
 The smoother the materials and information flow
through the system the greater the efficiency

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PROCESS APPROACH –
CONTINUAL
IMPROVEMENTS OF
PROCESS
Understanding and
meeting requirements
PLAN
Processes in terms
Of Added Value
DO
PDCA
Cycle
Measure results of process
Performance and effectiveness
- Objective Measurements
CHECK
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Continual improvements
of Processes based on
objective measurements
ACTION
SIMPLE PROCESS MAP
Monitoring
•Men
•Machines
•Materials
•Methods
•Measurement
Processes
•Administration
•Allocating
teaching loads
•Developing
course
catalogues etc.
Customer satisfaction survey
Process
outputs
•Teaching
modules
•Qualified
students
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Process
inputs:
EXERCISE - 1
three key processes
in your department and map
them together
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Identify
The Eight Quality
Management
Principles
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THE EIGHT QUALITY PRINCIPLES


A functional / effective quality system is based on
functional principles – these are the eight quality
management principles.
These principles make the management system
functional
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ISO 9001 AND QUALITY SYSTEMS


The ISO 9001: 2008 is based on the process
approach and the eight quality principles
Effective implementation of ISO 9001 ensure a
sound quality system based on with all the
quality principles maintained
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THE EIGHT QUALITY PRINCIPLES

Principle 1 Customer focus

Principle 2 Leadership

Principle 3 Involvement of people

Principle 4 Process Approach

Principle 5 System Approach to Management

Principle 6 Continual Improvement

Principle7 Factual Approach to Decision Making

Principle 8 Mutually Beneficial Supplier
Relationships
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1. CUSTOMER FOCUS

understand current and future customer needs

meet customer requirements

strive to exceed customer expectations.
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CUSTOMER FOCUS (2)




Organisations must identify their customers
Communicate their needs throughout the
organisation
Measure customer satisfaction
In educational institutions the learner is the
customer!
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2. LEADERSHIP




Leaders must establish unity of purpose and
direction
create and maintain the internal environment
where people become involved in achieving the
organisation’s goal.
Leaders must lead by example, demonstrate
visible commitment
Leaders must identify the vision and mission of
the institution and drive everyone along
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LEADERSHIP (2)
Management / Leaders should
Consider the needs of all interested parties
 Establish
clear visions for the future
 Establish
trust and eliminate fear
 Provide

resources, training etc.
freedom to act & recognizing people's
contributions (wisdom and skill) and use
all for the organization
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3. INVOLVEMENT OF PEOPLE




Quality is everybody’s business
People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization's
benefit.
Communication is essential (training is a means
of communication)
Involvement of people is the most effective way
for an educational organisation to achieve its
objectives
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INVOLVEMENT OF PEOPLE (2)
Organisations should help its people understand
the importance of their contribution and role

identify constraints to their performance

accept ownership of problems

share knowledge and experience

Openly discuss problems and issues.
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4. PROCESS APPRAOCH
A desired result is achieved more
efficiently when activities and
related resources are managed as a
process.
The systematic identification and
management of the processes is
referred to as Process Approach
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PROCESS APPROACH (2)



Identify processes, control process inputs and
monitor the characteristics for variation and
possible improvement
People, machines, methods, materials and
environment are classic inputs
Identified processes must relate to the objectives
of the organisation
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PROCESS APPROACH (3)
•
•
•
Systematically define the activities necessary to
obtain a desired result
Establish clear responsibilities and
accountability for managing key activities
Analyse and measuring of the capability of key
activities
•
Identify the interfaces of key activities
•
Focus on resources, methods, & materials.
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5. SYSTEM APPROACH TO
MANAGEMENT
 Identifying,
understanding and
managing interrelated processes as a
system contributes to the
organization's effectiveness and
efficiency in achieving its objectives.
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SYSTEM APPROACH TO
MANAGEMENT (2)




Understand the interdependencies between the
processes - one process output is another process
input.
Reduce cross-functional barriers – this causes
repetitions
Materials and information flow through the systems
must be smooth
Systems approach allows total optimization of
operational processes to achieve objectives for
the administrative standpoint.
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6. CONTINUAL IMPROVEMENT

Continual improvement of the organization's
overall performance should be a permanent
objective of the organization.
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CONTINUAL IMPROVEMENT (2)



The organisation should continually improve products,
processes and systems – this should be an objective for
every one in the organisation
Establish goals to guide and measures to track
continual improvement
Providing training in the methods and tools of
continual improvement.
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CONTINUAL IMPROVEMENT

P
E
R
F
O
R
M
A
N
C
E
C
B
A
TIME (YEARS)
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
Continual improvement:
Organizations are more efficient & effective when they continually
try to improve.
Organizations must make a permanent commitment to
continually improve their overall performance
7. FACTUAL APPROACH TO
DECISION MAKING
decisions are based on the
analysis of data and information.
(no one man decisions; avoid grapevines)
 Data
needs to be gathered factually
independently and without bias
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 Effective
FACTUAL APPROACH TO
DECISION MAKING (2)
We should:
take decisions and actions based on factual
analysis – facts not feelings

Make data accessible to those who need it

Ensure it is in a usable format to decision makers

Ensure data is accurate and reliable.
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
8. MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIPS
 An
organization and its suppliers are
interdependent and a mutually
beneficial relationship enhances the
ability of both to create value.
 Collaboration
with partners is
important to obtain optimal skill and
creativity to achieve learner value
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MUTUALLY BENEFICIAL
SUPPLIER RELATIONASHIPS
Identify and select key suppliers / partners

Establish clear and open communication

Pool expertise and resources

Establish joint development and improvement
activities with partners
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
MUTUALLY BENEFICIAL
SUPPLIER RELATIONASHIPS


Long term relationships enable the future to be
planned – it gives confidence
Performance may be reviewed for improvements review the performance of your partners and allow
them to review yours as well (2nd party audits)
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FOUR ADDITIONAL
PRINCIPLES
FOR ESTABLISHING
EDUCATIONAL SUCCESS
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IWA 1) CREATING LEARNER VALUE




Encourage learners to be satisfied with the
values they are receiving
Leaner satisfaction must be measured
Measurement must determine the degree to
which values received meet the learner’s needs
and expectations
It is key to improve processes for creating
learner value
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IWA 2) FOCUSING ON SOCIAL VALUE


Assess how / what learners and other interested
parties feel about ethics, safety and
environmental conservations
Educational organizations can ensure
sustainable growth only when the larger
society appreciates value-added output of
learners
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IWA 3) AGILITY


Sustaining growth in a drastically changing
environment is important
This agility turns and ever changing education
environment into an opportunity for success
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IWA 4) AUTONOMY


An educational organization must be free from
stereotyping
Self analysis helps the educational analysis to
make its own value decisions and keep it free
from stereotyping
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SUMMARY


With the IWA Guidance, there are a 12
management principles for and education
organization (EO)
In the EO, the learner is the customer and the
product / service provided is the education
service offered.
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EXERCISE - 2
1.
List the 12 quality management principles
for an EO
2.
Explain the principle “factual approach to
decision making”
3.
Identify three key collaborators / partners
that KNUST needs to establish mutually
beneficial relationships with.
4.
What is PDCA?
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EXERCISE - 2
5. Identify which of the 12 principles falls
under “plan”, which comes under “do”,
“check” and “act”?
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Benefits of a Quality
Management System
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BENEFITS OF A QMS STANDARD


The ISO QMS standard i.e. ISO 9001, outlines a
process approach to implementing and
supporting a QMS.
A key benefit is the increased involvement of top
management in all aspects of the company’s
activities.
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BENEFITS INCLUDE ….
•
•
Procedures ensure corrective actions are taken
whenever defects occur – the result is a decrease
in rework
Helps to achieve quality control/ quality
assurance;
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•
Well defined and documented procedures which
increases the consistency of output
BENEFITS INCLUDE ….
Increased organisational image
•
Increased customer satisfaction
•
•
Increased competitive power - increased market
share
Better relationship with supplier / partners
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•
BENEFITS INCLUDE ….

Gives room for continual improvement
Systematic and efficient operations – cost saving
- orderliness in the organization - removes
processes and activities which do not add value –
repetition/duplication of work reduced
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
BENEFITS INCLUDE ….
increases employee motivation and participation
– ownership of system –each is responsible for
his activities
 Speedy complaint redress – thus enhancing
customer satisfaction
 makes company managers and other employees
become more aware and conscious of "quality
management”

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BENEFITS INCLUDE ….

Like all standards, it gives us one language for
Quality Management implementation and puts
the company on the International platform
(speaking the international language!)
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
Finally the QMS standards gives one Quality
Management System standard used all over the
world
ISO 9001:2008
QUALITY MANAGEMENT SYSTEMS –
REQUIREMENTS
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GENERAL

Eight Clauses
 Clauses
1,2 & 3 are not auditable
 Clauses 4 – 8 are the auditable requirements.
1-Scope, 2-References , 3 – Definitions
 4 – Quality Management System
 5- Management Responsibility
 6 – Resource Management
 7 – Product Realisation
 8 – Measurement, Analysis, Improvement

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CLAUSE 1 -
SCOPE
 ISO
9001 specifies requirements for a QMS
when an organization needs to demonstrate
ability to consistently provide services that
meet customer and statutory requirements
 And for organisations aiming at
enhancing customer satisfaction
 Exclusions
are limited to clauses within
clause 7
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CLAUSE 2 NORMATIVE REFERENCES
 Normative

ISO 9000: 2005 – Quality Management
Systems – Fundamentals And Vocabulary
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references are other standards
needed for the complete implementation
of ISO 9001:2008
CLAUSE 3 –
clause usually defines key
terms and words used in the
standards
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 This
TERMS AND DEFINITIONS
CLAUSE 4 –
REQUIREMENTS OF THE
QUALITY MANAGEMENT SYSTEM
 4.1
– General Requirements

identify the processes and their application

determine their sequence and interaction,

ensure
availability
information

Ensure control on outsourcing of any process
affecting product conformity
of
resources
and
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
Establish - document - implement - maintain continually improve effectiveness
Management of processes

CLAUSE 4 – REQUIREMENTS OF THE QUALITY
MANAGEMENT SYSTEM
 4.2
– Documentation Requirements

Documented statements of Quality Policy & Quality
Objectives

Quality Manual

Documented procedures required by the Standard

Documents needed by the organization to ensure the
effective planning, operation and control of its processes

Records required – records provide information about
activities carried out
DOCUMENTS REQUIRED CONT.
Quality manual
 Establish and maintain a Quality
Manual
 Quality
Manual shall include:
Scope and justification for exclusions
 Documented procedures or reference
 Description of interaction between processes

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4.2.3

DOCUMENT CONTROL
Standard requires a document control procedure to
define..
 Encompass preparation, handling, issue and
recording of changes
•
Control must cover Internal and external documents
Approval prior to document issue
• Identify revision status
• Review, update & re-approve
•
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 How to control document
 What to control
 When to control
4.2.4 CONTROL OF RECORDS
 Establish and maintain records to
 Documented procedure to define
controls needed:
Identification
Storage
Protection
Retrieval
Retention time
Disposition
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provide evidence of conformity&
effective operation of QMS
 Legible, identifiable & retrievable
5
MANAGEMENT RESPONSIBILITY
Communicate the importance of meeting
customer and legal requirements
Conduct management reviews
Ensure availability of resources
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Top management shall demonstrate
commitment to the development,
implementation and improvement of
the QMS
5.1 MANAGEMENT COMMITMENT


Evidence of commitment of development
and implementation of QMS
Continually improve its effectiveness by:





Communicating customer requirements
Establishing quality policy
Establishing quality objectives
Conducting management reviews
Ensuring availability of resources
5.2 CUSTOMER FOCUS
 Ensure
that customer requirements are
determined and are met for enhancing customer
satisfaction. For this:
Identify customer needs & expectations
Translate them into requirements
Communicate requirements through out the
organization
Focus on improvement to ensure value for
customers
 For
details see 7.2.1 ( customer related
processes) & 8.2.1 ( customer satisfaction)
CUSTOMER FOCUS
 Need
to stop and think:
Who are my customers?
What do they really want? customer
requirements
What are my key processes to ensure that
they get what they want?

 More
emphasis on defining objectives
 Providing
leadership to enhance customer
satisfaction
5.3 QUALITY POLICY
Top management shall ensure
 Appropriate
 Commitment to meet requirements and
continually improve
 Framework for quality objectives
 Communicated
 Understood
 Reviewed
5.4 PLANNING
Quality Objectives must be established ,
communicated and worked at.
 These must be reviewed as system is continually
monitored

The Quality Objectives should cover relevant
functions and should be consistent with the
Quality Policy
 These should be SMART: - Specific,
Measurable, Acceptable, Realistic and Time-bound
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
5.5.2
MANAGEMENT REPRESENTATIVE
•Top management to appoint a
Management Representative with
Responsibility and authority for:
 ensuring
processes are established, implemented
and maintained for QMS
 reporting to top management on the performance
5.6 Top management must organize
periodic Management Review Meetings
6 RESOURCE MANAGEMENT

6.1 Provide resources to



6.2 Human resources




Competence, awareness and training
Evaluate effectiveness
Maintain records
6.3 Infrastructure




Improve effectiveness
Enhance customer satisfaction
Workspace
Equipment, hardware and software
Supporting services
6.4 Work environment
7.1 PLANNING OF PRODUCT REALIZATION
Plan and develop processes
 Quality objectives &requirements for product
 Establish processes, documentation and provide
resources.
 Verification, validation, monitoring, inspection
and test activities
 Records for evidence

7.2 CUSTOMER RELATED PROCESSES
Determine the product requirements
 Customer specifications including delivery and post
delivery requirements
 Requirements not specified by customers but
necessary for intended use
 Statutory and regulatory requirements
 Others
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7.3 DESIGN AND DEVELOPMENT
7.3.1 Planning
•
•
•
•
Stages of development
Review, verification & validation
Responsibilities& authorities
Interfaces
7.3.2 Inputs
7.3.3 Outputs
7.3.4 Review
7.3.5 Verification
7.3.6 Validation
7.3.7 Change Control
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WHAT DO
YOU WANT?
7.4 PURCHASING
 Purchasing process
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• Meeting purchase requirements
• Extent of Control on suppliers
• Evaluation and select
• Criteria for selection,evaluation & re-evaluation
• Maintain records
 Purchasing Information
• Product, procedures, processes and equipment
• Qualification of personnel
• Adequacy of specified requirements
 Verification of purchased product
Determine conformity to requirements
• By Organization
• By Customer
7.5 PRODUCTION & SERVICE PROVISION
7.5.1 Control of production and service provision
7.5.2 Validation of processes
7.5.3 Identification and trace-ability
7.5.4 Customer property
7.5.5 Preservation of product
7.6
Control of monitoring and measuring devices
7.5.1 CONTROL OF PRODUCTION AND SERVICE
PROVISION
 Controlled
Conditions
CONSISTENCY
CONFORMITY TO REQUIREMENTS
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Availability of information
 Work Instructions as necessary
 Suitable equipment
 Monitoring and measuring devices
 Monitoring and measurement activities
 Implementation of release , delivery,
and post-delivery activities

7.5.2 VALIDATION OF PROCESSES FOR
PRODUCTION AND SERVICE PROVISION
Validate processes
Define criteria for review and Approval,
Approval of equipment and
qualification of personnel
Use specific Methods & Procedures
Records
Re-validation

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7.5.3 IDENTIFICATION AND TRACE-ABILITY
 Identified by suitable means
 Trace-ability if required
 Record unique identification
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 Identify product status
7.5.4 CUSTOMER PROPERTY




Identified
Verified
Protected
Safeguard
Recorded and reported if
Lost, damaged or unsuitable
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
7.5.5 PRESERVATION OF PRODUCT
 Handling
 Storage
 Protection
Packaging
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 Preserve conformity during:
 Internal processing
 Delivery
 Identification
7.6 CONTROL OF MONITORING AND
MEASURING DEVICES (MAY BE EXCLUDED)
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 Determine measurements required
 Devices identified and calibrated
 Defined traceable standards
 Calibration status be determined
 Safeguard from adjustments
 Assessed & record if out of calibration
 Protected from damage & deterioration
 Software confirmed
 Records maintained
8 MEASUREMENT ANALYSIS AND CONTROL
8.1 General
Plan and implement monitoring,
measurement analysis and improvement
processes needed to:
 demonstrate conformity of the product
 ensure conformity of the QMS
 continually improve effectiveness of the
QMS
• Determine applicable methods including
statistical techniques, and the extent of
their use
8.2 MEASUREMENT AND MONITORING
• Measurement and monitoring is
the first step that leads to control
and eventually to improvement
If you can not measure something,
you can not understand it.
If you can not understand it,
you can not control it.
If you can not control it,
you can not improve it.
8.2.1 CUSTOMER SATISFACTION

Monitor information

Customer perception

Methods determined
One of the parameters of quality is the gap between
customer’s expectation and supplier’s capability. The
narrower this gap the better is the meeting of minds of
the customer and supplier
CUSTOMER SATISFACTION MEASURES
Periodic customer surveys
 Customer focus groups
 Customer aftercare calls
 Client meetings
 Customer churn rate
 Golf course approach - informal chats
 Market research
 Complaints

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8.2.2 INTERNAL AUDIT
 Documented Procedure
 Actual = Plan ?
 Effective, Objective, Impartial
 Independent Auditors
 Recorded Results
 Follow-up
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 Periodic Audits
8.2.3 MONITORING AND
MEASUREMENT OF PROCESSES
8.2.3
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8.2.3
 PROCESSES
 SUITABLE METHODS
 PLANNED RESULTS
 CORRECTION AND
CORRECTIVE ACTION
8.2.4
8.2.4 MONITORING AND
MEASUREMENT OF PRODUCT
 FOLLOW PLANNED ARRANGEMENTS
 EVIDENCE OF CONFORMITY
 RECORDS FOR AUTHORITY FOR RELEASE
 APPROVED BY RELEVANT AUTHORITY
 OR THE CUSTOMER
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 MONITOR AND MEASURE
8.3 CONTROL OF NONCONFORMING PRODUCT
What happens when things go wrong?
 Identified And Controlled
 Authority Defined
 Eliminate The Nonconformity
 Authorize, Release Or Acceptance
Under Concession
 After Delivery Or Use Has
Started, Appropriate Action
 Records Maintained
 Re-verified After Correction
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 Documented Procedure
8.4 ANALYSIS OF DATA
 Determine, collect And
Scatter plots
Process Capability
Establishing of limits
Control charts
Monitoring & controlling
production & measurement
Sampling & acceptance - Inspection and testing plans
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Analyse Data
 Identify Areas Of Continual
Improvements
 Provide Information Relating To:
Customer Satisfaction
 Conformance To Requirements
 Process Trends And Product
Characteristics
 Suppliers
Graphical methods
Pareto, Cause and effect,
8.5 IMPROVEMENT

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action
8.5.1 CONTINUAL IMPROVEMENT

Continually improve effectiveness
through:






Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review
8.5.2 CORRECTIVE ACTION
A
documented procedure must be
established
 Procedure must review nonconformities
 Identify the causes
 Review the effectiveness of the corrective
action
 Records shall be maintained
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8.5.3 PREVENTIVE ACTION
 Documented
procedure must be established
 Procedure
to evaluate need for action to
prevent occurrence of nonconformities
 Review the effectiveness of preventive action
taken
 Records shall be maintained
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GOD BLESS YOU
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