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Transcript of ISO 9001
UMTFZCO Gamal A. Hamid 2
ISO 9
001 - 2008
You have to be organized.
UMTFZCO Gamal A. Hamid 3
Contents
A- Quality Management Principles
1- Customer focus
2- Leadership
3- Involvement of people
4- Process approach
5- Systems approach to management
6- Continual improvement
7- Factual approach to decision making
8- Mutually beneficial supplier relationships
UMTFZCO Gamal A. Hamid 4
Contents
B- ISO 9001 – 2008 Standard
0. Introduction
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
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Contents
C- Steps to ISO 9001 Certification
1. Learn About ISO 9001
2. Identify Project Responsibilities.
3. Train Employees on ISO 9001
4. Perform a Gap Analysis
5. Prepare a Project Plan
6. Document Your System
7. Implement the QMS in Your Organization
8. Audit Your QMS
9. ISO 9001:2008 Registration Audit
10. Certification
11. Maintain and improve your management system
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ISO 9
001 - 2008
• The quality of something can be determined by comparing
a set of inherent characteristics with a set of requirements.
If those inherent characteristics meet all requirements, high
or excellent quality is achieved.
• The customers' perception of the value of the suppliers' work output
• The properties of products and/or services that are valued by the
consumer.
• A degree of excellence.
• The rate of what has been achieved of the process requirements.
Quality
Q
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ISO 9
001 - 2008
Document
Document
information and its supporting medium
for examples:
paper
magnetic
electronic or optical computer disc
photograph
master sample
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ISO 9
001 - 2008
Quality control is a set of activities intended to ensure that
quality requirements are actually being met.
Quality assurance is a set of activities intended to establish
confidence that quality requirements will be met.
QC & QA
Quality control is the fulfilling quality requirements
Quality assurance is the providing confidence that quality
requirements will be fulfilled
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ISO 9
001 - 2008
Policy
A procedure is a way of carrying out a process or activity.
According to ISO 9000, procedures may or may not be
documented. However, in most cases, ISO 9001 expects
you to document your procedures.
Policy & Procedure
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001 - 2008
Mission
Statement explains why an organization exists. It
defines its reason for being
Vision
Describes what it wants to be and how it wants to be
seen by interested parties.
Mission & Vision
UMTFZCO Gamal A. Hamid 11
ISO 9
001 - 2008An audit is an evidence gathering process. Audit evidence is
used to evaluate how well audit criteria are being met.
There are three types of audits: first-party, second-party, and
third-party audits. First-party audits are internal audits. Second
and third party audits are external audits.
A self-assessment is a comprehensive and systematic review of an
organization’s overall maturity and is used to help achieve and
sustain organizational success.
Audit & Assessment
UMTFZCO Gamal A. Hamid 12
ISO 9
001 - 2008
Preventive action
Action to eliminate the cause of a potential nonconformity
or other undesirable potential situation
Corrective action
Action to eliminate the cause of a detected nonconformity
or other undesirable situation
Preventive action &Corrective action
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ISO 9
001 - 2008
Is a set of interrelated or interacting elements that
organizations use to direct and control how quality policies
are implemented and quality objectives are achieved.
such as:
satisfying the customer's quality requirements.
Quality management system
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ISO 9
001 - 2008
Organize our thinking
How can ISO help us?
A 1- Develop your process.
2. Document your process.
3. Implement your process .
4. Maintain your process.
5. Monitor your process .
6. Measure your process .
7. Analyze your process.
8. Control your process .
9. Improve your process .
Q what is the steps for a good process?
UMTFZCO Gamal A. Hamid 15
ISO 9
001 - 2008Is a comprehensive and fundamental rule for leading and operating an organisation, aimed at continually
improving performance over the long term by focusing on customers while addressing the needs of all other stake holders".
Quality Management Principles
1. Customer-Focused Organisation
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships.
UMTFZCO Gamal A. Hamid 16
ISO 9
001 - 2008"Organisations depend on their customers and therefore should understand current
and future customer needs, meet customer requirements .
Principle 1 - Customer-Focused Organisation
Steps in application of this principle are ...
1. Understand customer needs and expectations for
products, delivery, price.
2. Communicate these needs and expectations
throughout the organisation.
3. Measure customer satisfaction & act on results.
4. Manage customer relationships
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ISO 9
001 - 2008 “Leaders should create and maintain the internal environment in which people can become
fully involved in achieving the organisation's objectives."
Principle 2 - Leadership
Steps in application of this principle are ...
1. Be proactive and lead by example.
2. Establish a clear vision of the organisation's future.
3. Provide people with the required resources and freedom
to act with responsibility.
4. Build trust and eliminate fear.
5. Consider the needs of all stake holders including
customers, owners, people, suppliers and society .
6. Educate, train and coach people.
UMTFZCO Gamal A. Hamid 18
ISO 9
001 - 2008"People at all levels are the essence of an organisation and their full involvement
enables their abilities to be used for the organisation's benefit".
Principle 3 - Involvement of People
Steps in application of this principle are...
1. Accept ownership and responsibility to solve problems.
2. Freely share knowledge & experience in teams.
3. Improve the way of representing the organisation to
customers, local communities .
4. Help people derive satisfaction from their work.
5. Make people to be part of the organisation.
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ISO 9
001 - 2008
"A desired result is achieved more efficiently when related resources and activities are
managed as a process."
Principle 4 - Process Approach
Steps in application of this principle are ...
1. Identify and measure the inputs and outputs of the process.
2. Evaluate possible risks, and impacts of processes on customers,
suppliers and other stake holders of the process.
5. Establish clear responsibility, authority, and accountability for
managing the process.
6. Identify internal and external customers, suppliers and other
stake holders of the process,
UMTFZCO Gamal A. Hamid 20
ISO 9
001 - 2008 "Identifying, understanding and managing a system of interrelated processes for a given
objective improves the organisation's effectiveness .
Principle 5 - System Approach to Management
Steps in application of this principle are ...
1. Define the system by identifying or developing the
processes that affect a given objective.
2. Structure the system to achieve the objective in the
most efficient way.
3. Continually improve the system through measurement
and evaluation.
4. Estimate the resource requirements .
UMTFZCO Gamal A. Hamid 21
ISO 9
001 - 2008
"Continual improvement should be a permanent objective of the organisation."
Steps in application of this principle are ...
1. Apply the basic improvement concepts.
2. Continually improve the efficiency and effectiveness of all processes.
3. Promote prevention based activities.
4. Provide every member of the organisation with appropriate education and
training, on the methods and tools of continual improvement .
5. Establish measures and goals to guide and track improvements.
Principle 6 - Continual Improvement
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ISO 9
001 - 2008
"Effective decisions are based on the analysis of data and information."
Steps in application of this principle are ...
1. Take measurements and collect data and information relevant to the
objective.
2. Ensure that the data and information are sufficiently accurate, reliable
and accessible.
3. Analyze the data and information using valid methods.
4. Understand the value of appropriate statistical techniques.
5. Make decisions and take action based on the results of logical analysis
balanced with experience and intuition.
Principle 7 - Factual Approach to Decision Making
UMTFZCO Gamal A. Hamid 23
ISO 9
001 - 2008 "An organisation and its suppliers are interdependent, and a mutually beneficial
relationship enhances the ability of both to create value."
Steps in application of this principle are ...
1. Identify and select key suppliers.
2. Create clear and open communications.
3. Initiate joint improvement of products and processes.
4. Jointly establish a clear understanding of customers' needs.
5. Share information and future plans.
6. Recognise supplier improvements and achievements.
Principle 8 - Mutually Beneficial Supplier Relationships
UMTFZCO Gamal A. Hamid 24
ISO 9001 – 2008 Standard
UMTFZCO Gamal A. Hamid 25
ISO 9
001 - 2008
Clause headings:
ISO 9001:2008 Standard
0. Introduction
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
UMTFZCO Gamal A. Hamid 26
ISO 9
001 - 2008
What does the term "ISO" stand for?
The term ISO stands for the International Organization for
Standardization. You would reasonably assume that it ought
to be IOS, but it isn't. Apparently, the term ISO was chosen
(instead of IOS),
because iso in Greek means equal, and ISO
wanted to convey the idea of equality - the idea that they
develop standards to place organizations on an equal
footing.
Introduction
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ISO 9
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What are the ISO 9000 standards ?
The ISO 9000 standards are a collection of formal International
Standards, Technical Specifications, Technical Reports, Handbooks and
web based documents on Quality Management.
ISO 9001 is NOT a product Standard - it contains no product
requirements. It is a series of generic requirements for quality
management systems.
ISO 9001 - 2008
UMTFZCO Gamal A. Hamid 28
ISO 9
001 - 2008
People in the organization will benefit by:
Better working conditions
Increased job satisfaction
Improved health and safety
Improved stability of employment
Owners and investors will benefit by:
Increased return on investment
Improved operational results
Increased market share
Increased profits
Why is ISO 9001 Important?
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001 - 2008
Suppliers and partners will benefit by:
Stability
Growth
Partnership and mutual understanding
Society will benefit by:
Fulfillment of legal and regulatory requirements
Improved health and safety
Reduced environmental impact
Increased security
Why is ISO 9001 Important?
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ISO 9
001 - 2008
(Company ) has developed and implemented this quality
management system to demonstrate its ability to
consistently provide product that meets customer and
statutory and regulatory requirements, and to address
customer satisfaction through the effective application of
the system, including continual improvement and the
prevention of nonconformity.
1.Scope
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ISO 9
001 - 2008
For undated references, the latest edition of the normative
document referred to applies. ISO 9000: 2005 Quality
Management System –Fundamentals and Vocabulary.
2.Normative Reference
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ISO 9
001 - 2008
“Supplier” and “Vendor” are synonymous and refer
to the external source used to acquire purchased
products by (Company Name).
3.Terms and Definitions
The terms and definitions of iso 9000 will applied
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ISO 9
001 - 2008
4.1 General requirements
4.Quality Management System
the organization establish, documented,
implemented and maintained a quality management
system and continually improved its effectiveness in
accordance with the requirements of this
International Standard.
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ISO 9
001 - 2008
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of quality records
QMS
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ISO 9
001 - 2008
The quality management system documentation shall include:
1. documented statements of a quality policy and quality objectives.
2. a quality manual .
3. documented procedures required by this International Standard .
4. documents needed by the organization to ensure the effective
planning, operation and control of its processes.
5. records required by this International Standard.
Document requirements
UMTFZCO Gamal A. Hamid 36
ISO 9
001 - 2008 Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008.
The documented quality policy has to be controlled according to the requirements of clause
4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet
the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3
(c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008.
These documented quality objectives are also subject to the document control requirements
of clause 4.2.3.
1- Statements of Policy and quality objectives
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ISO 9
001 - 2008
document specifying the quality management
system of an organization
2- Quality manual
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ISO 9
001 - 2008
What does Quality Manual Include?
The Quality manual includes the following
It fully describes the scope of QMS.
It completely explains each and every requirement of the ISO 9001 Standard
It contains complete detail and explanation of exclusions .
It contains references for the quality procedures used to describe all the QMS processes
A flow chart represent the series and interaction of your key business processes.
The organization's quality policies which shows that the organization is strictly committed to
quality
UMTFZCO Gamal A. Hamid 39
ISO 9
001 - 2008Following are the primary uses of the quality manual
To communicate management's expectations for quality to the organization
To reveal the organization conformity with ISO 9001 requirements
To serve as a measure for compliance to management's expectations for:
Internal audits
ISO Registrar audits
Customer audits
Primary Uses of Quality Manual
UMTFZCO Gamal A. Hamid 40
ISO 9
001 - 2008
Procedure is the specified way to carry out an activity or a process
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the
following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
3- Documented procedures
UMTFZCO Gamal A. Hamid 41
ISO 9
001 - 2008 Process maps, process flow charts and/or process descriptions
Organization charts
Specifications
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans
4- Documents needed by the organization
UMTFZCO Gamal A. Hamid 42
ISO 9
001 - 20085.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfill requirements
7.2.2 Results of the review of requirements related to the product and actions arising from
the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
5- Records required by ISO 9001 - 2008
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ISO 9
001 - 20087.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting
output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national
measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to
requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action
Cont.
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ISO 9
001 - 2008
Documents
information and its supporting medium
for examples:
paper
magnetic
electronic or optical computer disc
photograph
master sample
4.2.3 Control of Documents
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ISO 9
001 - 2008
A record is a type of document. Which provide evidence that
activities have been performed or results have been achieved.
Records management addresses six key issues:
identification
storage
protection
retrieval
retention
disposition
4.2.4 Control of quality record
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ISO 9
001 - 2008
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy 5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2&3 Review input & output
5.Management Responsibility
UMTFZCO Gamal A. Hamid 47
ISO 9
001 - 2008Top management is committed to the development and implementation of the quality
management system and continually improves its effectiveness by:
communicating to (Company Name) the importance of meeting customer as well as statutory
and regulatory requirements,
establishing a quality policy,
establishing quality objectives,
conducting management reviews, and
ensuring the availability of resources
Management commitment
UMTFZCO Gamal A. Hamid 48
ISO 9
001 - 2008
Steps in application of this principle are ...
1. Understand customer needs and expectations for products, delivery, price, dependability,
2. Ensure a balanced approach among customers and other stake holders (owners, people,
suppliers, local communities and society at large) needs and expectations.
3. Communicate these needs and expectations throughout the organisation.
4. Measure customer satisfaction & act on results, and
5. Manage customer relationships.
Customer focus
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ISO 9
001 - 2008
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, training and awareness
6.3 Infrastructure
6.4 Work environment
6.Resource Management
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ISO 9
001 - 20086.1 Provision of resources
(Company Name) determines and provides the resources needed
to implement and maintain the quality management system and continually improve its
effectiveness, and
to enhance customer satisfaction by meeting customer requirements.
Provision of resources
UMTFZCO Gamal A. Hamid 51
ISO 9
001 - 20086.2.1 General
Personnel performing work affecting conformity to product requirements are competent on the
basis of appropriate education, training, skills and experience.
6.2.2 Competence, training, and awareness
determines the necessary competence for personnel performing work affecting conformity to
product requirements,
where applicable, provides training or takes other actions to achieve the necessary competence,
evaluates the effectiveness of the actions taken,
ensures that its personnel are aware of the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives, and
maintains appropriate records of education, training, skills and experience .
Supporting Documentation QOP-62-01 Competence, Training, and Awareness
Human resources
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ISO 9
001 - 2008The organization shall determine, provide and maintain the infrastructure needed to achieve
conformity to product requirements.
buildings, workspace and associated utilities,
process equipment (both hardware and software), and
supporting services (such as transport, or communication, or information systems).
Infrastructure
UMTFZCO Gamal A. Hamid 53
ISO 9
001 - 20086.4 Work environment
set of conditions under which work is performed
NOTE Conditions include physical, social, psychological
and environmental factors (such as temperature).
Company determines and manages the work
environment needed to achieve conformity to product
requirements.
Work environment
UMTFZCO Gamal A. Hamid 54
ISO 9
001 - 20087.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2&3 Design and development inputs &output
7.3.4 Design and development review
7.3.5&6 Design and development verification &validation
7.3.7 Control of design and development changes
7.Product Realization
UMTFZCO Gamal A. Hamid 55
ISO 9
001 - 20087.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring equipment
7.Product Realization
UMTFZCO Gamal A. Hamid 56
ISO 9
001 - 20088.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3&4 Monitoring and measurement of processes & product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
8.Measurement, Analysis and Improvement
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Steps to getting ISO 9001
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ISO 9
001 - 2008
Steps to ISO 9001 Certification
1. Learn About ISO 9001
2. The cost of the project.
3. Identify Project Responsibilities.
4. Train Employees on ISO 9001
5. Perform a Gap Analysis
6. Prepare a Project Plan
7. Document Your System
8. Implement the QMS in Your Organization
9. Audit Your QMS
10. ISO 9001:2008 Registration Audit
11. Certification
12. Maintain and improve your management system
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001 - 2008
Learn About ISO 9001
Step 1
NO. Activity Who When How How Long
1ISO
purchaseMr. Farzad On line One day
2Study the
requirements
ISO Project Manager
Review One week
3
Study the requirement
sSteering team Action plan
Two meeting/
weekTwo weeks
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001 - 2008
The cost of the project
1. The consultant cost.
2. Hiring some peoples.
3. Training cost.
4. Infrastructure and documentation.
5. Software and format.
6. Registration and certificate cost.
Step 2
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Identify Project Responsibilities
1. Top management
2. Project manager.
3. Management representative.
4. Internal Auditors.
5. Steering team.
6. task team.
7. Infrastructure.
Step 3
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ISO 9
001 - 2008Establish the quality policy.
Ensure that quality objectives are established at all relevant levels of the organization.
Ensure availability of resources.
Ensure that the planning of the quality system is carried out to meet the requirements of the
standard and the quality objectives.
Ensure that responsibilities, authorities and their interrelation are defined and
communicated.
Ensure that appropriate communication is established within the organization and
effectiveness of the quality management system is communicated.
Responsibilities of Top Management
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001 - 2008
Choose your PM
1. The Project Manager completes the Training.
2. The Project Manager prepares a Project Plan.
3. Management and the Project Manager identify an ISO 9001 Steering Team.
4. The Project Manager and others conduct a Gap Analysis with the Gap
Analysis Checklist.
5. Revise processes and procedures and train those within your organization
Project manager
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001 - 2008
Choose your MR
1. The standard requires that the MR must be "a member of
management" serving primarily as the "eyes" and "ears" of top
management.
2. The MR primarily provides feedback( report) to top management on
the effectiveness of the quality management system.
3. Ensuring that processes needed for the quality management system are
established, implemented and maintained.
4. Ensuring the promotion of awareness of customer requirements
throughout the organization.
Management representative (MR)
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Choose your auditors team
1. Trained internal auditors for your audit program.
2. Auditing each area of your facility once or twice a year,
3. A general guidance number is 10% of the total number of employees; a company with 50
employees would train 5 auditors.
4. Look for employees that have a strength in investigating issues and that are good
communicators.
5. The better people skills the auditors have, the smoother your audits will be performed.
Internal Auditors
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001 - 2008
Choose your Steering team
Management must identify a steering team for the project. It
should be made up of managers from different areas of the
organization.
The purpose of the team will be to assign resources and
responsibilities for the project as well as providing
leadership for the project.
A team led by top management that will coordinate and lead
the implementation project
Steering team
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001 - 2008
1. Identify team members for each procedure.
2. Assign target start date and completion date for each team.
3. Identify training needs for employees and schedule training sessions for ISO 9001:2008
4. Meet on a regular basis to evaluate progress, answer questions for the teams and
evaluate resource needs for the
implementation.
5. Review and approve procedures as they are finalized.
6. Evaluate and choose a Registrar
Steering team responsibility
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001 - 2008
Choose your Task teams
The Task Team is led by a member of the Steering Team.
A Task Team is set-up for each Quality System Procedure that
needs to be developed.
Task team (quality team)
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001 - 2008
1. Review the “Implementation Steps” to the group
2. Review Responsibilities of the ISO 9001:2008 Steering Team
3. Review procedure that the team will be responsible for.
4. Review the section of the Gap Analysis that applies to the team.
5. Determine resources required for completion of the tasks.
Task team responsibility
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The organization shall determine, provide and maintain the
infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable
1. buildings, workspace and associated utilities.
2. process equipment (both hardware and software).
3. supporting services (such as transport, or communication,
or information systems).
Infrastructure
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001 - 2008
Train Your Organization
1. Top management.
2. Project manager.
3. Internal Auditors.
4. Steering team.
5. task team.
6. All employees.
Step 4
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ISO 9
001 - 2008Define the knowledge and skill needed for each employee to conduct their job.
Deliver training or other learning activities to develop the required knowledge and skill.
Provide a way to prove whether the training was effective (test for understanding)
Ensure employee awareness of how their activities contribute to the quality objectives. They
should understand the relevance and importance of their role.
Keep training records and records of employee education, skills and experience.
Management Overview
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ISO 9
001 - 2008ALL of the employees in an organization so they understand the importance of ISO 9001 and
their role in meeting the requirements.
The course will educate them on:
What is an ISO 9001 Quality Management System?
Why is our company involved with ISO 9001?
What does ISO 9001 require?
How does it impact me and how can I impact quality?
What and why are people auditing?
Employee Awareness
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Perform a Gap Analysis
Consider the start of your project as the date of the Gap Analysis.
Before conducting the Gap Analysis:
1. Identify one or more people to conduct the Gap Analysis; it is
helpful if they have some quality experience or audit experience.
2. Print the Gap Analysis Checklist.
3. Schedule the Gap Analysis, and communicate to all employees what
is being done, and why.
Step 5
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001 - 2008
Perform a Gap Analysis
Schedule the Gap Analysis
NO. Activity Who When How How Long
1
2
3
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ISO 9
001 - 2008
Question YES NO N/A Auditor Remarks
1 Do you identify the requirements that your customers want you to comply with?
2 Do you identify your customers' product requirements?
3 Do you identify your customers' delivery requirements?
4 Do you identify your customers' post-delivery requirements?
5 Do you identify warranty requirements?
6 Do you identify maintenance requirements?
Gap analysis check list
76
Chick list more than 50 pages and coves all the company activitiesFor example:
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ISO 9001 Gap Analysis Report
Summarize the audit findings in the form of a task list.
You will usually identify several categories of tasks.
Processes that comply with the standard and are documented.
Processes that comply with the standard and must be documented.
Processes that do not comply with the standard and must be redesigned.
Processes required by the standard that are not currently in place.
Gap analysis Report
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Prepare a Project Plan
ISO 9001 Step-by-Step Workbook
The Team Approach
Gantt chart
Step 6
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1- Prepare Your Organization
2- Develop Your ISO 9001 Quality Management System (QMS)
3- Implementation and ISO 9001 Registration
ISO 9001 Step-by-Step Workbook
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ISO 9
001 - 2008 Task 1: Management Describe your company
Task 2: Management Choose your ISO Management System
Task 3: Management Obtain the latest ISO 9001 standard
Task 4: Management Select the Management Rep & Steering Team
Task 5: ISO Steering Team Prepare an Organizational Chart
Task 6: ISO Steering Team Establish the Quality Team
Task 7: Quality Team Conduct First Team Meeting
Task 8: ISO Steering Team Formulate the Quality Policy / Objectives
Task 9: ISO Steering Team State the scope of the QMS
Task 10: Quality Team/ Identify applicable regulations ISO Steering Team
1- Prepare Your Organization
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ISO 9
001 - 2008 Task 11: Quality Team Identify/Describe processes/Prepare process flow diagrams
Task 12: ISO Steering Team Provide Communication Tools
Task 13: Quality Team Conduct a Preliminary Assessment –c/list
Task 14: ISO Steering Team Assign Improvement Actions for QMS
Task 15: ISO Steering Team Provide ISO 9001 training-Exercises A--F
Task 16: ISO Steering Team Manage the Implementation Project
Task 17: ISO Steering Team Complete Project Timing Chart
Task 18: ISO Steering Team Collect Existing Documents
Task 19: ISO Steering Team Perform financial study of costs and benefits
Task 20: ISO Steering Team Reconfirm the ISO 9001 Decision
Task 21: ISO Steering Team Promote and practice teamwork
2- Develop Your ISO 9001 Quality Management System (QMS)
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ISO 9
001 - 2008 Task 22: Obtain and Review a Model for a QMS Manual
Task 23: Use the Model as a Template to generate QMS documentation
Task 24: Implement the Quality Management System
Task 25: Conduct Internal Audit of the QMS
Task 26: Conduct the Management Review
Task 27: Select a Certification Body to register the QMS
Task 28: Receive Certification and Celebrate
3- Implementation and ISO 9001 Registration
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ISO 9
001 - 2008A Gantt chart is a graphical representation of the duration of tasks
against the progression of time.
A Gantt chart is a useful tool for planning and scheduling projects.
And helpful when monitoring a project's progress.
Action plan (Gantt chart)
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ISO 9
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Document Your System
How Much Documentation Do You Need?
Importance of Document Control
ISO 9001 QMS Templates
Step 7
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Clause 4.2.1 General explains that the quality management system
documentation shall include:
1. documented statements of a quality policy and quality
objectives;
2. a quality manual
3. documented procedures required by this International Standard
4. documents needed by the organization to ensure the effective
planning, operation and control of its processes, and
5. records required by this International Standard;
Document requirements
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Establish a documented procedure to:
Approve documents for adequacy prior to issue
Review, update as necessary, and re-approve documents
Identify the changes and current document revision status
Make relevant documents available at points of use
Ensure the documents remain legible and readily identifiable
Identify external documents and control their distribution
Prevent obsolete documents from unintended use
Apply suitable identification if obsolete documents are retained
Documents control
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Implement the QMS in Your Organization
Training on New Procedures
Training of Internal Auditors
Step 8
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ISO 9
001 - 2008Follow documented procedures and work instructions
Everyone in your organization should be performing processes following your documented
procedures and work instructions, complying with the QMS requirements.
Make improvements to the processes
Many of these procedures may be new to your organization, or have changed significantly
during your ISO 9001 project. Now that they are actually in use, you will most likely find areas
that can be improved. Make improvements using the Corrective and Preventive Action
process and the document revision process
Training on New Procedures
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Training Objectives:
Fully understand and successfully interpret the ISO 9001:2008 requirements
Understand how to audit using the process approach
Ask audit questions that get results
Identify and document nonconformities
Qualify additional staff to conduct internal audits
Gain knowledge to help manage a successful ISO 9001:2008 implementation project
Provide professional credentials to internal auditors
Provide critical knowledge for staff and management
Training of Internal Auditors
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Audit Your QMS
Conduct Internal Audits
Corrective/Preventive Action
Step 9
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During an internal audit you will compare your quality system
against the requirements of the standard.
You will select a group of internal auditors from within your
company to perform the audits.
Conduct Internal Audits
Schedule internal audits to cover all areas of the organization
before your Registration Audit. Allow time to take corrective
action on any findings.
A robust and effective internal audit program is one of the best
tools to finding and correcting shortcomings in the QMS before
your Registration Audit.
Conduct Internal Audits
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ISO 9
001 - 2008Corrective action is re-active ie dealing with the problem AFTER the event.
Your corrective action procedure must explain how you:
review non-conformance and customer complaints
decide the cause of the problem
decide an appropriate course of action to stop the problem recurring
put the plan into action
ensure that the action has solved the problem
Corrective Action
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ISO 9
001 - 2008Preventive action is a pro-active procedure ie dealing with the problem BEFORE it happens.
Your preventive action procedure must explain how you:
review potential problems
decide the potential cause of the problem
decide an appropriate course of action to stop the problem occurring
put the plan into action
ensure that the preventive action has solved the potential problem
Preventive Action
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ISO 9001:2008 Registration Audit
Selecting a Registrar
When to select a Registrar
Registration Costs
Choosing a Registrar
Registrar Questionnaire
Recommended Registrars
Step 10
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Typical ISO Registration Process
1- Registration
2- Initial assessment
3- Certification audit
4- Surveillance audits
5- Reassessments
6- Certificate
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Step 11 Certification
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Maintain and improve your management system
Step 12
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Thank you