Topic 4 ISO9000 X

PART 3: ISO9000
WHAT IS THE ISO 9000

ISO stands for International Organization for Standardization
ISO 9000 is defined as a set of international standards on quality management and
quality assurance developed to help companies effectively document the quality system
elements needed to maintain an efficient quality system.
ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and
achieve continual improvement. It should be considered to be a first step or the base level
of a quality system.
ISO 9001 is one of the most widely adopted International Standards in the world. With
over 1 million certificates issued worldwide, it spans all sectors of commerce and industry.
THE ISO 9000 STANDARDS
SERIES
ISO 9000:2015 • fundamentals and vocabulary, which sets out
the common terms and definitions for quality
Quality management systems management systems.
ISO 9001:2015 • requirements, which defines the requirements of

Quality management systems a quality management system.
ISO 9004:2009 • A quality management approach, which focuses

Managing for the sustained success of an on how to make a quality management system
organization more efficient and effective.
ISO 19011:2011 • provides guidance on internal and external

audits of quality management systems and is
Guidelines for auditing management systems the standard that NQA auditors adhere to
ISO 9001 CERTIFICATION
Achieving ISO 9001:2015 certification means that an organization has demonstrated the
following:
◦ Follows the guidelines of the ISO 9001 standard
◦ Fulfills its own requirements
◦ Meets customer requirements and statutory and regulatory requirements
◦ Maintains documentation
Certification to the ISO 9001 standard can enhance an organization’s credibility by showing
customers
The certification process includes implementing the requirements of ISO 9001:2015 and then
completing a successful registrar’s audit confirming the organization meets those requirements.
that its products and services meet expectations.
ISO 9001 CERTIFICATION
Organizations should consider the following as they begin preparing for an ISO 9001 quality
management system certification:
◦ Registrar’s costs for ISO 9001 registration, surveillance, and recertification audits
◦ Current level of conformance with ISO 9001 requirements
◦ Amount of resources that the company will dedicate to this project for development and implementation
◦ Amount of support that will be required from a consultant and the associated costs
PREREQUISITES
Before your registrar can commence your
Certification Audit, your organization
needs to meet the following prerequisites:
◦ Your ISO system needs to be fully
implemented
◦ You need to have completed an internal
audit
◦ There need to be sufficient records
available to verify compliance
Some certification bodies stipulate
additional requirements or a minimum
number of months (often two) for the
acquisition of records but this should be
discussed directly with your registrar.
Certification
Process
Application
Preliminary audit (optional):
Certification audit:
Issue Certificate
Surveillance audits
Re-certification
Why is ISO 9000 important?
European Union directive
◦ ISO 9000 certification required by suppliers of “Regulated
Products”
◦ health, safety, and the environment
◦ EC has strict corporate liability legislation protecting consumers
Globalization impact
Why adopt and implement ISO
9000?
To comply with customers who require ISO 9000
To sell in the European Union market
To compete in domestic markets
To improve the quality management system
To minimize repetitive auditing by similar and different customers
To improve subcontractors’ performance
To meet product certification requirements
To market and improve the company image for promotional purpose
Benefits of ISO 9001 for your
organization
Barriers to sucessful
implementation of ISO 9000
Lack of top management commitment and support.
Lack of awarenes training among employees.
Misinterpretation of the requirements
There is far too much effort devoted to documentation, paperwork, and bookkeeping and not nearly
enough to actually reducing variability and improving processes and products.
It is a quite costly. It has been estimated that ISO certification activities are approximately a $40 billion
annual business, worldwide.Much of this money flows to the registrars, auditors, and consultants and
the cost does not include all of the internal costs incurred by organizations to achieve registration and
recertification
QMS Documentation Level
Quality Policy/Manual
•The quality policy is a statement that defines the
company’s commitment to quality. It is a high-level
document outlining the values and principles regarding
quality and providing a framework for setting quality
objectives.
•At Simpler QMS, we advocate for creating quality policies
that clearly state the company’s desire to support high
and uniform quality in products and processes. It is
important for people reading the Quality Policy to see your
company’s identity reflected
Procedures
•A procedure describes the step-by-step activities of
processes within the company. It includes elements such
as the responsible departments or functions and the
frequency of the action.
•These procedures provide clear guidelines, helping
achieve efficiency, quality output, and consistent
performance while reducing miscommunication and
noncompliance with relevant requirements.
Work Instructions
•Work instructions are the most detailed documents in the
QMS structure. They describe in detail how specific tasks
must be performed.
•They are typically written by the people who perform the
work or people who are responsible for leading those who
perform the work. Work instruction can be developed in
the company or provided by customers.
•The instructions help ensure tasks are carried out
consistently and effectively and meet the applicable
requirements of the quality management system.
Records
•Records provide evidence that activities and events were
conducted, providing a historical record of actions.
•By performing internal audits and reviewing the records,
companies can support evidence-based decision-making
and demonstrate compliance with requirements.

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PART 3: ISO9000

WHAT IS THE ISO 9000

ISO 9001:2015 • requirements, which defines the requirements of

ISO 9004:2009 • A quality management approach, which focuses

ISO 19011:2011 • provides guidance on internal and external

Preliminary audit (optional):

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