The ISO standard is updated every five years and as it's a universal standard, it can be applied to

any business in any sector. The current version of ISO 9001 was published in 2015. This fifth
edition(version)ISO 9001:2015 cancels and replaces the fourth edition (ISO 9001:2008)

ISO 9001:2015 is the latest revision of previous standards and requirements that replaces
previous versions, most notably ISO 9001:2008. ISO 9001 is a globally recognized standard for
quality management. It helps organizations of all sizes and sectors to improve their performance,
meet customer expectations, and demonstrate their commitment to quality. Its requirements
define how to establish, implement, maintain, and continually improve a quality management
system. Implementing ISO 9001 means your organization has put in place effective processes
and trained staff to deliver flawless products or services time after time. Within the ISO 9000
family, which defines seven quality management principles including a strong customer focus and
continual improvement, ISO 9001 is the only standard that can be certified to (though
certification is not mandatory).

BENEFITS OF HAVING ISO 9001 CERTIFICATION:

 Customer confidence: The standard ensures that organizations have robust quality control
processes in place, leading to increased customer trust and satisfaction.
 Effective complaint resolution: ISO 9001 offers guidelines for resolving customer complaints
efficiently, contributing to timely and satisfactory problem-solving.
 Process improvement: The standard helps identify and eliminate inefficiencies, reduce waste,
streamline operations, and promote informed decision-making, resulting in cost savings and
better outcomes.
 Ongoing optimization: Regular audits and reviews encouraged by ISO 9001 enable
organizations to continually refine their quality management systems, stay competitive, and
achieve long-term success.

A process is a series of tasks and activities that produce an outcome. A procedure is a set of
instructions for completing a single task or activity within a process. The entire process of organizing
updated documentation according to ISO 9001 is commonly referred to as having a “control of
documented information.” Like its name suggests, ISO 9001 requires that you have a “controlled,”
or organized set of documents that reflect the details of your quality management system.

The need for quality system documented information is for the communication of quality and related
regulatory requirements throughout the organization. This provides effective control by
specifically stating the product or service criteria.

The training of personnel to perform their jobs is also enhanced through appropriate documented
information.

The key to developing QMS-documented information requires knowing which activities

need to be controlled by the documentation. The standard states: “may need to be
tailored by adding or deleting certain quality system requirements for specific contractual
situations,” this means that activities that are not applicable within the scope of the
quality management system must be declared as exclusion in the quality manual, this
exclusion may take the form of a written statement under the “scope of Quality
Management System” or in the body of the text when that particular activity is reached.

ISO 9001 contractual requirements

The Contract Review Process In 5 Steps

Generally, the contract review process involves five crucial activities, namely:

1. Communicating with the customer

2. Determining and reviewing customer requirements
3. Order entry
4. Changing or amending the contract
5. Contract risk assessment

What are quality records as per ISO 9001:2015: approved supplier list, purchasing records,
records of supplier evaluation, records of inspection of the purchased products or service, MINUTES of
management review meetings, internal audit reports etc.

internal adequacy audit is conducted to ensure all documented information comply

with ISO 9001 requirements.

The top management plays an important role in developing the overall quality system
and in identifying those activities that require a documented information

The key aspects of the documented process to be considered are its scope of coverage,
objectives, process steps and method, related resources and infrastructure, time scale
and desired output/effect.

No specific requirements have been stipulated on how a quality system documented

information should be organized. The company’s quality manual is typically used as a
main document to demonstrate the existence of a documented quality system.

Quality Plan: it may be necessary to produce a quality plan for major projects. A quality
plan is specific to a product, project or service and shows the responsibilities and
various tasks. It should be drawn up when required by a contract in order to
demonstrate how a company will control processes to ensure that the contract quality
requirements are met. It is a requirement of ISO 9001 standard that all controlled
documents shall be reviewed and approved by authorized personnel prior to issue.

Process Flow Chart: Therefore, it is the easiest and the most effective tool for
documenting an operating procedure.

SOME TIPS TO IDENTIFY ISO CLAUSE:

Customers Order/Requirements - 8.2.1 , 8.2.2 (Resources: Human, Infrastructure )

Ability to meet requirements - 8.2.1 8.2.3 (Resources: Human, Infrastructure )
Available Stock for production to customers requirements - 9.1.2 (Human, Database )
Production Plan (including QC) - 8.1 8.5 (Human, Material, Environment, Infrastructure )
Shipment Planning & Product Delivery - 8.5 8.6 (Human, Infrastructure )

Under ISO 9001:2015 standards, documented information must meet four main objectives:

 Communication of Information - Documentation must be able to communicate

information about the organization’s various systems and processes and the steps
needed to perform them
 Evidence of Conformity - ISO 9001 requires that organizations have documentation
in the form of records that support that they have met ISO 9001 requirements
 Knowledge Sharing - An organization’s documents must be written in a way that
employees across the company will be able to understand
 Preserve the organization’s Experiences – Documentation should serve as some
form of history of the organization’s experiences. For example, one form of
documentation may be the technical specifications of an early version of a product.
This information can then be used later to serve as a baseline for improving or
updating the product.
Continual Improvement can be achieved by these:Internal quality audits,
management reviews, preventive and corrective actions, and document and data control.

A documented quality management system that meets the ISO 9001 requirements,
provides objective evidence to show that these activities are controlled systematically.
This ensures that each activity is completed correctly before the next activity begins.

An ISO 9001 process approach is a management strategy which incorporates the plan-
do-check-act cycle and risk-based thinking. It means that processes are managed and
controlled.The type and extent of the documentation and the levels of documentation
hierarchy depends on the:

1. The size and type of organization.

2. The complexity and interaction of the working processes
3. Competence of personnel (Under the 2015 edition of the ISO 9001 standard, the
documented information can be made more detailed and concise or vice versa
based on the competence of the personnel performing the task)