ISO 9001

ISO 9001 document control is essential to a quality management system. Organizations have
flexibility in the way they choose to document their quality management system (QMS), the
standard defines how organizations develop the documentation needed in order to
demonstrate planning, operation and control of processes, and the implementation and
continual improvement of the QMS.

ISO 9001 Requires that you maintain control of documents

Control the documents required by the quality management system. Records are a special type
of document and must be controlled.

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

Control of Records

 Establish and control records as evidence of conformity to requirements and to

demonstrate the effective operation of the quality management system.
 Establish a documented procedure to define the controls needed for records:
 Identification, Storage, Protection, Retrieval, Retention, Disposition
 Keep records legible, readily identifiable, and retrievable.

What Documentation ISO 9001:2015 Really Requires?

While the ISO 9001:2008 version was explicit about documentation, ISO 9001:2015 allows
more freedom in how, what, and when to document a quality management process (such as
specific procedures).

This allows an organization the flexibility to reuse appropriate information, maintain current
versions easier, provide broader access/distribution and reduce costs associated with
documentation.

ISO 9001:2015 essentially allows the organization to tailor the completeness or complexity of
documentation to its own situation, as long as it still achieves its overall objectives. The shift
does not, however, lessen the requirement for proper documentation.
When information needs to be disseminated or shared

 To prove (and retain that proof) that a quality process has been completed and what
the results were.
 To retain organizational knowledge including:
 Processes, Specifications and revisions, Goals and expectations, Monitoring and
measuring
 Analysis, reviews, evaluations, and validations, Terminology, Decisions made,
Negotiations, Notifications, Authorizations, Actions taken, Assets, inventories and
property management, Position descriptions and qualifications.

ISO 9001“Maintain documented information to the extent necessary to support the operation
of processes and retain documented information to the extent necessary to have confident
that the processes are being carried out as planned.” Documented information is used as
evidence of conformance.

The Eight principles of Quality Management

ISO 9001 is based upon the Eight Principles of Quality Management. The Eight principles of
Quality Management can be used by senior management as a framework to guide their
organizations towards improved performance.

The eight principles are:

1. Customer focus: The organizations can establish this focus by trying to understand and
meet their needs and also strive to exceed their expectations.
2. Leadership: The organizations succeed when leaders establish and maintain a
conductive environment in which people can be fully involved in achieving the
company objectives.
3. Involvement of people: The organizations succeed by retaining competent employees,
encouraging continuous enhancement of their knowledge and skills, and empowering
them, encouraging engagement and recognizing achievements.
4. Process approach: Desired results are achieved more effectively when leaders
manage and control their processes, as well as the inputs and outputs that tie these
processes together.
5. System approach to management: Identify, understand and manage interrelated
processes as a system.
6. Continuous improvement: The organizations will maintain current levels of
performance, respond to changing conditions, and identify, create and exploit new
opportunities when they establish and sustain an ongoing focus on improvement.
7. Factual approach to decision making: The organizations succeed when they have
established an evidence-based decision making process that entails gathering input
from multiple sources, identifying facts, objectively analyzing data, examining
cause/effect, and considering potential consequences.
8. Mutually beneficial supplier relationships: This principle deals with supply chains. It
promotes the relationship between the company and its suppliers; recognising it is
 interdependent. A strong relationship enhances productivity and encourages seamless
working practices.

Functions of Inspection Department

The Inspection Department undertakes onsite inspection/investigation in business or

organisation to verify compliance to various regulations and specifications of products,
machineries etc.

- Undertaking inspection, Conducting enquiries and investigations

- Formulation of annual inspection plan and its execution

- Formation of teams for onsite inspections

- Pre inspection preparation including seeking inputs from other departments

- Sending advance intimations regarding onsite inspection

- Preparation and submission of detailed inspection reports

- Forwarding the inspection reports to the inspected entities for their response