A Procedure For Change Management

1/18/2019 A procedure for Change Management – TRACE INTERNATIONAL
TRACE INTERNATIONAL
Your Partner in ISO Standard compliance
☰ Menu
A procedure for Change Management
preteshbiswas Uncategorized December 22, 2018December 22, 2018 2 Minutes
1. SCOPE
The purpose of this procedure is to define the methods for managing changes to processes and other
aspects of the management system in a controlled manner so as to maintain the integrity of the QMS
and the organization’s ability to continue to provide conforming products and services during the
change.
2. PURPOSE
This procedure applies to all the activities within the scope of the XXX Quality Management System.
3. REFERENCE DOCUMENTS
3.1 XXX Quality Manual,
4. TERMS & DEFINITIONS

CM- Change Management
R-Risk
O-Opportunity
SOP- Standard Operating System
5. RESPONSIBILITY AND AUTHORITY
The Management Representative (MR) and HOD’s of all departments are responsible for the effective
implementation of this procedure.
6. DETAILS OF PROCEDURE
https://isoconsultantkuwait.com/2018/12/22/a-procedure-of-change-management/ 1/3
6.1. Properly planning a change by applying risk-based thinking can help to avoid negative
consequences such as rework or cancellation or postponement of service; it can also result in positive
consequences such as reduction of nonconforming outputs; or reduced incidents of human error
6.2 Management system processes will undergo changes, typically when:
Improvement opportunities have been identified, typically to improve process effectiveness.

Nonconformities within a process are identified and require corrective action.
Conditions in the industry or company change, requiring a process to be updated.
New processes are added which impact on existing processes, requiring changes.
Outsourcing important processes.
Persons in key roles leaving the organization.
Customer requirements result in a need to change processes.
Changes to active orders or contracts.
Any other reason determined by management.
6.3 In such cases, the process must be changed in a controlled manner to ensure proper authorization
and implementation of the changes.
6.4 Formal changes to process outputs will be used when the change is significant. Minor changes
may be made without formal control, however, the decision on what constitutes significant vs minor
change must be agreed upon by those involved in the change. If a customer indicates a change is
significant, this will trump any internal decision.
6.5 At a minimum, process changes shall include the steps herein:
The request for a process change shall be documented, typically in a Change Request. The
justification for the change shall be recorded.
Management shall evaluate the merits of the proposed change and determine the actions
necessary to address and implement the intended changes. Wherever it is deemed essential other
departments will be consulted about proposed changes. This may include discussions with
engineers, contractors, consultants, or other relevant parties before according approval for the
proposed change.
6.6 Before authorizing the implementation of changes, the following points shall be verified;
All necessary technical, safety, security and environmental reviews are completed;
Risks and consequences identified during the review processes are addressed to the utmost
satisfaction;
Proposed changes comply with regulatory and legal requirements;
Necessary approvals are obtained from the regulatory and/or legal authority wherever required;
All affected personnel are informed of the changes and adequately trained where necessary;
Documentation pertaining to changes and reviews are complete.
6.7 The change shall be reviewed by appropriate management, including the HOD responsible for the
process. Changes must be approved prior to implementation. CEO is authorized to approve the
implementation of proposed changes.
6.8 Upon implementation of change, MR shall verify the following.
Implemented changes are as intended;

Documentations are complete pertaining to changes;
Changes are communicated
Applicable regulatory and legal requirements are fulfilled;
Project Plan and Budget are amended
6.9 All Changes must be logged as per Change Log.(QMS F 014)
7. RETAINED DOCUMENTED INFORMATION
7.1 Change Management Request(QMS F 013)

7.12Change Log(QMS F 014)
Published by preteshbiswas
Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your
system development, training or auditing needs. He has helped dozens of organizations in implementing
effective management systems to a number of standards. He provide a unique blend of specialized knowledge,
experience, tools and interactive skills to help you develop systems that not only get certified, but also
contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has
experience in training at hundreds of organizations in several industry sectors. His training is unique in that
which can be customized as to your management system and activities and deliver them at your facility. This
greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification
body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several
industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in
recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety
of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries
include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic
and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic
equipment, assemblies & components, batteries, computer hardware and software, printing, placement and
Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call
centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students.
Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as
well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted
over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits
to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business
planning, restructuring, asset management, systems and process streamlining services to a variety of
manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage,
warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education &
professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001.
He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and
Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as
Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .
View all posts by preteshbiswas
Blog at WordPress.com.

A Procedure For Change Management - TRACE INTERNATIONAL

Uploaded by

Copyright:

Available Formats

A Procedure For Change Management - TRACE INTERNATIONAL

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

A Procedure For Change Management - TRACE INTERNATIONAL

Uploaded by

Copyright:

Available Formats

What is the purpose of change management?

What are some common reasons for changes to processes?

1/18/2019 A procedure for Change Management – TRACE INTERNATIONAL

Your Partner in ISO Standard compliance

preteshbiswas Uncategorized December 22, 2018December 22, 2018 2 Minutes

3.1 XXX Quality Manual,

4. TERMS & DEFINITIONS

5. RESPONSIBILITY AND AUTHORITY

6.2 Management system processes will undergo changes, typically when:

Improvement opportunities have been identified, typically to improve process effectiveness.

Implemented changes are as intended;

6.9 All Changes must be logged as per Change Log.(QMS F 014)

7. RETAINED DOCUMENTED INFORMATION

7.1 Change Management Request(QMS F 013)

You might also like