Many times your life
gives you the unexpected surprises at unexpected times. Such a surprise was
witnessed by me in June-2018. In the busy schedule of hardcore Mechanical
Engineering Industry of Machining one of my well-wisher suggested me to do Lead
Auditor Programme of ISO 9001:2015 from TUV-SUD Pune. He suggested me since I
am working as a Supplier Quality Engineer. Without much more questions I decided
to go for ISO course. Sometimes you have to stop much questioning and without
much hesitation, in the mind, you have to face the upcoming days. Luckily I got
leave of 10 days from my office. So I packed my bags and I started travelling
towards Pune. Pune is always my favourite place. My course was scheduled for 5
days from 9.00 A.M-6.30P.M. I had arrived in Pune one day earlier for Course.
Next day I got up early
from Bed for the first day of Lead Auditor Training. Luckily it was located in
the Aundh nearer from my room. I left my room and I had to reach to TUV-SUD
office at 9.00 A.M. I reached office at 8.59 A.M. I was thrilled to witness the
class office of TUV. I have no words to describe TUV SUD office from Aundh
Pune. At the reception, I entered my name and I had to go in a hurry in the Seminar
Hall of Training.
In Seminar Hall I took my
seat. As soon as I took my seat, I witnessed the atmosphere. There were 8
participants. Many of them were experienced Quality Engineers and Management
Representatives. I was noticing each participant. All of them were from well
versed MNC with 40+ ages. I was slightly saddened since there was no one of my
age 28. Suddenly I noticed one girl who was sitting in the corner of the hall with
wide eyes, large eyebrows, and 5 feet 6 inches with a Tattoo on the hand. I
assumed that she might be a typical Pune girl with the attitude. Her eyes were
much bigger. I noticed much attitude in her eyes as she was lost many times
in her world. But she proved me wrong. She was well-versed in English, a highly
decent and confident engineer from
Belgaum. Later during 5 days of training, we became good friends. Even she
helped me in many things. Finally, I noticed the man who was going to give us
Training. He reminded me of the Virus from 3 idiot’s movie with roaring and
terrible eyes, fake smile, white hairs, expanded the stomach and large spectacles
and much more fluent UK English. We began to introduce each other during the first
day itself. I Imagined I will be sturred in the 5 days. But all the
participants and this Virus guy proved me wrong. He later began with the
introduction of ISO basics and the PDCA cycle and we were thrilled to listen to
his teachings and experiences.
This 5 days proved
crucial to me. They almost sturred and changed me. They removed my group fear
and many more things. I got the overview and the importance of all the PDCA
cycle and the style of the ISO audit which is been conducted in the Industries
with finally passed certificate of LA-ISO 9001-2015.
I am presenting the
overview of ISO 2015. I hope It will prove beneficial to everyone.
ISO 9001:2015
Shall-Requirement/Necessary/Compulsory
Should-Recommend
May- Permission
Can-Possibility
4.0
Context of Organization
· 4.1 Understanding the organization and its
context
·
Organization shall determine external and
internal issues that are relevant to its purpose and that affect the ability to
achieve the Quality Management System.
·
This review shall be monitored.
·
Issues can be positive and negative.
·
External issues can be arising from
legal, technological, competitive, social and economic environment.
·
Internal issues can be issues related to
values, culture, knowledge and performance of the organization.
·
4.2 Understanding the needs and expectations of interested
parties
·
Interested parties are all outside
suppliers which include customers, vendors, equipment suppliers to the
organization.
·
Organization shall determine their needs
and expectations that are relevant to the QMS.
·
Organization shall monitor and review
information about these parties.
· 4.3 Determine the scope of the quality
management system
· Organization
shall determine boundaries and application of QMS
· Here
the organization shall consider clause 4.1 and 4.2
· Organization
should also consider the products and services of an organization
· This
scope of the Quality Management System shall be available and be maintained as
documented information.
·
4.4 QMS and its process
·
Organization shall establish, implement,
maintain and continually improve the quality management system.
·
The organization shall determine the process
needed for the QMS.
·
Organization shall determine inputs
required and output expected from the process.
·
Organization shall determine and apply
criteria and methods for monitoring and measurements needed to ensure effectively
operation and control of the process.
·
Process documentation by organization and
records.
·
Source of inputs, the receiver of outputs
·
Verification of appropriate criteria and
method for operational control of the process.
·
Monitor process through objectives and
performance indicators.
·
Various risks and opportunities.
5.1 Leadership and commitment
5.1.1 General
·
An organization should promote risk-based
thinking.
·
An organization should appoint the leader for QMS
·
Communicating the importance of QMS
·
Ensure that resource is available for
effective implementation of QMS
·
Monitor that QMS achieves its results
·
Communicating benefits of QMS
5.1.2 Customer focus
·
Customer satisfaction records
·
Complaint documentation and trend
·
Market analysis(regarding the needs of
customer)
·
Whether there is an understanding in the organization
regarding the needs of the customer.
5.2.1 Establish the quality policy
·
Customer shall establish, implement and
maintain the records of documented information of the quality policy
5.2.2 Communication of quality policy
·
It shall be available in the clinic
·
It shall be maintained as document
·
Mechanism of communication of quality
policy to the employees- Training and notices and evidence.
5.3 Organization roles and responsibilities
·
Define an individual role for each department
and make them a responsible person for their respected departments. Also, give
authority to respective departments to report the performance of QMS and any
opportunities for improvement
6.0 Planning(6.1;6.2;6.3)
·
Here customer shall determine are there
any risks to achieve the intended quality.
·
Customer should determine how are risks
evaluated and determine and managed?
·
When planning how to achieve QMS clinic
shall determine what will be done; what resources will be required; Who will be
responsible; When it will be finished; How results are evaluated?
·
Mechanism of communication with employees
·
SMART Objectives.
·
If there is any change organization shall
consider its purpose and availability of resources.
7.0 Support(7.1.1;7.1.2;7.1.3;7.1.4;7.1.5.1;7.1.5.2;7.1.6;7.2;7.3;7.4;7.5)
· The organization shall provide resource needed
for the establishment and continuous improvement of the quality system.
·
Housekeeping
·
The organization shall provide effectively
man-power.
· The organization shall provide effectively
infrastructure for the operation of QMS.
·
The organization should follow the maintenance
practices
·
Organization shall provide good and
effective environment to work for effective cms
·
What are the monitoring and measuring
equipment and resources used for conformity of the products.
·
Test certificates record
·
Calibration
list,records,details,certificates.
·
How knowledge is shared in the clinic
·
How the organization is encouraging them
employees to acquire knowledge through internal and external sources?
·
How organization safeguards from knowledge
loss( retirement or leave of staff)
·
Each and every person in an organization must be
aware of quality policies.
·
Various training given in the clinic
·
Skill matrix chart of employees
·
Various list of training
·
Organization shall determine competency
level of their staff.
·
Mode of communication relevant to QMS in
the organization(Clinic)
·
Documented information shall be maintained
and retained as per dentist manual.
·
While creating and updating the organization
shall consider reference no and title name on the document and its format
·
Documented information shall be available
when needed to all the interested parties and staff.
·
Documented information shall be protected
·
Availability of relevant documents
·
Documents identification
·
Records retention and preservation and
disposition
·
The system who is responsible to control
documents
8.0
Operation(8.1;8.2;8.3;8.4;8.5;8.6;8.7)
·
Availability of all quality plans
·
Project development schedules
·
Outsource process and control
·
Actions for addressing risks and
opportunities in the process of cms
·
Resource availability
·
List of appointments
·
Appointments records
·
Outsourcing of any appointment
·
Customer survey and report of customer
visit
·
Customer feedback and complaints
·
How communication is done when things are
not going well
·
Customer communication
·
Customer-specific enquiries
·
Legal requirements of products
·
Records on any discussion with a customer
·
Any customer request changes
·
Appointment confirmation to the customers
and from the customers
·
Organization shall maintain any new
a requirement of the services and products
·
Organization shall ensure that it can
fulfil customer requirements
·
Organization shall have approved list of
it is suppliers
·
Supplier selection, evaluation and
criteria
·
Evidence of supplier evaluation
·
Organization shall retain documents of
evaluation and selection criteria and list of approved suppliers
·
Incoming inspection of material and its
verification records
·
Test records of suppliers and all
equipment’s
·
The potential impact on the organization if
suppliers do not conform to their requirements
·
Acceptance criteria of inward material
·
List of purchase orders and PO approvals
·
PO in terms of commercial and technical
·
Availability of all documented procedures
·
Maintenance schedules
·
Process validation records
·
Qualification of personnel and equipment
and method
·
Availability of suitable infra and
environment
·
How the organization takes care of all the customer
properties?
·
System of identifying and protecting and
safeguarding customers property
·
When customer property is lost
the organization shall inform it to the customer and retain documented information on
what has occurred?
·
Methods of handling
·
Organization shall preserve outputs during
the production and service provision.
·
Organization shall ensure that outputs
that do not conform to their requirements are identified and controlled to
prevent their unintended use
·
Organization shall retain documented
information that describes actions taken and non-conformity
·
Any type of retreatment
·
Obtaining signs from the customer for any
treatments
9.0 Performance
evaluation(9.1;9.2;9.3)
·
Methods and monitoring and analysis of the
process and QMS
·
Monitoring results
·
Customer satisfaction analysis
·
Customer survey
·
Lost business analysis
·
Customer feedbacks
·
Conformity of services
·
Conduct an internal audit
·
Management reviews and inputs and outputs
·
Frequency and records of management
meetings
·
Business plans
·
Any improvements in QMS
10.0
Improvement(10.1;10.2;10.3)
·
Ways to improve process performance
·
System approach to identify root causes
©
Kaushik