ISO 9001:2015

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.

5.0 Leadership

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