Polymath College

Introduction to ISO 9001: 2015 Based Quality Management System

Presented by: Systems Care Incorporated
Organization and the Risk
1. Any company is working under a severe risk coming from various avenues. That includes technical, economical,
societal and legal. The organization has to prepare for these risks in order to survive in the market place.
2. When preparing to face these risks, the company has to determine the best practices.
3. The simplest way of doing so is selecting the internationally accepted tools, such as INTERNATIONAL STANDARDS.
These standards are providing the minimum requirements for organizations to deal with these risks. Some
examples for such standards are;
ISO 9001 – quality risks ISO 45001
ISO 14001
ISO 14001 – environmental risks ISO 9001
ISO 45001 – occupational risks
ISO 22000 – food safety risks
SA 8000 Common elements to all
ISO 27001 – information security risks
SA 8000 – social risks, etc.
Fig 1 – Integrated System

4. These standards can be implemented in isolation or in an integrated manner as indicated in the Fig. 1.
5. Our management has decided to adopt one of those standards as the starting point. That is ISO 9001 standard.
6. ISO 9001 is dealing with the QUALITY of an organization. By adopting ISO 9001, Fig 2 - Components of Quality may be:
some of the above mention risks can be eliminated or controlled. ▪ Staff and workers;
▪ Tools, machines and equipment;
7. ISO 9001 does not talk about just the quality of the product or/and the service ▪ Materials & methods;
that the organization delivers. But the quality of everything associated with ▪ The environment (internal/ext.).
the product and service.
8. The components of the ‘Quality’ of our school are indicated in Fig 2 in general.
9. Are we sure about the quality of our school? How do we assure the quality of our school?
10. It is not easy to talk about the quality of an organization (our school) if you take it as a whole. Because it is so
complex and it is not possible to use the same tool(s) for all of its aspects.
11. Therefore, we shall recognize the “PROCESSES” associated with our school. This is called PROCESS APPROACH.
12. Our school comprised of numerous interconnected processes. Some possible examples for those processes are:
Promotion, selection & registering of learners, Recruiting, developing & Staff
    
evaluating staff, Facility management, Course development & accreditation,
Teaching & assessing the learners, Security, health & safety management and
Feedbacks & complaint management.
13. These are the immediately recognizable processes or the KEY processes of our school.
14. There are some other processes, some of them can be recognized and some are
Fig. 3
hidden. Some examples are: communication, documents & data management,
corrective actions, management review, system auditing. These can be recognized as SUPPORTS or
supporting processes.
15. All of you (management, staff or workers) are falling under one or more of these processes. Try to fill the table in
Fig 3 with regard to the key processes.
16. All these processes are linked in a logical way as in the Fig 4.
17. As you can see, if any of these link or process is weaken, that affect the entire structure or the SYSTEM. This is
called process interaction. Some of these processes very important to achieve customer satisfaction. These are
called Key Processes. Others are Support Processes.
18. These processes are not working in isolation, these are interconnected as mentioned above. The Management
System (MS) of the school is comprised with these interconnected processes.
19. Outside of the management system, the customers exist. Those are leaners, parents or guardians (beneficiaries).

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20. A system should have a mission (purpose or reason for existence). The vision is about the possibilities of what
you can become and it is futuristic. The goals or objectives are the milestones that mark your progress toward
your vision.
21. To achieve the objectives, all processes are to be worked in harmony. The weakness of one process will affect the
other processes and then to the entire system. The objectives should be SMART (Specific, Measurable,
Achievable, Realistic and Time bound).
22. For the success of the business, the MS should be Vision Mission Strategy Objectives
implemented effectively. The MS should demonstrate the
QUALITY in all of its aspects. Therefore, we specify the MS as
Quality Management System (QMS). Values Fig 4

23. The customer satisfaction is fundamental to the success of the business. In achieving customer satisfaction, the
MS should run effectively. Since the MS is consisting of processes, the processes should run effectively.
24. A process receives some inputs and delivers some output. The output becomes the input of the next process. So,
to success a process, the inputs and outputs should be effective.
25. Unfortunately, the outputs are not always desirable. Sometimes we receive undesirable or NONCONFORMING
outputs. It is the responsibility of the process owner to run the process minimizing or avoiding the
nonconforming outputs or nonconformities or NC.
26. Proper planning could avoid NC situations. PLAN is the key word in process management. See the Fig 5.

Plan Plan

Do/Implement Do Plan

Continual Check Check

Improvement
Act PDCA Do
OK Not OK

Find Root Cause Cause Check

Act
Correction PDCA Cycle/Deming Cycle

Corrective
Action
Fig 5 – PDCA Cycle
27. If the gravity of the NC is not significant, a remedial action (‘correction’) may be Fig 6 –Seven Tools for
adequate. If the gravity of the NC is high or critical, or repetitive in nature, a Continual Improvement
1. Quality Policy
correction may not be adequate. In that case, finding of the ROOT CAUSE of the NC 2. Quality Objectives
is to be find out. 3. Corrective Action
28. If an action can be taken to eliminate the root cause, that action is called 4. Risk Assessments
5. Date Analysis
CORRECTIVE ACTION. 6. Internal Audits
29. CA are helping the organizations to improve its processes continually. The 7. Management Review
CONTINUAL IMPROVEMENT (CI) of an organization is a mandatory requirement of
ISO 9001 implementation.
30. Corrective action or CA is one tool of continual improvement. One other tool we have already been discussed
above. That is OBJECTIVES or more appropriately quality objectives. The complete set of tools for continual
improvement is given in Fig 6.
Fig 8 –Some Areas of Data Analysis
31. Continual improvement can be indicated as in Fig. 7.
A. Product/service data
B. Customer date
C. QMS data
D. Risk/Opportunity related data
E. External provider related data
F. Process data

Fig 7 – Continuous Improvement and continual improvement

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32. Another tool for CI is Data Analysis. Data analysis help us to recognize hidden information which cannot be
identified by looking at single or isolated set of data. Fig 8 indicates some channels to gather data for analysis.
33. Having learnt that, can we just say “satisfying the customers” is adequate to sustain the organization?
34. No. As we have mentioned in the item 1, the organization (our school) is subjected to various RISKS deriving from
various avenues. Some risks generating from internal sources (or internal issues) and some are from external
sources (or external issues). Also, numerous stakeholders (interested parties) are watching us. They have some
interest in our business. We have to recognize their interests or concerns, and if we disregard those concerns
those will become risks to our organization.
35. Accordingly, we can recognize organizational risks from two distinct avenues:
a. Risks based on INTERNAL and EXTERNAL ISSUES
b. Risks based on concerns (expectations) of INTERESTED PARTIES (stakeholders).
36. Therefore, we shall cultivate a RISK BASED THINKING to sustain our business.
37. These risks shall be recognized, listed and analyzed in order to find out the significant risks. Then take proactive
mechanism to address these risks. The RISK REGISTER is to be periodically reviewed and updated. The new risks
shall also be dealt in the same fashion.
38. Fig 8. Data analysis help us to recognize hidden information which cannot be identified by looking at single or
isolated set of data.
39. An organization has to conduct planned Management Meetings to review the system matters. The outcome of
the meeting (the minutes) to be in a form of decisions with responsibilities and timelines. By implementing the
decisions taken definitely will improve the organization.
40. Internal auditing is self-assessment tool to determine the planned actions of the system are implemented
effectively.
41. The quality policy is a statement that declared by the top management. Which drives the organization towards its
expectations or vision. The policy is to be established for a few years and to be supported by SMART objectives.
42. There are some principles guiding the QMS as indicated in Fig 9.
Fig 9 –QMS Principles Fig 10 – Fig 11 – Evolution of Fig 12 – 9000 Series
1. customer focus; Evolution of ISO QMS ➢ ISO 9000: 2015 – QMS - Fundamentals and vocabulary
2. leadership; 9001 ➢ Total QM ➢ ISO 9001: 2015 – QMS - Requirements
3. engagement of people; ➢ 2015 (current) ➢ Quality Mgt. ➢ ISO/TS 9002: 2016 – QMS - Guidelines for the
4. process approach; ➢ 2008 ➢ Quality Assurance application of ISO 9001: 2015
5. improvement; ➢ 2000 ➢ Quality Control
6. evidence-based decision making; ➢ 1994 ➢ Inspection/check
7. relationship management. ➢ 1987

Recruiting,
Leaners & Beneficiaries

developing & Course

evaluating staff development &
accreditation

Promotion, selection & Security, health

QMS of the School

registering of learners & safety mgt.

Teaching & assessing Facility

the learners managemen
Feedbacks & t
complaint mgt.

Other Stakeholders

Fig 13 – Diagram Showing Process Interaction

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