1. ISO, QMS & CIR Awareness 2013

2. Objectives
At the end of the training session, the team is expected to:
Be aware, know, and understand ISO 9001:2008 and its requirements.
Get familiar with and embrace the company QMS
Appreciate the policies, processes and procedures in place.
Learn the systematic process of Issuing CIR’s

3. Definition of Terms QMS (Quality Management Systems) Process Customer
the set of procedures for determining and implementing the intention of an organization as regards quality.
Process
an activity supported by resources and management for enabling the transformation of inputs into outputs. (control to these processes are called procedures)
Customer
internal or external. The team or the client.
Customer Satisfaction
a measure of how products and services supplied by a company meet or surpass customer’s expectations.
Continual Improvement
an ongoing effort to improve products, services or processes.

4. Definition of Terms Monitoring CAPA Corrective Action
being aware of the state of a system. (Checking, auditing)
CAPA
Corrective Action, Preventative Action
Corrective Action
procedure used to eliminate recurrence of a detected non conformity.
Preventive Action
a procedure used to eliminate the cause of a potential non conformity.
Non-conformity or Non conformance
Either a mistake made within the organization’s application of the processes or a mistake found in the drawings sent to the Shop
CIR (Continuous Improvement Request)
a document that is populated to identify any action that can be taken to show an improvement over any existing procedure, process, practice or any other way of improving business and the QMS

5. What is ISO? International Organization for Standardization
It was established in 1947 and is currently an association of 157 National Standard Bodies (from different countries).

6. What is ISO 9001:2008?
From ISO 9000 –
is a family of standards for quality management systems, maintained by ISO and is administered by accreditation and certification bodies.
It is a standard designed to specify requirement for a QMS where an organization:
Aims to enhance customer satisfaction through the effective application of the system including processes for continual business improvement and
Needs to demonstrate its ability to provide services that constantly meet customer and applicable regulatory requirements.

7. Basis of ISO 9001:2008 Standard The PDCA Cycle
The 8 Quality Management Principles
The Process Based Model

8. The PDCA Cycle Plan Do Check Act
establish the objectives and processes necessary to deliver results. Do
implement the processes
Check
monitor and measure processes and products against policies, objectives and requirements for the service and report results.
Act
take actions to continually improve process performance.

9. 8 Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships

10. The Process Based Model

11. Business Operations
PDC Asia-Pacific

13. Group Activity

14. The Production Process
PDC Asia-Pacific

16. The ISO Standards and Our QMS
PDC Asia-Pacific

17. 4.0 Quality Management Systems
Company Quality
Management System
ISO Standard
Quality Manual
Control of Documents
approval, review and update,
clear revisions, retrieval, legibility
and identifiability, and control.
3. Control of Records
Company QM and Department Quality Manuals
Approval stamps, review management, revision procedure, available (e-copy and hard copy), labels, control stamps and logs.
All Monitoring logs and stamps, printing by the DC’s, etc..

18. 5.0 Management Responsibility
Company Quality
Management System
ISO Standard
Management Commitment
Customer Focus
Quality Policy
Planning
Responsibility, Authority and Communication
Management Review
SMT support to QMS
BDM, Client Intimacy Strategy, Client Surveys
EXCEL
Strategic Planning
Org Structure, Communication Lines
Review of systems and changes/ improvement

19. One Minute Question

20. Quality Policy
PDC Asia-Pacific

21. PDC Asia Pacific is committed to:
E – Exceed Clients Expectations
Provide high quality product delivered on time, every time.
X – Error Free
Do things right the first time, every time.
C - Compliance
Comply to all client’s and regulatory requirements.
E – Empower The Team
Ensure involvement and quality communication.
L – Learn Continually
Continuously improve via a review of the continuing suitability of the QMS.

22. 6.0 Resource Management Company Quality ISO Standard Management System
Provision of Resources
Human Resources
Infrastructure
Work Environment
Recruitment, training and development
Employment, tardiness, absenteeism monitoring
Equipment; TEKLA licenses
Admin policies

23. 7.0 Product Realization Company Quality ISO Standard Management System
Planning of Product Realization
Customer-related processes
Design Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring equipment
Quality Objectives and the whole Production cycle
Client QA
Checklist, Forms etc.
Project Status Reports
Project targets and KPI
Added value

24. 8.0 Measurement, Analysis and Improvement
Company Quality
Management System
ISO Standard
Monitoring and measurement
Control of Nonconforming product
Analysis of Data
Improvement
QMS Monitoring
Internal Quality Audit
Project Audit
KPI
CIR’s, Corrective and Preventative Actions

25. The Internal Audit
PDC Asia-Pacific

26. What is IQA? Who Can Conduct IQA? Internal Quality Audit
A systematic, independent and documented process for obtaining evidences (of conformity ) and evaluating it objectively to determine the extent to which policies, procedures and requirements are fulfilled.
It is conducted for Management Review and other internal purposes
Who Can Conduct IQA?
Internal Quality Audit Team
Lead Auditor and Associate Auditors that are qualified and certified to be doing internal audits per the requirement of ISO

27. The CIR Process
PDC Asia-Pacific

28. Why we issue? When to issue? For continuous improvement.
To better analyze the cause so we can apply an adequate and appropriate corrective action.
To keep a record of Corrective and Preventive Action for possible future use.
To make the process owner aware of the mistake and the corrective action which is part of an education process for him/her.
When to issue?
Problems or non-conformances are identified.
When points for improvements are determined.

29. Origin of CIR’s? Non Conformance (NC) Formal Customer Complaint
This can be categorized depending on the gravity of the error either Major, Minor or Points for Improvement. This can be achieved by internal or external aspect. Either an error found on the product or a lapse in the application of certain process in the QMS.
Formal Customer Complaint
Any complaint, written or verbal passed on from a customer or customer’s representative concerning customer dissatisfaction or unmet expectation of products or services provided by the company.
Quality Improvement Request (QIR)
A suggested improvement concerning quality of our services or product or management systems. This is not originated from a non-conformance but is a potential point for improvement.
System Audit Findings
These are the result of the collective audit findings thru internal and external audit.

30. How to Issue Determine the need for a CIR.
Gather all information about the error or points for improvement.
Seek assistance from the QA Department*
Follow the QMI-009 – CIR Issuing Procedure.

31. What’s next when CIR is complete?
Corrective and preventive and follow up.
Create Lesson Learnt presentation incorporating the lessons from the errors.
Organize and implement improvement to the system.
Closing/ Sign-off

32. What do I do?
What Now

33. The Leader - is expected to lead by example. Listens…
Drives the team to a common goal
Represents the group
Develops leaders

34. The Team - Is a real team player. listens. speaks up.
is a leader himself.

35. The Impact of ISO Certification to the Company.
This gives us a seal that we are meeting the customer’s and regulatory requirements.
It allows us to improve the quality of our products, services and systems.
It makes us understand, document and communicate our company processes.
Provides for consistency in our operations.
It keeps the management and the team focused on quality.
It allows us to improve our efficiency, reduce waste and save money.
This is an affirmation that our Quality is guaranteed by an international body.

36. I speak you listen, you speak, I listen.
Question and Answer

37. Lessons from the geese.

38. FIN
Thank you very much!