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ISO 9001:2008 QMS

Internal Auditor Training

Worldwide Certification Services

Presented by:
Ashwin Varma | Principal Consultant isys Consulting FZE
m: 050 3097020 | e: ashwin@isys.ae PO Box 50970
Sharjah, UAE

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What you should know by the end of this session
Learning Objectives

• Detailed review of the


requirements of ISO
9001 QMS standard
• Internal Auditing
techniques

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ISO 9001 QUALITY MANAGEMENT SYSTEM
THE QUALITY MANAGEMENT SYSTEM

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The ISO Approach
The Management System Hierarchy

Policy and
Objectives

Procedures and
Work Instructions

Documents and
Forms

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The ISO Approach
Document, document, document

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•State what you do

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•Do what you state

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•Prove that you do it

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The ISO Approach
The 8 Management Principles
• CUSTOMER FOCUS: Customer needs must be understood and met with the aim of
enhancing customer satisfaction.
• LEADERSHIP: Every organization must establish its strategic objectives and then
create an environment to achieve its goals.
• INVOLVEMENT OF PEOPLE: Employees at all levels must be fully involved to
achieve organizational goals.
• PROCESS APPROACH: Processes within the organization must be identified and
managed effectively.
• SYSTEM APPROACH TO MANAGEMENT: The system approach views the
organization as a collection of inter-related processes.
• FACTUAL APPROACH TO DECISION MAKING: Organizations must base their
decisions on logical or intuitive data that has been analyzed.
• CONTINUAL IMPROVEMENT: Every activity can be improved
• MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

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ISO 9001 QUALITY MANAGEMENT SYSTEM
CLAUSES

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Non requirements
1. Introduction
2. Normative references
3. Terms and definitions

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ISO Requirements
4.1 General Requirements

 Has the organisation documented key


processes, work procedures and supporting
documentation including records
 REMEMBER: If it is not documented, you are
not doing it!
• Where an organisation chooses to outsource
any process that affects product conformity
with requirements, the organisation shall
ensure control over such processes.
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4.2 Documentation Requirements
4.2.1 General

• QMS shall include:


– Quality policy and quality objectives
– A quality manual
– Procedures and work instructions
– Documents and records
• The documentation can be in any form or
type of medium.

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4.2 Documentation Requirements
4.2.2 Quality Manual

• Quality manual shall include:


– the scope of the quality management system,
including details of and justification for any
exclusions
– QMS procedures
– Process interaction

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Mandatory Procedure
4.2.3 Control of Documents

• Do you approve documents prior to issue?


• Do you ensure that changes and the current
revision status of documents are identified?
• Do you ensure that relevant versions of
documents are available at points of use?
• Do you ensure that documents remain legible
and readily identifiable?

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Mandatory Procedure
4.2.4 Control of Records

• Are records legible, readily identifiable and


retrievable?
• Has a documented procedure been
established to define the controls needed for
the identification, storage, protection,
retrieval, retention time and disposition of
records?

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5. Management Responsibility
5.1 Management Commitment

 Has a Quality Policy been established?


 Does management communicate the
importance of meeting customer as well as
regulatory requirements?
 Does management conduct management
reviews?
 Does management ensure the availability of
resources?
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5. Management Responsibility
5.2 Customer Focus

• Ensure that customer requirements are


determined and are met with the aim of
enhancing customer satisfaction.

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5. Management Responsibility
5.3 Quality Policy

• Appropriate to the purpose of the


organisation
• Commitment to comply with requirements
• Framework for establishing and reviewing
quality objectives
• Communicated and understood within the
organisation
• Reviewed for continuing suitability.
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5.4 Planning
5.4.1 Quality objectives

• Establish quality objectives all levels within


the organisation.
• The quality objectives shall be measurable
and consistent with the quality policy
(SMART)

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5.4 Planning
5.4.2 Quality Management System
Planning
• Plan to implement
• Plan to change

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5.5 Responsibility, Authority & Communication
5.5.1 Responsibility & Authority

• Ensure that responsibilities and authorities


are defined and communicated within the
organisation.

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5.5 Responsibility, Authority & Communication
5.5.2 Management Representative

• Appoint a member of management as MR


reporting to Top management
• MR shall liaise with external parties on
matters relating to the quality management
system.

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5.5 Responsibility, Authority & Communication
5.5.3 Internal Communication

• Effective communication process


• Retain records for internal and external
communication

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ISO Requirements
5.6 Management Review

• 5.6.1 General
– Review the quality management system
• 5.6.2 Review Input
– Results of audits, customer feedback, process
performance, status of preventive and corrective
actions, follow-up actions from previous,
recommendations for improvement.
• 5.6.3 Review Output
– Product improvement, process improvement,
resource needs 22
ISO Requirements
6.2 Human Resources

 Are personnel performing work affecting


product quality competent on the basis of
appropriate education, training, skills and
experience?
 Does the organisation provide training or take
other actions to satisfy these needs?

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ISO Requirements
6.3 Infrastructure

• Does the organisation determine, provide and


maintain building, workspace, equipment
and supporting services needed to
achieve conformity to product
requirements?

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ISO Requirements
7 Product Realization

• Does the organisation plan and develop the


processes needed for product realisation?
• Does the organization determine and review
customer requirements?
• Does the organisation plan and control the
design and development of product?

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ISO Requirements
7 Product Realization

• Are processes in place to ensure that


purchased products conform to specified
purchase requirements?
• Does the organisation plan and carry out
production and service provision under
controlled conditions?
• Does the organisation monitor and calibrate
plant and equipment?

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8 Measurement, analysis and improvement
8.1 General

 Demonstrate product and system conformity


 Improve effectiveness of system

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8 Measurement, analysis and improvement
8.2.1 Customer Satisfaction

 Does the organisation monitor information


relating to customer perception as to whether
the organisation has met customer
requirements?
 Customer feedback surveys

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8 Measurement, analysis and improvement
8.2.2 Internal Audits

 Does the organisation conduct internal audits


at planned intervals?
 Does management responsible for the area
being audited ensure that actions are taken
without undue delay to eliminate detected
non-conformities and their causes?

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8 Measurement, analysis and improvement
8.2.3 Monitoring and measurement of
processes
 Test the ability of the process to achieve
results
8 Measurement, analysis and improvement
8.2.3 Monitoring and measurement of
processes
 Test the ability of the process to achieve
results

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Mandatory Procedure
8.3 Control of Non Conforming Products

 Do you ensure that products which do not


conform to product requirements are
identified and controlled to prevent
unintended use or delivery?

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Mandatory Procedure
8.5 Continual Improvement
 Does the organisation continually improve the
effectiveness of the QMS?

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Mandatory Procedure
8.5.2 Corrective Action

 Do you take action to identify, review and


eliminate the cause of non-conformities?

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Mandatory Procedure
8.5.3 Preventive Action

 Do you take action to prevent re-occurrence


of non-conformities?

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EXERCISE

CASE STUDY
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Case study
• The purpose of this exercise is to find out the
objective evidence (or the lack of it) and correctly
determine whether a case conforms to or deviates
from the ISO requirements.
– Use the blank CAR forms given
– Identify the appropriate ISO clause
– Identify the area under review
– Provide accurate and concise description of the NC, stating
objective evidence and the ISO requirements.
• Reference standard: ISO 9001:2008 standard
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Case #1
• While auditing Ticketing & Reservation Office
of Sky-Jet Airways, the auditor discovered that
no performance measures were established
for the sales process. The manager remarked
that their only measure is sale of more and
more tickets, hence he did not see need for
any other criteria.

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Case #2
• During a surveillance audit in a factory
manufacturing disposable polystyrene food
containers, the auditor asked about product
specifications and testing record. The
supervisor showed formulations for different
products but could not produce any code or
standard specifying testing requirements.

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Case #3
• During audit of a ship-repair facility, the
auditor found extensive sheet metal work
involving welding and riveting in the hull area.
When questioned about the welder’s
qualification, the production manager could
not provide any evidence of their competence
other than the claim that his people were
experienced and competent to do the job.

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Case #4
• The work instruction required the vaccine to
be stored at 5 -10°c. According to the
temperature monitoring record in a specific
clinic, the temperature was around 12 - 15°c
during noontime nearly everyday. The head
of that clinic said that she had informed the
maintenance department many times but no
action taken.

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