B0 9001 Auditor Training

8/7/2019 B0 9001 Auditor Training

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ISO 9001:2008 QMSInternal Auditor Training

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Worldwide Certification Services

Presented by:

Ashwin Varma | Principal Consultantm: 050 3097020 | e: [email protected]

isys Consulting FZEPO 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

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 andObjectives

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Procedures andWork Instructions

Documents and

Forms


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The ISO Approach

Document, document, document

1 State what you doState what you do

2 o w a you s a e o w a you s a e

3 Prove that you do itProve 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 andmanaged 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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Has the organisation documented key

processes, work procedures and supportingdocumentation including records

ISO Requirements

4.1 General Requirements

,

not doing it!

Where an organisation chooses to outsource

any process that affects product conformitywith requirements, the organisation shall

ensure control over such processes.

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QMS shall include:

Quality policy and quality objectives

A quality manual

4.2 Documentation Requirements

4.2.1 General

Documents and records

The documentation can be in any form or

type of medium.

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Quality manual shall include:

the scope of the quality management system,including details of and justification for any

exclusions

4.2 Documentation Requirements

4.2.2 Quality Manual

QMS procedures

Process interaction

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Do you approve documents prior to issue?

Do you ensure that changes and the currentrevision status of documents are identified?

Mandatory Procedure

4.2.3 Control of Documents

documents are available at points of use?

Do you ensure that documents remain legible

and readily identifiable?

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Are records legible, readily identifiable and

retrievable? Has a documented procedure been

Mandatory Procedure

4.2.4 Control of Records

the identification, storage, protection,

retrieval, retention time and disposition of

records?

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Has a Quality Policy been established?

Does management communicate theimportance of meeting customer as well as

5. Management Responsibility

5.1 Management Commitment

Does management conduct management

reviews?

Does management ensure the availability ofresources?

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Ensure that customer requirements are

determined and are met with the aim ofenhancing customer satisfaction.


5.2 Customer Focus

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Appropriate to the purpose of the

organisation Commitment to comply with requirements


5.3 Quality Policy

quality objectives

Communicated and understood within the

organisation Reviewed for continuing suitability.

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Establish quality objectives all levels within

the organisation. The quality objectives shall be measurable

5.4 Planning

5.4.1 Quality objectives

(SMART)

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Plan to implement

Plan to change

5.4 Planning

5.4.2 Quality Management System

Planning

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Ensure that responsibilities and authorities

are defined and communicated within theorganisation.

5.5 Responsibility, Authority & Communication

5.5.1 Responsibility & Authority

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Appoint a member of management as MR

reporting to Top management MR shall liaise with external parties on


5.5.2 Management Representative

system.

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Effective communication process

Retain records for internal and externalcommunication


5.5.3 Internal Communication

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5.6.1 General

Review the quality management system

5.6.2 Review Input

ISO Requirements

5.6 Management Review

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performance, status of preventive and corrective

actions, follow-up actions from previous,

recommendations for improvement.

5.6.3 Review Output

Product improvement, process improvement,

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Are personnel performing work affecting

product quality competent on the basis ofappropriate education, training, skills and

ex erience?

ISO Requirements

6.2 Human Resources

Does the organisation provide training or take

other actions to satisfy these needs?

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Does the organisation determine, provide and

maintain building, workspace, equipmentand supporting services needed to

ISO Requirements

6.3 Infrastructure

requirements?

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Does the organisation plan and develop the

processes needed for product realisation? Does the organization determine and review

ISO Requirements

7 Product Realization

Does the organisation plan and control the

design and development of product?

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Are processes in place to ensure that

purchased products conform to specifiedpurchase requirements?

ISO Requirements

7 Product Realization

production and service provision under

controlled conditions?

Does the organisation monitor and calibrateplant and equipment?

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Demonstrate product and system conformity

Improve effectiveness of system

8 Measurement, analysis and improvement

8.1 General

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Does the organisation monitor information

relating to customer perception as to whetherthe organisation has met customer

re uirements?


8.2.1 Customer Satisfaction

Customer feedback surveys

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Does the organisation conduct internal audits

at planned intervals? Does management responsible for the area


8.2.2 Internal Audits

without undue delay to eliminate detected

non-conformities and their causes?

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Test the ability of the process to achieve

results


8.2.3 Monitoring and measurement of

processes


8.2.3 Monitorin and measurement of

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Test the ability of the process to achieve

results

processes


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Do you ensure that products which do not

conform to product requirements areidentified and controlled to prevent

unintended use or deliver ?

Mandatory Procedure

8.3 Control of Non Conforming Products

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Does the organisation continually improve the

effectiveness of the QMS?

Mandatory Procedure

8.5 Continual Improvement

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Do you take action to identify, review and

eliminate the cause of non-conformities?

Mandatory Procedure

8.5.2 Corrective Action

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Do you take action to prevent re-occurrence

of non-conformities?

Mandatory Procedure

8.5.3 Preventive Action

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CASE STUDY

EXERCISE

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Case study The purpose of this exercise is to find out the

objective evidence (or the lack of it) and correctlydetermine 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 thatno performance measures were established

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that their only measure is sale of more andmore 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 foodcontainers, the auditor asked about product

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supervisor showed formulations for differentproducts 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 workinvolving welding and riveting in the hull area.

qualification, the production manager couldnot 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 -10c. According to thetemperature monitoring record in a specific

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during noontime nearly everyday. The headof that clinic said that she had informed the

maintenance department many times but no

action taken.

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