Professional Documents
Culture Documents
By S N Sastry – MR IMS
ISO9001:2008
QUALITY MANAGEMENT SYSTEM
Part-I : Overview of ISO9001:2008 Implementation
Part-II : Orientation Towards Quality Management
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Part -I
Overview of
ISO9001:2008 Implementation
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What is ISO ?
ISO stands for …
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What is ISO9001:2008 ?
ISO9001:2008 is an international standard on Quality Management
Systems, released on 15th November 2008.
The other two standards in the series, viz., ISO9000: 2005 and
ISO9004: 2000 supplement ISO9001:2008.
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Part -II
Orientation Towards
Quality Management
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SOME DEFINITIONS
1. QUALITY
Quality is the totality of features and characteristics of a
product or service that bears on its ability to satisfy stated or
implied needs.
(This is the formal definition of Quality as per ISO9000 standard)
2. GRADE
SOME DEFINITIONS
3. QUALITY POLICY
4. QUALITY MANAGEMENT
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SOME DEFINITIONS
5. QUALITY SYSTEM
6. QUALITY CONTROL
SOME DEFINITIONS
7. QUALITY ASSURANCE
8. QUALITY AUDIT
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Quality
Manual &
System
Procedures
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Notes :
1. Quality Manual & System Procedures are confidential documents.
Ideally, it should not be distributed to any outsiders. Clients / Auditors
may be allowed to see the documents for reference purpose only.
Part -III
Details of
ISO9001:2008 Standard
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Controls
QMS
Inputs Process Outputs
Feedback
Continual improvement of
Quality Management System
Management
Responsibility
Customers Customers
Value-adding activities 23
Information flow
Process-based Quality Management System
ISO 9000:2000 FamilyAnnexes A & B for
Measurement
information only
Quality management
systems - Fundamentals
ISO ISO
& vocabulary 9000 Audits 19011
Guidelines
Quality management
systems -
ISO ISO Quality management
systems -
Guidelines for 9004 9001
Requirements
performance
improvement
Technical
Reports
ISO 9001:2000 Process Approach
PROCESS
CONTROLS EFFECTIVENES
S
Extent to which planned
activities are realized and
PROCESS planned results achieved
“set of interrelated or
INPUT interacting activities OUTPUT PRODUCT
which transforms
inputs into outputs
PROCESS
RESOURCES EFFICIENCY
Relationship between the result
achieved and the resources used
contributes to the A
R
B
R
I
I
organization’s
C C
effectiveness and I Process Process O
C D
efficiency in achieving I = INPUT
O I
Note: Members of ISO (like the BIS of India) and IEC maintain
registers of currently valid International standards, available to public
for reference.
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The top management must have customer focus, and ensure that
customer requirements are determined and are met with the aim of
enhancing customer satisfaction.
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1. Defining criteria for process review & approval, and doing it.
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When planned results are not achieved, correction and corrective action
shall be taken as appropriate to ensure conformity of the product.
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Product release and service delivery shall not proceed until the
planned arrangements (inspection / testing etc.) have been satisfactorily
completed, unless otherwise approved by a relevant authority, and
where applicable, by the customer.
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The organisation shall ensure that product which does not conform
to product requirements is identified & controlled to prevent its
unintended use or delivery.
The controls and related responsibilities and authorities for dealing with
non-conforming product shall be defined in a documented procedure.
1. Customer satisfaction
2. Conformity to product requirements
3. Characteristics and trends of processes and products
(including opportunities for preventive action) and
4. Suppliers.
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Part -IV
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What is IMS at GRCD
– ISO 14001-EMS
– OHSAS 18001-SMS
– SA 8000-SAS
Document status
– APEX MANUAL – GCD-M-04
– PROCEDURES
0.0 Introduction - - - - 08
1.0 Foreword - - - -
1.0 Scope 1 1 1 I 02
2.0 References 2 2 2 II 06
8.2.3 Monitoring & measurement of process 8.2.3 4.5.1, 4.5.2 4.5.1 9.5(d)
8.2.4 Monitoring & measurement of products 8.2.4 4.5.1, 4.5.2 4.5.1 9.5(d)
8.3 Control of non conforming product / 8.3 4.4.7,4.5.3 4.4.7,4.5.2 9.5(d), 9.10
Activities
Part -V
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What is audit ?
Most of us are familiar with the term ‘audit’.
Typically, ‘audit’ is considered to be associated with financial
matters such as accounts, costing, taxation etc.
As a result, the very mention of ‘audit’ evokes fear, not comfort.
However, management system audits are totally different in nature,
whether on Quality Management Systems (ISO9001:2008) or
Environment Management Systems (ISO14001:2004).
The International Organization for Standardization (ISO) has even
published a standard (ISO19011:2002) to provide guidance on how
to conduct quality / environment management system audits.
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Definition of Audit
Audit is a systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit
criteria are fulfilled.
Scope of Audit:
It may include the examination of System Adequacy and/or
Compliance, and identification of Improvement Opportunities.
Types of Audit:
1. Internal Audit
2. External Audit
3. Combined Audit
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4. Joint Audit
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3. Combined Audit
When a quality management system and an environmental
management system are audited together, this is termed a
combined audit.
4. Joint Audit
When two or more auditing organizations co-operated to
audit a single auditee, this is termed a joint audit.
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Principles of Auditing
Audit can be an effective support tool for management by checking
the implementation status of policies & procedures, and providing
information that can help improving the process performance.
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Audit Management
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Stages of an Audit
Every management system audit has the following stages:
1. Audit Initiation
2. Document Review
3. Preparing for on-site audit
4. Conducting on-site audit
5. Preparing, approving and distributing the audit report
6. Audit Completion
7. Audit Follow-up
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The documents under review may include management system documents &
records, and previous audit reports. (The size, nature, and complexity of the
organization also matters.)
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The audit team leader should assign responsibility to each team member for
auditing specific processes, functions, site areas, or activities.
It should be done in consultation with the audit team, also taking into account …
- the independence and competence of auditors
- the effective use of resources
- roles & responsibilities of auditors, auditor-in-training, and technical experts.
Changes to the work assignments may be made as the audit progresses to ensure
the achievement of the audit objectives.
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When guides are appointed by the auditee, they should assist the audit team and
act on the request of the audit team leader. Their responsibilities may include the
following …
- establishing contact and timing for interviews
- arranging visits to specific parts of the site or organization
- ensuring that rules concerning site safety and security procedures are known
and respected by the audit team members
- witnessing the audit on behalf of the auditee
- providing clarification or assisting in collecting information
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- plan the audit and make effective use of resources during the audit
- represent the audit team in communication with the audit client and auditee
- organize and direct audit team members
- provide direction and guidance to auditors in training
- lead the audit team to reach the audit conclusion
- to prevent and resolve conflicts, and
- to prepare and complete the audit report
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Additional Requirements:
An audit team leader should have acquired additional audit experience gained
while acting in the role of an audit team leader under the direction and guidance
of another auditor who is competent as an audit team leader.
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CONCLUDING REMARKS
Coming to the end of this training session, you have learned
about various aspects of ISO9001:2008.
And, learning has no meaning unless the knowledge is utilized
in a proper manner.
I urge you to Strengthen Our Quality Management System
(QMS) ithat satisfies the requirement of ISO9001:2008 and
ensures customer satisfaction.
Thank You !
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