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Iso 9001-2015

The document summarizes key changes between ISO 9001:2015 and the previous version ISO 9001:2008. Some major changes include an increased focus on risk-based thinking, understanding organizational context, leadership requirements, and determining the scope of the quality management system. There is also reduced emphasis on documentation and more flexibility in how organizations meet requirements.
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0% found this document useful (0 votes)
346 views75 pages

Iso 9001-2015

The document summarizes key changes between ISO 9001:2015 and the previous version ISO 9001:2008. Some major changes include an increased focus on risk-based thinking, understanding organizational context, leadership requirements, and determining the scope of the quality management system. There is also reduced emphasis on documentation and more flexibility in how organizations meet requirements.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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QUALITY MANAGEMENT SYSTEM

ISO 9001:2015
ABOUT ISO
'International Organization for Standardization'
ISO is derived from the Greek word isos, meaning equal.
The ISO story began in 1946 when delegates from 25 countries met at
the Institute of Civil Engineers in London and decided to create a new
international organization ‘to facilitate the international coordination
and unification of industrial standards’. On 23 February 1947 the new
organization, ISO, officially began operations. Headquarter in
Geneva, Switzerland. In 1987, ISO publishes its first Quality
Management Standard i.e. ISO 9001:1987
ISO 9001:2015 Changes- compare to
previous version(ISO9001:2008)
• Risk based thinking

• A new common ISO format has been developed for use across all
Management System Standards-Annex SL

• A significant re-ordering of the key clauses

• increased emphasis on understanding and control of Risk to the


organisation

• reduced emphasis on Documentation

• no stated requirement for Documented Procedures

• no reference to a Quality Manual.

• no formal requirement for Preventive Action

• outsourcing is now External Provision


Cont.
• no requirement for a Management Representative

• enhanced Leadership Requirements

• Organisational Context – responsiveness to changing Business


Environment

• No exclusions, only Not Applicable clauses!


• Outsourcing and purchasing > External provision
• Supplier > External Provider
• Documents and records > Documented information
• Management representative > Assigned responsibility and authority

• Work environment > Environment for operation of processes


• Monitoring & measuring equipment > Monitoring & measuring resources

• Product > Products & services


Risk-based approach
• organisations are required to understand its context
(Clause 4.1) and determine the risks and opportunities that
need to be addressed (Clause 6.1)
• one of the key purposes of a QMS is to act as a preventive
tool
• there is no separate clause or sub-clause titled “preventive
action”
• the concept of preventive action is expressed through a
risk-based approach to formulating QMS requirements.

2015 – Annex A
Documented information
• a common clause of “Documented Information” has
been adopted
• the terms “documented procedure” and “record” have
both been replaced throughout the requirements by
“documented information”
• documented procedures (e.g to define, control or
support a process) are now expressed as a requirement
to maintain documented information
• records are now expressed as a requirement to retain
documented information.

2015 – Annex A
Organisational knowledge
• organisational knowledge (Clause 7.1.6) addresses the
need to determine and maintain the knowledge obtained
by the organisation and its personnel, to ensure that it can
achieve conformity of products and services
• the process for considering and controlling knowledge
needs to take account the organisation’s context, its size
and complexity, the risks and opportunities it needs to
address and the need for accessibility of knowledge
• the balance between knowledge held by competent
people and knowledge made available by other means is
at the discretion of the organisation.

2015 – Annex A
Control of externally provided
processes, products and services
• control of externally provided products and services (Clause
8.4) addresses all forms of external provision, whether by:
▫ purchasing from a supplier
▫ an arrangement with an associate company
▫ the outsourcing of processes and functions of the
organisation, or by any other means
• now required to take a risk-based approach to determine the
type and extent of controls appropriate to external providers
and externally provided products and services.

2015 – Annex A
Quality Management Principles
• ISO 9001:2008 was based on eight quality
management principles whereas the revised version
refers to just seven
• the principle of “a systems approach to
management” has been dropped
• the last principle is now called “Relationship
management” instead of “Mutually beneficial
supplier relationships”.

2008 – Clause 0.2


New Principles
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of People 3. Engagement of People
4. Process Approach 4. Process Approach
5. System Approach to
Management 5. Improvement
6. Continual Improvement
7. Factual Approach to 6. Evidence-based Decision
Decision Making Making
8. Mutually Beneficial 7. Relationship
Supplier Relationships Management.
2008 – Clause 0.2
Process Approach

• Understand and manage interrelated processes as a


system
• enables consistent and predictable results
• PDCA cycle is fundamental
• introduces risk based thinking (always been an implied
requirement).

2008 – Clause 0.3


CLAUSES IN ISO 9001:2015

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.
Section 1 - Scope
• consistently provide products and services to meet
requirements and enhance customer satisfaction
• all requirements are intended to be applicable to all
organisations, regardless of type, size and product
provided
• removal of exclusions.

2008 – Clauses 1.1 & 1.2


Section 2 – Normative references

• ISO 9000:2015, Quality management systems –


Fundamentals and vocabulary.

2008 – Clause 2
Section 3 – Terms and Definitions
• document – information and the medium on which it is contained

• documented information - information required to be controlled


and maintained by an organisation and the medium on which it is
contain

• record – document stating results achieved or providing evidence of


activities performed.
• interested party – person or organisation that can have an affect,
be affected by, or perceive itself to be affected by a decision or
activity
• competence – ability to apply knowledge and skills to achieve
intended results

2008 – Clause 3
More Terms
• improvement – activity to enhance performance
• nonconformity – non-fulfilment of a requirement
• correction – action to eliminate a detected nonconformity
• corrective action – action to eliminate the cause of a
nonconformity and prevent recurrence
• preventive action – action to eliminate the cause of a potential
nonconformity or other undesirable situation
• verification – confirmation that specified requirements have
been fulfilled
• validation – confirmation that requirements for a specified
intended use or application have been fulfilled.
2008 – Clause 3
More Terms
• product – output of an organisation that can be produced without
any transaction taking place between the organisation and the
customer
• service – output of an organisation with at least one activity
necessarily performed between the organisation and the
customer
• performance - measurable results
• risk - effect (positive or negative) of uncertainty
• outsource - to make an arrangement where an external
organisation performs part of an organisation’s function or
process - Note: An external organisation is outside the scope of
the management system although the outsourced function or
process is within the scope.
2008 – Clause 3
Section 4 – Context of the Organisation
4.1 Understanding the
• this is a new clause and
organisation and its context
provides a key insight
4.2 Understanding the needs into the organisation
and expectations of
interested parties
4.3 Determining the scope of
the quality management
system
4.4 Quality management
system and its processes
2008 – No direct equivalent
Section 4 – Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes

• determine external and internal issues relevant to the QMS


• must monitor these issues.

2008 – No direct equivalent


Section 4 – Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes

• determine interested parties relevant to the QMS


• determine their needs and expectations
• must monitor information about interested parties’ requirements.

2008 – No direct equivalent


Section 4 – Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes

• establish scope by determining boundaries and applicability of the QMS


to consider external/internal issues, requirements of interested parties
and the organisation’s products and services

• scope must be documented and available, justify any clauses of ISO


9001 that is not applicable

• any N/A clauses must not effect conformity of products/services and


customer satisfaction.
2008 – Clauses 1.2 & 4.2.2
Section 4 – Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes

• must establish, implement, maintain and continually improve the QMS


• interaction of processes required (but not documented!)
• assign responsibilities and authorities for processes
• retain documented information to ensure in the processes

Documented procedures are not necessarily required….


except where they are needed!

2008 – Clause 4.1


Section 5 – Leadership
5.1 Leadership and • top management to now
commitment have a greater involvement
in the QMS
5.2 Policy
5.3 Organisational roles,
responsibilities and
authorities

2008 – No direct equivalent


Section 5 - Leadership
5.1 Leadership and commitment
5.1.1 General
5.5.1 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises

• new clause
• must take accountability for the QMS’ effectiveness
• ensure Quality Policy and quality objectives are established
• ensure QMS is integrated into business processes
• ensure resources are available;
2008 – Clause 5
Section 5 - Leadership
5.1 Leadership and commitment
5.1.1 General…cont
5.1.2 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises

• communicate importance of effective QMS and conformance


• ensure QMS achieves intended results
• promote improvement
• support other management to demonstrate leadership.

2008 – Clause 5
Section 5 - Leadership
5.1 Leadership and commitment
5.1.1 General
5.5.1 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises

• top management must ensure:

• customer and regulatory requirements are met

• risks and opportunities are determined and addressed

• focused on enhancing customer satisfaction.

2008 – Clause 5
Section 5 – Leadership
5.1 Leadership and commitment
5.2 Policy
5.2.1 Establishing the quality Policy
5.2.2 Communicating the quality Policy

5.3 Organisational roles, responsibilities and authorities


• QUALITY POLICY


• We at Berger Nippon Paint Automotive Coatings Pvt. Ltd. are committed for total Customer Satisfaction through Timely
Supply of Defect Free Quality Products.

• We will comply with all Statutory, Regulatory and Customer Requirements as applicable to our organization and products.

• Dedication towards process and system improvements achieved through KAIZEN.

• Continually upgrading Safety Standards and to improve Productivity and Reduce Cost to deliver cost-effective products.

• We shall bring continual improvement by implementing & maintaining the Quality Management System.
• Issue Date: 01.06.2017
• MASARU SUMIDA

• (Managing Direct

2008 – Clause 5.3


Section 5 – Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organisational roles, responsibilities and authorities

• ensures responsibilities and authorities for relevant roles are


assigned, communicated and understood

• no formal requirement for specific management representative

• specific mention of changes to QMS.

2008 – Clause 5.5


Section 6 – Planning
6.1 Actions to address risks • introduces risk based
and opportunities approach to planning
6.2 Quality objectives and • addresses risks,
planning to achieve opportunities and quality
them objectives

6.3 Planning of changes

2008 – Clause 5.4.2


Section 6 – Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

• For planning, must consider external/internal issues and interested


parties

• determine risks to ensure QMS achieves results, enhance desirable


effect and achieve improvement

• must evaluate effectiveness of actions

• must be risk based.

2008 – Clauses 5.4.2 & 8.5.3 3


Section 6 – Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
• quality objectives need to be established at relevant functions, levels and
processes
• these objectives should be:
─ consistent with the Quality Policy, measurable and take into account
applicable requirements
─ relevant to conformity of products and services, and the enhancement
of customer satisfaction
─ monitored, communicated and updated as appropriate
• must determine what, how, who, when, etc
• quality objectives must be documented.
2008 – Clause 5.4.1
Section 6 – Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

• where change is needed, it needs to be carried out in a planned and


systemic manner

• must ensure integrity of QMS.

2008 – Clause 5.4.2


Section 7 - Support
7.1 Resources • newly constructed clause
7.2 Competence • much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness

7.4 Communication The support required to meet


the organisation’s goals.
7.5 Documented information

2008 – Clause 6
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge

• must provide resources for the implementation and maintenance of


the QMS

• must consider constraints of existing resources and what may be


provided from external providers.

2008 – Clause 6.1


Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge

• new clause

• must determine and provide people necessary for effective


information of QMS and operations/control of processes.

2008 – Clause 6.1


Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge

2008 – Clause 6.3


Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge

2008 –Clause 6.4


Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge
• determine resources needed to ensure valid and reliable monitoring
and measuring results
• resources must be suitable for the activity and maintained as fit for
purpose
• evidence of fit for purpose must be retained
• other requirements for measuring equipment unchanged.
2008 –Clause 7.6
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge

• new clause required to determine, maintain and make available the


knowledge necessary for the operation of its processes and to achieve
conformity of products and services

• particular care required for changing need and trends.

2008 – No equivalent clause


7.1.6 Organisational Knowledge
Note:

• organisational knowledge can include information such as intellectual


property and lessons learned

• may consider:

─ internal sources (learning from failures and successful projects,


capturing undocumented knowledge and expert experience)

─ external sources (standards, training, conferences, knowledge from


customers or external providers).

2008 – No equivalent clause


Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

• very similar to previous Clause 6.2.2

• removal of providing ‘training’ to ‘competence’

• documented information (record) must be obtained of competence.

2008 – Clause 6.2.2


Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

• specific clause for awareness

• must be aware of Quality Policy, quality objectives, contribution to


effective QMS and implication of not conforming with QMS.

2008 – Clause 6.2.2


Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

• much expanded clause for communication

• must now determine what will be communicated internally and


externally about the QMS, when, to whom, how and by whom.

2008 – Clause 5.5.3


Section 7 - Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information

• QMS needs documented information required by the Standard and


as determined by the organisation

Note: the extent of documented information can differ from one


organisation to another due to its size, activities, processes, products
and services, complexity of processes and their interactions, and the
competence of people.

2008 – Clause 4.2.1


Section 7 - Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information

• documented information requires:

▫ identification and description

▫ format and media

▫ review and approval.

2008 – Clause 4.2.3


Section 8 - Operation
8.1 Operational planning and control • covers many of the
8.2 Requirements for products and Product Realisation
services requirements
contained in Clause 7
8.3 Design and development of
of the 2008 version
products and services
8.4 Control of externally provided
The heart of the
processes, products and services
management system
8.5 Production and service provision (the business).
8.6 Release of products and services
8.7 Control of nonconforming outputs
2008 – Clause 7
Section 8 - Operation
8.1 Operational planning and control

• similar to previous Clause 7.1

• must plan, implement and control processes needed to meet


requirements for the provision of products and services

• must control planned changes and review unintended changes

• any outsourced processes must be controlled.

2008 – Clause 7.1


Section 8 - Operation
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of requirements for products and services
8.2.4 Changes to requirements for products and services

2008 – Clause 7.2.3


Section 8 - Operation
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of requirements for products and services
8.2.4 Changes to requirements for products and services

• same as previous Clause 7.2.1

• plus the organisation must meet the claims of products or services it


offers.

2008 – Clause 7.2.1


Section 8 - Operation
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of requirements for products and services
8.2.4 Changes to requirements for products and services

• combines previous Clauses 7.2.1 and 7.2.2

• documented information required on results of the review and any


new requirements.

2008 – Clause 7.2.2


Section 8 - Operation
8.3 Design and development of products and services

• where the detailed requirements of the organisation’s products and


services are not already established or not defined by the customer
or by other interested parties, such that they are adequate for
subsequent production or service provision, the organisation shall
establish, implement and maintain a design and development
process;

2008 – Clauses 7.3


Section 8 - Operation
8.3 Design and development of products and services…cont

• changes are mainly terminology and simplified wording

• there is, however, a significantly increased focus on the role the


customer has in all stages of the design process

• the need for documented information to confirm appropriateness of all


stages is also clearly stated

• any changes made to design inputs and design outputs during the
design and development must be clearly identified.

2008 – Clause 7.3


Section 8 - Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers

• changes are mainly terminology and revised wording (ie suppliers


become ‘external providers!’)

• much as before, each stage of the purchasing process, including


evaluation, selection, performance monitoring and re-evaluation remains
a key requirement

• there is a significant increase in the steps needed to control external


provision.

2008 – Clauses 7.4


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

• changes are mainly terminology and revised wording

• the most significant change is the move of monitoring and measuring


equipment to Section 7

• reference to ‘changes and post delivery activities’ have been strengthened.

2008 – Clauses 7.5


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

• previous Clauses 7.5.1 and 7.5.2 combined.

2008 – Clauses 7.5.1 & 7.5.2


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

2008 – Clause 7.5.3


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

2008 – Clauses 7.5.4


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

2008 – Clauses 7.5.5


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

• new clause for post-delivery activities

• a number of considerations are required

2008 – Clauses 7.5.1


Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

• specific clause for control of changes to ensure continuing conformity

• documented information must be retained describing the review of


changes and any action arising.

2008 – Clauses 7.3.7


Section 8 - Operation
8.6 Release of products and services

• must verify that product and service requirements have been meet
and evidence of conformity retained

• release to customer does not proceed until the planned verification


of conformity has been satisfactorily completed, unless otherwise
approved by a relevant authority and by the customer

• documented information to provide traceability to the person(s)


authorising release for delivery to the customer.

2008 – Clause 8.2.4


Section 8 - Operation

8.7 Control of nonconforming outputs

• similar to previous Clause 8.3

• documented information required describing nonconformity, actions


taken, any concessions and authority for taking action.

2008 – Clause 8.3


Section 9 – Performance Evaluation
9.1 Monitoring, Determining what is to be
measurement, analysis monitored, measured, analysed
and evaluation and evaluated will enable the
organisation to determine ‘if the
9.2 Internal audit management system suitable,
9.3 Management review adequate and effective ?’

How performance of the QMS


is evaluated.

2008 – Clause 8
Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation

• must determine what needs to be monitored and measured, the


methods for monitoring, measurement, analysis and evaluation, as
applicable, to ensure valid results

• additionally, when the monitoring and measuring is to be performed and


when the results from monitoring and measurement is to be analysed
and evaluated

• retain appropriate documented information as evidence of the results.

2008 – Clause 8.2.3


Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation

Can include: customer surveys, customer


feedback,compliments,warranty claims

2008 – Clause 8.2.1


Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation

• information resulting from monitoring and measuring appropriate


data should be analysed and evaluated

2008 – Clause 8.4


Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

• same as previous Clause 8.2.2

• still at planned intervals

• evidence of internal audits and results must be documented.

2008 – Clause 8.2.2


Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

• similar to previous Clause 5.6

• still at planned intervals

• clearer agenda items (inputs)

• evidence of management review results must be documented.

2008 – Clause 5.6


Section 10 - Improvement

10.1 General • QMS must continually


improve
10.2 Nonconformity and
corrective action • nonconformities must be
identified and reacted to
10.3 Continual improvement • corrective action must be
considered
Continual improvement
remains a core focus of the
QMS.

2008 – Clause 8.5


Section 10 – Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

• opportunities for improvement must be determined

• action must be taken to meet customer requirements and enhance


customer satisfaction:

▫ improve products and service

▫ correcting, preventing or reducing undesired effects

▫ improve performance and effectiveness of the QMS.

2008 – Clause 8.5.1


Section 10 - Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

• nonconformities (including complaints) must be reacted to and applicable


action taken

• root cause analysis must be considered based on its significance

• effectiveness of corrective action must be reviewed

• Update risks & opportunities determined during planning, if necessary

• evidence of action taken from nonconformities must be documented

• evidence of results of corrective action must be documented.


2008 – Clauses 8.3 & 8.5.2
Section 10 – Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

• organisations must continually improve the suitability, adequacy and


effectiveness of the QMS

• must consider results of analysis and evaluation, and outputs from


management review.

2008 – Clause 8.5.1


Auditing: As defined in ISO 19011:2018—Guidelines for auditing
management systems, an audit is a “systematic, independent and
documented process for obtaining audit evidence [records,
statements of fact or other information which are relevant and
verifiable] and evaluating .

• Auditor Attitude

• MUST BE POSITIVE/VALUE-ADD
• I really here to help.
• I am not here to find fault.
• We are on the same team.
• Together we can find opportunities.
• This benefits the business.
AUDIT TYPES
• Audits are of 3 types:
• First Party Audit • Self-audit (Client,auditor and
auditees are Internal)
• Second Party Audit • Audit by an interested
body (like a customer)
• Third Party Audit • Audit by independent body
(certification/registration body)
Any Questions?

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