Iso 9001-2015
Iso 9001-2015
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
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”.
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 – Clause 2
Section 3 – Terms and Definitions
• document – information and the medium on which it is contained
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
• 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
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
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
•
• 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.
• 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 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
• may consider:
• any changes made to design inputs and design outputs during the
design and development must be clearly identified.
• must verify that product and service requirements have been meet
and evidence of conformity retained
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
• 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?