The document discusses the new structure of ISO 9001:2015. Key points include: - The standard is now structured into 7 sections to facilitate sharing concepts across management systems. - Organizations must determine internal and external factors that affect their business and understand needs of interested parties in addition to customers. - A risk management approach is required when planning activities. - Documented information replaces terms like procedures and records. Requirements can be excluded with justification. It provides an overview of the new structure and emphasizes leadership, risk-based thinking, and involvement of people to ensure customer satisfaction and improvement. Implementation involves analyzing issues, risks and opportunities, and planning processes to meet customer and interested party needs.

1. ISO 9001: 2015

2. NEW STRUCTURE
 Structured in 7 Sections 4 to 10
 New Structure facilitates sharing of some common BASIC
CONCEPTS by Management Systems like QMS,EMS, ISMS,
 Basic Concepts like
 MANAGEMENT | CUSTOMER | REQUIREMENTS
 PERFORMANCE | INTERESTED PARTIES
 POLICIES | PROCEDURES | PLANNING
 OBJECTIVES | CONTROLS
 MONITORING | MEASURING | DECISION MAKING | RISKS

3.  CONTEXT OF THE ORGANAIZATION – Internal & External Factors
that affect the Organization's business environment must be determined.
 Apart from customers, the Organization should understand the needs &
expectations of the INTERESTED PARTIES
 There is a need for the Organization to adopt a RISK MANGEMENT
APPROACH in planning its activities.
 There is no need for the Organization to have a Quality Manual,
Procedures, Records but should maintain & retain DOCUMENTED
INFORMATION as required
 Any requirement can be EXCLUDED WITH JUSTIFICATION if it can not
be applied.
 NEW TERMS have been included like Object, Output
WHAT IS NEW ?

4. QUALITY MANAGEMENT PRINCIPLES
 Focus on Customer & Interested Parties
 Provide Leadership for your Organization
 Engage & Involve your People
 Use Process approach
 Use Evidence to make Decisions
 Encourage Improvement
 Manage your corporate relationships

5. CONTEXT4.0
LEADERSHIP5.0
PLANNING6.0
SUPPORT7.0
OPERATIONS8.0
IMPROVEMENT10.0EVALUVATION9.0
7 NEW SECTIONS

6. PDCA DIAGRAM OF NEW STRUCTURE
5.0
LEADERSHIP
7.0 SUPPORT &
8.0 OPERATION
9.0
PERFORMANCE
EVALUVATION
10.
IMPROVEMENT
6.0
PLANNING
CHEC
K
1. REQUIREMENTS OF
CUSTOERS & INTERESTED
PARTIES
2. RISKS & OPPORTUNITIES
3. RESOURCES AVAILABILITY
PLAN
1. PROMOTE RISK BASED THINKING
2. MOTIVATE & ENGAGE PEOPLE
3. ASSIGN ROLES, RESPONSIBILITIES,
AUTHORITIES
4. ENSURE CUSTOMER SATISFACTION & QMS
RESULTS
1. PROVIDE COMPETENT PEOPLE,
INFRASTRUCTURE & ENVIRONMENT
2. REVIEW CUSTOMER REQUIREMENTS ,
DESIGN
3. CONTROL EXTERNAL PROVIDERS &
PRODUCTION & SERVICE PROCESSES, NON
CONFORMING PRODUCTS
4. TEST & RELEASE PRODUCTS, SERVICES
5. POST DELIVERY ACTIVITIES
DO
1. MEASURE CUSTOMER
SATISFACTION
2. CONDUCT INTERNAL
AUDITS & MANAGEMENT
REVIEW
3. MEASURE QUALITY OF
PRODUCT & PROCESS
4. ANALYZE DATA
1. TAKE CORRECTIVE
ACTIONS
2. UPDATE RISK REGISTER
3. IMPLEMENT CONTINUAL
IMPROVEMENT
ACT

7. THE ADVANTAGE
 Reduced Cost & Complexities as the new
structure serves as a single framework for
multiple management system like QMS, EMS,
ISMS, etc.
 Risk based approach to ensure Business
Continuity
 More motivation for Organization as a result of
increased involvement & commitment of the Top
Management towards realizing organizational
goals & objectives both Business & Quality

8. HOW TO IMPLEMENT?
 List down
 INTERNAL & EXTERNAL ISSUES of the Organization
 List the Needs of Interested Parties along with Customer
Needs
 RISKS, OPPORTUNITIES for Quality, Business & Interested
Parties, Customers in meeting those needs
 Plan Processes, People, Equipment, to treat the identified
RISKS & realize product/service as per customer needs
& expectations taking into account the needs of Interested
Parties
 Work out the plan, Monitor & Measure Process, People &
Outputs of processes
 Standardize the Operations based on Results.

9. CONTACT FOR EXPERTISE
G.Sreedharan
ISO 9001:2015 CONSULTANT
Ph- +974 77299410
sreedharang@gmail.com
NEXT PRESENTATION WILL PROVIDE DETAILS TO COMPLY WITH SECTION 4 OF
ISO9001:2015