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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

MANAGEMENT BRIEFING ON

ISO 9001:2015 STANDARD

QUALITY MANAGEMENT SYSTEM STANDARD (QMS)

PRESENTATION BY:

ISO 9001: 2015 DOCS

QUALITY BEYOND TOMORROW

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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

New QMS STANDARD is about business

“SUSTAINABILITY” in an ever changing world
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Same high level structure now in use since 2013 for all ISO
STANDARD, making integration easier”

ACT IMPROVEMENT

CHECK PERFORMANCE EVALUATION

OPERATIONS DO
PLAN SUPPORT
PLANNING
LEADERSHIP
CONTEXT OF THE ORGANIZATION
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ISO 9001:2015 QMS REQUIREMENTS

ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Needs and Leadership

expectation
Of interested Context of
the Planning
parties,
organization
internal and
external
environment
Risk & Intended
opportunity outcomes of
management
Support the QMS
Improvement
Performance

Performance Operations
evaluation performance
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Context of the
organization
External environment

Risks

Internal Vision,
environment mission,
goals,

Opportunities
 Interested parties – persons or group of persons that may be affected or consider
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

themselves to be affected by organization’s operations, products and services

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The QMS apply to all organizational types and

ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

the scope, must be documented)

• Scope describes the boundaries of the QMS
• Scope describes the products, services, process and locations covered
• Scope should provide justification for the exclusion of any
requirement of the standard
• Exclusions do not remove responsibility for performance
 Leadership’s responsibility is also to
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

constantly ensure and promote:

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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Leadership
LEADERSHIP
• Ensure Quality Policies and objectives are established and communicated
• “NEW” Quality Policy to be made available to relevant interested parties.

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Setting objectives Click here to buy the toolkit now
What results/benefits can we expect?

Quality Management System

1. Reduction in quality and operational risks
2. Improvements in external providers
(suppliers/contractors) performance
3. Improvements in process performance
4. Continually improving products & service
conformity
5. Sustained customer satisfaction
 SAMPLE OBJECTIVES FOR THE FOLLOWING QMS SUCCESS CRITERIA
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING
QMS Key Outcomes
Product (goods and services
conformity (all through
standard)
Customer satisfaction (all
through standard)
ORGANIZATION’S OBJECTIVES
Reduce product NCs to 0.01% by end of year 2017
Ensure 100% compliance to statutory specifications in year
2017
Improve customer complaints resolution time to 24 hrs by
November 2017
Reduce customer complaints by 15% by the end of
November 2017
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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Action plans for objectives

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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

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LEADERSHIP COMMITMENT
 LEADERSHIP
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING
Leadership
REQUIREMENTS
1. Be accountable for the QMS
2. Ensure Quality Policies and objectives are
established
3. Ensure integration of QMS requirement
into relevant operational activities,
technology and material changes,
purchasing, induction, training and
decision making
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LEADERSHIP
EVIDENCES
1. Evidence of involvement in
planning, performance review and
improvement directives
2. Availability and continued review
of Quality Policies and objectives
3. Ensure objectives are cascaded
down the organizational structure
to the relevant processes,
procedures and work instructions
and ensure performance reviews
are done from bottom up
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Leadership
LEADERSHIP REQUIREMENTS LEADERSHIP OPTIONAL CONFORMANCE
EVIDENCES
4. Ensure resource needs for the QMS are 4. QMS maintenance budget & asset list
made available 5. Evidence of internal communications
5. Communicate the effectiveness and regarding QMS planning, performance and
importance of the QMS as well as effectiveness in meeting objectives
consequences/implications 6. Evidence of communications and
6. Plan and ensure QMS outcomes are directives on QMS performance
achieved 7. Evident in risk evaluations, decisions and
7. Promote risk based thinking and actions after reviews (e.g.: special
continual improvement directives, memos on improvements)

8. Evident in staff confidence in carrying out

8. Support staff and other management their roles, achieved through recognition,
members to provide leadership with commendations, encouragement, rewards
regards to the QMS and discipline
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Leadership
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• Ensure required roles, responsibilities and authorities for QMS are

established and communicated within the organization.

OPTIONS: use current structure or develop a new one by selecting the right
team and coordinator
The team structure helps to implement and integrate requirements of the
QMS
We need to determine who is/are responsible for coordinating, monitoring
and reporting QMS performances?
 6.0 QMS documented information and responsible holders
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Name of
Document or Document/type of
SN Documented information requirement ISO clause record information Responsible holders & Location
Quality Management
1 Scope 4.3 Document ?
System Scope
Process should be documented where
Departmental
2 necessary to ensure consistency of 4.4.2a Documents ?
manual
outputs and reduce variation
Production,
Process records should be maintained to
Maintenance,
3 the extent necessary to show process are 4.4.2b Records ?
Admin, HR and QA
carried out as planned
Process records
Quality Handbook,
4 Quality Policy 5.2.2a Document ?
Walls
Last
Departmental
5 Quality objectives paragraph Document ?
manual
on 6.2.1

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ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Top Management
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Responsibilities include: Liaison with

QMS team
Certification Body and consultants
Managing Corporate QMS activities coordinator

QMS QMS Change

QMS performance
representatives QMS Auditors management
evaluators (HODS)
and monitors team
Responsibilities Responsibilities Responsibilities Responsibilities
include: include: include: include:
• planning through • Conduct and report • Planning and • Reviewing change
objectives, actions internal audit Evaluating QMS requests
and processes results performance and • Planning and
• Execution of actions improvements communicating on
and monitoring • Identifying change change needs
QMS performance needs
• Reporting on QMS
performance
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

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 QMS Management Review Click here to buy the toolkit now
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING

Performance
of external Monitoring Changes in Status of
Actions on providers Audit & internal Previous
Risks and results and Feedback
opportunities measuring Process action
results external performance from
issues and product interested INPUTS
conformity parties

Customer
satisfaction

Improvement
opportunities

Changes
to QMSs OUTPUTS
Resource
needs
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INTERNATIONAL CERTIFICATION
CROSS ROAD
• CERTIFICATION TO • CERTIFICATION TO REQUIREMENTS,
LETTER/REQUIREMENTS ONLY SPIRIT AND PRINCIPLES OF THE
STANDARD

EVIDENCES ARE PRODUCED TO THE Performance results are achieved to the

SATISFACTION OF A CERTIFICATION BODY Satisfaction of the Certified Organization
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SUSTAINABLE
OUTCOMES
OUR AIM? CONTINUAL
IMPROVEMENT
ISO 9001: 2015 DOCS MANAGEMENT SYSTEMS TRAINING
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Thank you!