What changes will ISO 9001:2015
bring?
Introduction
This presentation will cover the following topics:
The ISO 9001 Revision Process Key Inputs to ISO 9001:2015 The “High Level Structure”
Key Changes in ISO 9001:2015
Key Inputs to ISO 9001:2015
ISO Mission
Develop high quality voluntary International Standards:
Facilitate international exchange of goods & services
Support sustainable and equitable
economic growth
Promote innovation
Protect health, safety and environment
ISO Mission
Develop, maintain and support products* that enable organizations worldwide to improve their performance by establishing generic QMS requirements providing guidance and support.
Worldwide ISO 9001 survey
A worldwide ISO 9001 survey was conducted. The survey questioned what the most
important concepts were to follow for a successful QMS. The results were based on 6,299 answers and the top 6 concepts are as followed:
1. Integration of Risk Management 2. Resource Management
3. Systematic problem solving and learning 4. Voice of the customer
5. Knowledge management
Key Inputs
Set of stable requirements to last 10 years, 2015 until 2025.
Incentivate process approach and effective process management. INPUT Process OUTPUT
Changes in practices to QMS and technology. Facilitate implementation in any organisation.
Effective verification by first, second and third party organizations. Simplified language and text
Quality Management Principles – Process approach include concept of “system” Simpler language for better understanding.
‘High Level Structure’
Alignment of management systems standards Identical titles and core text
Generic basic vocabulary
High-Level Structure – Annex SL Common main structure, common sub-clauses common terms and definitions
Key Changes in ISO 9001:2015
Exclusions
No text for possible exclusions of requirements
Intent remains as per clause 1.2 of present standard
Leadership
• Role of “Management Representative” eliminated Quality policy / objectives compatible with strategic direction
• Integration of QMS requirements into business processes
Goods and services
• “product” “goods and services”
• New term to make the standard more generic and more applicable to service organizations
Reduction of the prescriptive nature of some Requirements
Monitoring and measuring equipment
• ‘Evidence of fitness for purpose’
Development of goods and services
• Processes for the development • Control of development processes • Development transfer
• Necessary documented information
Context of the organization
• Two new clauses:
4.1 Understanding the
organization and its context
4.2 Understanding the needs
and expectations of interested parties
Key changes
Key changes
Significant changes Process approach• New clause: Process approach
• Determination of risk to conformity of goods
and services and to customer satisfaction
Knowledge as a resource
• Determine the knowledge necessary for the operation of the QMS and its processes
• Knowledge shall be maintained, protected and made available as necessary
• Foresee the need for changes in knowledge and the risk of not acquiring it in a planned and timely manner.
Key changes
Documented information• No mention of a “Quality Manual” Outsourcing of goods and services
Control of external provision of goods and services • Risk-based approach to determine
type and scope of controls Risk and preventive action
• Key purpose of a management system is to act as preventive tool
• “Risk-based thinking” introduced in all clauses
What is “risk-based thinking”?
Something we all do automatically and often Subconsciously
Concept of risk > always implicit in ISO 9001
Risk-based thinking
• already part of process approach
• makes preventive action part of the routine Risk often seen as negative
Risk-based thinking can also help identify
Where is risk addressed in ISO 9001:2015?
Main objectives of ISO 9001:
• “To provide confidence in the organization’s
ability to consistently provide customers with conforming goods and services”
• To enhance customer satisfaction” The concept of “risk” relates to the
In Clause 6 > the organization is required to plan and take action to address risks and opportunities
In Clause 4 > the
organization is required to determine risks that can affect its ability to meet objectives” In Clause 5 > top management are required to commit to ensuring Clause 4 is followed In Clause 8 > the organization is required to have processes which identify and address risk in its operations
In Clause 9 > the
organization is required to consider risks and opportunities when determining what
needs to be monitored, measured, analyzed and evaluated
In Clause 10 > the organization is
required to improve by responding to changes in risk and opportunities
Model of a process-based QMS
Leadership
Leadership
Planning
Planning
Support
Support
Support
Support
Operation
Operation
Operation
Operation
Operation
Operation
Operation
Performance evaluation
Performance evaluation
Conclusions
More leadership and commitment from top management Process approach as a requirement
Risk definition and management
Quality objectives at relevant functions, levels and Processes Organizational knowledge as a resource
Documented information
Planned and controlled operation Performance evaluation
