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ISO 9001:2015

Quality Management System

The Impact in International Standard for Quality Management System

Success through management excellence

What is the purpose of ISO?

Global Standards is happy to guide about quality management system – ISO 9001:2015 in a way that can easily be understood. The change is obvious, and the same applies this time for QMS standards with concrete impacts. This standard with new formation has value meanings for all the organizations on any scope to ensure customer satisfaction.

In this white paper, the core changes related to structure, auditable requirements, implications, and risk-based thinking have been incorporated for better guidance.

All ISO management system standards are subject to a regular review under the rules. Following a substantial ISO user survey, the committee decided that a review was appropriate and created the following objectives to maintain its relevance to the current market for long-term bases. However, this change is not going to change up to ten years so that organizations can penetrate QMS with more durability.

© 2017 Global Standards. All rights reserverd for this documented information shared for reading purpose only.

White Paper - ISO 9001:2015 Quality Management System

The ISO 9001:2015 standard is one of the most widely known standards for a quality management systems to achieve customer satisfaction as an outcome, is implemented by over 850,000 organizations in 163 countries.

The ISO 9001 certification has become an international reference for Quality Management requirements in Business-to-business relationships.

ISO 9001 certification helps organizations of any type and size with “Quality Management System” including:

• Fulfilling quality requirements of interested parties
• Meeting applicable statutory and regulatory requirements
• PDCA supports business processes to sustain
• Risk-based thinking assures a proactive approach
• Decrease in nonconformances

The standard has earned a worldwide reputation known as the “Quality Management System”, which is applicable to any organization irrespective of size and scope of business processes.

“Management system” refers to the organization’s structure for managing its processes or business Activities.

This structure transforms the input of resources into a product or service that meets the organization’s business objectives, satisfies the customer’s quality requirements, and complies with regulations.

ISO 9001 certification provides a framework of requirements for management to address customer focus, process the management approach, and pursue continual Performance improvement

White Paper - ISO 9001:2015 Quality Management System

BENEFITS OF ISO 9001 CERTIFICATION STANDARD

• Achieve consistency of product and service quality and compliance with legal and associated requirements of interested parties.
• Formalize good working practices through better planning.
• Assure satisfaction and added value to interested parties and features of existing services.
• Introducing Risk-based thinking approach as preventive action and to promote ‘Proactive Approach.
• Understanding and monitoring needs and expectations of interested parties.
• Be internationally recognized as a well-managed organization and business holder for quality management
system.
• To increase the promotion of products and services through this standard’s tools.
• Employee knows what to do and how to execute.
• Better management controls through the quality team.
• Monitoring of quality assured working environment.
• Increase credibility among business associates.
• Be confident through internal auditing, organizational knowledge, and management reviews.
• Achievement of goals through encouraging continual improvement.

The ISO 9001:2015 certification is based on the management Principles as shown below.

● Principle 1 – Focus on customer and interested parties
● Principle 2 – Provide leadership for your organization
● Principle 3 – Engage and involve your people
● Principle 4 – Use a process approach
● Principle 5 – Encourage improvement
● Principle 6 – Use evidence to make decisions
● Principle 7 – Manage your corporate relationships

Global Standards ensures to provide the essence of
all the core principles of ISO 9001:2015 certification. Previously
obsoleting the eight principles by introducing seven
principles to adopt QMS standard for any kind
of industries, working sector, volume and irgnomics.

White Paper - ISO 9001:2015 Quality Management System

WHAT IS THE CHANGE

STRUCTURE

ISO 9001:2015 will be based on Annex SL – the new high level structure (HLS) that brings a common framework to all ISO management systems. This helps to keep consistency, align different management system standards, offer matching sub-clauses against the top-level structure and apply common language across all standards.

PDCA MODULE
AUDITABLE CLAUSES

4- Context of Organization
5- Leadership
6- Planning
7- Support
8- Operation
9- Perfomance Evaluation
10- Improvement

DOCUMENTED INFORMATION

As part of the alignment with other management system standards a common clause on ‘Documented Information’ is a new requirement. The terms “documented procedure” and “record” are now part of term the ‘documented information’. Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or support a process) as a requirement to maintain documented information.

White Paper - ISO 9001:2015 Quality Management System

COMPARISION

ISO 9001:2008 ISO 9001:2015
4  Quality management system 4  Quality management system
4.1  General requirements 4.4  Quality management system and its processes
4.2  Documentation requirements 7.5  Documented information
4.2.1  General 7.5.1  General
4.2.2  Quality manual 4.3  Determining the scope of the quality management system
7.5.1  General
4.4  Quality management system and its Processes
4.2.3  Control of documents 7.5.2  Creating and updating
7.5.3  Control of documented Information
4.2.4  Control of records 7.5.2  Creating and updating
7.5.3  Control of documented Information
5  Management responsibility 5  Leadership
5.1  Management commitment 5.1  Leadership and commitment
5.1.1  Leadership and commitment for the quality management system
5.2  Customer focus 5.1.2  Customer focus
5.3  Quality policy 5.2  Quality policy
5.4  Planning 6  Planning for the quality management system
5.4.1  Quality objectives 6.2  Quality objectives and planning to achieve them
5.4.2  Quality management system planning 6  Planning for the quality management system
6.1  Actions to address risks and opportunities
6.3  Planning of changes
5.5  Responsibility, authority and communication 5  Leadership
5.5.1  Responsibility and authority 5.3  Organizational roles, responsibilities and authorities
5.5.2  Management representative Title removed
5.3 Organizational roles, responsibilities and authorities
5.5.3  Internal communication 7.4 Communication
5.6  Management review 9.3  Management review
5.6.1  General 9.3.1  General
5.6.2  Review input 9.3.1  Review input

White Paper - ISO 9001:2015 Quality Management System

COMPARISION

5.6.3  Review output 9.3.2  Review output
6  Resource management 7.1 Resources
6.1  Provision of resources 7.1.1  General
7.1.2  People
6.2  Human resources Title removed
7.2 Competence
6.2.1 General 7.2 Competence
6.2.2 Competence, training and awareness 7.2  Competence
7.3  Awareness
6.3 Infrastructure 7.1.3 Infrastructure
6.4 Work environment 7.1.4 Environment for the operation of processes
7 Product realization 8 Operation
7.1 Planning of product realization 8.1 Operational planning and control
7.2 Customer-related processes 8.2 Determination of requirements for products and services
7.2.1 Determination of requirements related to the product 8.2.2 Determination of requirements related to products and services
7.2.2 Review of requirements related to the product 8.2.3 Review of requirements related to the products and services
7.2.3 Customer communication 8.2.1 Customer communication
7.3 Design and development 8.5 Production and service provision
7.3.1 Design and development planning 8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
7.3.2 Design and development inputs 8.3.3 Design and development Inputs
7.3.3 Design and development outputs 8.3.5 Design and development outputs
7.3.4 Design and development review 8.3.4 Design and development controls
7.3.5 Design and development verification 8.3.4 Design and development controls
7.3.6 Design and development validation 8.3.4 Design and development controls
7.3.7 Control of design and development changes 8.3.6 Design and development changes
7.4 Purchasing 8.4 Control of externally provided products and services
7.4.1 Purchasing process 8.4.1 General
8.4.2 Type and extent of control of external provision

White Paper - ISO 9001:2015 Quality Management System

COMPARISION

7.4.2 Purchasing information 8.4.3 Information for external providers
7.4.3 Verification of purchased product 8.6 Release of products and services
7.5 Production and service provision 8.5 Production and service provision
7.5.1 Control of production and service provision 8.5.1 Control of production and service provision
8.5.5 Post-delivery activities
7.5.2 Validation of processes for production and service provision 8.5.1 Control of production and service provision
7.5.3 Identification and traceability 8.5.2 Identification and traceability
7.5.4 Customer property 8.5.3 Property belonging to customers or external providers
7.5.5 Preservation of product 8.5.4 Preservation
7.6 Control of monitoring and measuring equipment 7.1.5 Monitoring and measuring resources
8.0 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis and evaluation
8.1 General 9.1.1 General
8.2 Monitoring and measurement 9.1 Monitoring, measurement, analysis and evaluation
8.2.1 Customer satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal audit 9.2 Internal audit
8.2.3 Monitoring and measurement of processes 9.1.1 General
8.2.4 Monitoring and measurement of product 8.6 Release of products and services
8.3 Control of nonconforming product 8.7 Control of nonconforming process outputs, products and services
8.4 Analysis of data 9.1.3 Analysis and evaluation
8.5 Improvement 10 Improvement
8.5.1 Continual improvement 10.1 General
10.3 Continual Improvement
8.5.2 Corrective action 10.2 Nonconformity and corrective action
8.5.3 Preventive action Clause removed
6.1 Actions to address risks and opportunities (see 6.1.1, 6.1.2)

The correlation between ISO 9001 ver 2008 & 2015 better
differentiate the difference the change to adopt the impact
easily with less associated risks. It will help organizations
to implement or transit their quality management system
in better and right ways.

White Paper - ISO 9001:2015 Quality Management System

ANNEX-SL

A new high level structure for all management standards

Annex-SL, is a type of structure that was introduced by ISO technical committee to eliminate the gap among all its management standards. This provides the framework of ‘common structure’ with similar use of terms, definitions, clause patterns and easy integration of standards for organization at the same time.

The common structure of standard requirements:

Clause 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

TRANSITION TIME LINE

September 2018, is the deadline for the transition. Transition should be executed timely to those who are already on ver 2008. After September 2018 no organization shall be eligible to continue ISO 9001:2008 version at all. The timely transition shall secure your continuation of certification and involvement of people to understand the new standard for the continuation of quality management system with spirit of confidence.

The quick contact to Global Standards shall be in benefit to
introduce your organization for true means of ver. 2015 with
effective implementation. Global Standards is passionate to
deliver for the change and integration with similar standards.

© 2017 Global Standards. All rights reserverd for this documented information shared for reading purpose only.

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