ISO 9001:2015 Draft International Standard

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ISO 9001:2015 Draft International Standard is published. The revised version of the quality management system standard is due to release in September 2015, by the International Organization for Standardization (ISO).

Back ground of ISO 9001

Back ground of ISO 9001

WHY ISO 9001:2015?

As per the policy of ISO all standards needs to be reviewed and revised in every 5 Years and to incorporate the new “High Level Structure” as defined in the “Annex SL” of ISO 17021. ISO new version main objective is to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services and to enhance customer satisfaction.

New ISO 9001:2015 standard characterize a technical revision compared to 2008 edition. It also adopts revised clause sequence, quality management principles and addition of new concepts.

Some concepts introduced in new standard are:

  • Integration of Risk Management
  • Resource Management
  • Systematic problem solving and learning
  • Voice of the customer
  • Knowledge management
  • Measures (examples are performance, satisfaction and ROI.)

ISO 9001:2015 – REVISION PROCESS

REVISION PROCESS

QUALITY MANAGEMENT PRINCIPLES used in ISO 9001:2015 DIS

Seven Management System Principles were used in ISO 9001:2015 DIS standard

  • Customer Focus
  • Leadership
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence based Decision Making
  • Relationship Management

Major Changes in ISO 9001:2015 DIS

  • “High Level Structure” is used in text writing (i.e. clause sequence, common text and terminology)
  • New clause sequence is adopted in new version which is consistent with “Annex SL”, highlighted in main body of the text (clause 1 to 10).
  • No specific reference and text for possible exclusions of requirements
  • No specific requirement and text for‘documentedprocedures’ and ‘records’. Both have been replaced throughout by the text ‘documented information’.
  • Role of“Management Representative” Now the activities of Management Representative should be performed by one of group of Senior Management.
  • No mention of a “Quality Manual”. Specific word “Quality Manual” is no-were mentioned in the Draft Standard.
  • Quality policy / objectives compatible with strategic direction
  • Integration of QMS requirements into business processes
  • Change of tem ‘product’ to ‘product and services’. New term include all output categories i.e. hardware, services, software and processed materials
  • Organization needs to determine the knowledge necessary for the operation of the QMS and its processes and to achieve conformity of process
  • “Risk-based thinking” introduced in all clauses
  • Organization needs to determine the risks to conformity of goods and services and to customer satisfaction and opportunities in place of preventive action

 

RISK ADDRESSED IN FOLLOWING CLAUSES OF ISO 9001:2015 DIS

Clause 4 Organization is required to determine risks that can affect its ability to meet objectives.
Clause 5 Top management are required to commit to ensuring Clause 4 is followed.
Clause 6 Organization is required to plan and take action to address risks and opportunities.
Clause 8 Organization is required to have processes which identify and address risk in its operations.
Clause 9 Organization is required to consider risks and opportunities when determining what needs to be monitored, measured, analyzed and evaluated.
Clause 10 Organization is required to improve by responding to changes in risk and opportunities.

 

PDCA CYCLE APPROACH IN RISK MANAGEMENT

PDCA CYCLE APPROACH

ISO 9001:2015 DIS CLAUSES

CLAUSE 4: Context of an organization

4.1       Understanding the organization 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

 

CLAUSE 5: Leadership

5.1       Leadership and commitment

5.2       Quality policy

5.3       Organizational roles, responsibilities and authorities

 

CLAUSE 6: Planning for quality management system

6.1       Actions to address risks and opportunities

6.2       Quality objectives and planning to achieve them

6.3       Planning of changes

 

CLAUSE 7: Support

7.1       Resources

7.2       Competence

7.3       Awareness

7.4       Communications

7.5       Documented information

 

CLAUSE 8: Operations

8.1       Operational planning and control

8.2       Determination of requirements for products and services

8.3       Design and development of products and services

8.4       Control of externally provided products and services

8.5       Production and service provision

8.6       Release of products and services

8.7       Control of nonconforming process outputs, products and services

 

CLAUSE 9: Performance Evaluation

9.1       Monitoring, measurement, analysis and evaluation

9.2       Internal audit

9.3       Management review

 

CLAUSE 10: Improvements

10.1     General

10.2     Nonconformity and corrective action

10.3     Continual improvement

 

ISO 9001:2008 Standard Mapping with ISO 9001: 2015 DIS

ISO 9001:2008 ISO 9001:2015 DIS Remarks
List of Clauses Description List of Clauses Description  
1 Scope
1.1 General 1 Scope
  4.1 Understanding the organization and its context New Clause
  4.2 Understanding the needs and expectations of interested parties New Clause
1.2 Application 4.3 Determining the scope of the quality management system Documented scope required
2 Normative Reference 2 Normative Reference
3 Terms and Definitions 3 Terms and Definitions
4.0 Quality Management System 4 Context of the organization
4.1 General Requirements 4.4 Quality management system and its processes New – Determination of risks and opportunities
4.2 Documentation Requirements 7.5 Documented information New term introduced in place of ‘documents’ and ‘records’. No requirement of documented procedure.
4.2.1 General 7.5.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents 7.5 Documented Information
4.2.4 Control of Records 7.5 Documented Information
5.0 Management Responsibility 5 Leadership Responsibilities are re-defined
5.1 Management 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 New requirements added and only 7 quality management principles introduced
5.4 Planning 6. Planning for the quality management system
5.4.1 Quality Objectives 6.2 Quality objectives and planning to achieve them More specific requirements introduced
5.4.2 Quality Management System Planning 6.3 Planning of change
5.5 Responsibility, Authority and Communication 5.3 Organizational roles, responsibilities and authorities
5.5.1 Responsibility and Authority 5.3 Organizational roles, responsibilities and authorities
5.5.2 Management Representative
5.5.3 Internal Communication 7.4 Communication
5.6 Management Review 9.3 Management Review New requirements introduced
5.6.1 General 9.3.1 Management Review
5.6.2 Review Input 9.3.1 Management Review
5.6.3 Review Output 9.3.1 Management Review
6.0 Resource Management 7.1 Resources
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.1.2 People New Clause
6.2.1 General 7.2 Competence
6.2.2 Competence, Awareness and Training 7.2 Competence
7.3 Awareness New Clause
  7.1.6 Monitoring and measuring resources New Clause
6.3 Infrastructure 7.1.4 Infrastructure
6.4 Work environment 7.1.5 Environment for the operation of processes New Clause
7.0 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 ‘products and services’ new term
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 products and services
7.2.3 Customer Communication 8.2.1 Customer communication
7.3 Design and Development 8.3 Design and development of products and services ‘products and services’ new term
7.3.1 Design and Development Planning 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
7.4.2 Purchasing information 8.4.3 Information for external providers
7.4.3 Verification of purchased product 8.4.2 Type and extent of control of external provision and 8.6 Release of products and services
8.6 Release of products and services
7.5 Production and service provision 8.5 Production and service provision New requirements introduced
7.5.1 Control of production and service provision 8.5.1 Control of production and service provision
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 7.1.6 Monitoring and measuring resources
8.0 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis and evaluation New Clause
8.1 General 9.1.1 General
8.2 Monitoring and measurement 9.1.1 General
8.2.1 Customer satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal audit 9.2 Internal Audit New requirements introduced
8.2.3 Monitoring and measurement of processes 9.1.3 Analysis and evaluation
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 New requirements introduced
8.4 Analysis of data 9.1.3 Analysis and evaluation
8.5 Improvement 10 Improvement
  10.1 General New Clause
8.5.1 Continual improvement 10.3 Continual Improvement
8.5.2 Corrective action 10.2 Nonconformity and corrective action
8.5.3 Preventive action 6.1 Actions to address risks and opportunities
 

 

You have questions about ISO 9001:2015?

Please contact us for questions about the new standard and your next assessment.

Contact Details

Mr. Rajendra Khare, + 91 9810268573, rkhare@dqsindia.com

Source: Information collected from ISO Website

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