Keshav Ram Singhal
A quick reference journey to ISO/DIS 9001 QMS document is as under:
Introduction
0.1 General
This Para provides a general introduction of quality management system - its adoption ought to be a strategic decision for an organization. It discusses influence by the context of an organization.
0.2 The ISO standards for quality management
This Para provides brief details of three core standards -ISO 9000, ISO 9001 and ISO 9004, and also other standards developed to support for implementing quality management system in the ISO 10000 number range.
0.3 Process approach
This Para discusses adoption of process approach in the quality management system.
0.4 Plan-Do-Check-Act Cycle
This Para discusses PDCA methodology to be applied to all processes and to the quality management system.
0.5 'Risk-based thinking'
This Para discusses the concept of risk-based thinking.
0.6 Compatibility with other management system standards
This Para states adoption of 'high level structure' developed by ISO to improve alignment among other management system standards.
Quality management systems - Requirements
Clause 1 - Scope
This clause discusses the scope of ISO/DIS 9001 in general.
Clause 2 - Normative references
This clause states that there are no normative references to ISO/DIS 9001.
Clause 3 - Terms and definitions
This clause provides 69 terms and definitions sourced from ISO/DIS 9000:2014 document for the purpose of ISO/DIS 9001.
Clause 4 - Context of the organization
This clause states requirements related to the understanding the organization, its context, understanding the needs and expectations of interested parties, scope of the quality management system, quality management system and its processes. This clause has following sub-clauses:
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
Sub-clauses 4.1 and 4.2 mention new requirements.
Clause 5 - Leadership
This clause mentions leadership requirements including requirements for commitment for the quality management system, customer focus, quality policy, organizational roles, responsibilities and authorities. This clause has following sub-clauses:
5.1 - Leadership and commitment
5.1.1 - Leadership and commitment for the quality management system
5.1.2 - Customer focus
5.2 - Quality policy
5.3 - Organizational roles, responsibilities, and responsibilities
Clause 6 - Planning for the quality management system
This clause states planning requirements for the quality management system that include to consider the issues referred in clause 4.1 and requirements referred in clause 4.2, plan actions to address risks and opportunities, establish quality objectives and planning to achieve such established objectives and planning of changes to the quality management system. This clause has following sub-clauses:
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
Support of resources is necessary to achieve desired outputs, as such this clause deals with the requirements to determine and provide resources needed for the quality management system including people (human), infrastructure, environment for the operation of processes, monitoring and measuring resources, organizational knowledge, competence, awareness, communication and documented information. This clause has following sub-clauses:
7.1 - Resources
7.1.1 - General
7.1.2 - People
7.1.3 - Infrastructure
7.1.4 - Environment for the operation of processes
7.1.5 - Monitoring and measuring resources
7.1.6 - Organizational knowledge
7.2 - Competence
7.3 - Awareness
7.4 - Communication
7.5 - Documentation information
7.5.1 - General
7.5.2 - Creating and updating
7.5.3 - Control of documented information
Clause 8 - Operation
This clause states the requirements related to operational processes related to customer, and products and services. This clause has following sub-clauses:
8.1 - Operational planning and control
8.2 - Determination of requirements for products and services
8.2.1 - Customer communication
8.2.2 - Determination of requirements related to products and services
8.2.3 - Review of requirements related to products and services
8.3 - Design and development of products and services
8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development controls
8.3.5 - Design and development outputs
8.3.6 - Design and development changes
8.4 - Control of externally provided products and services
8.4.1 - General
8.4.2 - Type and extent of control of external provision
8.4.3 - Information for external providers
8.5 - Production and service provision
8.5.1 -Control of production and service provision
8.5.2 - Identification and traceability
8.5.3 - Property belonging to customers or external providers
8.5.4 - Preservation
8.5.5 - Post-delivery activities
8.5.6 - Control of changes
8.6 - Release of products and services
8.7 - Control of nonconforming process outputs, products and services
Clause 9 - Performance evaluation
This clause states requirements related to processes for performance evaluation that includes requirements for monitoring, measurement, analysis, evaluation, customer satisfaction, internal audit and management review. This clause has following sub-clauses:
9.1 - Monitoring, measurement, analysis and evaluation
9.1.1 - General
9.1.2 - Customer satisfaction
9.1.3 - Analysis and evaluation
9.2 - Internal audit
9.3 Management review
Clause 10 - Improvement
This clause states requirements related to processes for improvement. This clause has following sub-clauses:
10.1 - General
10.2 -Nonconformity and corrective action
SIGNIFICANT CHANGES
Please go through the article 'What's new? A Look at the Changes in ISO/DIS 9001', however significant changes observed may be summarized as under:
1. The term 'product' (used in ISO 9001:2008) is replaced by the term 'goods and services (in ISO/DIS 9001)
2. Two new clauses are added in ISO/DIS 9001
- 4.1 - Understanding the organization and its context
- 4.2 - Understanding the needs and expectations of interested parties
3. 'Process approach' is added as requirement (clause 4.4.2) in ISO/DIS 9001 - The requirements to use process approach has been more explicit now.
4. ISO/DIS 9001 does not include a specific clause for 'preventive action'. ISO 9001:2008 has clause 8.5.3 as requirements for preventive action.
5.ISO/DIS 9001 includes requirements for 'actions to address risks and opportunities' (clause 6.1). Risk management , thus, will be part of the QMS.
6. The structure in ISO/DIS 9001 has been changed. There are 10 clauses in ISO/DIS 9001 instead of eight clauses in ISO 9001:2008.
Eight clauses in ISO 9001:2008 are:
Clause 1 - Scope
Clause 2 - Normative reference
Clause 3 - Terms and definitions
Clause 4 - Quality management system
Clause 5 - Management responsibility
Clause 6 - Resource management
Clause 7 - Product realization
Clause 8 - Measurement, analysis and improvement
Ten clauses in ISO/DIS 9001 are:
Clause 1 - Scope
Clause 2 - Normative references
Clause 3 - Terms and definitions
Clause 4 - Context of the organization
Clause 5 - Leadership
Clause 6 - Planning for the quality management system
Clause 7 - Support
Clause 8 - Operation
Clause 9 - Performance evaluation
Clause 10 - Improvement
7. The terms 'document' and record' (used in ISO 9001:2008) have been replaced by the term 'documented information' in ISO/DIS 9001
8. The term 'continual improvement' (used in ISO 9001:2008) has been replaced by the term 'improvement' in ISO/DIS 9001.
9. The existing standard ISO 9001:2008 is based on eight quality management principles, while ISO/DIS 9001 is based on seven quality management principles.
ISO 9001:2008 standard is based on following eight quality management principles: (i) Customer focus, (ii) Leadership, (iii) Involvement of people, (iv) Process approach, (v) System approach to management, (vi) Continual improvement, (vii) Factual approach to decision making, and (viii) Mutually beneficial supplier relationship.
One principle 'System approach to management' is dropped in ISO/DIS 9001. There are some editorial changes also. Seven quality management principles, on which ISO/DIS 9001 is based, are: (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship management.
10. Quality manual is not required in ISO/DIS 9001.
11. Management representative is not required in ISO/DIS 9001. Role of management representative is assigned to the top management.
12. ISO 9001:2008 requires six mandatory documented procedures. No mandatory documented procedure is required in ISO/DIS 9001.
Note: The ISO 9001 revision process moves on to the next stage. Readers should note that there may be some changes in the requirements. The above article is for academic purpose. Readers' comments are invited.
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