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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Thursday, January 22, 2015

IATF announces plans to develop a design specification for revising ISO/TS 16949 in line with forthcoming ISO 9001:2015 QMS standard



The International Automotive Task Force (IATF) has announced that it has set up a working group of IATF member organisations “to develop a design specification for the revision of ISO/TS 16949 to align with the ISO 9001:2015 based structure and requirements.” The ISO/TS 16949 is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 QMS standard. First edition of ISO/TS 16949 was published in March 2002 as ISO/TS 16949:2002. Second edition of this standard was published in 2009 as ISO/TS 16949:2009 that is in line with ISO 9001:2008 QMS standard.

It was prepared by the IATF and the 'Technical Committee' of ISO. It harmonizes the country-specific regulations of quality Management systems The IATF is an "ad hoc" group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide.

With best wishes,

Keshav Ram Singhal

Tuesday, January 13, 2015

When is ISO 9001:2015 going to become effective?



ISO 9001:2015 is going to become effective from the date of its publication. ISO 9001:2015 is due to be published by the end of 2015. However, there will be transition period of three years (after the formal publication of ISO 9001:2015 standard), during which organizations implementing ISO 9001:2008 standard should move to ISO 9001:2015 version.

Best wishes,

Keshav Ram Singhal

Tuesday, January 6, 2015

ISO/DIS 9001 - QUICK REFERENCE JOURNEY AND SIGNIFICANT CHANGES


ISO/DIS 9001 - QUICK REFERENCE JOURNEY AND SIGNIFICANT CHANGES

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.

Please share this article on social media for creating awareness on changes coming in forthcoming ISO 9001:2015 QMS. Thanks.






Sunday, January 4, 2015

ISO/DIS 9001 - Scope and Normative reference



ISO/DIS 9001 - Scope and Normative reference

Keshav Ram Singhal

Clause 1 to 3 of ISO/DIS 9001 are organized as under:

Clause
1 Scope
2 Normative references
3 Terms and definitions

Scope

In ISO/DIS 9001 the 'scope' title is not sub-divided, as it is sub-divided in ISO 9001:2008 QMS standard - 1.1 - General and 1.2 - Application. Requirements of application of ISO/DIS 9001 are now part of sub-clause 4.3 under the title 'Determining the scope of the quality management system'.

Scope of ISO/DIS 9001 mentions the extent of the area or subject matter to which ISO/DIS 9001 is relevant. ISO/DIS 9001 specifies requirements for a quality management system:

- where an organization needs to clearly show the existence of the organization's ability by giving proof or evidence (demonstrate the organization's ability) to consistently provide product or service that fulfils: (i) customer requirements, and (ii) applicable legal (= statutory + regulatory) requirements, and

- where the organization aims to increase, strengthen or further improve the value of (enhance) customer satisfaction through: (i) the effective application and continual improvement of the system and processes, and (ii) the assurance of conformity to customer requirements and applicable legal (= statutory + regulatory) requirements.

All requirements mentioned in ISO/DIS 9001 are generic. These are intended to be applicable to all organizations without consideration (regardless) of type, size and product/service. Accordingly, ISO/DIS 9001 requirements are applicable to all types of businesses, whether they are manufacturing industries (such as, chemical, electronic, paper, steel, pharmaceutical etc.) or services (such as, banking, insurance, health, transportation, travel, hotel etc.).

In ISO 9001:2008 QMS standard, the term 'product' is used for the product intended for a customer, or the product required by a customer, and it includes services. As such, ISO 9001:2008 QMS standard used the term 'product' to include all output categories (hardware, services, software and processes materials), which is changed to 'product and service' in ISO/DIS 9001. The specific inclusion of 'service' in ISO/DIS 9001 is intended to highlight the difference between product and service.

Normative references

ISO/DIS 9001 does not mention any normative references.

Terms and definitions

ISO/DIS 9001 includes 69 terms and definitions that apply to the purpose of ISO/DIS 9001 document. All terms and definitions are sourced from ISO/DIS 9000:2014, which is also under revision process.

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. Thanks.


Saturday, January 3, 2015

ISO/DIS 9001 - Context of the organization



ISO/DIS 9001 - Context of the organization

Keshav Ram Singhal


ISO/DIS 9001 mentions new requirements with regard to the context of the organization - clause 4.1 - understanding the organization and its context, and clause 4.2 - understanding the needs and expectation of interested parties. Now as per ISO/DIS 9001, an organization establishing a quality management system needs to understand the organization and its context by determining relevant internal and external issues, understand the needs and expectation of interested parties and their requirements.

Clause 4 of ISO/DIS 9001 provides requirements related to the context of an organization. Context of an organization means the business environment. Business environment of an organization may be the organizational environment or ecosystem of the organization that includes combination of internal and external factors and conditions. Internal and external factors and conditions can have an effect on the organization's approach to organization's products, services, investments and interested parties. Interested parties with respect to the organization may be persons or organizations, such as customers, owners, people in the organization, suppliers, bankers, unions, partners, or society including competitors or pressure groups. It is clarified that the requirements of this clause are applicable to no-for-profit organizations, public sector organizations and organizations seeking profits.

The relevant sub-clauses are as under:
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 an its processes

Understanding the organization and its context

The title for this sub-clause provides for alignment with other management system standards. The intent of this clause is to provide a clear understanding of the important issues that can affect (positively or negatively), the way the organization manages activities and responsibilities related to its quality management system. There may be some external and internal issues relevant to the purpose of the organization and also to the strategic direction to which the organization moves. Such issues are important topics for the organization including problems for debate and discussion, issues for changing circumstances that affect the organization's ability to achieve the intended outcomes it sets for its quality management system.

What is required to do? First, determine and understand external and internal issues, and second, monitor (means determine the status of) and review ( means determine the suitability, adequacy and effectiveness of) the information about the determined external and internal issues.

How to understand internal issues? This can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

How to understand external issues? This can be facilitated by considering issues arising from legal, technological, competitive, market, culture, social, and economic environments. These can be national, international, regional or local.

Important points:
(i) Determine - What are the internal issues?
(ii) Determine - what are the external issues?
(iii) Monitor and review all such determined issues.

Suggestion: The organization may document its knowledge of the organization's context as appropriate.

Understanding the needs and expectations of interested parties

The title for this sub-clause also provides for alignment with other management system standards. First understand who may be included in interested parties. Interested party of an organization includes person or organization that (i) can affect a decision or activity, (ii) can be affected by a decision or activity, or (iii) can perceive himself to be affected by a decision or activity. As such, interested parties of an organization may be customers, people in the organization, suppliers, bankers, unions, competitors, pressure groups or society. Interested parties may have impact or potential impact on the organization's ability to consistently provide products and services (that meet customer requirements and applicable statutory and regulatory requirements).

What is required to do? First, determine interested parties that are relevant to the organization, second, determine requirements of the determined interested parties, and third, monitor (means determine the status of) and review (means determine the suitability, adequacy and effectiveness of) the information about the interested parties and their relevant requirements.

Important points:
(i) Determine - Who are the interested parties relevant to the organization?
(ii) Determine - What are the requirements of interested parties in relation to the organization's quality management system?
(iii) Monitor and review the determined information.

Suggestion: The organization may document its knowledge of relevant interested parties requirements, as appropriate.

Determining the scope of the quality management system

To establish the scope of the quality management system, the organization needs to determine boundaries and applicability of the quality management system.

What is required to do? First, determine the boundaries (limits) and applicability (usefulness) of the organization's quality management system (by considering the internal and external; issues relevant to the organization's quality management system, the determined requirements of relevant interested parties, and the products and services of the organization), second, Make available and maintain documented (controlled) information of the scope of the quality management system (by mentioning the products and services covered by the organization and justification for any instance where the organization is not able to meet any ISO/DIS 9001 requirement), and third, make sure that the organization's ability or responsibility to ensure conformity of products and services is not affected if any ISO/DIS 9001 requirement cannot be applied.

Important points:
(i) What are the boundaries (limits) and applicability (usefulness) of the organization's quality management system
(ii) What are the products and services covered by the organization's quality management system
(iii) Justification for any instance where the organization is not able to meet any ISO/DIS 9001 requirement
(iv) Documented (controlled) information (data) of the scope

It should be noted that ISO/DIS 9001 no longer makes specific reference to 'exclusions' but continues to allow for exclusions (provided in clause 1.2 of ISO 9001:2008 QMS standard), but not restricted to the specific clause (as done in ISO 9001:2008 QMS standard: clause 7).

Quality management system and its processes

Requirements of this section are similar to those mentioned in clause 4.1 of ISO 9001:2008 with some editorial changes. According to the requirements of ISO/DIS 9001, the organization is required to:
* establish (set-up on permanent basis, install, or create) a quality management system, processes needed and their interaction
* implement (as established) the quality management system, its processes and their interaction
* maintain the quality management system, its processes and their interaction
* continually improve the quality management system, its processes and their interaction

What is required to do? Organization needs to do the following:
(i) Determine the processes needed for the quality management system and their application throughout the organization
(ii) Determine the inputs for the determined processes
(iii) Determine the outputs expected from the determined processes
(iv) Determine the sequence and interaction of the determined processes
(v) Determine the criteria, methods, measurements indicators and related performance indicators needed to ensure effective operation and control of the determined processes
(vi) Determine the resources needed and ensure their availability
(vii) Determine the assignment of responsibilities and authorities for the determined processes
(viii) determine the risks and opportunities (as per clause 6.1)
(ix) Determine methods for monitoring, measuring (as appropriate), evaluation of processes and, if needed, the change of processes
(x) Determine opportunities for improvement of the processes and the quality management system
(xi) Plan and implement the appropriate actions to address determined risks and opportunities
(xii) Ensure that the methods and processes achieve desired (intended) results
(xiii) Maintain and retain documented information that are necessary to support the operation of processes and that provide evidence (and confidence) that the organization is carrying out the processes as planned.

Important points:
(i) What are the processes (and their inputs, intended outputs, sequence and interaction)?
(ii) How to ensure effective operation and control of processes? Think: criteria, methods, indicators (for measurement and performance), planning and implementing
(iii) What are the resources needed to carry out determined processes? Also make available resources needed
(iv) Who are the responsible people and their responsibilities and authorities?
(v) What are the risks and opportunities? Also think: Plan and implement appropriate actions to address risks and opportunities
(vi) What are the output results?
(vii) Maintain and retain documented information

ISO/DIS 9001 makes risk-based thinking more explicit and incorporates it in requirements for establishing, implementing, maintaining and continually improving the quality management system. Understanding organizational context and risks is helpful for an organization for its preparation to pursue, retain or take the amount and type of risk. It is important to understand risk sources. A risk source is an element, which alone or in combination of other risk source/sources, has the intrinsic potential to give rise to risk, where 'risk' is 'uncertainty in achieving objectives'. A risk source in an organization can vary and affect organization's objectives, so there is need to plan and implement appropriate actions to address the risk and its source.

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. Thanks.