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ISO 9001

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ISO 9000 - Quality management

ISO 9001 : 2015 is the latest version of the Standard

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

There are many standards in the ISO 9000 family, including:

  • ISO 9001:2015 - sets out the requirements of a quality management system
  • ISO 9000:2005 - covers the basic concepts and language
  • ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective
  • ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

ISO 9001:2008 

(Note : ISO9001:2008 is  superseded by ISO 9001:2015. ISO9001:2008 is concurrently used till changeover. Refer requirements of ISO 9001:2015 given below for any other purpose)

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001 is implemented by over one million companies and organizations in over 170 countries.

Quality Management Principles

The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. The standard is built on 7 solid Principles. They are:-

Principle 1 – Customer focus
Principle 2 – Leadership
Principle 3 – Engagement of people
Principle 4 – Process approach
Principle 5 – Improvement
Principle 6 – Evidencebased decision making
Principle 7 – Relationship management
 

These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

 

The ten clauses of proposed ISO 9001:2015 are:-

 
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 
 

 

What is new in ISO 9001 : 2015?

ISO 9001 is one solid standard that has stood the test of time for 28 years. Being a prescriptive procedural standard when it was born in 1987, it has undrgone a slow but substantial change in 2015. As it stands today, it is no longer prescriptive, but more towards the Principle it espoused in the 2000 version.
The changes  in ISO9001:2015 are considerably more substantial than those produced during the 2008 revision. 
 
1) The standard is rewritten according to the HLS (High Level Structure)
 
 
The new structure is consistent with Appendix SL to the ISO Directives, Part I. With this new common structure, ISO aims to help businesses and organizations more easily integrate all or parts of their various management systems and ultimately achieve a truly unified management system.
 
This consistent common structure makes it easier for companies to include components of other standards that it deems relevant: parts of the environmental standard ISO14001:2015, the asset management standard ISO 55001 and even the future ISO 45001 standard on occupational health and safety management.
 
2) Risk management becomes a foundation of the standard
Risk management based on a “risk-based thinking” approach has become fundamental in the revised standard: risk identification, qualification and management. 
Quality results from proper management of these risks, which go beyond the strict scope of the product or service delivered. Quality cannot exist unless the organization can provide its client a conforming product or service over the long term.
 
Risk has its counterpart: opportunity. The ISO9001:2015 standard also embraces this concept of positive uncertainty.
Of course, risk is an additional concept that in no way supersedes the concept already present in the standard. Risk is incorporated into the fundamentals. As such, the process approach and PDCA remain two essential pillars.
Managing risk also means working towards continuous improvement. Corrective action corresponds to an unidentified, wrongly qualified or mismanaged risk; preventive action addresses a risk of possible but un-occurred noncompliance.
 
3) Leadership
 
The commitment to quality through strong and visible leadership is strengthened:
  • The idea of a “management representative” disappears completely. (Leadership at all levels are Management Representatives of Quality !!!)
  • The quality policy and stated goals must be deeply in keeping with the strategic orientations. (This is where the context of the organization is anchored)
  • QMS requirements must be merged into business processes.
 

4) A standard that is more abstract and open to all Industries ( Particularly Service Industries)

 

The revision of this standard takes into account the evolutions in the way organizations do their business or activities. So far the standard is perceived as drawn up for manufacturing and industrial sectors,  and many organizations from other areas have not looked at it as needed for their own quality management
 
The ISO9001:2015 revision takes these changes into consideration. Its choice of vocabulary and level of abstraction simplify implementation in all industries, including services
 
5) Quality manual, is it needed?!
 
The most  integral part of the ISO standard, will the quality manual disappear?
 
The idea of the quality manual is deeply rooted into the culture of ISO9001 based organization. Slowly but steadily in the near future, there is possibility that the quality manual may disappear.
 
However, that the documentation requirement is still part of the standard. It is still necessary to document, maintain and preserve relevant information. A quality manual therefore remains one possibility for fulfilling this requirement, but not the sole solution.
The purpose of the standard is to take account of technological and societal changes. Information is no longer created, organized, managed, maintained, disseminated and accessed as it was 28 years ago when paper was the primary medium.
This change also allows for greater flexibility in companies’ organization. It is now possible to comply with the standard, as long as the fundamental principles of documentation are respected.
Documents and can be internal in electronic media or external references, as long as managerial ability can be demonstrated.
 
6) Importance of the context surrounding the organization and to its stakeholders
 
Two new clauses (4.1 and 4.2) require greater consideration of the context surrounding the organization. They require a context analysis, as well as the stakeholder identification and the understanding of their expectations. This is just the beginning of stakeholder identification and inclusion towards the journey of sustainability.

 

7) Knowledge is a key resource (So far ISO 9001 considered only Human Resource and Infrastructure are the key resource)

 

In  2015 revision, ISO9001 is once again adapting to its times. Knowledge has become key to successful projects and business development. The new standard considers knowledge like any other resource to be managed:

  • Identify the knowledge necessary to carry out the activity in compliance with the QMS and to achieve the defined objectives. (This may have an impact on the way Comepetence is managed so far)
  • Knowledge must be maintained, protected and made available where necessary. (Knwledge management alters document management significantly)
  • Anticipate changes in knowledge needs and manage the risk of failing to acquire knowledge in due time. (Greater emphasis on knowledge becoming obsolete and may have tobe factored in Risk)
 

 

 

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E-Qual receives appreciation from TI Group

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E-Qual receives appreciation from  Mahindra & Mahindra

for knowledge support in implementing Energy Management System to ISO 50001: 2018 

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"We are extremely delighted to have your consultancy for the successful completion of the process

 

Thank You for all your support and guidance"

 

Regards,

 

MRV Infra Management

E-Qual receives appreciation from Salcomp

We are extremely appreciative of the efforts of Management Consultants  E-Qual. 
 
As implementing partner of Assist, they developed skills,  20 QEHS Champions (Quality, Environmental, Health and Safety ) in our supply chain and bringingout  an excellent QEHS implementation handbook for continued guidance in their day to day implimentation
 
Managing Director

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