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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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Monday, June 22, 2015

ISO/DIS 9001 - SUPPORT - Documented information




Keshav Ram Singhal

DOCUMENTED INFORMATION


ISO 9001:2008 QMS standard has its clause 4.2 that describes documentation requirements including general requirements (sub-clause 4.2.1), requirements for quality manual (sub-clause 4.2.2), control of documents (sub-clause 4.2.3) and control of records (sub-clause 4.2.4) and accordingly the standard describes two types of documentation (documents and records). Records are a special types of document and many people confuse between a document and a record. ISO/DIS 9001 attempts to reduce the confusion between a document and a record by introducing a common term 'documented information' and thus the implementation will be more transparent. ISO/DIS 9000:2014 defines documented information as the information (meaningful data) required to be controlled and maintained by an organization and the medium on which it is contained. Documented information can be: (i) in any format, (ii) in any media, and (iii) from any source. Documented information can refer to: (i) the quality management system, (ii) any related processes, (iii) information (meaningful data) relevant for the organization's operation, and (iv) evidence of results achieved.

The terms 'documented procedure' and 'record' (used in ISO 9001:2008 QMS Standard) have both been replaced throughout the requirements text in ISO/DIS 9001 by 'documented information'. Where ISO 9001:2008 QMS standard refers to documented procedure, this now expressed as to maintain documented information in ISO/DIS 9001. Where ISO 9001:2008 QMS standard refers to records, this now expressed as to retain documented information in ISO/DIS 9001.

Clause 7.5 (documented information) of ISO/DIS 9001 has following sub-clauses:
7.5.1 - General
7.5.2 - Creating and updating
7.5.3 - Control of documented information

As per the requirements of ISO/DIS 9001, the quality management system of the organization must include (i) documented information required by ISO/DIS 9001, and (ii) documented information determined by the organization for the organization's effective quality management system.

Documented information required by ISO/DIS 9001

Documented information required by ISO/DIS 9001(with clause number) are given below:

4.3 - Scope of the quality management system mentioning the products and services covered and justification for any instance where any ISO/DIS 9001 requirement cannot be applied

4.4 - (i) Necessary to support the operation of processes, and (ii) to have confidence that the processes are being carried out as planned

5.2 - Quality policy

6.2 - Quality objectives

7.1.5 - (i) Monitoring and measuring resources - evidence of fitness, and (ii) Basis used for calibration or verification where no international or national measurement standard exists

7.2 - Evidence of competence

8.1 - Operation planning and control - (i) Processes are carried out as planned and (ii) Conformity of products and services

8.2.3 - (i) Result of the review of requirements, including any new or changed requirements for the products and services, and (ii) Where requirements for products and services are changed, amendment of relevant document information

8.3.2 - Confirmation that design and development requirements are met

8.3.3 - Design and development inputs

8.3.4 - Design and development control activities

8.3.5 - Results from design and development outputs

8.3.6 - Design and development changes, results of reviews, authorization of changes and the actions taken to prevent adverse effects

8.4.1 - (i) Results of evaluation, (ii) Monitoring of performance, and (iii) Re-evaluation of external providers

8.5.1 - Information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved

8.5.2 - Necessary to maintain traceability

8.5.6 - (i) Results of the review of changes, (ii) Personnel authorizing the change, and (iii) Any necessary action

8.6 - Traceability to the person(s) authorizing release of products and services for delivering to the customer

8.7 - (i) Action taken on nonconforming process outputs, products and services, (ii) Any concession obtained, and (iii) Person or authority that made the decision regarding dealing with the nonconformity

9.1.1 - Evidence of results in monitoring, measurement, analysis and evaluation

9.2 - (i0 Evidence of the implementation of the internal audit programme, and (ii) Internal audit results

9.3 - Evidence of the results of management review

10.2 - Evidence of (i) nature of nonconformities and subsequent actions , and (ii) Results of any corrective action


Although ISO/DIS 9001 does not mention the requirement to have documented information for the following, however, it would be better in the opinion of the author of this article if the organization determines to have documented information for the following:

5.3 - Organizational roles, responsibilities and authorities

6.1 - Actions to address risks and opportunities

8.3.4 - Clearly defining the results to be achieved by the design and development activities

- To be continued ....

Wednesday, June 17, 2015

ISO/FDIS 9001:2015 EXPECTED SOON



As per the latest information, the Final Draft International Standard (FDIS) for forthcoming ISO 9001:2015 QMS standard is expected to be issued in July 2015.

More information/relevant articles may be seen in this blog.

- Keshav Ram Singhal

Thursday, May 28, 2015

ISO/DIS 9001 - SUPPORT - Competence, Awareness and Communication



ISO/DIS 9001 - SUPPORT - Competence, Awareness and Communication

Keshav Ram Singhal



COMPETENCE

Competence is defined as the ability to apply knowledge (available collection of information, i.e. meaningful data being a justified belief and having a high certainty to be true) and skills to achieve desired outputs or intended results. When competence is demonstrated, it sometimes referred to as qualification. Competence is a standardized requirement for an individual to properly perform a specific job. It encompasses a combination of knowledge, skills and behaviour to improve performance. Competence can be measured by the achievement of results.

Clause 7.2 of ISO/DIS 9001 deals with the requirements for competence. As per requirements, the organization is required to: (i) determine the necessary competence of people, who work under organization's control and whose work affects quality performance of the organization, (ii) ensure that the people working in the organization are competent on the basis of appropriate education, training or experience, and (iii) retain documented information as evidence of competence. Where there is need to acquire the necessary competence, the organization is required to take actions (such as providing training, mentoring of people, reassignment of people, hiring, contracting of competent persons) to acquire the necessary competence and evaluate the effectiveness of actions taken. It should be noted that the documented information should provide information on (i) determined necessary competence, and (ii) competence of people.

AWARENESS

Awareness is common knowledge or understanding about any issue and training is a way to foster awareness and competence. Organizations need to check their employees' competence, awareness and training regularly.

Clause 7.3 of ISO/DIS deals with the requirements of awareness. As per the requirements, people working in organization (for example - employees, contract workers, contractors) must be aware of the (i) quality policy of the organization, (ii) relevant quality objectives established at relevant functions, levels and processes, (iii) their individual contribution to the effectiveness (i.e. successful in achieving the desired results) of the quality management system, (iv) benefits of improved quality performance (action or process of performing a task). and (v) implications (conclusions that can be drawn) of non-conformance (non fulfillment) of requirements.

How to improve competence and awareness?

Organizations can compare the current competence of the people, working in the organization, against what they require. This may be termed as 'awareness and competence gap analysis'. The gaps determined should be filled through training or by acquiring additional awareness and competence. Training may be at the actual workplace (as on the job training), in-house or at some external location. It is not sufficient to just provide (and record) training, the organization must evaluate it.


COMMUNICATION

Effective communication is significant in an organization to perform its planning and functioning in a systematic way. Communication helps employees to perform their jobs and responsibilities. It serves as a foundation for planning. Communication promotes motivation. It is a source of information and information is very essential for every organization. In brief, we can say that communication (i) establishes effective leadership, (ii) helps toward motivation and morale development, (iii) helps in smooth working, (iv) promotes cooperation among people and teams, (v) acts as a basis of coordination and cooperation, (vi) acts as a basis for decision making, and (vii) increases managerial and employees efficiency.

Clause 7.4 of ISO/DIS 9001 deals with the requirements of communication. As per ISO/DIS 9001, the organization needs to determine appropriate (suitable and proper) internal and external communication processes relevant to the quality management system of the organization by determining the following:
- Contents of the communication
- Time of the communication
- Receivers of the communication
- Mechanisms of the communication

Although ISO/DIS 9001 states to determine 3Ws1H (What, When, Whom and How) with regard to communication, however we suggest to determine the following 2Ws (where to communicate and why to communicate) also, so that your communication becomes significant, effective and purposeful.

ISO 9001:2008 QMS standard has two clauses relevant to communication:
Clause 5.5.3 - Internal communication
Clause 7.2.3 - Customer communication

Customer communication is a part of external communication, and now ISO/DIS 9001 has one clause (titled communication) instead of two (titled internal communication and customer communication) as in ISO 9001:2008 QMS standard.

Mechanism of communication may include periodic meetings, email,, bulletin boards, suggestion boxes, circulars, product information brochures, catalogues, specifications, information etc.

To be continued ....


Tuesday, May 5, 2015

ISO/DIS 9001 - SUPPORT




Keshav Ram Singhal

Clause 7 of ISO/DIS 9001 provides requirements related to support. It includes requirements related to resources (including human resources, infrastructure, environment for the operation of processes, monitoring and measurement resources, organizational knowledge), competence, awareness, communication and documented information. More or less similar requirements under the heading 'Resource management' are mentioned in clause 6 of ISO 9001:2008 QMS standard. Documentation requirements of clause 4.2 of ISO 9001:2008 QMS standard are now part of the support requirements in clause 7.5 of ISO/DIS 9001.

Clause 7 of ISO/DIS 9001 now deals with support requirements, whose relevant sub-clauses are as under:

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 - Documented information
7.4.1 - General
7.4.2 - Creating and updating
7.4.3 - Control of documented information

RESOURCES

Clause7.1 of ISO/DIS 9001 deals with the requirements of resources needed for the quality management system. As per requirements, the organization is required to determine and provide the resources (such as people, infrastructure, environment, monitoring and measuring resources, organizational knowledge) needed for implementing, maintaining and continually improving the quality management system of the organization. The organization needs to consider:
- the capabilities of existing internal resources available in the organization,
- the constraints on existing internal resources, and
- resources needs to be sourced from external providers.

The organization needs to ensure to consistently meet customer and applicable legal (statutory and regulatory) requirements to achieve conformity of products and services for which the organization is required to provide:
(i) competent persons for effective operation of the quality management system including the processes needed for the quality management system,
(ii) infrastructure for the operation of processes,
(iii) environment (including physical, social, psychological, environmental and other factors such as temperature, humidity, ergonomics and cleanliness) necessary for the operation of the processes,
(iv) monitoring and measuring resources to ensure valid and reliable results.

Infrastructure needed may include:
- buildings and associated utilities,
- hardware and software equipments,
- transportation,
- information and communication technology.

Evidence of conformity of products and services to specified requirements are essential for a robust quality management system for which there are instances where monitoring and measuring resources are used for collection the evidence of conformity of products and services to specified requirements. In such instances the organization needs to determine the resources needed (such as monitoring and/or measuring equipments) to ensure valid and reliable monitoring and measuring results. The organization needs to ensure that the monitoring and measuring resources are suitable and fit (useful) for the purpose they are being used and the organization needs to retain appropriate documented information as evidence of fitness of such resources.

There may be instances where measurement traceability (history) may be a legal (statutory or regulatory) requirement, customer expectation, relevant interested party expectation or organization's consideration to be necessary of providing confidence in the measurement results' validity. In such instances the organization must (i) verify or calibrate the measuring instruments at specified intervals or prior to use against national or international measurement standards, or where no national/international standard exists, retain as documented information the basis used for calibration or verification, (ii) identify the measuring instrument in order to determine its calibration status, (iii) safeguard from adjustments, damage or deterioration that may invalidate calibration status or measurement results.

The organization must: (i) determine if the validity of previously measurement results has been adversely affected, (ii) determine when a monitoring/measuring instrument is found to be defective during its planned verification or calibration or during its use, and (iii) take appropriate corrective action as required.

ISO/DIS 9001 has included new requirements related to organizational knowledge. As a resource, organizational knowledge (such as information on intellectual property and lessons learned) may be necessary for the operation of organization's processes and to achieve conformity of products and services to specified requirements, for which the organization is required to: (i) determine the knowledge, (ii) determine ways or methods to acquire or access the necessary additional knowledge, (iii) maintain the knowledge, (iv) make available the knowledge to the extent necessary, and (v) consider its current knowledge when addressing changing needs and trends.

When team knowledge from several subunits, departments or groups of an organization is combined and used to create new knowledge, the resulting knowledge can be called organizational knowledge.

The organization is required to:
- determine the knowledge necessary for the operation of organization's processes and to achieve conformity of products and services to requirements,
- maintain the knowledge, and
- make available the knowledge to the extent necessary.

When addressing changing needs and trends, there is a need to acquire or access the additional knowledge for which the organization needs to consider the organization's current knowledge and determine the ways to acquire or access the necessary additional knowledge. The organization can consider internal and external sources. Internal sources may include learning within the organization from failures and successes, capturing knowledge that is not documented and experience of local experts. External sources may include standards, academic references, conferences, knowledge from customers or others, such as suppliers, providers.

To be continued ....


Monday, April 13, 2015

Transition Planning for ISO 9001:2015



Transition planning guidance document, prepared by the International Accreditation Forum (IAF) in cooperation with ISO/TC 176/SC 2/WG 23, has been published by the International Accreditation Forum (IAF) that provides guidance for the transition from ISO 9001:2008 to ISO 9001:2015. This document can be seen at IAF website at http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf.

According to a IAF resolution 2013-15 passed by the IAF General Assembly in Seoul (South Korea) on 23 October 2013, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three year transition period from the publication date of ISO 9001:2015 standard. ISO 9001:2015 standard is expected to be published in the last quarter of 2015.

ISO 9001:2008 certifications will not be valid after three years from the publication date of ISO 9001:2015 standard.

The guidance document provides specific guidance for interested parties involved in certification and accreditation services. According to the guidance document, for any organization the degree of change necessary will be dependent upon maturity and effectiveness of the current management system, organizational structure and practices, therefore an impact analysis / gap assessment is strongly recommeded in order to identify realistic resources and time implications.

The IAF document also provides guidance to organizations implementing ISO 9001:2008 QMS standard. The document recommends to take following actions by the organizations implementing ISO 9001:2008 QMS standard:

- Identify organizational gaps which needs to be addressed to meet new requirements of ISO 9001:2015
- Develop an implementation plan for ISO 9001:2015 implementation in the organization
- Provide appropriate training and awareness for all parties that have an impact on the organization's effectiveness
- Update the existing quality management system of the organization to meet the revised requirements and provide verification of effectiveness
- Liaise with certification body for transition arrangements, where applicable (i.e. where the organization seeks certification).

It has been suggested that preparation can be carried out at the DIS stage, however significant changes should not be implemented until the Final Draft International Standard (FDIS) to ISO 9001:2015 is issued and the technical content of the forthcoming standard is finalised.

The editor of this blog has designed a awareness training. Those interested, in 'Forthcoming ISO 9001:2015 QMS Awareness Training' in Ajmer, Ahmedabad, Bangalore and Goa, may contact by sending an email mentioning proposed date of training and number of participants.

- Keshav Ram Singhal



Friday, March 6, 2015

ASK YOUR QUESTIONS ON FORTHCOMING ISO 9001:2015 QMS





If you have any questions on Forthcoming ISO 9001:2015 QMS, please ask the same.

We wish to make this blog as a resource for information and awareness on ISO 9001:2015 QMS.

Best wishes,

Keshav Ram Singhal

Sunday, March 1, 2015

ISO/DIS 9001 - Quality Management Principles



ISO/DIS 9001 - Quality Management Principles

Keshav Ram Singhal

A quality management principle is a comprehensive and fundamental belief, for leading and operating an organization, aimed at improving performance on a long-term by focusing on customers while addressing needs of all other stakeholders. The revision and development of ISO 9001 and ISO 9004 standards in the year 2000 had been on the basis of eight quality management principles, namely - (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. ISO 9001:2008 and ISO 9004:2009 standards were also revised, updated and developed on the basis of these eight quality management principles.

The development of forthcoming ISO 9001:2015 standard is being carried out on the basis of seven quality management principles. We observe that quality management principles have been reduced from eight to seven, namely - (i) Customer focus, (ii) Leadership, (iii) Engagement of people, (iv) Process approach, (v) Improvement, (vi) Evidence-based decision making, and (vii) Relationship management.

From the change, we find the following:
- The principle 'involvement of people' is now 'engagement of people'. It is an editorial change, no change in the concept or belief.
- The word 'continual' is dropped and the principle 'continual improvement' is now 'improvement'. The new term has the wider meaning and 'improvement' now includes all types of improvement, such as, continual improvement, continuous improvement, constant improvement.
- The principle 'system approach to management' does not appear. 'Process approach' in fact includes the system approach. Quality management system of an organization is composed of interrelated processes and interrelated processes function as a coherent system.
- The principle 'factual approach to decision making' is now 'evidence-based decision making'. It is also an editorial change, no change in the concept or belief.
- The principle 'mutually beneficial supplier relationship' is changed to 'relationship management'. Earlier principle values relationship between the organization and its suppliers. Now the scope of the principle is widened by 'relationship management' that now covers relationship of the organization with all interested parties including its suppliers.

The seven quality management principles are described below.

1st Principle - Customer focus

An organization always depends on its customers. The primary focus of the quality management system is to meet customer requirements and to strive to exceed customer expectations.

Quality is a moving target that is defined and judged by customers of the organization. Sustained success of an organization depends on attracting and retaining the confidence of customers and other interested parties. Customer interaction and customer feedback provide opportunity to an organization to create more value for the customer. Therefore an organization should:
- understand current and future needs (and expectations) for products and services including delivery, price, dependability etc.
- ensure a balanced approach, create awareness and communicate customer requirements throughout the organization
- meet customer requirements
- strive to exceed customer expectations
- monitor customer perceptions and obtain information relating to customer views and opinions

By understanding current and future needs (and expectations), meeting customer requirements, exceeding customer expectations, monitoring customer perceptions and obtaining information relating to customer views and opinions, an organization becomes a customer focused organization. By monitoring customer perceptions and listening to the 'voice of the customer', the organization gets valuable information and inputs to drive improvement initiatives.

Benefits that may be derived from the use of 'customer focus' principle include:
- Increased business
- Increased market share
- enhanced customer satisfaction
- repeat business

2nd Principle - Leadership

Leaders establish unity of purpose, direction and engagement of people in the organization that align organization's strategies, policies, processes in achieving quality objectives. Leaders focus on communication by listening to the people and defines a strategic plan or direction of the organization. Leaders help people to work in a team.

Leaders in an organization should create and maintain the internal environment in which people can fully engage themselves to achieve organization's quality objectives. For this top management of the organization needs to play leadership role through its commitment, action and communication. They should communicate to the people in the organization the importance of meeting requirements. They need to establish quality policy, ensure ensuring establishing quality objectives at relevant functions, levels and processes, ensure availability of resources and conduct management reviews.

The leaders of the organization should:
- be proactive,
- understand and respect to changes that are visible in the industry environment,
- establish clear vision of the organization,
- build trust, eliminate fear and motivate people.

Benefits that may be derived from the use of 'leadership' principle include:
- Employee's motivation towards organization's goals and objectives
- Better understanding of organization's objectives
- Better communication within the organization

3rd Principle - Engagement of people

There are various activities in an organization that are performed by the people. People at all levels are essence of an organization. Without engagement of people, nothing can be achieved. People of the organization need to be competent. They should be empowered and engaged in delivering value. Their engagement at all levels in the organization enable their abilities to be used for the organization's benefits.
Top management of the organization should make sincere efforts to maximize engagement of people in the organization by taking steps to empower and motivate them and by providing ways to increase their skills and knowledge. If people of the organization are competent, empowered and engaged throughout, it will enhance organization's capability to create value and achieve its objectives.

Benefits that may be derived from the use of 'engagement of people' principle include:
- Motivation and commitment of people
- Involvement and engagement of people at all levels
- Innovation and creativity of employees
- Employee's participation and contribution for improvement

4th Principle - Process Approach

A desired output (consistent and predictable result) can be achieved more efficiently when all related resources and activities are understood and managed as a coherent system that functions as interrelated processes.

ISO/DIS 9001 promotes the adoption of a process approach. It is the intention of ISO/DIS 9001 that the organization must adopt process approach when developing, implementing and improving the effectiveness of its quality management system. The main objective behind adoption of process approach is to enhance customer satisfaction by meeting customer requirements.

To function effectively and efficiently, an organization has to determine and manage numerous linked activities. What is a process? An activity that comprises set of interrelated or interacting activities which transform inputs into outputs can be termed as a process. In organization's activities, output from one process can form the input to the next process. The application of a system of processes within an organization can be said the 'process approach'. Process approach requires determination of processes, interaction of determined processes and their management. Management of determined processes and the system as a whole can be achieved using a PDCA methodology with an overall focus on 'risk based thinking'. Risk based thinking helps at preventing undesirable outputs.

Process approach is helpful in ensuring: understanding and consistently meeting requirements, consideration of processes in terms of added value, the achievement of effective process performance, and improvement of processes based on evaluation of data and information.

Benefits that may be derived from use of 'process approach' principle include:
- Effective use of resources
- Lower cost
- Shorter cycle times
- Improved, consistent and desired outputs

5th Principle - Improvement

Improvement is the process of a thing or system changing or moving from one state to another state considered to be better from the first state, usually through some action intended to bring about that better state. The concept of improvement is important to organizations as well as to individuals.

Successful organizations have all time continual focus on improvement. Improvement is essential for every organization to be successful to maintain its level of performance, to react to changes in its conditions (internal and external) and to create new opportunities.

Improvement is necessary for growth and success of an organization. Clause 10 of ISO/DIS 9001 specifically mentions requirements for improvement.

Benefits that may be derived from use of 'improvement' principle include:
- Performance advantage
- Improvements
- Alignment of improvement activities
- Consistent growth

6th Principle - Evidence-based Decision Making

Desired results or intended outputs are likely to be obtained when decisions based on analysis and evaluation of data and information are taken. Decision making becomes easier if there is analysis and evaluation of data and information.

Decision making always involves some uncertainty, so it can be termed as a complex process. There are multiple sources of information, multiple sources of inputs and a number of interpretations that can lead to a subjective decision. It is always better to have an evidence-based decision making as facts, evidence and analysis of data and informationb lead to greater objectivity and confidence in decision making.

Proper use of statistical techniques will ease analysis of data and information that will lead to evidence-based decision making. Decisions taken based on analysis of data and information will lead to the right path for consistent improvement of the organization's system including processes and resulting product and services.

In India and also in other countries, it is seen that large and medium-sized organizations are using statistical tools, however there is a need to increase awareness for using statistical tools among people working in small-scale industry.

Benefits that may be derived from use of 'evidence-based decision making' principle include:
- Increased ability to have decision based on analysis
- Increased ability to review, challenge and change opinions and decisions
- Improvement in the system

7th Principle - Relationship Management

An organization and its interested parties (such as suppliers) are interdependent. Interested party or parties can affect a decision or activity of an organization. And also interested party or parties can be affected by a decision or activity of an organization. Interested parties can influence the performance of an organization. A mutually beneficial relationship between the organization and its interested parties (such as suppliers) enhance the ability to both to create value to each other.

To get maximum benefits of relationship management on organization's performance, it is necessary for the organization to manage its relationship with interested parties, such as suppliers, partner network.

Benefits that may be derived from use of 'relationship management' principle include:
- Increased ability to create value for the organizationand its interested parties
- Optimization of resources
- Long-term benefits


Monday, February 16, 2015

Forthcoming ISO 9001:2015 QMS - What Should We Do Now?



Forthcoming ISO 9001:2015 QMS - What Should We Do Now?

Keshav Ram Singhal

We know that ISO 9001:2008 QMS standard is undergoing revision process. ISO 9001 revision is currently at the Final Draft International Stage (FDIS), the fifth stage of the six stage process of ISO 9001 revision. The forthcoming standard is likely to be published in the last quarter of 2015, however many people may ask you -"What should we do now?"

People, particularly involved in quality management system implementation, should be careful of the changes in the QMS standard. There have been lot of discussions over the forthcoming changes that are available on internet. Many articles have been published on internet. People can carefully watch and read such discussions and articles. A number of websites/blogs are providing information on forthcoming standard. In this connection, website of 'International Organization for Standardization', who are the developer of the standard, is the prime source providing authentic information on forthcoming standard. Information on 'ISO 9001 Quality Management System's Revision' can be seen at http://www.iso.org/iso/iso9001_revision. International Organization for Standardization (ISO) has published a news-article 'ISO 9001 revision moves on to final stage' by Maria Lazarte on its website at http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1905, which provides current status of the revision process.

The author of this article is involved in creating awareness on quality management system and his blogs 'Quality Concepts and ISO 9001:2008 QMS Awareness' and 'Forthcoming ISO 9001:2015 QMS Awareness' can be useful sources of information providing academic interest articles. These blogs are being visited and appreciated by people world over.

There is enough time for the publication of forthcoming standard. Denise E. Robitaille (a member of the U.S.TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards) says, "The standard is still on track to be issued before the end of 2015. In the meantime, it's a bad idea to jump the gun and start making changes in anticipation of the standard - that is, in most instances. Organizations should be wary of the changes in the standard that suggest that requirements, for example, for the quality manual and documented procedures are going away. That may indeed be the case, but any action on this and several other changes would be premature and might end up causing additional work and unnecessary confusion." (Source - http://www.qualitydigest.com/inside/quality-insider-article/iso-9001-2015-things-you-can-do-now.html)

Therefore, it is suggested not to make any changes in your QMS documentation on the basis of forthcoming revision. However, you should be ready to prepare yourself to carry out revision in your quality management system:
- Think and understand issues related to the context of the organization
- Think and understand issues related to the introduction of risk-based thinking
- Think how you can incorporate addition of requirements relating to responsibility, taking action, monitoring, and revising quality objectives
- Read relevant articles, visit relevant websites/blogs
- Undertake relevant training
- Understand the transition period for implementing the new standard.

At this moment, when there is enough time in publication of ISO 9001:2015 QMS standard, any changes to the quality management system on the basis of ISO/DIS 9001 or ISO/FDIS 9001 is not suggested and it is better to wait till ISO 9001:2015 QMS standard is published.

ISO/DIS 9001 - PLANNING FOR THE QUALITY MANAGEMENT SYSTEM - Quality objectives, planning to achieve them, planning of changes



Continued from the last post .....

ISO/DIS 9001 - PLANNING FOR THE QUALITY MANAGEMENT SYSTEM - Quality objectives, planning to achieve them, planning of changes

Keshav Ram Singhal

Quality objectives and planning to achieve them

As per the requirements of ISO/DIS 9001, the organization is required to establish (set up, install or create) quality objectives at relevant functions, levels and processes, and such objectives must consider applicable requirements and must also be: (i) consistent with the quality policy, (ii) measurable, (iii) relevant to conformity of products and services, (iv) relevant to the enhancement of customer satisfaction, (v) monitored, (vi) communicated, and (vii) updated, as appropriate. The organization is also required to retain documented information on quality objectives.

As per requirements of ISO/DIS 9001, to achieve the quality objectives, the organization is required to determine:
- ways, procedures or processes,
- resources needed,
- responsible personnel,
- completion time,
- ways, procedures or processes to evaluate results.

Quality objectives are the basis of improvement and growth of the organization. Quality objectives must be in line with the quality policy of the organization. These should be measurable, so that organization's performance can be evaluated. The quality objectives must be appropriate or closely connected to conformity of products and services and also to the customer satisfaction enhancement. The organization must observe and check the progress of quality objectives over a period of time. There must be a systematic review of quality objectives and updated, as appropriate. Quality objectives must be communicated within the organization, so that the responsible personnel can take appropriate actions. It would be better if SMART (Specific, Measureable, Achievable, Realistic and Time-bound) quality objectives are set and regularly monitored. An organization can define in process monitoring and output measures. In this regard, following action plan can be useful:
- Establish quality objectives at relevant functions, levels and processes
- Ensure that quality objectives are consistent with quality policy, measurable and relevant to conformity of products and services as well as to the customer satisfaction
- Determine ways, procedures or processes to achieve the quality objectives, resource needs, responsible personnel, completion time and procedures to evaluate results
- Communicate within the organization established quality objectives, monitoring and evaluating methods
- Update, as appropriate, quality objectives from time to time
- Monitor and evaluate quality objectives as per determined procedure

Planning of changes

Monitoring quality management system performance may provide opportunities for improvement, change or innovation and whenever it is established the need for change to the quality management system, the organization is required to carry out the same in a planned and systematic manner. In this regard, the organization must consider: (i) the purpose of change and any of its potential consequences, (ii) quality management system's integrity, (iii) available resources, and (iv) the allocation/reallocation of responsibilities and authorities.

Sunday, February 15, 2015

ISO/DIS 9001 - PLANNING FOR THE QUALITY MANAGEMENT SYSTEM - Actions to address risks and opportunities



ISO/DIS 9001 - PLANNING FOR THE QUALITY MANAGEMENT SYSTEM - Actions to address risks and opportunities

Keshav Ram Singhal

Clause 6 of ISO/DIS 9001 deals with the requirements related to planning for the quality management system. ISO/DIS 9001 broadly follows the PDCA cycle and this clause is the part of its first action 'plan.'

The relevant sub-clauses are as under:

6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

Actions to address risks and opportunities

This is a new clause in ISO/DIS 9001, which is not a part of ISO 9001:2008 QMS standard. As per requirements of ISO/DIS 9001, the organization is required to consider (i) issues related to the understanding the organization and its context, and (ii)requirements related to the understanding the needs and expectations of interested parties. In this connection, please refer to the relevant portion of the previous article 'ISO/DIS 9001 - Context of the organization'. The organization needs to determine the risks and opportunities, that (i) provide assurance of quality management system achieving intended results, (ii) prevent/reduce undesired effects (happenings), and (iii) achieve continual improvement.

The organization is required to plan:
- actions to address determined risks and opportunities,
- procedures to integrate and implement actions into the processes of the quality management system, and
- procedures to evaluate the effectiveness of the actions taken.

Actions, to address risks and opportunities taken by the organization, must be proportionate to the potential impact on the conformity of products and services.

There can be various options to address risks and opportunities and that can include:
- avoiding risk
- converting the risk into an opportunity
- eliminating the risk source
- changing the likelihood or consequences
- sharing the risk
- retaining risk by informed decision

While going through the recent changes in ISO/DIS 9001, we should note that these new requirements will influence organizations worldwide. A risk-based approach to the quality management system will now influence the success of the quality management system of an organization. Risk-based approach will now assist an organization in building and operating safety margins within its quality management system. Understanding organizational context and risks is helpful for an organization for its preparation t pursue, retain or take the amount and type of risk. It is very important to understand risk sources. A risk source is an element, which alone or in combination of other risk source(s), has the intrinsic potential to give rise to risk, where 'risk' is 'uncertainty in achieving objectives'. A risk source in an organization could vary and affect organization's objectives.

In a manufacturing organization considering an objective related to conformity of product quality, the typical examples of risk sources could be purchasing process, manufacturing process, measurement process, competence of people, technology, methods, machines, work environment etc.