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.

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.

ISO/DIS 9001 - LEADERSHIP - Quality Policy, Organizational roles, reponsibilities and authorities

Continued from the last post ....

ISO/DIS 9001 - LEADERSHIP - Quality Policy, Organizational roles, reponsibilities and authorities

Keshav Ram Singhal

Quality policy

Quality policy can be termed as 'intentions and direction of the organization related to quality', as formally expressed by the top management of the organization. As per ISO/DIS 9001 requirements, top management of the organization is required to establish (that is required to set up, install or create), review (determine the suitability, adequacy or effectiveness) and maintain a quality policy for the organization. Such quality policy must be appropriate to the purpose (goals and objectives) and context of the organization. The quality policy of the organization must provide a framework for setting and reviewing objectives related to quality. The quality policy must include a commitment to: (a) satisfy applicable requirements, and (ii) continual improvement of the quality management system.

The quality policy of the organization must be available as documented information (in any format and in any media).It must be communicated and understood within the organization. The employees working in the organization must be aware of the quality policy. The quality policy must be applied within the organization. It should also be available to relevant interested parties, as appropriate.

Organizational roles, responsibilities and authorities

Requirements with regard to organizational roles, responsibilities and authorities are mentioned in clause 5.3 of ISO/DIS 9001. As per requirements of ISO/DIS 9001, it is the responsibility of the top management to ensure (i) assigning and communicating responsibilities and authorities for relevant roles, and (ii) that such assigned duties are understood within the organization.

Accordingly, top management of the organization needs to ensure that everyone in the organization know and understand their responsibilities (what they are expected to do) and their authorities (what they are allowed to do). ISO/DIS does not stipulate the method to be used for communicating responsibilities and authorities, however, there can be several ways, such as organizational structure diagram, function description, job description, flow chart, description in procedures etc.

As per requirements of ISO/DIS 9001, top management of the organization must assign responsibility and authority for the following:
- ensuring: (i) that the quality management system of the organization conforms to ISO/DIS 9001 requirements, (ii) that the processes in the organization deliver their intended outputs, (iii) promotion of customer focus culture throughout the organization, and (iv) maintaining the quality management system integrity at the time of planning and implementing changes to the quality management system.
- reporting quality management system performance, improvement opportunities and need for change or innovation.

ISO 9001:2008 standard specifically mentions requirements for management representative. ISO/DIS 9001 does not now define the term 'management representative', however all the requirements for the role of management representative from ISO 9001:2008 are included in the responsibilities of the top management with some minor changes.

ISO/DIS 9001 - LEADERSHIP

ISO/DIS 9001 - LEADERSHIP

Keshav Ram Singhal

Clause 5 of ISO/DIS 9001 provides requirements related to the leadership. Leaders at all levels in an organization establish unity of purpose and direction of the organization to achieve the purpose. Leaders create suitable environment in which people become fully involved and engaged in achieving organization's quality objectives. Here it is important to note that 'leadership' is one of the quality management principles on which ISO/DIS 9001 is based.
The relevant sub-clauses are as under:
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 authorities

Similar requirements are the part of ISO 9001:2008 standard in clause 5 under the heading 'Management responsibility'.

Leadership and commitment for the quality management system

As per requirements of ISO/DIS 9001, top management of the organization is required to provide evidence of (demonstrate) leadership and commitment with respect to the quality management system of the organization. Accordingly, top management is required to:
- take accountability of the quality management system effectiveness
- ensure: (i) establishing quality policy and quality objectives for the quality management system that are compatible with the strategic direction to which the organization moves and the context of the organization, (ii) communicating, understanding and applying quality policy within the organization, (iii) business processes of the organization are carried out with the integration of the quality management system requirements, (iv) availability of resources needed for the quality management system, (v) quality management system of the organization achieving organization's intended results
- promote: (i) process approach awareness, (ii) continual improvement
- communicate: (i) importance of effective quality management system, (ii) importance of meeting quality management system requirements
- engage, direct and support people to contribute to quality management system effectiveness
- support other relevant management roles

It has been clarified in ISO/DIS 9001 that the term 'business' in ISO/DIS 9001 mean those activities that are core to the purposes of the organization's existence and it applies to the organization that is public, private, for profit or not for profit.

The development of the quality management system of the organization is the responsibility of the top management at the strategic level in the organization. Accordingly, implementation of all requirements of ISO/DIS 9001 is the responsibility of the top management, however, requirements mentioned in clause 5 of ISO/DIS 9001 are indeed the main responsibility of the top management. All requirements in clause 5 commence with the wordings - "Top management shall ...."

Top management of the organization has important and relevant role in implementing quality management system in the organization. Top management is the person or group of people who directs and control the organization. Top management has the power to delegate authority and provide resources within the organization.

Commitments, on the part of the top management, were added in ISO 9001:2000 standard, also retained in ISO 9001:2008 and now part of ISO/DIS 9001, were not mentioned in 1994 versions of ISO 9001/2/3 standards.

Customer focus

Customer focus is one of the quality management principles on which ISO/DIS 9001 is based. The term 'customer focus' with respect to the quality management system means that the organization makes sincere efforts for continual successful relationship with its customers, potential customers and end-users of the product or service that is provided by the organization to meet customer requirements and to strive to exceed customer expectations. A customer is a person or organization that could or does not receive a product or a service, which is intended for or required by this person or organization.

As per ISO/DIS 9001 requirements, top management is required to provide evidence of (demonstrate) leadership and commitment with respect to the customer focus. Top management is required to:
- determining: (i) customer requirements, (ii) applicable legal (statutory and regulatory) requirements, (iii) risks and opportunities (that can affect conformity of products and services, and the ability to enhance customer satisfaction)
- addressing determined risks and opportunities
- meeting determined customer requirements and applicable legal requirements
- maintaining the focus on: (i) consistently providing products and services that meet customer and applicable legal requirements, (ii) enhancing customer satisfaction.

If we carefully look to the ISO/DIS 9001, the whole document addresses the requirements for the quality management system with the aim to achieve customer satisfaction.

... To be continued

PDCA CYCLE

Plan-Do-Check-Act (PDCA) Cycle plays a significant role in implementing QMS. It provides a feedback mechanism for quality improvement. There is a good news that ISO/DIS 9001 has recognized the importance of PDCA in its Para 0.4.

Plan-Do-Check-Act (PDCA) Cycle is a popular tool for implementing ideas or system in a controlled way. This tool is also known as PDCA Cycle , or Deming Cycle. ISO 9001:2008 QMS standard suggests applying PDCA methodology to all processes. When you want to do something, something you wanted to improve, or something wrong you wanted to fix, then PDCA methodology provides you a better solution to achieve your goal.

You should use PDCA methodology:
- when you wish to bring improvement or wish to start a project
- when you wish to develop a new design of process or product
- when you wish to implement any change in your process or product

The four phases in the Plan-Do-Check-Act (PDCA) Cycle involve:
* Plan - Indentifying and analyzing what to do - First you should identify and establish your objectives and processes necessary to deliver your desired results.
* Do - Implement the processes as planned.
* Check - Measuring how effective the implementation has been, and also analyzing whether there could be any improved way. You should measure processes and product.
* Act - Implementing the improved solutions you analyze during the Check

ISO/DIS 9001 includes a figure that shows schematically how a single process within the quality management system can be managed using the PDCA cycle. It states:
- Plan the process - Extent of planning depends on risk
- Do - Carry out the process
- Check - Monitor/measure process performance
- Act - Incorporate improvements as necessary and again move to plan process and so on.

ISO 9001:2008 QMS emphasizes 'continual improvement' and ISO/DIS 9001 has removed the word 'continual' and now the term 'improvement' will include all types of improvements, such as continual improvement, constant improvement, continuous improvement.

With best wishes,

- Keshav Ram Singhal