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Welcome!
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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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Saturday, September 26, 2015

TRAINING ON 'ISO 9001:2015 QMS AWARENESS'



AN OPPORTUNITY TO LEARN AND UPDATE YOUR KNOWLEDGE
ON
'ISO 9001:2015 QMS AWARENESS'




LEARNING OBJECTIVES


UNDERSTAND THE IMPACTS OF NEW STANDARD ON YOUR QMS

After attending the training you will be able to understand KEY CHANGES that affect your organization and your quality management system implementation, including the following -
• Structure and terminology
• Context of the organization
• Risk-based thinking
• Knowledge management
• Role of top management
• Management representative's role?
• Documentation impact and requirements for documented information
• Internal audit
• Understanding ISO 9001:2015 QMS requirements
• Transition planning guidance
• Implementation Guidance


WHY SHOULD YOU ATTEND?


ISO 9001:2008 QMS certified organizations are required to comply with major change to ISO 9001:2015 QMS standard. Understanding what is different is the first step in implementing the revised standard. You will require to ensure that the requirements mentioned in ISO 9001:2015 QMS standard are implemented in your organization before recertification.


WHO SHOULD ATTEND?


• Top, middle and junior management executives
• Personnel involved in QMS implementation
• Internal auditor
• Any individual


TRAINER

Keshav Ram Singhal

You will learn from an expert professional and well known writer, who will help you understand the changes and what they mean to you and your organization.

Click Here for Trainer's Profile.

Click Here for his blog on 'Quality Concepts and ISO 9001:2008 QMS Awareness' - Total hits more than 275,000.

Click Here for his blog on 'Quality Concepts and ISO 9001:2015 QMS Awareness' - Total hits more than 4,500.



MODES OF TRAINING


Face-to-face Training
One day duration
For Single Participant
Participant can visit Ajmer with prior appointment.

Group Training
One day duration
For a group consisting 2 to10 participants
Interested participants can visit Ajmer with prior appointment.

In-house Training
One day duration
At Your Place
Sponsoring organization can call the trainer to conduct training programme.
Sponsoring organization needs to arrange venue, photocopy facility and also staying arrangement for the faculty.

Distance Training (To be commenced from 13 October 2015)
For people interested to learn at their home. The learner can study and learn whenever he wants, wherever he wants. Training material and assignments will be sent by email. Learning registration will be valid for one month.

Certificate will be provided to successful candidates after evaluation.
New skills and knowledge makes a learner more valuable.
Contact by email with your requirements and learner's details to:
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com


Wednesday, September 23, 2015

Name of the Blog Changed



Name of the Blog Changed

International Organization for Standardization (ISO) has since published ISO 9001:2015 QMS standard on 23 September 2015, I have also changed the name of this blog from 'Forthcoming ISO 9001:2015 QMS Awareness' to 'Quality Concepts and ISO 9001:2015 QMS Awareness'.

We hope readers will patronize my efforts of creating awareness. Please share this information on social media (Facebook, Linkedin, etc.), so that more people may know about this blog.

With best wishes,

Keshav Ram Singhal

NEW VERSION 'ISO9001:2015 QMS' STANDARD HAS BEEN PUBLISHED


NEW VERSION 'ISO9001:2015 QMS' STANDARD HAS BEEN PUBLISHED

Please refer to our earlier news mentioning. "As per the latest information, forthcoming ISO 9001:2015 QMS standard has almost come to a conclusion and has been approved for publication. It is expected that the forthcoming standard will be published on 23 September 2015." Click Here for the earlier news link

As per the news from International Organization for Standardization (ISO), the latest edition of ISO 9001 quality management system standard has been published on 23 September 2015.

ISO 9001 revision work by experts from nearly 95 participating and observing countries took over three years time to revise the standard in the present new version - ISO 9001:2015 QMS standard.

More than 1.1 million organizations worldwide have implemented ISO 9001 QMS and obtained certification to its conformance.

The new version, ISO 9001:2015 QMS standard, follows a new, higher level structure to make this standard easier to use in conjunction with other management system standards (such as ISO 14001 EMS etc.), with increased importance to risk-based thinking and understanding the needs and expectations of interested parties.

- Keshav Ram Singhal

Saturday, September 19, 2015

Forthcoming ISO 9001:2015 QMS - OPERATION - Requirements for products and services - Determination and review of requirements



Click Here for the article on " ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication"


Forthcoming ISO 9001:2015 QMS - OPERATION - Requirements for products and services - Determination and review of requirements

Keshav Ram Singhal

Clause 8.2.2 requires determining requirements and clause 8.2.3 requires reviewing requirements related to products and services.

Ensure to define:
- Requirements for product and services
- Applicable legal requirements
- Requirements considered necessary

Review (before committing to supply product/service to the customer)
- Requirements specified by the customer
- Requirements for delivery and post-delivery
- Requirements necessary for specified and intended use
- Requirements determined by the organization
- Legal requirements applicable to product/service
- Contract/order requirements changed/differed from previously communicated

Ensure
- To meet claims offered for products and services
- Organization has ability to meet the requirements
- Resolving contract/order requirements changed/differed from previously expressed
- Confirming customer's requirements before acceptance, when customer not providing documented statement of his requirements.

Retain documented information (as applicable)
- Results of review
- Any new requirements for the product/service

Friday, September 18, 2015

Certification Bodies



Certification Bodies Operating in India and Neighbouring Countries

The editor of this blog is collecting details of certification bodies operating in India and Neighbouring Countries. Please send details (name, address, email, website, etc.) by email to:
keshavsinghalajmer@gmail.com
or
krsinghal@rediffmail.com.

Thanks,

Keshav Ram Singhal

Developing and Implementing Forthcoming ISO 9001:2015 QMS ...


Keshav Ram Singhal

From the last post .... - Last post link

Step 5 - Appointing a QMS consultant

A quality management system consultant is a person who assist the organization on quality management system realization, giving advice or information. Appointing a consultant is not a requirement. It is not necessary appointing a consultant, however, appointing a consultant may be a worthwhile investment. A good consultant effects speedy transfer of knowledge and skills to the organization and he may be needed to provide timely guidance to keep the ISO 9001:2015 QMS implementation programme on track. Consultant provides the people power to complete the work when needed, at reasonable cost. Steering committee or top management of the organization should determine whether a consultant is required.

There are five general reasons to hire and appoint consultants:
(i) Consultants have appropriate experience, expertise and time that employees may not. An organization turns to a consultant to fill knowledge and time gaps.
(ii) Consultants provide flexibility of time. Consultants work any time - including nights, weekends and holidays. They leave when the project is completed.
(iii) Consultants offer the latest and objective point of view. Consultants bring the latest and unbiased ideas from their vide experiences.
(iv) Consultants are more efficient and they focus on assigned project with sincerity.
(v) Consultants may be proof of honest endeavour. Organizations may use consultants to show that an effort is being made to correct gaps in compliance with regulations.

Thus, a consultant may be an important resource to assist and guide an organization in developing, implementing and maintaining ISO9001:2015 QMS and getting its certification from an accredited certification body. However, it is essential, before appointing a consultant, to check their competence, education, knowledge and skills with regard to ISO 9000 series and ISO 9001:2015 QMS. He should be well aware of certification and accreditation systems. Costs are an important consideration in deciding to engage a consultant, therefore, the organization should obtain quotations from several consultants. However, please note that the cheapest consultant may not always be the best. Emphasis should on consultant's qualifications, knowledge and experience.

It is necessary to establish what the consultant is expected to do and what the organization people are expected to do or provide. Hiring, engaging or appointing a consultant should not be regarded as an exercise in shifting the responsibility for establishing and maintaining the quality management system to someone else.

International Organization for Standardization (ISO) has published a standard ISO 10019: 2005, which provides guidelines for the selection of quality management consultants and use of their services. Organizations may refer to this standard for detailed guidance.

Step 6 - Obtaining Information about QMS and ISO 9000 Family

The organization should collect information about quality management system and ISO 9000 family. If the organization has appointed a consultant, then it will be easier for the organization. For general information on quality management system, ISO's website is a useful source from which ISO's brochure 'Selection and use of the ISO 9000 family of standards' can be downloaded. Please refer to the link http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm. The organization should download relevant and supporting information from following websites:
- ISO website - http://www.iso.org
- IAF website - http://www.iaf.nu
- ISO TC 176 website - http://isotc.iso.org/livelink/livelink/open/tc176SC2public

The organization should also obtain relevant information from other websites and blogs. The organization should also purchase the following:
- ISO 9000:2015, Quality management system, Fundamentals and vocabulary
- ISO 9001:2015, Quality management system, Requirements
- ISO 9004:2009, Managing for the sustained success of an organization, A quality management approach
- ISO 19011:2011, Guidelines on auditing management systems
- Various other publications and literature providing knowledge on ISO 9001:2015 QMS and related issues


Step 7 - Start 'ISO 9001:2015 QMS Awareness' Programme

The organization should organize 'ISO 9001:2015 QMS Awareness' programme to communicate to the employees: (i) the aim of ISO 9001:2015 QMS, (ii) the advantages quality management system offers to employees, customers and the organization, (iii) how the quality management system will work, and (iv) employees' roles and responsibilities within the system.

This programme can be conducted by a personnel, who is well aware of ISO 9001:2015 QMS standard, an outside consultant or a trainer to talk to different levels of employees. For general awareness, the duration of such programme may be four hours.


Step 8 - Formulate an Action Plan

An action plan should be formulated for the implementation of ISO 9001:2015 quality management system. The action plan should (i) define the responsibilities of different departments and personnel, and (ii) set target dates for the completion of different activities. The following activities can be included in the action plan:
- Establishing steering committee
- Establishing task force
- Assigning responsibilities and authorities
- Appointing a consultant
- Obtaining information about QMS and ISO 9000 Family
- Purchase of standards, books and literature
- Awareness programme: Top management
- Awareness programme : Steering committee
- Awareness programme: Task force
- Awareness programme: Employees
- Training: Internal audit
- Training: Statistical tools
- Training: QMS Documented Information
- Training: .......... (on specific identified subject)
- Initial status survey
- Developing quality policy
- Establishing quality objectives
- Implementation (including retaining documented information) to begin
- Performance evaluation (including internal audit)
- Management review
- Pre-assessment audit
- Certification body selection
- Application for selection
- Certification audit


Step 9 - Training and Guidance

Training is crucial for organizational development and success. It is essential to the achievement of organization's goals and objectives. It is beneficial to both organizations and employees. A trained employee becomes more efficient and productive. An organization can develop the potential of its employees through training.

For better implementation of ISO 9001:2015 QMS, training programmes should be organized for different categories of employees, such as senior managers, supervisors, employees and workers. Training should cover the basic concepts of ISO 9001 2015 QMS and its overall impact on the achievement of the strategic goals of the organization, quality management principles, organizational processes, and the likely work culture implications on the organization's system. In addition, initial training may also be necessary on risk-based thinking, documented information, auditing, performance evaluation, statistical tools etc.

An in-depth training programme covering the following areas (as necessary) should be organized for steering committee and task force members:
- ISO 9001:2015 QMS Awareness
- Internal QMS audit
- Statistical tools
- QMS documented information

The organization can organize such trainings as in-house programmes. The consultant, if appointed, or outside trainer or an external training institution could be invited to conduct in-house training programmes. When in-house capacity to carry out such training programmes is not available, the organization can depute its personnel to external training programmes organized be professional trainers or training organizations.

The task force coordinator can be a key personnel for the implementation of ISO 9001:2015 quality management system. He should obtain guidance on specific topics within the quality management system from time to time. Some topic-specific standards (the latest versions) that may be referred to are mentioned below:
- ISO 10001, Quality management, Customer satisfaction, Guidelines for codes of conduct for organization
- ISO 10002, Quality management, Customer satisfaction, Guidelines for complaints handling in organizations
- ISO 10003, Quality management, Customer satisfaction, Guidelines for dispute resolution external to organizations
- ISO 10004, Quality management, Customer satisfaction, Guidelines for monitoring and measuring
- ISO 10005, Quality management systems, Guidelines for quality plans
- ISO 10006, Quality management systems, Guidelines for quality management in projects
- ISO 10007, Quality management systems, Guidelines for configuration management
- ISO 10008, Quality management, Customer satisfaction, Guidelines for business-to-consumer electronic commerce transactions
- ISO 10012, Measurement management systems, Requirements for measurement processes and measuring equipment
- ISO/TR 10013, Guidelines for quality management system documentation
- ISO10014, Quality management, Guidelines for realizing financial and economic benefits
- ISO 10015, Quality management, Guidelines for training
- ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
- ISO 10018, Quality management, Guidelines on people involvement and competence
- ISO 10019, Guidelines for the selection of quality management system consultants and use of their services
- ISO 19011, Guidelines for auditing management systems


Step 10 - Conducting Initial Status Survey

The organization should conduct initial status survey to establish organization's current status and to determine the gaps between the organization's quality management system and the requirements of ISO 9001:2015 QMS standard. The organization may use one or more of the following:
- Self assessment
- Assessment by an external organization or by a consultant

Self assessment can be conducted by task force team members, who are competent and trained in ISO 9001:2015 QMS. Many external (consulting) organizations and consultants also provide initial status survey service.

Initial status survey should be helpful in determining the following:
- Any need of efforts required for the development and implementation of ISO 9001:2015 QMS
- Any need of documented information in compliance to ISO 9001:2015 QMS standard in the organization
- Any need of change in the organizational structure
- Any need of change in the organizational processes
- Any need of change in the action plan
- Any need of additional resources

Checklist questions may be helpful for conducting self assessment. Personnel involved should obtain or prepare checklist questions for proper assessment. After conducting initial status survey, the organization will be in a position to know the gaps between the organization's quality management system and the requirements of ISO 9001:2015 QMS standard. Now the organization knows the clear path of implementation and expected timetable as mentioned in the action plan.


Step 11 - Establishing and Developing Quality Policy and Quality Objectives, and Creating and Updating Documented Information

ISO 9001:2008 QMS standard used the terms 'document', 'documented procedure', 'quality manual' and 'quality plan', however these terms are not used in ISO 9001:2015 QMS standard, instead a new term 'documented information' has been used.

ISO 9001:2015 QMS standard requires: (i) to develop a quality policy, (ii) to establish quality objectives at relevant functions, levels and processes, (iii) to create, update, control and retain documented information. The standard also requires to maintain documented information to support the operation of its processes and retain them to have confidence that the processes are carried out as planned.

ISO 9001:2015 QMS standard requires to maintain following documented information:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- In addition to the above, the organization should determine documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)


ISO 9001:2015 QMS standard also requires to retain following documented information:
- Monitoring and measuring resources - evidence of fitness, and basis used for calibration and verification, where no international or national measurement standard exists (7.1.5)
- Evidence of competence (7.2)
- Operation planning and control (8.1)
- Results of the review of requirements, including any new or changed requirements, for the products and services, and where requirements for products and services are changed, amendment of relevant documented information (8.2.3)
- Confirmation that design and development requirements are met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls activities (8.3.4)
- Design and development outputs(8.3.5)
- Design and development changes, results of reviews, authorization of changes, and actions taken to prevent adverse impacts (8.3.6)
- Results of evaluation, monitoring of performance, and re-evaluation activities of external providers and any necessary actions (8.4.1)
- Necessary information to maintain traceability (8.5.2)
- Information regarding property belonging to customers or external provider is lost, damaged or otherwise found to be unsuitable for use and reporting to the customer or external provider (8.5.3)
- Results of the review of changes, personnel authorizing the changes, and any necessary action (8.5.6)
- Traceability to the person(s) authorizing release of products and services for delivering to the customer (8.6)
- Information that describes nonconformity, the actions taken, any concession obtained, and that identifies the authority deciding the action (8.7.2)
- Evidence of results in monitoring, measurement, analysis and evaluation (9.1.1)
- Evidence of the implementation of the internal audit programme, and internal audit results (9.2)
- Evidence of the results of management review (9.3)
- Evidence of nature of nonconformities and subsequent actions, and results of any corrective action (10.2)
- In addition to the above, the organization should determine documented information (to retain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

It is better, in the beginning, to formulate the organization's quality policy and quality objectives in line with vision, mission and long-term business goals of the organization. Quality objectives need to be established at relevant functions, levels and processes needed for the quality management system.

Therefore, the members of the task force may be assigned the following work:
- Defining the scope of the organization's quality management system
- Formulating organization's quality policy
- Formulating quality objectives
- Determining documented information to maintain
- Determining documented information to retain

The task force should take decision with regard to the documented information that are not created or updated by the members of task force:
- Who will create or update?
- Who will control?

Created and updated documented information should be reviewed and approved for suitability and adequacy.


Step 12 - Implementation

The organization needs to close the gaps, as identified in step 10, allocate resources to perform actions and implementation, assign roles, responsibilities and authorities and establish a final time schedule to complete the needed actions. For guidance and reference to requirements, please refer to ISO 9001:2015 QMS standard.

It will be a good practice to implement as per the documented information developed and maintained by the organization. In large organizations, implementation may be more effective if implementation done in a phased manner, while in small organizations, the quality management system is often implemented all at once throughout the organization.
Where phased implementation takes place, the effectiveness of the system in selected area can be evaluated. It will be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system as per ISO 9001:2015 QMS standard. The steering committee of the organization should monitor the implementation progress on a regular basis.


Step 13 - Conducting Internal Audit

As the quality management system is being installed, its effectiveness should be checked by internal audits conducted at planned intervals. Internal audits are conducted to ensure that the quality management system of the organization conforms to: (i) the organization's own requirements for its quality management system, and (ii) ISO 9001:2015 QMS standard requirements, and also to ensure that the quality management system is effectively implemented and maintained. When a quality management system has been operating for three to six months, an internal audit should be conducted. A few staff members should be trained to carry out internal audit. Even after the quality management system of the organization stabilizes and starts functioning, internal audit should be planned and performed as an ongoing strategy. After conducting the internal audit, the organization is able to know the detected nonconformities. Therefore, appropriate correction and corrective action should be taken promptly to eliminate the detected nonconformities and its verification.

The organization should make sure that information on non-conformance pointed out in internal audit are resolved by ensuring appropriate correction and corrective action and turned to conformance. The organization should make sure to retain documented information as evidence of the internal audit programme implementation and audit results. Please note that ISO 19011:2011 standard provides guidelines for auditing management systems.


Step 14 - Conducting Management Review

When implementation of quality management system has been operating for three to six months and an internal audit has been conducted, a management review should be conducted by the top management of the organization by considering the following inputs:
- Changes in external and internal issues relevant to organization's quality management system
- Information on the performance and effectiveness of the quality management system
- Trends in customer satisfaction
- Trends in feedback from relevant interested parties (customers, users, etc.)
- Achieving quality objectives
- Process performance
- Conformity of products and services
- Nonconformities, corrections and corrective actions
- Monitoring and measurement results
- Audit results
- Performance of external providers
- Adequacy of resources
- Effectiveness of actions taken to address risks and opportunities
- Opportunities for improvement

Management review outputs should include decisions and actions related to the following:
- Improvement opportunities
- Any need for changes
- Resource needs

Actions as decided in the management review should be appropriately implemented. Management review forms an integral part of the quality management system and it should be conducted at planned intervals. In the subsequent management reviews, please also consider the status of actions from previous management reviews. Make sure to retain documented information as evidence of the results of management reviews.

Step 15 - Arranging Pre-assessment Audit

When deficiencies in the organization's quality management system are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Organization's consultant or an independent consultant may be able to do such an audit. Sometimes certification bodies also provide this service for a nominal charge. The pre-assessment audit will provide a degree of confidence for finally going ahead with an application for certification.


Step 16 - Going for Certification

Once the quality management system as per ISO 9001:2015 QMS standard has been in operation for a few months and has stabilized and the steering committee is satisfied with the implementation, the organization should make a formal application to a selected certification body. The certification body normally first carries out an adequacy audit and thereafter an on-site audit. If the certification body finds the quality management system to be working satisfactorily and conforming to ISO 9001:2015 QMS standard requirements, it awards the organization a certificate, generally for a period of three years. During a three-year period, the certification body will carry out surveillance audits to ensure that the quality management system of the organization is continuing to operate satisfactorily.

Certification is not a mandatory requirement of ISO 9001:2015 QMS standard. An organization may implement ISO 9001:2015 QMS standard without obtaining its certification. If an organization wishes to obtain ISO 9001:2015 QMS certification, then efforts should be made to obtain the certification from an accredited certification body. Please ensure that the certification body is accredited to grant certification in the area the organization operates.


Friday, September 11, 2015

ISO 9001:2015 QMS Standard Expected To Be Published Soon




As per the latest information, forthcoming ISO 9001:2015 QMS standard has almost come to a conclusion and has been approved for publication. It is expected that the forthcoming standard will be published on 23 September 2015.

Reacting on the news, Keshav Ram Singhal, the editor of this blog, announced, "Every efforts will be made to increase awareness with regard to the revised standard. I will write analytical articles, organize 'ISO 9001:2015 QMS Awareness' trainings and take other steps, all aimed at helping people and organizations to have a smooth transition to the new standards. Organizations can organize in-house trainings by sending an invitation to me or can nominate their staff to training programmes organized in Ajmer. One-to-one training or small group training facility is also available for which organizations can nominate their personnel on a mutually agreed date. Fees will be reasonable and this will not be a major issue. Efforts will also be made to design and develop online training. Let us start our efforts."





Tuesday, September 8, 2015

Transition Planning for ISO 9001:2015 QMS




Keshav Ram Singhal

Many organizations and professional have questions with regard to transition planning for ISO 9001:2015 QMS and validity of ISO 9001:2008 QMS certification.

International Accreditation Forum (IAF), on 12 January 2015, has issued a IAF Informative Document 'Transition Planning Guidance for ISO 9001:2015 - Issue 1', prepared by IAF Technical Committee in cooperation with ISO/TC 176/SC2/WG 23, and approved by IAF members. The objective of the IAF Informative Document is to provide advice to interested parties (such as organizations, certification bodies, accreditation bodies, training bodies, consultants, etc.) on transition arrangements to be considered before implementing ISO 9001:2015 QMS standard.

The IAF Informative Document has identified activities to be considered by relevant interested parties (such as organizations, certification bodies, accreditation bodies, training bodies, consultants, etc.). The informative document is helpful in increasing the understanding of the context of ISO 9001:2015 QMS standard. Forthcoming ISO 9001:2015 QMS standard will be based on Annex SL of Directives, a high-level structure (HLS). This HLS has standardized sub-clause titles, core text of the standard, common terms and core definitions with an objective to increase compatibility and alignment with other management system standards (such as, ISO 14001 EMS, etc.).

ISO 9001:2015 QMS standard has following changes:
- Adoption of the HLS as set out in Annex SL of ISO Directive
- Adoption of risk based thinking
- Improved understanding and application of the process approach
- Fewer prescribed requirements
- Less emphasis on documentation
- Improved applicability of the requirements to service organizations
- Include requirement to determine the scope (boundaries) of the quality management system
- Emphasis on understanding the organization and its context
- Increased requirements for top management
- Greater emphasis on achieving desired outcomes to enhance and improve customer satisfaction

As per the IAF Informative Document, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment have agreed to a three year transition period from the date of publication of ISO 9001:2015 QMS standard. ISO 9001:2015 QMS standard is expected to be published on any date after 9 September 2015. Please note that International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published

ISO 9001:2008 QMS certifications will be valid during transition period only. After three years from the publication date of ISO 9001:2015 standard, ISO 9001:2008 certifications will not be valid. Accordingly, ISO 9001:2008 QMS certifications issued during the transition period will be valid during the transition period and after three years from the publication date of IS 9001:2015 QMS standard, ISO 9001:2008 QMS certifications will not be valid.

Organization implementing ISO 9001:2008 QMS standard needs to upgrade its quality management system in line with ISO 9001:2015 QMS standard and accordingly the organization should take following actions:
- Conduct initial status survey to identify gaps, which need to be addressed to meet new requirements of ISO 9001:2015 QMS standard
- Prepare an action plan with target dates for implementation of ISO 9001:2015 QMS standard
- Organize appropriate training and awareness programme for people in the organization
- Update the existing quality management system to meet ISO 9001:2015 QMS standard requirements and implement as per ISO 9001:2015 QMS standard
- Conduct internal audit
- Conduct management review
- Contact Certification Body for ISO 9001:2015 Certification (if the organization seeks certification)

The IAF Informative Document also provides guidance to certification and accreditation bodies. This document can be downloaded from the IAF website (iaf.nu).




Friday, September 4, 2015

Developing and Implementing Forthcoming ISO 9001:2015 QMS





Keshav Ram Singhal

It is a strategic decision for an organization to adopt ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015, following step-by-step process may be useful.

Step 1 - Leadership and Commitment from Top Management

Following three things from the top management will facilitate proper development and implementation of ISO 9001:2015 QMS:
- Leadership role
- Commitment
- Active involvement

It is necessary for the top management to demonstrate leadership and commitment to implement ISO9001:2015 QMS standard. Top management of the organization must be convinced that implementing ISO 9001:2015 QMS standard will provide a number of potential benefits to the organization. Top management must know that although certification and registration is not mandatory, however certification and registration will enable the organization to demonstrate a visible commitment to quality, quality management system and sustainable development initiatives. Top management must be aware of the overview of ISO 9001:2015 QMS standard, for which one-day presentation training can be organized covering the following issues:
- ISO 9001:2015 QMS Overview
- Importance of understanding the organization and its context
- Risk-based thinking
- Identification of goals and expectations
- Leadership role
- Quality policy
- Quality objectives
- Engaging persons to contribute QMS effectiveness
- Establishing a steering committee
- Establishing a task force
- Appointing a consultant
- Implementation process

Presentation training covering the above issues can be organized by a personnel, who is well aware of ISO 9001:2015 QMS standard. An outside consultant or trainer may be asked to organize the training.

Top management of the organization should demonstrate leadership, commitment and determination to implement ISO 9001:2015 QMS standard by involving themselves actively in the following tasks:
- Ensuring people in the organization understand the importance of meeting requirements
- Establishing organization's quality policy and quality objectives
- Integrating quality management system requirements into the organization's business processes
- Promoting the use of the process approach and risk-based thinking
- Engaging, directing and supporting people in the organization
- Providing necessary resources
- Promoting improvements
- Performing 'management reviews' at planned intervals to ensure continuing suitability, adequacy, effectiveness and alignment of organization's quality management system with the strategic direction of the organization.

Top management of the organization should identify objectives or goals the organization wants to achieve. Typical objectives or goals of an organization ma b following:
- Providing more efficient products and services
- Be more profitable
- Producing products and services that consistently meet requirements
- Achieving customer satisfaction
- More business for the organization
- Maintaining market share (business)
- Improving processes in the organization
- Improving communication in the organization
- Improving morale in the organization
- Reducing costs
- Reducing liabilities
- Reducing waste
- Reducing rework
- Increasing confidence in the production process
- Technical up-gradation

Top management needs to ensure that intended results are achieved. So, top management must take all possible steps to develop and implement ISO 9001:2015 QMS standard as per the requirements stated in the standard and determined by the organization.

Step 2 - Assigning responsibilities and authorities

ISO 9001:2008 QMS standard has a requirement to appoint a management representative to coordinate quality management systems activities. ISO 9001:2015 QMS standard does not have a requirement to appoint a management representative. However, the standard requires assignment of responsibilities and authorities for relevant roles within the organization. As such, top management of the organization should assign the responsibility and authority for :
- Ensuring that the organization's quality management system conforms to ISO 9001:2015 QMS requirements
- Ensuring that the organization's processes deliver intended outputs
- Reporting quality management system performance to the top management
- Reporting opportunities for improvement to the top management
- Ensuring the promotion of customer focus throughout the organization
- Ensuring maintaining quality management system's integrity while planning and maintaining changes to the quality management system

One or more persons can be selected and assigned above mentioned responsibilities and authorities or the top management can perform such role.

Step 3 - Establishing a steering committee

ISO 9001:2015 QMS standard does not mention requirement for establishing a steering committee, however, it is better a better idea to establish and set up a steering committee. A member of the top management of the organization should head the steering committee and other members of the steering committee should be:
- Persons selected and assigned specified duties as mentioned in step 2
- Department and functional heads
The steering committee should be responsible for the overall planning of the implementation process, giving directions and allocating resources. The members of steering committee should be trained on ISO 9001:2015 QMS by a professional trainer, consultant or training organization.

Step 4 - Establishing a task force

The steering committee should determine whether a task force is required and if determined then it should set up a task force with a coordinator. Its coordinator can be selected from persons selected and assigned duties as mentioned in step 2. The task force should be allocated the work of determining documented information and their creation.. It can also be assigned the job of: (i) identifying organization's risks, (ii) determine how critical each risk is, and (iii) determine actions to be taken.

The task force members should have good understanding of the organization's processes and also good communication-writing skills. The members of the task force should be trained on 'ISO 9001:2015 QMS' and specially on 'QMS Documented Information' by a professional trainer, consultant or training organization.

To be continued .....

Note

Organizations, desirous of conducting or participating 'ISO 9001:2015 QMS Awareness' training, may contact your training and development partner.









Thursday, September 3, 2015

DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES IN FORTHCOMING ISO 9001:2015 QMS




K. R. SINGHAL

Design and development is a set of processes that converts or transforms needs and expectations for an object or entity (such as product, service, process, person, organization, system, resources) into more detailed requirements (needs and expectations). The words 'design' and 'development' and the term 'design and development' are sometimes used synonymously. Forthcoming ISO 9001:2015 QMS standard mentions requirements for design and development of products and services in its clause 8.3 that has following sub-clauses:

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

General

Organization needs to establish, implement and maintain a design and development process consisting of:
- Design and development planning
- Design and development inputs
- Design and development controls
- Design and development outputs
- Design and development changes

Design and development planning

Organization needs to determine stages and controls for design and development for which the organization must consider the following:
- Nature of design and development activities
- Duration of design and development activities
- Complexity of design and development activities
- Required stages for the design and development process
- Applicable design and development reviews
- Verification activities for design and development
- Validation activities for design and development
- Responsibilities and authorities involved in design and development process
- Internal and external resource needs for design and development process
- The need to control interfaces involved between person involved in design and development process
- The need for involvement of customers and users in the design and dvelopment process
- Requirements for subsequent provision of products and services
- What customers expect for the level of control on design and development process
- What interested parties expect for the level of control on the design and development process
- What documented information needed that can demonstrate meeting design and development requirements

Design and development inputs

Consider the following:
- Functional and performance requirements
- Information from previous similar design and development activities
- Legal requirements
- Standards to implement
- Codes of practice to implement
- Potential consequences of failure because of nature of the products and services

Determine:
- Requirements essential for the products and services that are to be designed and developed

Ensure:
- Input requirements to be adequate, complete and unambiguous
- Resolving the conflicting design and development inputs

Retain
- Documented information on design and development inputs


Design and development controls

Apply controls to design and development process

Ensure:
- Defining of results to be achieved
- Conducting reviews to evaluate the ability of results of design and development and meeting requirements
- Conducting verification activities to ensure that the design and development outputs meet the design and development inputs requirements
- Conducting validation activities to ensure that resulting products and services meet the requirements for the specified application and intended use
- Taking any necessary actions on problems determined during design and development control activities (i.e., during review, verification and validation activities)
- Retaining documented information of design and development control activities


Design and development outputs

Ensure the following:
- Design and development outputs meet the input requirements
- Design and development outputs are adequate for the subsequent processes
- Design and development outputs include or mention (i) appropriate monitoring and measuring requirements, and (ii) acceptance criteria
- Design and development outputs specify the characteristics of the products and services (that are essential for their intended purpose and their safe and proper provision)

Retain:
Documented information on design and development outputs


Design and development changes

Indentify:
Design and development changes

Review:
Design and development changes

Control:
Design and development changes to ensure no adverse impact on conformity to requirements

Retain:
- Documented information on identified design and development changes
- Documented information on results of reviews
- Documented information on authorization of the changes
- Documented information of actions taken


Design and development in ISO 9001:2008 vs ISO 9001:2008

Design and development in ISO9001:2008 has following seven sub-clauses:
- Design and development planning (7.3.1)
- Design and development inputs (7.3.2)
- Design and development outputs (7.3.3)
- Design and development review (7.3.4)
- Design and development verification (7.3.5)
- Design and development validation (7.3.6)
- Control of design and development changes (7.3.7)

Requirements of design and development process have been restructured and earlier seven sub-clauses have been reduced to following six sub-clauses in ISO 9001:2015:
- General (8.3.1)
- Design and development planning (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls (8.3.4)
- Design and development outputs (8.3.5)
- Design and development changes (8.3.6)


Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.

Wednesday, September 2, 2015

EXCLUSIONS IN RELATION TO APPLICABILITY OF REQUIREMENTS IN FORTHCOMING ISO 9001:2015




K. R. SINGHAL

ISO 9001:2008 QMS standard referred the exclusions by providing that where any requirement(s) of ISO 9001:2008 QMS standard cannot be applied due to the nature of the organization and its product, this can be considered as exclusion and such exclusions are limited to requirements within clause 7 only and not permitted in other clauses of the standard.

Forthcoming ISO 9001:2015 QMS standard does not refer to exclusions in relation to applicability of its requirements to the organization's quality management system. All the requirements of ISO 9001:2015 are generic and applicable to the organization, regardless of its type or size, or the products and services it provides. However, an organization, implementing ISO9001:2015, needs to determine the boundaries and applicability of the quality management system to establish its scope, that needs to be available and be maintained as documented information.

Accordingly, if an organization determines that any ISO 9001:2015 QMS requirement is not applicable to the organization's scope, then organization (i) needs to provide justification for the non-applicability, and (ii) ensure that the requirements determined as not being applicable do not affect the organization's ability or responsibility to provide products and services that meet requirements to enhance customer satisfaction.

In this way, we see that ISO 9001:2008 allowed the exclusions within clause 7 only, while ISO 9001:2015 does not mention such limitation to non-applicability of requirements.

Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.