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.