For any organisation to run smoothly, it needs various resources like people, infrastructure, equipment, communication channels, training, knowledge repositories and the necessary environment in which all of these can operate. No organisation can be successful without these critical support systems in place. Therefore, it is important that the management determine the right number and quality of resources required to effectively run their businesses and be profitable at the same time.
Clause 7 of ISO 9001, rightfully called “Support”, specifically talks about People, Infrastructure, Environment for operation of processes, Monitoring and Measuring Resources, Organizational Knowledge, Competence, Awareness, Communication and Documented Information as support resources that shall be determined and their effectiveness evaluated to ensure that the organization deliver high-quality product and services and meet the customer requirements always.
Why Is it important?
People are a critical part of any organisation. Well trained, competent and motivated personnel help an organisation achieve its goal. Human Resources are key to the success of organisations especially those which are heavily dependent on people like Construction or IT industry. Lack of skilled resources and high attrition rates are some issues that many industries face today. With attrition, there is always a drain of knowledge which the organisation sometimes pay heavily with the deterioration of the quality of services they deliver or the products they produce. It becomes important for organisations to determine their needs related to competence and number of resources required to operate effectively. At the same time, management also needs to ensure that a good working environment is provided for people to remain motivated and continue working with high productivity. This requires that organisations hire competent people, provide the training and organisational knowledge that would be required, put in place right HR policies to keep the working environment safe and friendly, etc.
Other than the human resource and other aspects related to them, the physical environment in which people operate also form an important support system for all key operations of the company. This includes building, hardware, software, utilities, tools which are required to deliver high-quality products and services to its customers. It is also important that the organisations have monitoring and measurement resources that may be required to ensure that a product/service confirms to all the customer’s requirements. All such equipment used should be in good working condition and fit to use. Measurement or calculation error due to uncalibrated equipment used may result in bad deliveries to the customer which do not meet their requirements. Maintenance and calibration, therefore, become important to ensure that all such tools and equipment are in good condition and giving accurate results.
Effective Communication forms the backbone of any organisation. As is commonly known, inefficient or insufficient methods of communication can lead to a number of issues in an organisation. A simple case of client miscommunication may lead to non-conforming products and can result in customer dissatisfaction and a bad reputation. Therefore, it is important to plan communication methods and provide enough resources to communicate effectively.
Last but the least, documented information is as important as communication. All key aspects of the project shall be documented to ensure that records are available that corroborate the requirements of the customer and what was finally delivered. Apart from records, certain documents which form the knowledge repositories, provide vital information on how the processes should work, work instructions for employees, etc form important assets of an organisation and shall be maintained in order to ensure smooth execution of processes and progress of the project.
As we have discussed in clause 5, leadership is responsible to ensure that adequate resources are provided for effective implementation of the Quality Management System. Let’s understand what are these resources and the requirements of ISO 9001 for each of this resource.
- People: Adequate people should be provided to ensure effective execution of processes and quality management system. Organisations need to evaluate their needs at regular intervals as the needs may vary over a period of time. Management also needs to understand what are the capabilities and constraints of internal resources and where support from external providers will be required.
- Infrastructure: This sub-clause requires that the organisation determine, provide and maintain Infrastructure required for the smooth operation of the organisation. Infrastructure includes hardware, software, equipment, utilities, instruments, communication and transportation facilities etc. The infrastructure shall be maintained to keep it in a good working condition so that there is no hindrance in smooth execution of the operations.
- Environment for operation of processes: This sub-clause requires that social, psychological and physical aspects of work environment are maintained to provide a conducive and stress-free environment for people to operate efficiently. The physical aspects include workplace location, humidity, heat, light, pollution, cleanliness and facilities like washrooms, break-out areas, cafeteria, etc. A calm social environment in the offices with policies like non-discrimination, conflict management, get-togethers, celebrations help in providing a stress-free environment and increases productivity.
- Monitoring and Measuring Resources: This sub-clause requires that the organisation identify measuring and monitoring resources and apply controls to ensure that these resources are fit for use. Maintenance and calibration methods should be put in place for monitoring and measurement activities carried out in the organisation. These activities shall be carried out by competent personnel and shall be recorded. Typically, a maintenance and calibration register which will list down the frequency, status, due date of calibration, etc is maintained by the organisations.
- Organisational Knowledge: This sub-clause requires that the organisations demonstrate that they capture knowledge and retain it through methods like lesson learning at the end of milestone/project, best practices conferences, meetings or through other forums created within the organisation. Apart from internal resources, external resources like conferences, academia, standards, etc shall be leveraged to build internal knowledge and keep themselves updated with the changes in the business environment or other improvement initiatives.
An organisation shall determine the competency requirements for various activities carried out in the organisation. These are typically done through creating position/job description. The competencies shall be determined in terms of their education, training or experience. Next, the organisation shall ensure that people with required competencies are hired/trained or externally sourced. To accomplish this, an organisation shall focus on its recruitment and training processes so that required competency is maintained in the organisation. At the time of recruitment, methods like screening the resumes, interview with appropriate manager, background checks, referrals, etc shall be put in place to ensure the person hired has the required competencies. Once the right person is hired, skill gaps if any shall be determined and training arranged to fill these skill gaps. The training may also be required to cater to the changing needs of the business.
Appropriate records of education, training, skills and experience shall be retained for all the personnel. This may include their education records, certification records, training obtained, experience, etc.
Organisations shall also have methods in place to evaluate the effectiveness of training or recruitment processes. This can be done through an employee performance review or by evaluating the training effectiveness.
This clause requires that the organisation make arrangements to ensure that all personnel are aware of the quality policy, quality objectives and the Quality Management System. This is required to ensure that employees or contractual workers working under your control understand the importance of processes and appreciate quality. They should be made aware of the purpose of the work they are performing, the process that needs to be followed for the work they are doing and importance of carrying out their work as per the quality management system and how this will help in achieving quality objectives. Quality Awareness may be raised in the organisation through methods like induction training, meetings, workshops, etc.
Employees shall also be motivated to contribute to the improvement of QMS by giving improvement suggestions.
Organisations shall arrange for effective internal and external communication methods for effective implementation of the quality management system. Communication includes the provision of infrastructure and processes for faster, accurate and complete communication. Internal Communication may be done through meetings, emails, telephone, etc and methods of external communication may include marketing material, internet, email, meetings, etc.
This clause requires that the organisation identify and maintain documents required for the effective working of the quality management system. Methods should be put in place to ensure confidentiality, integrity is maintained and improper use for documented information is prevented. Organisations shall ensure that all documented information is identified, stored, maintained and controlled through the following methods:
- Documents shall be identified with a title, number, date or other such methods. Methods shall be put in place to review the documents for suitability and adequacy.
- The organisation shall specify where the documented information is stored. This can be done by maintaining documents at a common location (server/cloud, etc).
- The organisation shall ensure easy accessibility of the documents and availability to those who need the document. This can be done by maintaining documents at a common location (server/cloud, etc) and making them accessible to limited personnel who need these documents.
- Documents shall be protected from unauthorised access. Access rights and password policies shall be put in place to maintain the confidentiality of documents. Adequate training shall be provided to employees so that they understand the importance of maintaining the confidentiality of the documents.
- Distribution of the documents shall be controlled to ensure that only current versions are available for use. Deleting obsolete versions or keeping it aside in a separate folder to avoid unintentional use of the older version can be a mechanism to handle this.
- Periodic backups of electronic documents and restoration tests shall be performed to ensure documents are preserved.
- Changes to the documents shall be controlled to maintain the integrity of the documents. Revisions shall be approved considering the purpose of the changes and their consequence, integrity, resources required and changes in responsibilities. The documented information shall be revised after review and approval, measures shall be put in place to ensure that employees are using the latest version and changes notified to relevant parties.
- Retention and disposition of documents shall be defined. Organisation need to identify retention time for records as per your business, contractual or legal requirements and dispose of the documents when the retention period is over. Typical dispositions include archive, recycle or shred.
This clause also addresses external documents and preventing unintended modifications of retained information. The organisation shall identify external documents used and control the use of these documents. These may include standards, legal documents, customer-provided documents, etc.