The organization should determine and provide the resources needed to establish, implement, maintain, and continually improve the QMS. And should consider the capabilities of, and constraints on, existing internal resources; and what needs to be obtained from external providers.
- How resources are determined for the establishment, implementation, maintenance, and continual improvement of the QMS.
- Show how the capabilities and constraints on internal resources are considered.
- Show how needs from external providers are considered.
- The top management has the responsibility to ensure the availability of resources to develop and maintain your QMS. This is typically done through business and quality planning.
- While planning for your resources needed the organization must consider what existing internal resources it has considering its capabilities and constraints and what needs to be obtained by external providers.
- The actual amount of resources needed may vary from day to day and over time. This is one reason why top management must review QMS performance regularly
The organization should determine and provide the persons necessary for the effective implementation of its QMS and also for the operation and control of its processes.
1) How does the organization provide persons necessary to consistently meet customer, applicable statutory, and regulatory requirements for the QMS including the necessary processes?
1) This standard expects an organization to determine and provide the appropriate number of personnel to effectively implement the QMS and for the operation and control of its processes and also the proper allocation of staff in order to achieve the required outcome.
The organization should determine, provide, and maintain the infrastructure for the operation of the processes to achieve conformity of products and services. Infrastructure may include buildings and associated utilities; equipment including hardware and software; transportation resource, information and communication technology.
1) How does the organization determine, provide and maintain the infrastructure for the operation of processes to achieve products and service conformity?
1) Essentially a company needs to consider all the things they will need in order to deliver a service/product to the customer/client. This needs to include:
- buildings / water / gas / electric, etc.
- equipment – for example, computers / operating systems (e.g. alarm master);
- vehicles – for engineers/management/sales and survey staff;
- information – standards that have to be applied, mobile phones/tablets, etc.
2) Any infrastructure changes related to product realization affecting customer requirements require notification to, and agreement from, the customer.
7.1.4 Environment for the Operation of Processes
The organization should determine, provide, and maintain the environment necessary for the operation of processes and to achieve conformity of products and services. A Suitable environment for the operation of processes can be a combination of human and physical factors such as social (for e.g. non-discriminatory, calm, non-confrontational, etc), psychological (for e.g. stress-reducing, burnout prevention, emotional protective), physical (for example, temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ depending on the type of product and service provided by the organization
- How does the organization determine, provide and maintain the environment for the operation of processes to achieve products and service conformity?
1) Environment for the operation of processes can include physical, social, psychological, environmental, and other factors (such as temperature, humidity, ergonomics, and cleanliness). It includes
- Equality Opportunities / whistleblowing / anti-bullying policy
- Violence at work/counseling support / lone working
- Office-based risk assessment, space, noise levels and other environment issues
7.1.5 Monitoring and Measuring Resources
The organization should determine and provide the resources needed for valid and reliable monitoring and measuring results, where monitoring or measuring is used for evidence of conformity of products and services to specified requirements. The organization should ensure that the resources provided are suitable for the type of monitoring and measurement activities being undertaken and are maintained to ensure continued fitness for their purpose. The Organization should retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.
220.127.116.11 Measurement Traceability
Where measurement traceability is a requirement(statutory or regulatory or customer or relevant interested party expectation) or considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring instruments must be verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. The organization must retain the basis used for calibration or verification as documented information if no such standard exists as documented information. Measuring instruments must be identified in order to determine their calibration status; It must be safeguarded from adjustments, damage, or deterioration that would invalidate calibration status and subsequent measurement results. The organization should determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.
- How are the resources determined for ensuring valid and reliable monitoring and measuring results, where used?
- How does the organization ensure that resources provided are suitable for the specific monitoring and measurement activities and are maintained to ensure continued fitness for purpose?
- Show the documented information which is evidence of fitness for purpose of monitoring and measurement resources.
- Where applicable, show how measurement instruments are verified or calibrated at specified intervals against national or international measurement standards;
- If there are no standards, show the documented information which is used as the basis used for calibration or verification.
- Show how measurement instruments are identified to determine their calibration status.
- Show how they are safeguarded from adjustments.
- Show how they are safeguarded from damage and deterioration.
- How do you determine the validity of previous measurements if you find an instrument to be defective during verification or calibration? What appropriate actions can you take?
- This clause is applicable only with monitoring and measuring devices and equipment used to monitor the product (or service) and does not apply to monitoring and measuring the quality system.
- Operation planning must determine the following what specific product and process characteristics need to be monitored and measured, the criteria for product acceptance, the type of Monitoring and Measurement Device needed, frequency i.e. at what stages of realization to do it, sample size, etc.
- Requirements for what needs to be measured and the acceptance criteria may come from the customer, regulatory, industry, and own organization. The organization must then determine what Monitoring and Measurement Device is appropriate for each measuring or monitoring requirement.
- To ensure valid measurement and monitoring results, the Monitoring and Measurement Device must be controlled. A process is required, to control the identification of monitoring measurement, selection, purchase, status, identification, calibration, verification, adjustment or readjustment, use, handling, maintenance and storage, training, handling of nonconforming Monitoring and Measurement Device’s, etc.
- Personnel using Monitoring and Measurement Devices must have competence and training in the use of Monitoring and Measurement Devices in terms of their function, range and precision of measurement, reliability, use, and maintenance.
- You must keep appropriate records to demonstrate effective operation and control of your Monitoring and Measurement Device processes. These records must include calibration and verification records traceable to national, international, or other benchmarks used for calibration.
- Customer or internal engineering changes may result in a change in product measurement, requirements, and/or the Monitoring and Measurement Device to be used. These changes should be reflected in your quality plan.
- Performance indicators such as the monthly trends in the number of out of calibration Monitoring and Measurement Device’s, or the number of Monitoring and Measurement Device’s past their calibration due date, number of Monitoring and Measurement Device’s being used and not controlled, reduction in untrained personnel found using Monitoring and Measurement Device’s, etc. Use these indicators to tighten and improve the effectiveness of your Monitoring and Measurement Device process.
- Where a Monitoring and Measurement Device is found to be out of calibration, you must take appropriate corrective action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibrating the defective Monitoring and Measurement Device.
Clause 7.1.6. Organizational Knowledge
The organization should determine the knowledge necessary for the operation of its processes and achieve conformity of products and services. This knowledge shall be maintained and made available to the extent necessary. When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Organizational knowledge can be based on: a) Internal Sources (e.g., intellectual property, the knowledge gained from experience, lessons learned from failures and successful projects, capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products, and services); b) External Sources (e.g., standards, academia, conferences, gathering knowledge from customers or external providers).
- How does the organization determine the necessary knowledge for the operation of processes?
- How does the organization necessary the knowledge to achieve conformity of products and services?
- How does the organization maintain this knowledge and make it available to the extent necessary?
- How does the organization consider current knowledge and how do you acquire additional knowledge when addressing changing needs and trends?
- Organizational knowledge can include information such as intellectual property and lessons learned.
- To obtain the knowledge required, the organization can consider internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization) and external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
- The organization shall determine the knowledge necessary for the operation of the QMS, ensure conformity of products and services, enhance customer satisfaction. The organization is responsible for maintaining, protecting, and making sure the knowledge is available
- Depending on the size and complexity of the organization, the risks and opportunities it needs to address, the need for accessibility of knowledge, the process for considering and controlling past, existing, and additional knowledge needs is to be considered.
- Knowledge is to be considered when making changes to the organization
The organization must determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of its QMS; It must ensure that these persons are competent on the basis of appropriate education, training, or experience and where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; It must retain documented information as evidence of competence. Applicable actions can include, for example, training, mentoring, or reassignment of currently employed persons; or hiring or contracting of competent persons. “Competence” is defined in the section on terms as the ability to apply knowledge and skills to achieve intended results. Demonstrated competence is sometimes referred to as “qualification”.
- How does the organization determine the necessary competence of its employees whose work affects the performance and effectiveness of the QMS?
- How does the organization ensure that its employees are competent on basis of appropriate education, training, or experience?
- How does the organization take applicable actions to acquire the necessary competence and evaluate the effectiveness of action taken?
- Show the appropriate documented information as evidence of competence?
- HR process must include determining competency criteria, skills evaluation, identification of training needs, types of training, provision of training, how training effectiveness is evaluated, methods to communicate an awareness of the importance of quality requirements, and meeting quality objectives, to all employees.
- Applicable actions to acquire competency can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.
- Criteria for competency must be developed based on appropriate education, skills, training, and experience for activities, tasks, functions, and processes. The level and detail of such qualifications, skills, training, and experience will depend upon the complexity of the product, process, technology, and customer and regulatory requirements. Appropriate record of employees skills, education, training, the experience must be maintained
- A “Skills Matrix” is a useful tool used by organizations to determine and manage the competency levels required by different activities and functions. An organization may create a comprehensive training program based on the skill Matrix that is fully integrated with the quality management system. The appropriate record must be kept of training which must include the evaluation of the training
Persons doing work under the organization’s control must be aware of the quality policy; relevant quality objectives; their contribution to the effectiveness of the QMS, including benefits of improved quality performance; and the implications of not conforming with system requirements.
- How does the organization ensures that the persons doing work under the organization’s control are aware of its quality policy, relevant quality objectives, their contribution to the effectiveness of QMS including the benefits of improved performance and the implications of not meeting QMS requirements?
- The process to promote quality awareness may include the use of methods such as – cross-functional teams, involvement in quality planning, quality circles, improvement suggestions, product workshops, zero defect programs, product review checklist, etc.
- Organizational personnel must be motivated to achieve the organization’s quality objectives. The process to motivate employees may include the use of methods such as – employee recognition awards, ongoing training programs, performance reviews, employee surveys, poster campaigns, etc,.
- Performance indicators to measure the effectiveness of the HR process in determining competency and training needs of the workforce could include – employee turnover, employee complaints, number of instances unqualified personnel was found performing QMS activity, number of instances competency criteria were not met, and number of instances no training or competency records maintained; etc.
The organization should determine the internal and external communications relevant to the QMS, including: on what it will communicate; when to communicate; with whom to communicate; how to communicate.
- How does the organization determine the internal and external communication relevant to the QMS including what it will communicate, when to communicate, with whom to communicate, how to communicate, and who communicates?
- Top management must plan for internal and external communication methods and resources at a high level using the business planning process and deploy these methods through the information technology, logistic, and HR processes.
- Each process owner must identify the methods of communication such as a computer, documents, telephone, meetings, directives, visual, etc, used and determine whether these methods are appropriate and are they effective for the purpose intended?
- Communication plan can include: a) What will be communicated, b) When you will communicate, c) With whom you will communicate, d) How you will communicate, e) Who will do the communication.
7.5 Documented Information
The Organization’s QMS must include all documented information required by ISO 9001 and the documented information determined by the organization as being necessary for the effectiveness of the QMS. The extent of documented information can differ from one organization to another due to the size of the organization and its type of activities, processes, products, and services; complexity of processes and their interactions; competence of persons.
7.5.2 Creating and Updating
When creating and updating documented information the organization must ensure appropriate identification and description (e.g., a title, date, author, or reference number); format (e.g., language, software version, graphics), and media (e.g., paper, electronic); review and approval for suitability and adequacy.
7.5.3 Control of Documented Information
Documented information required by Your QMS and by ISO 9001 must be controlled to ensure it is available and suitable for use, where and when it is needed; It must is adequately protected from loss of confidentiality, improper use, or loss of integrity.
For the control of documented information, the organization must address, as applicable: distribution, access, retrieval, and use; storage and preservation, including preservation of legibility; control of changes (e.g., version control); retention and disposition. Documented information of external origin determined by the organization to be necessary for the planning and operation of the system must be identified as appropriate and controlled. Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
- What documented information is included in the organization’s QMS as required by ISO 9001:2015 and determined by the organization necessary for the effectiveness of the QMS?
- While creating and updating documented information, how does the organization ensure it is appropriate in terms of identification & descriptions?
- Show how does the organization control documented information.
- Show how it is made available and suitable for use.
- How do you protect the organization’s documented information?
- When controlling documented information, how do you address the following:
Distribution, Access, Retrieval, Use, Legibility, Control of changes, Retention and disposition, Storage and preservation;
- How does the organization identify as appropriate and control documented information of external origin which has been determined as necessary for the QMS?
- The term “documented procedure” and “record” have both been replaced by “documented information”.“Documents”, “Documentation” and “Records” are combined to become “Documented information”. The document is expressed as maintaining documented information and the record is expressed as Retain documented information.
- Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
- The extent of documented information for a quality management system will depend on:
a) the size of the organization and its type of activities, processes, products, and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
Documented Information if applicable
- Employee Requisition Form
- List of Machines
- Instruments Calibration history chart
- Calibration Schedule
- Lesson learnt log
- Competency matrix
- Training Needs Identification.
- On Job training
- Training attendance sheet
- Training feedback form
- Training effectiveness form
- Employee Satisfaction Survey Questionnaire
- Communication plan
- Document Matrix
- Master list of forms and formats