After addressing the context, commitment, and planning, organizations will have to look at the support needed to meet their goals and objectives. This includes resources, targeted internal and external communications, as well as documented information that replaces previously used terms such as documents, documentation, and records. The organization needs to supply competent resources to deliver its goods and services. Again, nothing new here, awareness has been strengthened so now everyone needs to know the implications of not conforming to the management system requirements. The organization needs to consider the need for both internal and external communications relevant to the management system – what, when, and with whom it will communicate. The final support requirement is going to generate a lot of heat but not much light – documented information. Gone are the terms documents, documentation, and records. However, the requirements for the management of documented information are not new, exceptional, or excessive. One skeleton which is finally laid to rest is the idea that everyone needs work instructions no matter how experienced or senior they are in the organization. Auditing awareness and communication should be easier; the requirements are crisper. The organization needs to:
- Determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the management system.
- Determine the necessary competence of person(s) doing work under its control that affects its discipline speciﬁc performance.
- Ensure that these persons are competent on the basis of appropriate education, training, or experience.
- Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken
- Retain appropriate documented information as evidence of competence
Clause 7, Support, has five sub-clauses.
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the Operation of Processes
- 7.1.5 Monitoring and Measuring Resources
- 7.1.6 Organizational Knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented Information
In addition to clause 7.1, there are other references to resources throughout the standard, for example:
4.4.d – determine the resources needed for QMS processes and to ensure their availability
5.1.1.e– top management ensure resources needed for QMS are available
6.2.2.b –The organization should determine what resources are needed to achieve quality objectives
6.3.c –The organization should consider the availability of resources for planning any changes in QMS
8.1.c –the organization should determine any resources needed to achieve conformity to product and service requirements.
8.3.2.e – the organization should consider the internal and external resource needs for the design and development of products and services.
8.5.1.b – the availability and use of suitable monitoring and measuring resources
9.3.2.d – management review of the adequacy of resources
9.3.3. – management review of resource needs
The organization should determine and provide 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.
This clause updates the ISO 9001:2008 clause 6.1 on Resources. It removes any mention of resources for customer satisfaction. Customer satisfaction is mentioned at multiple clauses, including 9.1.2. It adds consideration of internal resources and external providers. Additional resource considerations are the capabilities of, and constraint on existing internal resources and what needs to be obtained from external providers.
The top management has the responsibility to ensure the availability of resources to develop and maintain your QMS. Clause 7.1 requires you to determine the nature and availability of such resources. This is typically done through business and quality planning. Having adequate resources is vital to ensure product conformity or satisfy customer requirements – e.g. having adequate personnel, materials, and equipment to ensure timely production and delivery of the product. Use business planning (clause 5.1.1), quality management planning (clause 6.2.2), planning for QMS processes (clause 4.4), and also during planning for any change in QMS(clause 6.3) to identify and determine the nature of resource needs of QMS each process and plan for its availability. 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(clause 9.3.3). 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. Consider developing performance indicators for each major category of resources used, (e.g. machinery and equipment; human resources; facility and environment; transport; communication systems; etc.) to determine the effective use of such resources. This applies even in case the resources are being made available by the external provider. Where the resource planning process is performed off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance may include – a copy of their ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant ISO 9001 requirements that you would have to implement, had you carried out the process at your own facility.
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 resources; information and communication technology.
The only relevant requirement is that we must “determine, provide and maintain” that which is necessary to make conforming products and services requirement. Compliance with this requirement would require evidence that the organization has, “determined”, and then continue to “provide and maintain” the required infrastructure. This need not be a document and consensus among those interviewed will suffice. This also assumes there is a consensus that the infrastructure is reliable based on its maintenance.
Planning for the types of infrastructure resources needed for your business may include facility, production equipment, IT equipment and software, laboratory, packaging, dies, molds, tooling, jigs, fixtures, storage, transportation, communication, office, materials, labor, utilities, and supplies, etc. The key strategic business factors to be considered for infrastructure planning include future needs, current availability, and capacity, cushion for growth, contingency planning, linkage to current and future product programs. This planning may be done through business planning (clause 5.1.1), quality management planning (clause 6.2.2), planning for QMS processes (clause 4.4), and also during planning for any change in QMS(clause 6.3). The actual deployment of such resources may be determined by each process owner. You are required to maintain your infrastructure. Your planned preventive maintenance program should include controls for schedule and timing, availability and training of personnel, types, and scope of maintenance, maintenance, and competency/training records, tracking to maintenance objectives, use, storage and control of spare parts, control of any maintenance outsourcing, etc. The notes identify the types of infrastructure that might be considered:
- Buildings and associated utilities – Is the building and equipment suitable? For example, if you are manufacturing metal stampings or storing metal products, a leaky roof, non-enclosed travel paths between buildings, etc may not be suitable to ensure you can consistently provide conforming products (if “rust-free” is a requirement). Water treatment services, beyond public water/sewer, may be required to ensure regulatory compliance where processes produce wastewater unsuitable for discharge into the sewer, etc. This should be the focus of consideration for buildings and associated utilities. Some auditors may inquire as to contingency plans to ensure your infrastructure is maintained. Most organizations have at least a basic contingency plan either for compliance or customer assurance.
- Equipment including hardware and software – This is pretty obvious that the organization must have the proper equipment, however, the addition of the “hardware and software” wording has given pause to quite a few both in the 2008 version and in this one. The intent is that the organization understand their equipment, but also maintain and upgrade as appropriate, the related software. This may be specific to a piece of manufacturing equipment within the building, a measuring system or device in the lab, or it may also be the organization’s ability to meet the customers’ needs with regard to communication (such as being able to send/receive design files, programs for programmable machinery, etc). And the expectation is that someone knows the status of these items and has a plan to maintain them.
- Transportation – Again, this is pretty obvious. If the product must be maintained at a certain temperature, for example, the proper fleet (either internal or by an external provider) must be maintained. If a certain number of trips is required to provide just-in-time delivery, a scheduling process must be maintained, etc. And there should be a contingency plan in the event of service interruption.
- Information and communication technology – Customer requirements often specify their preferred method of communication and order processing, and the organization must be able to meet their criteria (ie – electronic purchase orders & acknowledgments, advance ship notices, electronic billing, etc)
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
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and achieve conformity of its goods and services. The “NOTE” adds, “physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics, and cleanliness)”.The clause NOTE adds social and psychological environments, adds factors of ergonomics and cleanliness, and drops the examples of noise, lighting, and weather from the ISO 9001:2008 standard. The environment for the operation of the process is Work Environment which includes controls for ergonomics, personnel safety, and facility conditions that are conducive to achieving product quality. Some of the factors to consider in determining and managing the work environment include ergonomics (worker movement; fatigue; manual effort and loads, etc), workplace location, heat, light, humidity, airflow, noise, vibration, hygiene, cleanliness, pollution, adequate facilities (lockers, lunchroom, cafeteria, washrooms, etc); health and safety regulations; cleanliness of premises; etc. the extent to which the above environmental factors may apply to any organization will vary based on size, risk, and other considerations. The ISO 9001:2015 also wants the organization to look into social issues such as a nondiscriminatory environment, and also a calm and non-confrontational environment. psychological Issues such as stress-reducing, burnout prevention, and emotional protection, etc. should also be not ignored by the organization. The focus should be on employee safety, welfare, and product conformity. Performance indicators to measure the effectiveness of processes that determine and control the effective use of infrastructure may include equipment maintenance – uptime/downtime; productivity – equipment and workforce; accident and safety incidents; non-value-added use of floor space; excessive handling and storage; the number of instances specific resources were not available or delayed; Though there is no need for a documented information requirement, social and psychological surveys can be shown as objective evidence in these areas.
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 the purpose of monitoring and measurement resources.
126.96.36.199 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.
This clause is specifically about monitoring products and services for conformity. This clause replaces old clause 7.6 on Control of Monitoring and Measuring Equipment and is one of the structural changes in the 2015 revision. the use of the term “equipment” has been changed to “resources”. It needs evidence of the fitness for purpose of the resources. Humans may carry out the activity without equipment. Calibrated equipment now termed “instruments”. Monitoring and measuring the quality system has a whole clause (9 Performance Evaluation) dedicated to it. This clause is sticking only with monitoring and measuring devices and equipment used to monitor the product (or service). So, the organization must ensure they have identified and put in place the appropriate resources including (7.1.2 People, 7.1.3 Infrastructure, 7.1.4 Environment) and now 7.1.5 Monitoring and measuring resources.
Requirements for what needs to be measured and the acceptance criteria may come from the customer, regulatory, industry, and your own organization. Product realization 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. You must then determine what Monitoring and Measurement Device is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the Monitoring and Measurement Device which may have to be several times greater than the tolerance criteria for product measurement. This would depend on the industry you are in and the criticality of end-use for the product for e.g. the precision requirements for ball bearings may be much greater than say for cutting cloth to make a shirt. 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. Monitoring and Measurement Devices may include measurement and testing tools, equipment, hardware, and software. They may be owned by your organization, your employees, or the customer. Monitoring and Measurement Devices may be used to verify product as well as to measure process conformity for e.g. a temperature controller on an oven. Besides Monitoring and Measurement Device’s used for product conformity, you may need to calibrate and control certain Monitoring and Measurement Device’s used in related and peripheral processes such as production equipment, tooling, maintenance, etc. 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. 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.
All Monitoring and Measurement Devices used for product verification must be capable of being calibrated, verified, or both. Calibration is setting or correcting a Monitoring and Measurement Device, usually by adjusting it to match or conform to a dependably known and traceable standard for e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards. Verification is confirming that the Monitoring and Measurement Device is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment for e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard. A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued. There are Monitoring and Measurement Device’s that are capable of being both calibrated and verified for e.g. a CMM- coordinate measuring machine and may require both to be done in specific situations based on the frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose capability and calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals.
You must define the frequency and method of calibration for each type and level i.e. whether used in the shop floor, laboratory, or standard of Monitoring and Measurement Device. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards. In rare circumstances, national or international standards may not exist for calibrating a specific Monitoring and Measurement Device. In such situations consider using industry, manufacturer, or even your own organizational standard to validate the accuracy and reliability of your Monitoring and Measurement Device. Consult with your customer if the contractual circumstances require it. Your quality plan must define the measurement and monitoring required and the type of Monitoring and Measurement Device needed for it, including the frequency of measurement and acceptance criteria. Depending on the risk and precision and reliability of measurements needed, you might consider doing statistical studies on Monitoring and Measurement Device’s referenced in your quality plans. Ensure that personnel performing such statistical studies are trained and competent to do so. A multitude of software tools is available to manage and control Monitoring and Measurement Devices. There are many acceptable methods to identify Monitoring and Measurement Device and their calibration status. The methods you select must consider the manufacturers’ recommendations, frequency of use, environment the Monitoring and Measurement Device is used in, risk in misuse or incorrect tool being used, etc. 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. 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 would normally be reflected in your quality plan. If you use external calibration services, you are still expected to impose the specific control requirements of this clause to the external organization.
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. You could use a product quality plan, documented procedure, or other combination of specific practices, procedures, documents, and methods. Look at the risks related to your product, processes, and resources in determining the extent of documented controls you need to have.
The organization should ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken. The organization should have the right instruments and equipment on hand and they must be capable of determining “good” from “bad”. The word “suitable” provides the expectation that the instruments be accurate, reliable, and precise enough to make appropriate judgments about the product (and services). This includes the very common disciplines of calibration, reproducibility & reliability studies, etc to ensure the instruments used to measure product (and service) are suitable. They should be maintained to ensure their continued fitness for their purpose. Once the organization has selected and confirmed the appropriate monitoring and measuring devices, they must have a surveillance program to ensure their continued suitability. The organization should retain appropriate documented information as evidence of fitness for the purpose of monitoring and measurement resources. There should be documented records of these activities. Where measurement traceability is a statutory or regulatory requirement a 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. Where no such standards exist, the basis used for calibration or verification shall be retained as documented information. There must be a generally accepted calibration program that should always include traceable standards and a schedule for verification/calibration. The use of traceable standards is required because simply having something to measure your devices by does not necessarily ensure an adequate calibration program. For example, using old worn gauge blocks, pins, hardness standards, etc is not a best practice. Your standards (in addition to your instruments) should be maintained and traceable to an international standard to ensure the validity of your monitoring and measuring program. The devices must be identified in order to determine their calibration status; This is the simplest thing to do – a simple calibration sticker will suffice. Keep in mind that it is NOT required that stickers be on every device, but why not do it? If each instrument has its own unique serial number and is properly identified and can be cross-referenced to its calibration status, that meets compliance requirements. However, auditors just feel a better warm and fuzzy feeling if there is a sticker including “last calibrated” or “next calibrated”. And even if you do have a database or master list of instruments that tell you the status of each instrument, a quick glance at the instrument itself doesn’t hurt to ensure your instruments are maintained 100% of the time. The devices must be safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. Safeguarding from damage and deterioration is the simplest of these three. Obviously protective cases, protective films, filters, etc keep an instrument in its tip-top condition. Regular maintenance helps too – removable of dust, atomized grease, etc. Safeguarding from adjustments is a little more difficult, but can be easily achieved by removing adjustment tools from general use, using seals on access panels, etc. Most auditors are reasonable with regard to this, however, if someone wanted to make an adjustment to an instrument, there are many ways to work around the safeguards. It is unlikely to happen, and between calibration, checks can add an additional assurance that instruments are safeguarded against adjustments.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. The addition of intermittent checks (between calibration checks) helps to mitigate the impact should an instrument be found to be out of calibration. For example, if a micrometer is calibrated monthly and on today’s monthly check it is found to be out of calibration, every measurement it has taken for the past 30 days must be validated. This can require isolation of product, product recall, etc in the absence of any other evidence of compliance. Between calibration, checks help to detect adjustments, errors, etc. ISO9001:2008 used to include a reference to the “ability of computer software to satisfy the intended application shall be confirmed.” This was an attempt to ensure that dependence on software is confirmed (rather than simply taking a computer’s word for it). The idea was to prove out software and use common sense before turning it over. For example, implementing the use of a coordinate measuring machine requires a great deal of validation. A poorly programmed measuring routine can result in software rejecting “good” parts due to measurement or calculation errors. This section was intended to prevent that. However, the language was not clear and was often met with blank stares by those who were asked to demonstrate compliance in this area. So the specific reference to software was removed. The use of the word “suitable” at the beginning of this section applies to all monitoring and measuring equipment (including software), so the removal of it has little or no real effect.
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.
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”.
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.
This clause requires determining what is needed/necessary. Ensure persons are competent to meet those needs. Where there are gaps, fill the gaps. And maintain records. Top management is responsible for ensuring the availability of resources which includes HR. Clause 5.3 requires top management to define the organization’s roles and their responsibilities and authorities. Clause 7.1.2 required that adequate Human Resources be determined and provided. And here in clause 7.2, the specific requirements for controlling HR are defined. In clause 7.3 awareness needed by the personnel working under its control is defined. Planning for HR process controls 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. Although training may end up being the best solution, don’t overlook other actions, such as changing processes, improving procedures, rotating jobs, outsourcing, or recruiting fully trained and competent people. 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. It is up to your organization to determine the necessary criteria for the various functions and activities affecting products and QMS based on these factors. 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 that is fully integrated with the quality management system. It should begin with the identification of processes. Then the processes are described and that becomes the basis of the training program – ensuring the persons performing the work understand the processes and are competent to perform them. And as persons are chosen and assigned to processes, they are evaluated based on their previous education and experience versus the requirements of the process, and where gaps are identified, they are provided with additional training.
Organizations undergo significant changes through growth or decline, acquisitions, new technology, and new products and processes, Also, many organizations are now outsourcing their production labour to save on payroll costs and benefits. Labour-related nonconformities can easily arise in such cases. Planning for your HR process must ensure that contract and agency personnel performing work affecting product quality have adequate competency and training. Appropriate records must be kept of such training.
Quality awareness must be focused on meeting customer and regulatory requirements and Quality objectives. The organization must also promote awareness of its quality policy. 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. QMS 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,. You must determine and keep appropriate records of education, training, skills, and experience. These records must demonstrate the effective operation of the HR process controls. 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.
Communication is a complex and difficult activity. Poor communication leads to chaos, poor performance, poor morale, and other bad things. Good communication can foster a sense of community, teamwork, and a clear sense of purpose and direction. The organization must decide what, when, with whom, and how we will communicate both internally and externally. Problems may arise due to incomplete, ambiguous, or inaccurate information being transmitted; transmission to the wrong person, too late or at the wrong time; use of inappropriate or unreliable media, etc. Communication problems are probably the most common cause of QMS nonconformities. Tracking some of the more serious communication issues could serve as useful performance indicators to determine and improve communication process effectiveness. Clause 4.4 control of processes requires you to determine the sequence and interaction of QMS processes. Each process requires inputs to flow from one process and outputs to flow to another process. There is a continuous (communication) flow regarding tangible (materials and product) and intangible (information) inputs and outputs taking place within your organization.
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, logistics, 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? – (do they prevent non-conformities from arising due to the reasons mentioned above?). Process owners should provide feedback on communications effectiveness to the processes providing and controlling such resources. Communication by the MR on the effectiveness of the QMS must not only take place at the top management level but also at appropriate levels within the organization. If everyone is responsible for the quality, then all process owners, as well as their personnel, are entitled to receive periodic feedback on their areas of responsibility.
Included in this determination of relevant QMS communication, according to the requirements, are the following five items that need to be included in your communication plan:
- What will be communicated – What communications will you have for your QMS? You will most likely need to communicate on product and service nonconformances, but do you have to communicate all of them (such as spare parts that you determine to be scrap)? Do you have legal requirements to report on certain elements of your QMS, such as problems that occur in a nuclear power plant? Will you report to the media, shareholders, or other stakeholders on some topics but not others?
- When you will communicate – If you are reporting on the nonconforming product, how long will you wait until you report? When will you communicate on a change in your company’s location? Do you have contractual or legal requirements that dictate these items? When do you need to let shareholders and stakeholders know of important developments in your Quality Management System?
- With whom you will communicate – You will likely have customers in your list of people to communicate with, but what other stakeholders will be included in some, if not all, of your communications? Will your list of people to communicate with include employees, shareholders, suppliers, customers, business partners, or members of the public? Will you report to the media or shareholders depending on the communication topic? Do you have legal requirements to let a government agency know of certain QMS-related information?
- How you will communicate – There are many ways to communicate, and some will work better than others for different information and for different stakeholders. You could use email, phone, text, press release, or even in-person discussions depending on what you need to communicate and to whom. All of these factors need to inform your decisions on communication.
- Who will do the communication – This may change depending on the information to be relayed or the severity of the information. Critical failures may need to be communicated by the CEO, while smaller nonconformances may be communicated by a project team. You may even have dedicated individuals who can speak to the media about your company, and this should be part of your communication plan.
While there is no requirement in ISO 9001:2015 that your communication plan needs to be documented information it might be a good idea to do so if it is complicated. If you are a small organization that will have the CEO do all communication, and you will only communicate what is defined in your contracts and legal requirements, you may not need to document your plan, but if it becomes more complex with different people communicating to different parties, in different ways, on different topics, a documented plan might be a good idea.
|Entity||What||When||How/ How OFTEN||Who|
||Marketing Manager/customer executive|
||Purchasing Manager/ Purchasing executive|
||HR Manager/ Team leader|
||legal advisor /HR Manager|
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