ISO 9001:2015 QMS Awareness – Operation – General Information, Operational Planning and Control, Requirements for Products and Services

ISO 9001:2015 QMS Awareness – Operation – General Information, Operational Planning and Control, Requirements for Products and Services

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Clause 8 of ISO 9001:2015 QMS standard deals with support requirements.

 

Operation = An organized activity that carried out by many people in the organization doing many tasks

 

Operation is the action of functioning of the organization to achieve its objectives.

 

Operation = Operational planning + Operational control + Customer communication + Determining, review of and changes to requirements for products and services + Design and development activities (including planning, inputs, controls, outputs and changes) + Control of externally provided processes, products and services (including type and extent of controls, information for external providers) + Production and service provision (including control, identification, traceability, external providers’ property, preservation, post-delivery activities, control of changes) + Release of products and services + Control of nonconforming outputs.

 

Requirements for operation 

Requirements for support are mentioned in clause 8 of ISO 9001:2015 QMS standard. The relevant sub-clauses of Clause 8 of the standard are as under:

8 Support

 

8.1 Operational planning and control

 

8.2 Requirements for products and services

 

8.2.1 Customer communication

8.2.2 Determining the requirements for products and services

8.2.3 Review of the requirements for products and services

8.2.4 Changes to requirements for products and services

 

8.3 Design and development of products and services

 

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development control

8.3.5 Design and development outputs

8.3.6 Design and development changes

 

8.4 Control of externally provided processes, products and services

 

8.4.1 General

8.4.2 Type and extent of control

8.4.3 Information for external providers

 

8.5 Production and service provision

 

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes

 

8.6 Release of products and services

 

8.7 Control of nonconforming outputs

 

 

Operational Planning and Control

 

The organization needs to plan, implement and control – Processes (please refer to the requirements mentioned in clause 4.4).

 

The organization needs to implement – Actions determined in planning (Please refer to the requirements mentioned in clause 6).

 

The organization needs to determine – (i) Requirements for products / services, (ii) Resource needs, (iii) Documented information to retain and maintain to the extent necessary.

 

The organization needs to establish – (i) Criteria for processes, and (ii) Criteria for acceptance of products / services.

 

The organization needs to implement – Control as per established criteria.

 

The organization needs to control – (i) Planned changes, and (ii) Outsourced processes.

 

Outsourced processes = Processes done by others (people / organization)

 

The organization needs to review – Consequences of unintended changes.

 

Unintended = Not planned as a goal

 

The organization needs to take – Necessary action to mitigate (to make less severe) any adverse effects.

 

The organization needs to maintain documented information – As determined

 

The organization needs to retain documented information – As determined

 

We find that requirements for operational planning and control in ISO 9001:2015 QMS standard focuses on operational planning and control that requires the organization to plan, implement, and control the processes to meet its quality management system (QMS) requirements. A few real-life examples are mentioned below:

 

1.     Production Scheduling – A manufacturing organization is involved in production activities and is required to plan and control its production activities effectively. The organization may use techniques like production scheduling, capacity planning, resource allocation etc to ensure its production processes in a coordinated manner, which will help in meeting customer requirements, optimizing resources and minimizing delays in production.

 

2.     If an organization relies on external suppliers, then the organization needs to carefully select and evaluate its suppliers.

 

3.     When implementing change to processes, products or services, the organization must have effective control measures in place. By effective change management, the organization can minimize potential risks to its processes, maintain product / service as per requirements, and ensure a smooth change to processes, products or services.

 

4.     Operational planning and control must have risk-based thinking. The organization should identify and assess potential risks to their processes, products and services. The organization can develop mitigation strategies, implement controls and regularly monitor and review risk levels.

 

5.     By maintaining and retaining adequate documented information, the organization can have proper operational planning and control. Documented procedures provide clear instructions about the activities to be carried out, including control measures, responsibilities, and process flow.

 

 

Requirements for Products and Services

 

The organization needs to communicate with customers – (i) Providing information on product / service, (ii) Handling enquiries, (iii) With regard to contracts / orders, (iv) With regard to changes, (v) with regard to obtaining customer feedback / customer complaints, (vi) With regard to handling / controlling customer property, (vii) For establishing specific contingency action requirements, when relevant.

 

A few real-life examples of customer communication that involve providing information, handling enquiries, handling feedback and handling customer property are mentioned below:

 

1.     Providing Product / Service Information and Specifications – Customer communication involves providing detailed information about the features of the product / service, its specifications, usage guidelines, and any applicable warranties. This will help the customer to make an informed decision and will ensure the customer has a clear understanding of the product / service s/he is considering.

 

2.     Handling Enquiries and Requests – Customer communication also involves promptly addressing inquiries and requests from customers. This include responding to queries about product / service availability, pricing, delivery options, technical support etc. Timely and accurate response demonstrates better customer service and helps build customer trust and customer satisfaction.

 

3.     Resolving Customer Complaints – In situations where a customer raises a complaints and / or expresses dissatisfaction, effective customer communication plays a crucial role in building customer trust and customer satisfaction. Here the customer communication involves actively listening to the customer’s concerns, empathizing with the customer situation, and working toward a resolution. Keeping the customer informed throughout the complaint resolution process will help manage expectations of the customer and also demonstrate a commitment to the customer satisfaction.

 

4.     Collecting Customer Feedback – Collecting customer feedback is an essential part of customer communication. There are various methods for collecting customer feedback that may include survey, feedback form, or online platform to collect customer opinions and experiences. Customer feedback provides valuable insights for improvement and helps the organization identify areas for improvement.

 

5.     Handling Customer Property – There may be situations where customer property is entrusted to the organization for various purposes. A repair service may handle customer’s device. In such a case, effective customer communication involves providing clear information to the customer how customer’s property will be handled, stored, protected and applicable terms and conditions, if any.

 

6.     Order Tracking / Updating Status – Organizations dealing with product delivery or providing service, customer communication includes providing updates on order status, tracking information and expected delivery time.

 

7.     Service Renewal Reminder – Customer communication also involves informing customers about the service renewal, maintenance schedules etc. Sending timely reminder builds trust and relationship of the organization with the customer

 

The organization needs to ensure – (i) Defining product / service requirements (including legal and others considered necessary, and (ii) Organization’s ability to meet product / service requirements.

 

The organization needs to review (before commitment to supply the product / service to a customer) – (i) Customer requirements, (ii) Requirements for delivery, (iii) Requirements for post-delivery activities, (iv) Requirements not stated by the customer, but necessary for the specified / intended use, when known, (v) Requirements specified by the organization, (vi) Applicable legal requirements, and (vii) Changed contract / order requirements.

 

Legal requirements = Statutory requirements + Regulatory requirements

 

The organization needs to resolve – Changed contract / order requirements.

 

The organization needs to ensure – (i) Amendment of changed requirements in relevant documented information, (ii) Providing information of changed requirements to relevant persons, and (iii) Organization’s ability to meet changed requirements.

 

The organization needs to confirm (before acceptance) – Customer requirements, if customer does not provide documented information.

 

The organization needs to retain documented information (records) – (i) Review results, and (ii) New requirements for product / service.

 

It should be noted that where a formal review is impractical for each other, for example online sales, the review will cover product information / catalogue.

 

Think of the following Questions

 

(1)   What activities are involved in the operational planning and control?

 

(2)   How can you improve customer communication in your organization?

 

(3)    What documented information you may need to maintain for operational activities?

 

(4)   What documented information you may need to retain for operational activities?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

ISO 9001:2015 QMS Awareness – Support – Resources, Competence, Awareness, Communication and Documented Information

ISO 9001:2015 QMS Awareness – Support

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Clause 7 of ISO 9001:2015 QMS standard deals with support requirements.  

 

Support = Help = Assistance

 

Support in relation to a quality management system is to provide assistance or help in implementation of the quality management system of an organization by providing adequate resources, competence, awareness, communication and documented information (documents and records). The term "support" in this context refers to the resources and infrastructure needed to establish, implement, maintain, and continually improve the Quality Management System (QMS) of an organization.

 

The support requirements outlined in Clause 7 of the standard include the provision of resources such as people, infrastructure, and equipment, as well as ensuring that personnel are competent and aware of the quality management system requirements. This clause also addresses the need for effective communication and the availability of documented information to support the quality management system.

 

Overall, support requirements are critical to the success of a quality management system. By providing adequate resources, competence, awareness, communication, and documented information, an organization can ensure that its quality management system is effective and continually improving.

 

Requirements for support 

Requirements for support are mentioned in clause 7 of ISO 9001:2015 QMS standard. The relevant sub-clauses of Clause 7 of the standard are as under:

7 Support

 

7.1 Resources

 

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for 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

 

7.5.1 General

7.5.2 Creating and updating

7.5.3 Control of documented information

 

Resources

 

Resource = A stock or supply of money, materials, staff (people) and other assets that can be drawn on by a person or organization in order to function or operate effectively.

 

Resource in ISO 9001:2015 QMS standard refers to people, infrastructure, environment, monitoring and measuring resources (= monitoring and measuring equipment) and organizational knowledge, necessary for the effective implementation and operation of the organization’s quality management system and control of organization’s processes, so that product / service conformity is achieved.

 

The organization needs to consider – (i) Capabilities of existing internal resources, (ii) Constraints on existing internal resources, and (iii) What will be obtained or available from external providers.

 

The organization needs to determine – Resources, needed for the establishment, implementation, maintenance and continual improvement of the quality management system, that include (i) People, (ii) Infrastructure, (iii) Environment, (iv) Monitoring and measuring resources, and (v) Organizational knowledge.

 

The organization needs to provide – Determined resources, needed for the establishment, implementation, maintenance and continual improvement of the quality management system, that include (i) People, (ii) Infrastructure, (iii) Environment, (iv) Monitoring and measuring resources.

 

The organization needs to identify and safeguard – Monitoring and measuring resources.

 

The organization needs to ensure – Suitability of monitoring and measuring resources.

 

The organization needs to maintain – (i) Infrastructure, (ii) Environment for the operation of processes, and (iii) Continuing fitness of monitoring and measuring resources.

 

The organization needs to carry out calibration / verification of monitoring and measuring resources – At specified intervals or prior to use against measurable standards (applicable when measurement traceability is required or the organization considers necessary).

 

The organization needs to determine at the time when the measuring equipment found to be unfit – Whether the validity of previous measurement results adversely affected?

 

The organization needs to take appropriate action – If the validity of previous measurement results adversely affected.

 

The organization needs to maintain and make available – Determined knowledge.

 

When addressing changing needs and trends, the organization needs to (i) Consider current knowledge maintained and available in the organization, and (ii) Determine ways to acquire or access any necessary additional knowledge and required updates.

 

It is necessary to understand the term ‘organizational knowledge’ or ‘knowledge’ used above. The term ‘organizational knowledge’ or ‘knowledge’ refers to the knowledge specific to the organization, which gained by experience the people of the organization. This knowledge is used and shared to achieve the organization’s objectives. Sources of knowledge can be – (i) Internal, such as intellectual property (copyrights, patents, design etc.), knowledge gained from experience, lessons learned from failed projects and successful projects, captured and shared knowledge and experience (documented and undocumented), results of improvement initiatives in processes, products and services. (ii) External, such as standards, book, literature, publication, academia, conference, customer, external provider etc.

 

The organization needs to retain documented information (records) as evidence of – (i) Fitness of monitoring and measuring resources, (ii) Basis used for calibration / verification when there is no measurement standard available or exist.

 

While implementing the requirements of the standard, following should be clearly understood:

 

(i)              Infrastructure can be land, building, associated utilities (electricity, water), equipment, machinery, hardware, software, transportation resources (two / three / four-wheeler, etc.), information, communication technology etc.

 

(ii)             A suitable environment for the operation of processes can be a combination of human, psychological and physical factors. Human factors may be social (such as, non-discriminatory, calm, non-confrontational), psychological (that reduces stress, prevention from fire / burn, emotional protection) and physical (such as, temperature, heat, light, airflow, hygiene, noise etc.).

 

Non-discriminatory = Not making an unfair or prejudicial distinction between people

 

Calm and non-confrontational = That tends to deal with situations calmly and diplomatically, not aggressive or hostile

 

(iii)            Monitoring and measuring resources are needed to ensure valid and reliable results when monitoring and measuring is used to verify product / service conformity to requirements.

 

 

Competence

 

Competence = The fact of having the ability or skill that is needed for doing something

 

Competence is the ability or skill to do something successfully or efficiently. Competence means that a person or an organization has the ability to do something well. The person or the organization is capable of performing a task or job effectively. Competence can be described as the combination of training, skills, experience and knowledge that the person has and his ability to apply them to perform a task or job safely. Other factors, such as attitude and physical ability of the person, can also affect the person’s competence. Competence is ability to apply knowledge (available collection of information and meaningful data) and skills to achieve intended results.

 

The organization needs to determine necessary competence of persons doing the work related to the quality management system of the organization.

 

The organization needs to ensure – Persons are competent. Basis – Appropriate education / training / experience.

 

The organization needs to take action to acquire necessary competence, where applicable.

 

The organization needs to evaluate effectiveness of the actions taken.

 

The organization needs to retain documented information (records) of competence evidence.

 

Clarification – Actions to improve competence in the organization can be – (i) Providing training to people, (ii) mentoring (guidance) of people, (iii) Reassignment of people, (iv) Hiring / contracting competent people etc.

 

Awareness

 

Awareness is the knowledge that something exists or understanding of the subject matter.

 

The organization needs to ensure – People know and understand – (i) Quality policy of the organization, (ii) Quality objectives established by the organization, (iii) People’s contribution to the organization’s quality management system effectiveness, (iv) Benefits of improved performance, (v) Implications of not meeting the quality management system requirements.

 

One may have following questions:

 

(i)              Why people should know quality policy of the organization?

 

(ii)             Why people should know the established quality objectives?

 

(iii)            What are the benefits of improved performance?

 

(iv)           If quality management system requirements are not met, what are the implications?

 

Please consider following answers to above questions:

 

(i)              The quality policy of an organization is a statement of organization’s commitment to quality and it provides a framework for setting quality objectives. When people within the organization know and understand the quality policy of the organization, they can align their work according to the direction set by the quality policy. Understanding the quality policy of the organization helps to create a culture of quality within the organization, which is helpful for the successful implementation and maintenance of the quality management system.

 

(ii)             Quality objectives are established at relevant functions, levels and processes needed for the quality management system. Quality objectives are specific, measurable, and time-bound targets that an organization sets for itself to achieve. When people within the organization know and understand the established quality objectives, they can align their work with these objectives, and ensure that their efforts contribute to achieve them. This helps to ensure that people in the organization is working towards achieving established goals, which is needed for the successful implementation and maintenance of the quality management system.

 

(iii)            Improved performance in an organization leads to a range of benefits for the organization, including customer satisfaction, improved product and service quality, increased productivity, increased efficiency, reduced costs, and improved competitiveness. These benefits ultimately lead the organization to its increased profitability and long-term success.

 

(iv)           If quality management system requirements are not met in an organization, the organization may experience a range of negative consequences that may include bad product, bad service, customer complaints, lost business, decreased productivity, increased costs, potential legal and regulatory consequences etc. Not meeting quality management system requirements can damage an organization’s reputation that can have long-term consequences for its success. Therefore, it is required that the organization ensures that it meets all quality management system requirements to avoid the negative consequences mentioned above.

 

Communication

 

Communication =The act of imparting, sharing or exchanging information, ideas or feelings

 

Communication is imparting, sharing or exchanging of information by speaking, writing or using some other medium.

 

The organization needs to determine – Internal communication and external communication that include – (i) Contents (what) to communicate, (ii) Timing (when) to communicate, (iii) People / Organizations / Parties (whom) to communicate, (iv) Methods / means (how) to communicate, (v) Person / authority / organization (who) to communicate.

 

Documented Information

 

Documented information = Information contained in a medium / format

 

Documented information is the meaningful data and facts about something, which can be in any format and media and from any source. Retaining documented information serves as an evidence of conformity, nonconformity or results achieved.

 

Annex A of ISO 9001:2015 QMS standard provides clarification that an organization can choose to use terms which suit their operations, for example, using ‘records’, ‘documentation’ or ‘protocols’ rather than ‘documented information’.

 

The terms ‘documentation’, ‘quality manual’, ‘documented procedures’, ‘records’ used in ISO 9001:2008 QMS standard are replaced and used by the term ‘documented information’ in ISO 9001:2015 QMS standard.

 

ISO 9001:2015 QMS standard requires to either maintain or retain documented information in some of its clauses. Documented information may be (i) As required by ISO 9001:2015 QMS standard, and (ii) As determined by the organization.

 

The organization needs to ascertain – (i) What documented information required by ISO 9001:2015 QMS standard, and (ii) What documented information determined by the organization.

 

For creating and updating a documented information, the organization needs to ensure appropriately – (i) Identification, (ii) Description, (iii) Format, (iv) Media, and (v) Review and approval for suitability and adequacy.

 

For controlling documented information, the organization needs to – (i) Ensure – Availability for use, suitability for use adequately protected, (ii) Address – As applicable – Distribution, access, retrieval, use, storage, preservation, preservation of legibility, version (change) control, (iii) Identify, determine and control – External origin documented information, (iv) Protect the documented information retained as evidence of conformity – From unintended alteration.

 

Protected = Remained adequately confidential, proper use, sincere, truthful

Access = Permission to view, or the permission and authority to view and change

 

It should be noted that documented information required for the quality management system of one organization may differ from another organization due to size, type, products / services, processes, processes complexity, processes interaction, competence of persons.

 

Additional Reading Suggested –  A Concise Guide on Creating and Updating Documented Information (eBook)

 

Think of the following Questions

 

(1)   What support needed for the quality management system?

 

(2)   Why support needed for the quality management system?

 

(3)   What do you understand by the terms ‘maintaining documented information’ and ‘retaining documented information’?

 

(4)   What are the requirements of ISO 9001:2015 QMS standard for support of the quality management system?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.