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ISO 9001:2015 Consultants in Pune India

ISO 9001:2015 – Quality Management System :

ISO 9001 is revised with the new standard, ISO 9001:2015 published in September 2015. Those businesses currently registered to ISO 9001:2008 will need to migrate before September 2018.

TechnoSysCon would like provide guidance for the organizations, which are planning to move from ISO 9001:2008 to ISO 9001:2015. This will also help organizations, which are newly adopting QMS requirements and would like to seek certification for ISO 9001:2015. However the interpretations, guidance information will be enriched based on the feedback of the users.

Following are some of the benefits that organizations will have as a result of adopting and implementing a system that meets the requirements of ISO 9001:2015. The new standard allows:
- Broaden business opportunities by demonstrating compliance
- Become a more consistent competitor in your marketplace
- Better quality management helps you meet customer expectations
- Efficient ways of working will save time, money and resources
- Improved operational performance will prevent errors and increase profits
- Motivate and engage staff with more efficient internal processes
- Win more high value customers with better customer service

Following table will gives you brief about, how the new requirements of ISO 9001:2015 shall be adopted by an organization.

Clause#	Title	Comment & Guidance	ISO 9001:2008 Reference
4	Context of the Organization	The whole section addresses the planning phase of P-D-C-A approach
4.1	Understanding the organization and its context	Determine external and internal issues Monitor and review information about issues	None
4.2	Understanding the needs and expectations of interested parties	Identify the interested parties relevant to the quality management system Determine the requirements of interested parties Monitor and review information about interested parties and their requirements	None
4.3	Determining the scope of the quality management system	Define the scope of the QMS Take into account the external and internal issues Take into account the requirements of interested parties Take into account the products and services. All products and services proposed by the company without exception Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS Maintain the scope of the QMS as documented information Include in the scope of the QMS justification for any requirements which cannot be met Every requirement of the ISO 9001 standard which cannot be applied in the company implies a justification	1.2
4.4	Quality management system and its processes	The Organization is free to decide how to apply the QMS without forgetting the issues (see clause 4.1) and requirements (see clause 4.2) Establish, implement, maintain and improve a process-based QMS Determine the needed processes and their application Determine process inputs and outputs Determine the sequence and interaction of processes Determine the criteria and methods to control processes Determine and provide the resources Assign process responsibilities and authorities, Consider the risks and opportunities for each process Evaluate processes and if necessary modify them Determine the improvement opportunities of processes and the QMS Maintain documented information on process operation Retain documented information on process operation	4.1
4.15	Leadership	Section title. Top Management needs to demonstrate involvement in the establishing QMS covering requirements of all the phases of P-D-C-A approach	None
5.1	Leadership and commitment		5.1
5.1.1	General	Top management demonstrates leadership (assumes its responsibility and commitment). Focus on quality and customers Demonstrate accountability for effectiveness of QMS Establish a quality policy and quality objectives. Ensure policy and the objectives are compatible with strategic direction and context of the company Integrate QMS requirements in the internal process requirements Raise awareness of the process approach and process approach and risk-based thinking Provide the necessary resources for the QMS Raise awareness on the importance of an effective and conforming QMS Ensure the achievement of intended results of the QMS Support the staff contribution to the effectiveness of the QMS Promote continual improvement Support the leadership of managers Responsibility and authority of managers are backed at all times by top management	5.1
5.1.2	Customer focus	Determine and meet customer, statutory and regulatory requirements Determine and address the potential risks and opportunities. Any risk and opportunity that may influence the conformity of products and services and customer satisfaction. Maintain the objective of better satisfying the customer	5.2
5.2	Policy		5.3
5.2.1	Developing the quality policy	Policy shall be appropriate to the purpose, strategic direction, culture and business context Establish, implement and maintain a suitable quality policy Provide a framework to define and review the quality objectives Include meeting the applicable requirements Include a commitment to continuously improve the QMS	5.3
5.2.2	Communicating the quality policy	Maintain the quality policy as documented information Communicate the quality policy Keep the quality policy available to interested parties	5.3
5.3	Organizational roles, responsibilities and authorities	Define and communicate the responsibilities and authorities - Assign all relevant roles in the QMS - Assign all relevant roles according to the requirements of the ISO 9001 standard - Assign all relevant roles so that processes deliver expected results - Assign all relevant roles so that reporting on the performance of the QMS and improvement opportunities is done, (clause 10.1 ) - Assign all relevant roles so that customer focus is ensured (first quality management principle) - Assign all relevant roles so that implemented changes to the QMS do not affect its integrity	5.5.1
6	Planning	Section title. The whole section addresses the planning phase of P-D-C-A approach	Not Available
6.1	Actions to address risks and opportunities	In order to ensure that the QMS can achieve its expected results, (Clauses 4.1 (context) and 4.2 (interested parties). Take into account risks and opportunities Take into account opportunities, to increase the desirable effects (positive impact) Take into account risks, to reduce the undesirable effects (negative impacts) Take into account risks and opportunities, to confirm the approach of continual improvement, (Clause 10.3) Plan actions to address risks and opportunities Define how to integrate actions in the QMS processes, (Clause 4.4) Plan and implement actions Plan and evaluate actions Adapt actions to risks and opportunities, considering the potential impact on the conformity of products and services	None (Though this new requirement borrows ideas previously found in 8.5.3, 5.4.2 and 7.1)
6.2	Quality objectives and planning to achieve them	Establish quality objectives at relevant functions, levels and processes Define measurable objectives Consider applicable requirements Adopt relevant objectives Monitor objectives Communicate objectives Update objectives Maintain documented information on the quality objectives Define plan Determine necessary resources Plan responsibilities Plan deadlines - Plan the way to evaluate results	5.4.1
6.3	Planning of changes	Determine need for changes and Plan the changes of the QMS Consider the purpose of the change and the possible consequences Consider the maintenance of the integrity of the QMS Consider the available resources Consider the assigned responsibilities and authorities	5.4.2
7	Support	Section title. The whole section addresses the Do phase of P-D-C-A approach	Not Available
7.1	Resources		6.1
7.1.1	General	Provide the necessary resources to achieve effectiveness in performance of QMS Take into account existing resources and their capabilities and constrains Take into account the need for the use of external providers, to provide necessary services not available inside the company	6.1
7.1.2	People	determine and provide the persons necessary for the operation and control of its processes	6.2
7.1.3	Infrastructure	Provide and maintain the infrastructure necessary to the functioning of processes to achieve conformity of products and services. Example: buildings, equipment, transportation, hardware, software etc	6.3
7.1.4	Environment for the operation of processes	Provide and maintain the suitable environment necessary to the functioning of processes to achieve conformity of products and services. Can be defined in combination of human and physical factors such as Social, psychological, physical, as applicable to organization Example: Work culture, work atmosphere, temperature, ergonomics etc	6.4
7.1.5	Monitoring and measuring resources	Determine the need for monitoring and measuring resources Provide adequate resources for monitoring & measurements (Clause 7.2) Maintain resources (calibrated or verified, or both, at specified intervals, or prior to use) Identification and fitness for use In order to ensure fitness for their purpose Retain documented information on the adequacy of inspection resources (Clause 7.5) Initiate actions, when measuring equipment is found to be unfit for its intended purpose	7.6
7.1.6	Organizational knowledge	Determine the necessary knowledge to control the processes and the conformity of products and services Acquire, maintain and make organizational knowledge available to maintain the performance of the QMS Take into account the need for additional knowledge When needs and trends have changed	None
7.2	Competence	Determine the necessary competence Identify people who have an influence on the performance & effectiveness of QMS Ensure the competence, based on appropriate training or experience Undertake activities to acquire the necessary competence and evaluate the effectiveness of these activities Retain documented information on staff competence (Clause 7.5)	6.2.2
7.3	Awareness	Ensure the staff is aware of the quality policy Including people who carry out work under the company's control.(Clause 5.2 Ensure the staff is aware of the quality objectives (Clause 6.2 Ensure the staff is aware of its contribution In order to improve the performance of the QMS Ensure the staff is aware of negative impacts If QMS requirements are not met	6.2
7.4	Communication	Determine the internal and external communications. Define methodology for internal and external communications Define with whom to communicate Communication Define responsibility for internal and external communications	6.2
7.5	Documented information
7.5.1	Control of Documented Information	Determine documented information required by the ISO 9001 standard Determine documented information necessary for the effectiveness of QMS	4.2.3, 4.2.4
7.5.2	Creating and updating	Create, identify and describe the documented information Choose the format and the media of the documented information Review and approve the adequacy of the documented information	4.2.3, 4.2.4
7.5.3	Control of documented information	Management of availability of the documented information Management of distribution, access and use of the documented information Management of storage of the documented information Management of changes of the documented information Management of retention time and the removal of the documented information Management of documented information of external origin Protect the documented information	4.2.3, 4.2.4
8	Operation	Section title. The whole section addresses the Do phase of P-D-C-A approach	Not Available
8.1	Operational planning and control	Plan and determine the requirements for the products and services Establish the criteria for control of process Determine necessary resources Plan and Control the processes Determine, maintain and retain the documented information on process control Determine, maintain and retain the documented information on product and service conformity Control planned and unplanned changes Analyze the consequences of unplanned changes, actions to limit the effects Control the outsourced processes	7.1
8.2	Requirements for products and services		7.2
8.2.1	Customer communication	Provide information to customers, related to products and services Control communication with customers related to contracts, orders, changes and consultations Control communication with customers regarding the perception, opinions, complaints and recommendations. Control communication with customers regarding their property. Establish communication with customers regarding specific requirements for contingency actions	7.2.3
8.2.2	Determination of requirements related to products and services	Determine the requirements for the products and services Develop specific activities for products and services, to determine statutory and regulatory requirements Define internal requirements, Related to processes, products and services. Determine the feasibility to meet customer requirements Determine process to respond to claims, in a relevant way (with facts)	7.2.1
8.2.3	Review of requirements related to products and services	Determine ability to meet the requirements for products and Services Review explicit customer requirements, Before order acceptance, including delivery and post-delivery activities requirements Review implicit customer requirements, Before order acceptance (unformulated requirements but necessary for specified use or use intended by the customer) Review internal requirements identified by organization Review statutory and regulatory requirements applicable to the products and services Review gaps, Between requirements of an order (or contract) and those previously expressed Resolve gaps, Before order acceptance and commitment to provide products and services Confirm requirements before accepting an order, when requirements are not documented Retain the documented information on the results of the reviews of requirements, (Clause 7.5) Retain the documented information on any new or changed requirement for the products and services, (Clause 7.5)	7.2.2
8.2.4	Changes to requirements for products and services	Communicate changes to relevant persons, After changing requirements in the documented information	7.2.2
8.3	Design and development of products and services
8.3.1	General	Establish, implement and maintain a process of design and development	7.3.1
8.3.2	Design and development planning	Plan the design and development stages Consider the specificity of design and development activities Consider the process requirements and applicable reviews Consider the verification and validation activities Consider the necessary responsibilities and authorities Consider the needs of internal and external resources Consider the relations between persons participating in the design and development Consider the need for involvement of customers and users Consider the requirements for subsequent products and services Consider the level of control expected by interested parties Consider the documented information meeting design and development requirements. (Clause 8.3.3, 8.3.5 and 8.3.6)	7.3.1
8.3.3	Design and development inputs	Determine essential requirements, regarding specific types of products and services from design and development Determine functional requirements, Consider also the performance requirements Consider the information from similar activities Consider the statutory and regulatory requirements Consider the corporate culture, internal rules of art Consider the potential consequences of product and service failure Check that the inputs are complete and unambiguous, In order to realize suitable design and development process Resolve potential conflicts between inputs, In order to obtain complete and unambiguous inputs Retain the documented information on design and development inputs, (Clause 7.5)	7.3.2
8.3.4	Design and development controls	Define clearly the expected results, Regarding processes, products and services Conduct reviews as planned , Regarding processes, products and services Check that outputs meet input requirements, (Clause 8.3.5) Validate products and services , To ensure that the specified application requirements or those for the intended use are satisfied Take actions in response to identified problems, during reviews, verifications and validations Ensure that the documented information is retained (Clause 7.5, 8.3.3, 8.3.5 and 8.3.6)	7.3.4, 7.3.5, 7.3.6
8.3.5	Design and development outputs	Ensure that outputs meet input requirements, (Clause 8.3.3) Ensure that outputs are in line with the subsequent processes, processes regarding the products and services Ensure that outputs include monitoring and measuring requirements, including acceptance criteria is defined Ensure that outputs are suitable for their intended use, proper use or planned by the customer in complete safety Retain the documented information on outputs, (Clause 7.5 )	7.3.3
8.3.6	Design and development changes	Identify, review and control the changes made to inputs and outputs, ensure that the changes have no impact on meeting the requirements Retain the documented information on changes (Clause 7.5) Retain the documented information on results of reviews (Clause 7.5 Retain the documented information on who authorized the changes (Clause 7.5) Retain the documented information on actions, in order to prevent negative impacts. (Clause 7.5)	7.3.7
8.4	Control of externally provided processes, products and services		4.1
8.4.1	General	Ensure that the outputs of external providers meet specified requirements Apply the requirements for the control of products and services provided by external providers When the products and services are integrated internally, apply the requirements for the control of products and services When the products and services are provided directly to customers by external providers on behalf of the company, apply the requirements for the control of process done by external providers determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers Retain the documented information on the results of the evaluation and monitoring(Clause 7.5)	7.4
8.4.2	Type and extent of control	Determine & apply the level of control of external providers on meeting the requirements Ensure that the processes of external providers are controlled Define how to control the external provider and its process outputs Consider the potential impact of the outputs of the external provider Consider the control of the external provider, and effectiveness of this control Define how to control the outputs of externally provided processes Verification and other activities necessary to ensure that the provision of external providers does not affect the conformity of products and services delivered to the customer	4.1, 7.4
8.4.3	Information for external providers	Verify the adequacy of the requirements, prior to communication to the external provider Communicate the requirements to the external provider, regarding the processes, products and services to provide regarding the approval of products and services regarding the approval of methods, processes and equipment regarding the approval of the release of products and services regarding the competence (including required qualifications) regarding the relations between the external provider and the company regarding the control and monitoring of the external provider's performance regarding the verification or validation activities that the organization or its customer intends to realize at the external provider's premises	None
8.5	Production and service provision		7.5
8.5.1	Control of production and service provision	Apply controlled conditions of production and service provision including delivery and post-delivery activities Maintain documented information of specifications of products and services and the expected activities (Clause 7.5) Save the documented information of results to be achieved (Clause 7.5) Include in the controlled conditions the inspection resources (Clause 7.1.5) the inspection activities, to verify that the appropriate stages of the processes' outputs meet the criteria Include in the controlled conditions adequate infrastructure and environment (Clauses 7.1.3 et 7.1.4 the staff competence, the necessary qualification, (Clause 7.2 the validation of the ability of a process to achieve the expected results, when the outputs cannot be checked , the actions to prevent human error the activities of release, delivery and post-delivery (Clause 8.6 and paragraph 8.5.5	7.5.1
8.5.2	Identification and traceability	Use appropriate means to control the unique identification of process outputs, to ensure the conformity of products and services when needed Inspect processes throughout the production and service provision Control the traceability of process outputs, When traceability is a requirement, the unique identification is used Retain the documented information on traceability	7.5.3
8.5.3	Property belonging to customers or external providers	Exercise care with property owned by customer or external provider Identify, check, protect, monitor and safeguard customer or external provider property Notify the customer or external provider when his property has been damaged or lost and maintain the documented information on the situation	7.5.4
8.5.4	Preservation	Preserve the process outputs throughout production and service provision activities, Ensure: identification, packaging, handling, storage, transport, protection	7.5.5
8.5.5	Post-delivery activities	Meet the requirements for post-delivery activities Consider statutory and regulatory requirements Consider negative impacts related to products and services Consider the nature, the intended use and lifetime of products and services consider the requirements of interested parties Consider customer feedback	7.5.1, 7.2.1
8.5.6	Control of changes	Review and control unplanned changes Retain the documented information on unplanned changes	4.2.3, 5.4.2, 7.3.7

Documented information to maintain (documented procedures) :
- scope of the QMS (Clause 4.3)
- process control (Clause 4.4.2 a)
- quality policy (Clause 5.2.2 a)
- quality objectives (Clause 6.2.1)
- operational control (Clause 8.1)

Documented information to retain (records) :
- process performance (Clause 4.4.2 b)
- fitness for purpose of inspection persons (Clause 7.1.5.1)
- calibration (Clause 7.1.5.2)
- staff competence (Clause 7.2)
- conformity of products and services (Clause 8.1)
- results of the review of products and services requirements (Clause 8.2.3.2)
- design and development inputs (Clause 8.3.3)
- design and development outputs (Clause 8.3.5)
- design and development changes (Clause 8.3.6)
- evaluation activities and actions of external providers (Clause 8.4.1)
- traceability of products and services (Clause 8.5.2)
- situation of the property of a customer (Clause 8.5.3)
- results of the review of changes (Clause 8.5.6)
- release of products and services (Clause 8.6)
- treatment of nonconforming products and services (Clause 8.7.2)
- inspection results (Clause 9.1.1)
- audit programme and audit results (Clause 9.2.2)
- management review outputs (Clause 9.3.3)
- nonconformities, actions and results (Clause 10.2.2)

Your transition journey
TechnoSysCon has identified a step-by-step journey to help you through the transition and realize the benefits of ISO 9001:2015. We have mapped out a framework which guides you through the options and support available from TechnoSysCon to ensure you have the knowledge, information and support you require. TechnoSysCon has a full range of services available including GAP assessments, in-house trainings, documentation, implementation, internal audits and complete support till certification. If you have questions regarding Transition or certification for ISO 9001:2015 call us.