ISO 9001:2015

One day workshop for organisations which want to upgrade to the new

standard from 2008 version

Quality Management Principles

• Customer Focus• Leadership• Engagement of people• Process Approach• Improvement• Evidence based decision making• Relationship management

Process Approach

• Standard advocates a process approach. This approach enables the organisation to control the interrelationships and interdependence among the processes.

A Single Process in a system

PDCA Cycle and the standard

Is this possibl

e?

Risk Based thinking

• This is a new requirement in the standard.• Organisation needs to plan and implement

actions to address risks and opportunities. • Opportunities arise due to change in external

circumstances like the new technology.• Risk is effect of uncertainty. It is due to

possible consequences of certain actions. Risks can be positive or negative.

Main clauses (changes)

• 4. context of the organisation• 5. Leadership• 6. Planning• 7. Support• 8. Operation• 9. Performance evaluation• 10. Improvement

4. Context of Organisation

• 4.1 Understanding the organisation– Determine external and internal issues that are relevant for

the purpose of the organisation (P/D/R/A) • 4.2Understanding the needs and expectations of

customers and interested parties– The Interested parties are key for survival of the organisation

and their requirements are important (P/D/R/A)• 4.3 Determining the scope of the QMS

– Boundaries, products and services etc (P/D/R/A)– Note P=Procedure D=Document R= Record A=only action

Extent of documentation at

this clause

4.4 QMS and its processes• What are the processes needed to achieve the objectives in the

system?• Inputs, outputs, interactions, measures for these processes

need to be defined. D• Resources roles and responsibilities to be defined. D• Risks and opportunities need to be determined. A• Evaluate and improve the processes A• Create and maintain documented information related to these

processes D• Retain documented information to have confidence R• (P/D/R/A )

5. Leadership

• 5.1 Leadership and commitment• 5.2 Policy• 5.3 Organisational roles and responsibilities

5.1 Leadership and Commitment• 5.1.1 General

– Quality Policy, Objectives, Ensuring the resources required are provided, Promoting Risk based thinking, promoting Improvement, supporting other management roles relevant for QMS A

– Policy and objectives (P/D/R/A) • 5.1.2 Customer Focus

– Customer requirements are determined. Statutory requirements are determined. Risks and opportunities related to the products and services determined. Focus on enhancing customer satisfaction is maintained.

– Statutory requirements (P/D/R/A)

5.2 Policy

• 5.2.1 Establishing the Quality Policy– Establish, maintain a quality policy– (P/D/R/A)

• 5.2.2 Communicating the Quality Policy– Policy should be available and should be

communicated – (P/D/R/A)

5.3 Organisational roles and responsibilities (P/D/R/A)

• Ensuring that the QMS conforms to the requirements of the standard.

• Ensuring that the processes are delivering their intended inputs

• Reporting on the performance of QMS• Ensuring the promotion of customer focus• Ensuring the integrity of the QMS when

changes are implemented

6 Planning• 6.1 Actions to address risks and opportunities

– While planning consider the issues and requirements and determine the risks and opportunities

– Plan the actions to address the risks and opportunities– How to integrate these actions in QMS – P/D/R/A

• 6.2 Quality objectives and planning– Measurable, monitored, communicated updated P/D/R/A– Determine how to achieve quality objectives P/D/R/A

• 6.3 Planning of changes – Changes should be carried out in a phased manner P/D/R/A

7 Support

• 7.1 Resources– 7.1.1 capabilities of and constraints on existing internal

resources and what needs to be done on external service providers P/D/R/A

– 7.1.2 People- Determine and provide the persons necessary for implementation of QMS P/D/R/A

– 7.1.3 Infrastructure-Provide and maintain the infrastructure necessary for operation of processes P/D/R/A

– 7.1.4 Environment for operation of processes- social, psychological and physical aspects P/D/R/A

7.1.5 Monitoring and measuring resources

– 7.1.5.1 provide resources required for measuring and monitoring activities and maintain them for continuing fitness.

– P/D/R/A– 7.1.5.2 Measurement traceability: where

traceability is a requirement, calibration shall be done and records will be maintained

– P/D/R/A

7.1.6 Organisational Knowledge

• Knowledge shall be maintained for the operation of its processes and will be made available. P/D/R/A

• Current knowledge available and acquisition of additional knowledge. P/D/R/A

7.2 Competence

• Determine the competence required to perform tasks-P/D/R/A

• Ensure that the persons doing the tasks are competent -P/D/R/A

• Where applicable, take actions to acquire the competence-P/D/R/A

• Retain appropriate documented information regarding the actions taken as evidences. P/D/R/A

7.3 Awareness

• Ensure that people are aware of– Quality policy– Quality Objectives– Their contribution to the effectiveness of QMS– Implications of not conforming to the QMS – P/D/R/A

7.4 Communication

• Determine internal and external communications relevant to the QMS– What to communicate, when to communicate

with whom, how and who will communicate– P/D/R/A

7.5 Documented Information

• 7.5.1-Documented QMS will include documented information required by the standard and documented information required as necessary by the organisation

• 7.5.2 Creating , updating and control of documented information is to be ensured.

• Documents of external origin should be identified. P/D/R/A

8 Operation

• 8.1 Operation Planning and Control– Determining requirements for products and services

Establishing criteria for products, services and processes P/D/R/A

– Determining resources required to achieve the conformity to requirements P/D/R/A

– Implementing control of processes P/D/R/A– Determining , retaining documented information to have

the confidence that the processes have been carried out as planned and products and services meet the requirements. P/D/R/A

8.2 Requirements for products and services

• 8.2.1 Customer communication– Providing information (related to products and

services) P/D/R/A– Handling enquiries P/D/R/A– Obtaining feedback P/D/R/A– Handling customer property P/D/R/A– Establishing specific requirements for contingency

actions P/D/R/A

8.2.2 Determining requirements for products and services

• Requirements for products and services should be defined including statutory requirements and its own requirements.

• P/D/R/A• It should ensure that it meets the claims to

meet the requirements. P/D/R/A

8.2.3 Review of the requirements for products and services

• Organisation should conduct a review of requirements and its ability to meet them before committing to supply products and services. P/D/R/A . These include stated , unstated, legal, and own requirements.

• Organisation should retain the documented information and manage changes. P/D/R/A

8.3 Design and Development of products and services

• 8.3.2 Design and Development planning– While doing the planning the organisation should

consider the complexity of the design, the required stages, the need for reviews and verifications, responsibilities , internal and external resources, interfaces, involvement of customers, requirements for the products being designed, nature of control of customers in the design process and the documented information needed to demonstrate that the requirements have been met. P/D/R/A

8.3.3. Design and development Inputs

• Functional and performance requirements P/D/R/A• Information from previous design activities• P/D/R/A• Statutory and regulatory requirements P/D/R/A• Standards and codes of practice P/D/R/A• Potential causes of failure due to the nature of

products P/D/R/A• Conflicting inputs should be resolved. P/D/R/A

8.3.4 Design and Development controls

• Controls applicable– The results to be achieved should be defined D– Reviews to be conducted to evaluate the ability of

design to satisfy the requirements A– Verification to be done to evaluate whether design

outputs meet the input requirements A– Validation to be done to evaluate whether the product

meets the requirements of the specific application A– Needed actions should be taken on problems noticed

during the reviews, verification or validation. A

8.3.5 Design and Development outputs

• Design and development outputs should meet the input requirements

• be adequate for the subsequent processes• include reference monitoring requirements• Specify characteristics of the products and

services essential for their intended purpose and for safe provision. P/D/R/A

8.3.6 Design and Development changes

• Organisation should maintain documented information on– Design and development reviews– Authorization of changes– Decisions taken to prevent adverse impacts – P/D/R/A

8.4 Control of externally provided products and services

• Products and services could be supplied to the organisation for incorporation in its products and services

• Products and services could be directly supplied to customer on behalf of the organisation

• Process(es) for making a product/providing a service itself could be provided by an external organisation

8.4.2 Type and extent of control on external suppliers

• Externally provided processes should be within the control of the QMS

• Controls should be on the processes as well as the products

• Controls should be appropriate to the a) impact of the external supplier on the organisation’s ability to supply acceptable products b) the existing controls of the supplier. These controls will include inspection and verification.

8.4.3 Information for external providers

• Organisation to provide information in the form of (P/D/R/A)– Requirements for products, services– Approval of products, services– Competence of people– Interactions with external providers (reviews)– Monitoring of the performance of external

providers

8.5 production and service provision

• Controlled conditions for production provision– Availability of documented information D– Availability of monitoring resources A– Implementation of monitoring and measurement A– Use of suitable infrastructure and environment A– Appointment of competent people D– Validation of certain processes R– Implementation of error proofing activities A– Implementation of release , post release and delivery

activities A

8.5.2 Identification and traceability

• Organisation to – Identify outputs when it is necessary for products – Identify status of outputs with respect to

monitoring and measurement– Uniquely identify the outputs when required for

traceability P/D/R/A

8.5.3 property belonging to customers or external providers

• Property belonging to customers and external providers need to be identified, verified and protected when it is in the control of the organisation. P/D/R/A

• When the property is lost, damaged or stolen it should be reported to the owner Of the property. P/D/R/A

• The property may be tangible or intangible.

8.5.4 Preservation

• Organisation should preserve the outputs during production provision to the extent it is necessary to ensure conformity to requirements P/D/R/A

8.5.5 Post Delivery activities

• Post delivery activities should be in line with– Statutory and regulatory requirements – Risk associated with installation or commissioning– Usage during life time of the product including

disposal or recycling of the product– Customer requirements– Customer feedback

8.5.6 Control of changes

• Review changes in the production provision and control them. P/D/R/A

• Retain results of reviews of changes , actions arising from the reviews and the persons authorising the changes subsequent to the reviews P/D/R/A

8.6 Release of the products

• Products can be released only after the intended verification activities are completed. P/D/R/A

• Incase they have to be released, they have to be approved by appropriate authority. P/D/R/A

• Organisation to retain documented information on a) evidence of conformity of product with the criteria and b) the identity of the person authorising the release. P/D/R/A

8.7 Control of non conforming outputs

• Outputs from processes which do not conform to the requirements should not be delivered to customer. P/D/R/A

• Organisation should take action depending on the non-conformity and the effect of such non-conformity on the use of the product. P/D/R/A

8.7 Control of non conforming outputs

• Organisation can deal with non conformities in one of the following ways– Correct the non conformity– Segregate, contain, return or suspend the product– Inform the customer (and request for decision)– Obtain the authorization under concession– When the outputs are corrected they should be again

verified for conformity.– All information about the non conformity and

subsequent actions should be retained. P/D/R/A

9. Performance evaluation

• 9.1 Monitoring, Measurement, Analysis and information– Organisation should decide what are the

measurements to be collected about the processes or products and when and how the measurements should be collected. P/D/R/A

9.1.2 Customer satisfaction

• Organisation should monitor perceptions of customers about the extent to which their needs and expectations are being fulfilled by the organisation while delivering the product and service. P/D/R/A

9.1.3 Data Analysis

• Whatever data comes from the monitoring and measurement, it should be analysed. P/D/R/A

• By analysis the following can be evaluated– Conformity of products– Degree of customer satisfaction– Effectiveness of QMS– Successful completion of plans– Effectiveness of risk management – Performance of external providers– Need for improvements (which process?) R

9.2 Internal audit

• Audits will be conducted at planned intervals with personnel who are qualified and in an objective manner. A

• The entire audit programme shall be based on the importance of the processes, changes to QMS and the results of previous audits. D

• Results of audits should be reported and actions taken without delay. R

9.3 Management review

• Management should review the QMS at periodic intervals for suitability, adequacy, effectiveness and alignment with the strategic direction. A

• The inputs should include all measurement results, customer feedback, effectiveness of actions to address risks and performance of external providers. D

• Outputs should include opportunities for improvement, changes required and resource needs. R

10 Improvement

• 10.1 General• Improvement should be for enhancing

customer satisfaction.– Improving products and services to meet current

requirements and future needs– Correcting, preventing or reducing undesired

effects of products and services – Improving the performance and effectiveness of

QMS

10.2 Non conformity and corrective action

• 10.2.1• When a non conformity occurs/complaint is

received D– React to the non conformity, take action to correct

the non conformity– Deal with the consequences (inc case correction is

not feasible) – evaluate the need for actions to eliminate the

causes for non conformity so that it does not recur

10.2 Non conformity and corrective action

• Continued from last slide– Implement actions needed– Review the effectiveness of actions– Update the risks (due to changes)– Make changes in QMS, if needed

– Keep documented information regarding corrective actions and results thereof. R

10.3 Continual improvement

• Organisation should implement actions for continual improvement of its QMS A