ISO 9001 revision 2015

ISO 9001 REVISION
2015
TRANSITION

ISO 9001:2015 revision

issued on: 15 September 2015

transition period: 3 years

ISO 9001:2008 certifications: valid until 15 September 2018

The latest revision of ISO 9001 standard brings an evolution in quality management and move forward from recording and documenting to efficient process managing with associated risks control. Previous versions of ISO 9001 had become a flagship quality management standard, worldwide recognized and used by over million certified organizations. The new revision will support the growing trend and bring new view and approach developed on industry evolution related to globalization, complexity of supply chain modern needs and on the other hand increasing customers expectations and demanded value, customers requirements and other interested parties.

What the new revision means to my current ISO 9001:2008 certification?

Transition period has been determined in order to provide manufacturers or other organizations following quality management standard ISO 9001 to adapt to new changes and approaches. New version was developed to meet the needs of today business environment however is recommended to follow the implemented quality management system and adjust it accordingly with new changes or additional aspects specified by ISO 9001:2015 standard version.

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Essential steps to by followed prior ISO 9001:2015 transition

  • Familiarize yourself with the new ISO 9001:2015 revision, changes and their affect on established quality management system.
  • Based on a maturity and effectiveness of the current management system analyze organization readiness and identify gaps which need to be addressed to meet new requirements.
  • Develop an transition implementation plan within your organization
  • Aware all interested parties and train staff about new ISO 9001 standard and necessary changes and their impact on established processes, common practice and organization structure.

See the correlation matrix below to understand ISO 9001:2015 and ISO 9001:2008 linking.

ISO 9001:2015 - structure matrix

1              Scope

 


4         Context of the organization


4.1      Understanding the organization and its context


4.2      Understanding the needs and expectations of interested parties


4.3      Determining the scope of the quality management system

 


4.4      Quality management system and its  processes

 


5          Leadership


5.1      Leadership and commitment


5.1.1  General


5.1.2  Customer focus


5.2      Policy


5.2.1  Establishing the Quality Policy


5.2.2  Communicating the Quality Policy


5.3      Organizational roles, responsibilities and  authorities

 

 


6         Planning


6.1      Actions to address risks and opportunities

 


6.2      Quality objectives and planning to achieve them


6.3      Planning of changes


7         Support


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


7.1.5.1  General


7.1.5.2  Measurement traceability


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

 


8         Operation


8.1      Operational planning and control


8.2     Requirements for products and services


8.2.1  Customer communication


8.2.2  Determination of 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 controls

 

 


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


9         Performance evaluation


9.1      Monitoring, measurement, analysis and evaluation


9.1.1  General

 


9.1.2  Customer satisfaction


9.1.3  Analysis and evaluation


9.2      Internal audit


9.3      Management review


9.3.1  General


9.3.2  Management review input


9.3.3  Management review output


10       Improvement


10.1   General


10.2   Nonconformity and corrective action

 


10.3   Continual Improvement

 


ISO 9001:2008 - structure matrix

1         Scope

1.1      General


4         Quality management system


4         Quality management system


4         Quality management system


1.2      Application

4.2.2  Quality manual


4         Quality management system

4.1      General requirements


5         Management responsibility


5.1      Management commitment


5.1      Management commitment


5.2      Customer focus


5.3      Quality policy


5.3      Quality policy


5.3      Quality policy


5.5.1  Responsibility and authority

5.5.2  Management representative

5.4.2  Quality management system planning


5.4.2  Quality management system planning


5.4.2  Quality management system planning

8.5.3  Preventive action


5.4.1  Quality objectives


5.4.2  Quality management system planning


6         Resource management


6         Resource management


6.1      Provision of resources


6.1      Provision of resources


6.3      Infrastructure


6.4      Work environment


7.6      Control of monitoring and measuring equipment


7.6      Control of monitoring and measuring equipment


7.6      Control of monitoring and measuring equipment


No equivalent clause


6.2.1  General

6.2.2  Competence, training and awareness


6.2.2  Competence, training and awareness


5.5.3  Internal communication


4.2     Documentation requirements


4.2.1  General


4.2.3  Control of documents

4.2.4  Control of records


4.2.3  Control of documents

4.2.4  Control of records


7         Product realization


7.1      Planning of product realization


7.2      Customer-related processes


7.2.3  Customer communication


7.2.1  Determination of requirements related to the product


7.2.2  Review of requirements related to the product


7.2.2  Review of requirements related to the product


7.3     Design and development


7.3.1  Design and development planning


7.3.1  Design and development planning


7.3.2  Design and development inputs


7.3.4  Design and development review

7.3.5  Design and development verification

7.3.6  Design and development validation


7.3.3  Design and development outputs


7.3.7  Control of design and development changes


4.1     General requirements

7.4.1  Purchasing process


7.4.1  Purchasing process


7.4.1  Purchasing process

7.4.3  Verification of purchased product


7.4.2  Purchasing information

7.4.3  Verification of purchased product


7.5      Production and service provision


7.5.1  Control of production and service provision

7.5.2  Validation of processes for production and service provision


7.5.3  Identification and traceability


7.5.4  Customer property


7.5.5  Preservation of product


7.5.1  Control of production and service provision


7.3.7  Control of Design and Development Changes


7.4.3  Verification of purchased product

8.2.4  Monitoring and measurement of product


8.3     Control of nonconforming product


8       Measurement, analysis and  improvement


8       Measurement, analysis and   improvement


8.1      General

8.2.3  Monitoring and Measurement  Processes


8.2.1  Customer satisfaction


8.4     Analysis of data


8.2.2  Internal audit


5.6     Management review


5.6.1  General


5.6.2 Review input


5.6.3 Review output


8.5    Improvement


8.5.1 Continual improvement


8.3    Control of nonconforming product

8.5.2 Corrective action


8.5.1 Continual improvement

8.5.3 Preventive action


  • Accordingly implement actions and update your existing quality management system to meet the revised requirements.
  • Contact bqs. and inform about options for certification transitioning to new ISO 9001:2015.

What are key changes in ISO 9001:2015?

  • Context of the organization
    Organization shall consider and take into account needs and expectations of all interested parties as a combination of internal and external factors and conditions that may have an effect on products, services or interested parties.
  • Risk-based thinking approach
    Risk-based thinking has become a main pillar of the new ISO 9001:2015 standard. Risk control approach well know for example form European directives for medical devices, shall be the main tool for management of processes within the organization as well as basis start point for activities known from ISO 9001:2008, Preventive actions which are not longer determined in the new revision.
  • The engagement of interested parties
    Suppliers, customers, shareholders, regulators, environment are now included as interested parties which can affect, be affected by, or perceive themselves to be affected by a decisions or activities. As an organisation, awareness of the importance of related interested parties’ expectations, requirements and needs shall be promote and implemented into decision making and strategic planning.
  • Leadership
    Emphasis on leadership and management commitment is enhance in ISO 9001:2015 more than any time before. Greater involvement of top management is required for controlling and building quality management system.  It requires greater involvement by top managers and business leaders in controlling the quality management system in stead of management representative as was mentioned on ISO 9001:2008.
  • Documented information
    Step forward from documented procedures and records. Important are information necessary for effective performance of implemented quality management system. ISO 9001:2015 even does not requires quality manual.
  • High level structure
    Current standardization approach of ten clauses structure has been implemented as well to ISO 9001:2015. This means as well the new revision and its integration to other management system or conversely is simpler and smooth.

How long is ISO 9001:2008 certification valid?

In general ISO 9001:2008 certification is recognized and valid three years after issuance of the certificate however if you received certificate from bqs. after 15 September 2015, its validity has been automatically limited to 15 September 2018 and this is your ISO 9001:2008 expiration. From this date all certifications will be performed against the requirements laid down be new revision ISO 9001:2015, however we from 2017 bqs. will certify solely according the new revision of the standard. Please note, bqs. will start automatically re-certification process of your current ISO 9001:2008 certification 6 months prior its expiration however all bqs. clients, clients waiting for gentrification transfer to bqs. will have to pass auditing and assessment process prior ISO 9001:2008 deadline.

Is possible to make transition during current ongoing certification cycle?

Definitely yes! We at bqs. even recommend to start the transition process and perform transition/certification audit during planned upcoming surveillance audit in case your quality management system and organization are ready to be challenged by our auditors and technical expert against requirements of new ISO 9001:2015 revision. We will keep your current audit schedule and certification cycle if you prefer. Please contact us and ask for possible options.

How to achieve certification according to ISO 9001?

Certification to ISO 9001 consists of several steps prior we are able to grant you certificate as a result of compliance with all applicable requirements of ISO 9001 standard or other relevant regulations.

The steps to ISO 9001 certification

  • Pre audit and gap analysis Voluntary activity performed prior the formal assessment activities. We will challenge your implemented quality management system against the all applicable requirements set by ISO 9001 standard, in order to have a closer look over your system, facilities and processes, identify and determine all possible gaps in compliance and analyze potential risks and opportunities for improvement. Based on the status of organization`s readiness to comply with ISO 9001 the assessment activities will be planned.
  • Off-site assessment Before we take a on-site visit related to conformity assessment, our auditors will review your quality management documentation, procedures and controls over processes you have implemented. All in order to get familiar with specific aspects of your production and found strong and weak points in management system documentation.
  • Stage one audit and stage two audits Audit teams will challenge your quality management system, process controls, staff and other resources and determined their compliance with applicable ISO 9001 requirements. All findings identified during the stages will be communicated with your organization and subsequent actions verified.
  • Certification body decision On the basis of audit team recommendation certification body will take a decision related to issuance of certification. In the case you prove an ability to meet requirements of ISO 9001 quality management systems standards, a certificate with three year validity will be granted to your organization.
  • Post certification activities In order to prove continuous compliance with ISO 9001, bqs. as your certification body will annually perform surveillance audits over your facilities and quality management system in order to verify your commitment to continuous improvement and compliance with customer requirements.

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