Implementation Guideline For Clause 7 of ISO 9001 2015 Standard

Clause 7 of ISO 9001 2015 standard is a support clause. As name suggests, it supports the operation in terms of providing and managing resources. Resources are peoples, Infrastructure, Work environment, Knowledge, Documentation etc.

Following is clause wide guideline for Clause 7 – Support

7.1 – Resources.

7.1.1 – General.

This clause requires that organization shall do a kind of feasibility study inline with fulfillment of requirement of Quality management system. Feasibility study will give output as what are capabilities of internal resources. What are weaknesses of internal resources. Also based on weakness of internal resources and to fulfill requirements of Quality management system, what shall be obtained from external providers.

7.1.2 – People.

Peoples are key strength of any system. ISO 9001 2015 standard asks that peoples shall be provided to ensure an effective quality management system, for better operation and control of quality system processes.

7.1.3 – Infrastructure.

Infrastructure includes hardware, software, equipments, instruments, utilities, communication and transportation facilities etc. Infrastructure shall be provided to achieve conformity with product requirements and operation of quality system processes. As it already suggests that technical processes have enough infrastructure for achieving product requirements.  All managerial processes shall have adequate infrastructure for operation ( performing ) and control of processes.

7.1.4 – Environment for operation of processes .

ISO 9001 2008 standard was specifying work environment. Where as ISO 9001 2015 standard specifies Environment for operation of processes. Earlier version of ISO 9001 standard was focusing upon work environment – mainly technical aspects. However 2015 operation covers almost all processes and demands that environment shall be effective so that process can achieve intended results.

7.1.5 – Monitoring and Measuring Resources.

As per ISO 9001 2008 version, this clause requires calibration and upkeeping of instruments used for monitoring and measurement activity. Monitoring and measurement includes for both products and processes that affects product requirements. If calibration is carried out then national / international traceability of basis used for calibration shall be maintained.

7.1.6 – Organizational Knowledge.

Organizational knowledge is a new addition of ISO 9001 2015 standard. However it was almost hidden in earlier version. All documentation is a kind of knowledge of organization. ISO 9001 2015 version stats that organization shall strengthen documentation activity and ensure that whatever is there in the minds of people that gets reflected in the documents. Documents shall guide various problems occured in the past and their solution so that in future they can be handy during implementation.

 

7.2 – Competence .

ISO 9001 2015 version stats that organization shall determine competence of persons in its control whose work affects performance and effectiveness of quality management system. This covers all employees and contract peoples. Even this may be extended to suppliers if convenient. Competence shall be determined in terms of experience, education and training. If any person is not fulfilling required competence level then suitable actions shall be taken including training or position transfer. Organization shall evaluate effectiveness of this action taken.

7.3  – Awareness.

ISO 9001 2015 version stats that all persons who are in control of organization shall be aware of

  • Quality policy
  • Quality objectives
  • What is the purpose of work they are performing ? What will be benefit if they improve their performance?
  • What are issues if they do not follow required process ?

Awareness clause will connect persons of organization with vision and mission – overall strategy of organization.

7.4 – Communication.

ISO 9001 2015 version stats effective internal and external communication arrangements shall be done for an effective quality management system. Communication includes provision of infrastructure and processes for faster, accurate and complete communication. Communication process may include a matrix

  • what to communicate
  • when to communicate
  • who will communicate
  • to whom it will communicate
  • how it will communicate

7.5 – Documented information.

ISO 9001 2015 version stats that all documents shall be identified with a title / number / date. Format of document shall be defined. Document shall be reviewed and approved.

Document shall be available whenever and wherever required. Document shall be protected against unauthorised access and protected for loss of its integrity.

Document’s distribution shall be controlled to ensure that relevant versions are available at required places. Retention and disposition of documents shall be defined.

Documentation includes internal and external documents.

 

Above is an overview of clause wise requirements of ISO 9001 2015 standard. This shall be taken as guideline and not as confirm requirement. Organizations interested in achieving fresh ISO 9001 2015 certification, upgrading their existing ISO 9001 2008 standard to ISO 9001 2015 standard may contact us for training on requirements of ISO 9001 2015 standard and consultancy for implementation of ISO 9001 2015 standard.

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