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Quality System ISO 9001:2015

Quality management ISO 9001: 2015
First revision: Jul.17, 2018
Last revision: Jan.07, 2019
    Me, as a QMR (Quality Management Representative) of the Company, that I had worked and studied together with the Freelance ISO 9001, I fell and got that ISO 9001: 2015 had very usefully for the company. 

 
Quality management systems - Requirements03

Contents
Foreword
Introduction
1     Scope
2     Normative references
3     Terms and definitions
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
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
                 7.1.6     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     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 controls
                 8.3.5     Design and development outputs
                 8.3.6     Design and development changes
       8.4     Control of externally provided process, 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, analyis 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 inputs
                 9.3.3     Management review outputs
10    Improvement
       10.1    General
       10.2    Nonconformity and corrective action
       10.3    Continual improvement   






9.3 Management Review01
       The management review is a management tool in the hands of the top management for evaluating the QMS. It is one method (among others) dictated by the standard for monitoring the QMS and evaluating its performances and effectiveness. The management review is an activity usually performed as a meeting where representatives of the top management are presented with data and information regarding the performances of the QMS. The objective of the review is to give the top management a chance to periodically evaluate the QMS. Let us review the ISO 9001 Standard requirements.

9.3.1  General
  • Top management shall review the QMS at defined intervals.
  • The review shall be planned.
  • The review shall ensure the consecutive suitability, adequacy, and effectiveness of the organization.

Goal of the Management Review
     The ISO 9001 Standard clearly specifies the goal of the management review - to ensure its continuing suitability, adquacy, effectiveness, and alignment with the strategic direction of the organization of the QMS. Let us interpret it.
  • The strategic direction of the organization was determined while discussing the context of the organization and should be documented (e.g., in the quality manaul in case you are still choosing to maintain one). In practice, you may review the quality policy in order to ensure its suitability to the purpose of the organization.
  • To ensure the continuing suitability of the QMS refers to the review whether characteristics of the QMS are appropriate for their objectives.
  • To ensure the adequacy of the QMS refers to the review whether the QMS can act correctly in order to fulfill its requirements and achieve its objectives.
  • To ensure the effectiveness of the QMS refers to extent of achievement of quality objectives.


Participants of the Management Review
     Participants of the management review are clearly defined by the standard - the top management. But who is considered as the top management? According to the ISO 9000, the top management consists of persons or group of people who direct and control an organization at the highest level. To this definition I choose to add a person or a group of persons who have the authority to appoint resources for the QMS. But when the scope of the QMS refers only to a part of the organization, for example, the logistic center or the service center, the top management is not considered as the board of directors of the whole organization but the organizational role who steers and directs the logistic center or the service center. This fact makes it simpler to define the relevant top management.


9.3.2 Management Review Inputs02
      For effective review and decision making, the management review shall take into account the following issues:
  • Follow-ups from previous reviews and status of decisions and actions taken.
  • The review shall discuss changes in external and internal issues that are relevant to the quality management and their influence on it.
  • Information regarding the performance of the QMS with reference to trends and indicators such as
    • Results of customer satisfaction and feedback measurements
    • The extent to which quality objectives have been met
    • Process performance and product conformance supported by evidences
    • Audit results: Internal, external, and customer audits
    • Information about nonconformities and status of corrective actions
    • Results of monitoring and measurement activities
    • Issues related to suppliers and external providers that may affect products, services, and the QMS.
  • The adequacy of resources
  • The effectiveness of actions taken to address risks and opportunities
  • Opportunities for impovement  





Sources & Narratives:
01.  9001quality.com/9-3-management-review/, retrieved date: 17 July 2018.
02.  9001quality.com/9-3-2-management-review-inputs/, retrieved date: 17 July 2018.
03.  https://infostore.saiglobal.com/preview/is/en/2015/i.s.eniso9001-2015.pdf?sku=1822374, retrieved date: 07 September 2018.




 
 
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