Sunday 18 April 2021

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ISO 9001 Implementation

 

Quality One ISO9001 Implementation

Organisational Process Maturity Survey Organisational Process Maturity Survey
Conducting the As Is State Conducting the As Is State
The Process Maturity Score The Process Maturity Score
ISO9001 Gap Analysis ISO9001 Gap Analysis
Planning to the To Be State Planning to the To Be State
Implementing ISO9001 Implementing ISO9001
Implementing Process Maturity Plan Implementing Process Maturity Plan

ISO9001 Implementation Home Organisational Process Maturity Survey

In order to implement ISO9001 with a level of process maturity that will in the long term reduce the administrative burden on the organisation the current level of process maturity needs to be obtained in order to determine the actions required for implementation.

The first step in determining the current level of process maturity is to conduct an Organisational Process Survey - this allows for the As Is state to be revealed.

The survey covers the levels of process delivery in key areas of process development. It should establish the levels of maturity of the organisational process capability and the administrative system that has the objective of reducing the burden to deliver the required level of capability.

Survey questions would include whether process elements are present and the levels they are developed to. As an example questions could be but are not limited to:

  • Are process maps present
  • Do process maps include
    • A SIPOC View
    • Swimlanes to indicate resource requirements
  • Is there an explanation of language and nomenclature present
  • Are KPI present for processes
    • Does KPI include the physical targets of the product
    • Do KPI represent customer expectation levels
    • Are KPI linked to critical and significant process/service/product characteristics
    • Is there analysis of process interaction for conflicting KPI
  • Is a process hierarchy present
    • Is the hierarchy in distinct levels
    • Does the process hierarchy match reporting requirements
  • Is a process interaction matrix present
    • Is the risk of each process identified
  • Are processes and process maps linked to procedure documents
  • Are the skills required to deliver each process present
    • Are the skills required linked to the training matrix
  • Is the ability to conduct change management of a process present
    • Is process documentation version controlled
    • Can the organisation identify all the process documentation and administration touch points of the change
Questions on personnel and data should also be introduced in the Process Maturity Survey. To seek assistance in implementing an Organisational Process Maturity Survey please contact us via our contact page.

ISO9001 Implementation Home Conducting the As Is State

The Organisational Maturity Survey is a first step in discovering the As Is state in an ISO9001 Implementation. The As Is state is simply the current level of process management and process maturity in the organisation. The As Is state will determine the actions and activities that are required by the organisation to reach the triumvirate of process elements - personnel, process and data - integrating in collaboration to continuously improve each element. This is essentially the cornerstone of an integrated system that satisfies the requirements of ISO9001.

The As Is state requires further investigation beyond the survey to realise the current process position and level of process maturity. The survey asks for the presence of process elements and the type of evidence that may or may not exist with them. It is essentially a pre-audit against ISO9001 with organisational needs as its focus. The As Is state actively seeks the evidence for each process within the organisation and the level of maturity in each which can be used to then audit against ISO9001 and its clauses.

This leads to process maturity scores and gap analysis to allow the organisation to reach the To Be state which is a system meeting ISO9001 requirements. To seek assistance in conducting the As Is State for ISO9001 Implementation please contact us via our contact page.

ISO9001 Implementation Home The Process Maturity Score

The Process Maturity Score defines the level of maturity of individual processes and escalates to an overall score for the organisation. The process maturity score is based on the results of the process maturity survey and the As Is state and can be a progressive score that is updated after process actions are delivered from gap analysis, audit actions and continuous improvement programs etc. The higher the score the less likely any non conformances or observations will occur in an ISO9001 audit.

In a well developed mature management system that delivers to Personnel, Process and Data the process score be calculated as part of the electronic driven management system as a continuous audit process enhancing any continuous improvement program fulfilling Clause 10 in 9001:2015 – Improvement.

The process maturity score is calculated by using data on the presence of key process elements across all levels of the process hierarchy determining the levels of maturity for personnel, process and data. In an ISO9001:2015 Implementation the process maturity of the process is also overlaid with the ISO Risk Profile (ISORP) which determines the importance of each clause to the organisation and the process risk levels and maturity score of the process to deliver the level of importance of each process and any gaps that exist within it.

Personnel, process and data considerations within the process maturity score include but are not limited to:

  • All skills captured for all personnel
  • Each process having a SIPOC view
  • Process maps for each process at the instructional level
  • KPI being attached to process
  • Process Risk being calculated for each process
  • Personnel roles being rated in terms of risk
  • IDP (Individual Development Plans) for personnel created on the basis of risk in process and personnel roles
For assistance in implementing a Process Maturity score for ISO9001:2015 implementation please contact us via our contact page.

ISO9001 Implementation Home ISO9001 Gap Analysis

Gap Analysis is achieved by taking the As Is state and the To Be state and analysing the differences. The differences become the actions to reach the To Be state which is successful ISO9001:2015 implementation. Gaps are considered in the three main elements of Process Maturity Personnel, Process and Data and can include:

  • Personnel
    • All personnel are included in at least one process
    • All skill required for processes are captured in the Skills Matrix
    • Gaps in skill requirements to deliver IDP
  • Process
    • Measurements are attached to the processes required
    • Procedure, Work Instruction, Policy documents exist for each appropriate process level
    • Process maps exist and are up to date for each required process
  • Data
    • Is collected on each required process
    • Is accessible by those who need it
    • Is used in management decisions
Further gap analysis is conducted against each clause allowing the maturity model to see the level of capability for each clause within the organisational process hierarchy.
ISORP Analysis


Well structured management systems will have a continuous view of these gaps along with the process maturity score. Organisational Robustness Analysis is the key theory that underpins the continuous gap analysis capability which leads to efficient delivery of ISO9001:2015 and other standards.

To seek assistance in implementing Process Maturity Gap Analysis for Implementing ISO9001:2015 please contact us via our contact page.

ISO9001 Implementation Home Planning to the To Be State

Planning to the To Be State includes all the actions that come from the gap analysis and any audit activity that results in actions. Enterprise Integrated Management Systems is developed to be the continuous view of the To Be State and has its grounding in Organisational Robustness Analysis which contributes to delivering the requirements of ISO9001:2015. Well developed electronic management systems will be capable of defining gaps and placing them as actions in a To Be State plan as a continuous task list as the To Be State is delivered. The ultimate end To Be State is the delivery of personnel, process and data in balanced union. The data feeds improvements in process and personnel, Processes reveal potential requirements in personnel, data and other processes and personnel seek and analyse better ways of delivering processes and data requirements as the processes and data have identified their areas of weakness to update the personnel's capability. For assistance in Planning and Implementing the To Be State for Implementing ISO9001:2015 please contact us via our contact page.

ISO9001 Implementation Home Implementing ISO9001

Implementing ISO9001:2015 involves:

  • Obtaining the standard and acknowledging the clauses
    • Context of the Organisation
    • Leadership
    • Planning
    • Support
    • Operation
    • Performance Evaluation
    • Improvement
  • Identifying Organisational Processes
    • Hierarchy
    • Process variables
      • Owner, Frequency, Personnel etc.
    • Process Chain
    • Data and Metric Requirements
  • Identifying Personnel
    • Roles
    • Skills and Competencies
  • Identify ISO9001:2015 Clauses inherent in the organisation
  • Identify Process ISO Clause relationship
  • Identify Process Maturity State
  • Identify Gaps in the management system
  • Action Identified Gaps
  • Construct targeted auditing processes
  • Conduct Audit
  • Develop ongoing and ongoing tools to administer Management System.
To seek assistance in Implementing ISO9001:2015 please contact us via our contact page.

ISO9001 Implementation Home Implementing Process Maturity Plan

Process Maturity Implementation follows the structure of discovering the current or As Is State to ascertain the level of process maturity in the organisation from a personnel, process and data perspective and is key to ISO9001:2015 implementation. Products and Services can be considered outcomes or outputs of processes within the business. The warranty/customer feedback, SPC product characteristic data and service AQLs are the process measures that can deliver the data on products and services – all contribute to the level of process maturity and assuring a positive ISO9001:2015 Implementation.

Implementing and Developing Process Maturity is delivered by:

For assistance in Process Maturity Implementation and ISO9001:2015 Implementation in your organisation please contact us via our contact page.

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