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Evidence for clause 8.1.1 and 9.1.1

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Guest user Created:   Aug 21, 2020 Last commented:   Aug 21, 2020

Evidence for clause 8.1.1 and 9.1.1

What do you show as evidence to satisfy the requirement of clause 8.1.1 and 9.1.1 in ISO 9001:2015

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Aug 21, 2020

Let us start by checking clause 8.1 item by item.

  • About item a) – your company must have specifications for their products.
  • About item b) – your company must have process control specifications to allow process monitoring, less defects and more productivity and safety (for example, parameters for machine operation, like temperature, speed, pressure, …). Your company must have specifications for quality control of raw materials, intermediate and finished products.
  • About item c) – when designing and planning your production process, your company should ensure resources for the operations (people for production and quality control, equipment, materials, monitoring resources, …).
  • About item d) – most companies have process control plans and quality control plans that they implement
  • About item e) – your company must decide what procedures and instructions will be needed and what forms it will use to record and evidence performance and results. 

About clause 9.1.1, the purpose of this subclause is to ensure that companies perform monitoring, measurement, analysis and evaluation, to check if intended results are being achieved. Evidence that the organization has determined:

  • What needs to be monitored and measured
  • What methods to be used to analyze and evaluate the performance and effectiveness of the quality management system
  • What records will be retained as evidence 

You can find more information below:

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Aug 21, 2020

Aug 21, 2020