ISO 9001 & Quality News

8.3.6 Design and Develoment Changes

on . Posted in The ISO 9001 2015 Standard Plainly Written

When a change to the design occurs, the organization must ensure that their are no problems or variances that will impact conformity.

Retained and Documented Information must be kept on:
  • changes to any design or development process
  • the results of reviews taken from the changes
  • the control of the changes (i.e. authoriazation)
  • risk - potential adverse effect resulting from a change


8.3.5 Design and Development Outputs

on . Posted in The ISO 9001 2015 Standard Plainly Written

The outputs of the Design and Development Processes must:
  • meet the input requirements
  • sufficient for the subsequent processes
  • include monitoring, measurement to determine the acceptance
  • specify the essential characteristics of the product or service

Documented Information must be retained about the outputs.

8.3.4 Design and Development Controls

on . Posted in The ISO 9001 2015 Standard Plainly Written

The organization must ensure:
  • the expected results are documented
  • reviews and review methods are documented and scheduled the document the results
  • methods are developed to verify and validate that the requirements meet the intended use
  • actions are taken to remediate and problems from verification and validation
  • the review activities and results are documented
Verification, review and validation are distinct and can be conducted as the organization sees fit.



8.3.3 Design and Development Inputs

on . Posted in The ISO 9001 2015 Standard Plainly Written

The organization must determine what is essential (at a minimum) for the product and service design; including:
  • performance requirements (functionality)
  • inputs from a previous process used in each subsequent process
  • legal and regulatory requirements
  • other standards or codes the organization has committed to in terms of quality
  • risk analysis - determine the consequences of failure for each process

Every input for a process must be designed and stated in clear language and must contain methods and means to address conflicts between each stage of the design and development process.

The organization must maintain documented information on the inputs for the design and development process.


8.3.2 Design and Development Planning

on . Posted in The ISO 9001 2015 Standard Plainly Written

For each stage and for each control point for design and development these are the items to take into account:

  1. overall scope, the timeframe and complexitiy of design and development tasks
  2. required process stages including the review process
  3. verification methods and techniques
  4. who is responsible at each point during the design and development process
  5. resources needed (both internal and external)
  6. control points between each stage and the people responsible
  7. customer involvement
  8. requirements for future changes
  9. what the level (i.e. scope) is needed to control the process by relevant parties and customers
  10. what documentation is needed to verify the requirements are compliant

How to prepare for the new ISO 9001 revision

on . Posted in ISO 9001 2015

The new revision is available for purchase.  Typically organizations often
  1. underestimate the resources necessary to develop and implement a quality management system
  2. assume that only a small number of people are needed to understand the application of quality management principles and how to effective implement them
The new ISO 9001 standard aligns with high-level organizational structure, requiring all new ISO management system standards to be aligned on that structure. There is more of an emphasis on risk-based thinking for the QMS and a focus on achieving value for the company and customers.  It does offer more flexibility for documentation, and a better structure for service organizations.

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8.2.3.1 Requirement review

on . Posted in The ISO 9001 2015 Standard Plainly Written

The ISO 9001 standard requires that an organization meets the requirements for products and services and it must provide a formal method to review these requirements.  It goes on to specify specific conditions
  • specific customer requirements
  • requirements not specified by customer but required none the less
  • organizational requirements
It goes on to require that if the requirements (for an order) are know to be deficient, they are resolved before being accepted by an organization.

If your products or services are provided or ordered over the internet, the organization must clearly state (brochures, emails, website) these requirements.

8.2.3 Review of requirements related to products and services

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This ISO 9001 requirement requires that an organization knows, documents, and communicates the product and service requirements to the customer.  It also states that if there are any deficiencies in the requirements, the organization and customer are aware of them and they are resolved.

Then as a matter of course, any communications, and documentation is retained.

8.2.1 Customer communication

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There are specific requirements in this ISO 9001 clause on how and what to communicate to your customer as it relates to your QMS.  Your Management System must provide for these when you update and inform your customers:
  • you must give useful information about your products / services
  • you must provide some mechanism to have your customers ask about the products / services
  • provide a way for customers to inquire about your invoices and fees
  • the customer must have a way to ask about changes
  • there should be a way to collect customer complaints
  • provide a way to collect feedback
  • if your customers provide their property as a part of your product / service, they must be able to understand how it is handled
  • if there are any risks associated with your product or service, your customer must be told of them and how they are handled
Note: one of the easiest and effective way to handle these communications is through a newsletter or a survey.  Ingentius can provide these tools through our Conformance Portal.

8.2 Requirements for products and services

on . Posted in The ISO 9001 2015 Standard Plainly Written

Although fairly short, these ISO 9001 requirements are important  for your Quality Management System and how you implement it in your operation.  It covers:
  • Customer Communication
  • Determining the requirements related to products and services
  • Review of requirements related to products and services
  • Changes to requirements for products and services

8.1 Operational planning and control

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This ISO 9001 requirement requires the organization to plan and control their operation using clause 4.4 as a guide, to conform to their stated standard using clause 6.

The organization must determine the requirements for their products and services and develop quality criteria.  It must document the resources (internal and external) needed and control the process used in the manufacture or delivery of the products and services.

Also, the organization must be able to show how the quality of a product or service corresponds to the requirements including the planning stage and the effect of risk (i.e. unintended changes).

8 Operation

on . Posted in The ISO 9001 2015 Standard Plainly Written

The largest section in the ISO 9001 standard, the Operation section covers many aspects and requirements:
  • 8.1 Planning & Control,
  • 8.2 Requirements for Products & Services,
  • 8.3 Design & Development,
  • 8.4 Externally Provided Products & Services,
  • 8.5 Production & Service Provisioning,
  • 8.6 Product & Service Release
  • 8.7 Controlling Non-Conforming Outputs

7.5.2 Creating and Updating

on . Posted in The ISO 9001 2015 Standard Plainly Written

In your documentation, be sure to include
  • Date/Time
  • Author
  • Title
  • Reference Number
  • Approval & Review designations
Also make sure you detail how, what and where the documented information is kept.

NOTE: the Ingentius portal supports all of the requirements for documented information.

7.3 Awareness

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The awareness clause of the ISO 9001 standard requires that employees know about:
  • the organization's quality policy
  • the goals and objectives of the quality initiative
  • how employees contribute to quality and the benefits that are derived
  • what happens if the organization does not meet the goals (risk based)

7.2 Competence

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In terms of Competence, the ISO 9001 standard requires four actions:
  1. define what is competence for those under the Quality Management System umbrella
  2. provide mechanisms to improve or maintain competence through training, education or from experience
  3. evaluate the employee's retention and measure their competence
  4. maintain retained information regarding the employee's competence
On an organization-wide basis, required competence levels can also be met through employment policies, reassighment and mentoring.

7.1.6 Organizational knowledge

on . Posted in The ISO 9001 2015 Standard Plainly Written

What is Organizational Knowledge?
This is the "brain trust" of the organization from the line worker to the executive board, it spans the entire organization.  Knowledge does not exist as data points or information in a vacuum.  It is the humans acting upon information and experiences then applying it to produce better product or provide improved service.

The ISO 9001:2015 standard acknowledges the necessity of organization knowledge by requiring the organization to
  • maintain a form of knowledge base and provide access to it
  • determine what is there and what is lacking (a kind of Gap for the knowledge base)
  • provide a mechanism to update the knowledge base

7.1.5.2 Measurement traceability

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When an organization measures a process, product or service using a defined piece of equipment, tool or device, it must be calibrated to operate and measure correctly.  The organization must document how the devices are maintained and how the status is obtained.

Also, the organization must show how the measuring device is "fixed" if it is shown to be faulty.

7.1.5.1 General

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This clause requires that an organization has the resources needed to monitor the products and services in regards to their conformance to the standard.  Further, it states the obvious that the resources to monitor are appropriate and are kept current and working.

The clause also requires that documents are kept (retained information) about the methods and types of monitoring.

7.1.3 Infrastructure

on . Posted in The ISO 9001 2015 Standard Plainly Written

It is imparative that the organization has the facilities and capabilities to conform to the ISO requirements including (for instance):
  • buildings and utilities
  • hardware, software, networks and equipment
  • transportation
  • communication resources (i.e. like the Ingentius Conformance Portal)

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