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PDCA CircleThe purpose for using our tools as a management system conformance portal is twofold:

1. To improve productivity

2. To help you conform to the ISO standards

Of course, using our tools does not guarantee a successful audit.  It does, however, improve your Management System deployment, make it easier for you to document and retain information that helps during your audit.

We have found organizations using our portal can help improve competence, awareness and communication to all employees.

 
 ISO Management System 
 Standard Clause

 
Objective Evidence for
the Auditor
 		 
Conformance Portal Solution
           
5.1 Leadership & Commitment
  • Ensure integration of QMS into business process
  • Ensure resources needed for QMS are available
  • Communicating importance of effective quality management and conforming to requirements
   Auditor's Objective Evidence
  • Show regular communications
  • Show where staff submits ideas
   On your portal
  1. Describe how the portal is being used in the Management System in a document AND create a short test to ensure people have read and understand the description
  2. The fact that a portal is being used is objective evidence that resources are used for the Management System
  3. Use the collaboration system to communicate regularly with staff
5.1.2 Customer Focus
   Auditor's Objective Evidence
  • Use a Customer Satisfaction Survey
   On your portal
  1. Create one or many surveys for customers. 
  2. Direct links to the survey can be given to the surveys.
5.2 Quality Policy
  • Employees and contractors should understand and how it relates to their work
   Auditor's Objective Evidence
  • Posted on portal


   On your portal
  1. Take a digital version and publish it on the portal
  2. To ensure it is being read and understood, create a small test about the Quality Policy
6.1 Actions To Address Risk And Opportunities & 6.1.2 the organization shall plan actions to address these risks & opportunities; How to:
  • Integrate and implement actions in QMS
  • Evaluate the effectiveness of actions
   Auditor's Objective Evidence
  • Risks identified (per company process) focusing on context & interested parties
  • Actions planned with evaluation of effectiveness
   On your portal
  1. Use our CAPA system
  2. In a Document how risks are processed and what interested parties are affected
6.2 Quality Objectives And Planning
  • What are the objectives?
  • Consistent with Quality Policy


   Auditor's Objective Evidence
  • Is there documented information about the Quality Policy and its objectives
  • How are the objectives communicated
   On your portal
  1. Communicated via portal's collaboration system
  2. Quality Objectives and Procedures are saved in the Document Management System
  3. A test to show it was read and understood
7.1.3 Infrastructure
  • IT & Communication technology


   Auditor's Objective Evidence
  • Look at the IT / Communication Systems


   On your portal
  1. Show the portal as part of the information and communication technology and
  2. how it relates to the MS
7.1.4 Environment For Operation
  • Social


   Auditor's Objective Evidence
  • Look for evidence of proper work environment for laboratories (Temp, humidity…), inspection areas, computer network rooms…
    On your portal
  1. The collaboration tool is used as a social platform for employees
7.1.5.1 Monitoring And Measurement
  • Ensure valid and reliable results to verify conformity of products and services to requirements.


   Auditor's Objective Evidence
  • Retain appropriate documented information of fitness for purpose
   On your portal
  1. The Document Management system provides a method to retain appropriate documentation
7.1.6 Organizational Knowledge (very important)
  • Determine the knowledge necessary - how much information is required
  • How are standard processes consistently understood?
  • Readily available
  • How do staff access instructions? Can they find them?
  • Verification of access for W.I. and Procedures
   Auditor's Objective Evidence
  • Work Instruction & procedures as determined necessary
  • Verification of access
   On your portal
  1. Provide both employee and supervisor access to the portal to the auditor
  2. Auditor can "see" what is available
  3. Auditor can review the work instructions (can access off site to reduce audit costs)
7.2 Competence
  • Determine necessary competence of Staff / Contractors
  • Ensure staff/contractors is competent
  • Take appropriate steps (training…)
  • Retain appropriate documented information
  • Training Needs / Competency requirements matrix or equivalent – Who needs what?
  • Records of competency
   Auditor's Objective Evidence
  • Training Needs / Competency requirements matrix or equivalent – Who needs what?
  • Records of competency
  • Related to work instructions (OJT is common)
   On your portal
  1. Document training procedures, needs and matrix
  2. Retain Job Descriptions on portal link job description to portal training courses
  3. Use the testing tool to show actual training results
  4. Use the testing tool to show employee evaluation
7.3 Awareness - Persons working under organizations control are aware of:
  • Quality policy
  • Relevant quality objectives
  • Their contribution to the effectiveness of QMS
  • The implications of not conforming with QMS
   Auditor's Objective Evidence
  • Staff & Contractors
  • Is Staff aware of QMS Policy?
  • Aware of their contribution to effectiveness of QMS & Objectives? & Consequences of not conforming?
  • Aware of related work instructions
   On your portal
  1. Document Management can retain and provide access to the Quality Policy and statements of effectiveness and implications of QMS
  2. A Simple test can ensure the employee or contractor has read and understands the Quality Policy
7.4 Communication - Internal communications

   Auditor's Objective Evidence

Evidence of
  • Training
  • Company meetings
  • postings…
   On your portal
  1. The collaboration system shows a wall of notifications
  2. The collaboration system group discussions shows all communication and minutes of meeting by department
  3. The training system can be used to send notification of course completion and test results
7.5 Documented Information

   Auditor's Objective Evidence
  • Creating and updating
  • Verify control of document information
  • All documents are identified and controlled per process (Approved, protected…)
  • Available for use
  • Verify external documents (e.g. cust. specs)
  • Records protected from unintended alterations
   On your portal
  1. The document management systems has all the controls needed to verify 7.5
8.5.3 Property Belonging To Customers/External Providers
  • Shall identify verify protect and safeguard
  • Report any loss, damage, unsuitable to the customer or external provider and retain documented information on what has occurred
   Auditor's Objective Evidence
  • Review logs
   On your portal
  1. Document management system - Create the policy and procedure for handling external provider property
  2. Create short test on the policy and verify understanding
  3. Use the forms manager to log customer property and its disposition
8.7 Control Of Nonconforming Outputs
  • Verify Nonconforming records (e.g. Logs…)
  • Describes the nonconformity
  • Describes the actions taken
  • Describes any concessions obtained
  • Identifies the authority deciding the action in respect of the nonconformity
  • Requirements verified when corrected
   Auditor's Objective Evidence

Verify Nonconforming records (e.g. Logs…)
  • Describes the nonconformity
  • Describes the actions taken
  • Describes any concessions obtained
  • Identifies the authority deciding the action in respect of the nonconformity
  • Requirements verified when corrected
   On your portal

  1. Use the built in CAPA system to identify a process that created a non-conforming products
  2. Use the forms tool to log the Nonconformity
9.1.2 Customer Satisfaction
  • Surveys, interviews (Would need record for review)
   Auditor's Objective Evidence
  • Surveys, interviews (Would need record for review)
   On your portal
  1. Use the survey system to keep and maintain customer satisfaction results
 10.2 Nonconformity And Corrective Action
  • Shall retain documented information as evidence of...
  • The nature of nonconformities and any subsequent actions taken
  • The results of any corrective action
   Auditor's Objective Evidence
  • Look for repeat nonconformances
  • Verify root cause really defines cause
  • Verify corrective action addresses root cause exactly
  • Small issue = small corrective action
  • Verify Corrective Actions closed timely
  • Verify the CA was completed
   On your portal
  1. Use the built in CAPA system to identify and log N/C processes
  2. Show reports showing repeat N/Cs, timely resolutions