ISO Management
  System 
  Standard Clause

Objective Evidence
for the Auditor

Conformance Portal Solution

• Ensure integration of QMS into business process
• Ensure resources needed for QMS are available
• Communicating importance of effective quality management and conforming to requirements

• Show regular communications
• Show where staff submits ideas

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

• How is customer satisfaction addressed?

• Use a Customer Satisfaction Survey

1. Create one or many surveys for customers. 
2. Direct links to the survey can be given to the surveys.

• Employees and contractors should understand and how it relates to their work

• Posted on 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

• Integrate and implement actions in QMS
• Evaluate the effectiveness of actions

• Risks identified (per company process) focusing on context & interested parties
• Actions planned with evaluation of effectiveness

1. Use our CAPA system
2. In a Document how risks are processed and what interested parties are affected

• What are the objectives?
• Consistent with Quality Policy

• Is there documented information about the Quality Policy and its objectives
• How are the objectives communicated

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

• IT & Communication technology

• Look at the IT / Communication Systems

1. Show the portal as part of the information and communication technology and
2. how it relates to the MS

• Social

• Look for evidence of proper work environment for laboratories (Temp, humidity…), inspection areas, computer network rooms…

1. The collaboration tool is used as a social platform for employees

• Ensure valid and reliable results to verify conformity of products and services to requirements.

• Retain appropriate documented information of fitness for purpose

1. The Document Management system provides a method to retain appropriate documentation

• 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

• Work Instruction & procedures as determined necessary
• Verification of access

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)

• 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

• Training Needs / Competency requirements matrix or equivalent – Who needs what?
• Records of competency
• Related to work instructions (OJT is common)

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

• Quality policy
• Relevant quality objectives
• Their contribution to the effectiveness of QMS
• The implications of not conforming with QMS

• 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

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

• Training
• Company meetings
• postings…

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

• 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

1. The document management systems has all the controls needed to verify 7.5

• 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

• Review logs

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

• 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

• 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

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

• Surveys, interviews (Would need record for review)

• Surveys, interviews (Would need record for review)

1. Use the survey system to keep and maintain customer satisfaction results

• Shall retain documented information as evidence of...
• The nature of nonconformities and any subsequent actions taken
• The results of any corrective action

• 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

1. Use the built in CAPA system to identify and log N/C processes
2. Show reports showing repeat N/Cs, timely resolutions