ISO Management System Standard Clause
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Objective Evidence for the Auditor |
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Conformance Portal Solution |
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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
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Auditor's Objective Evidence
- Show regular communications
- Show where staff submits ideas
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On your portal
- 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
- The fact that a portal is being used is objective evidence that resources are used for the Management System
- Use the collaboration system to communicate regularly with staff
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5.1.2 Customer Focus
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Auditor's Objective Evidence
- Use a Customer Satisfaction Survey
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On your portal
- Create one or many surveys for customers.
- Direct links to the survey can be given to the surveys.
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5.2 Quality Policy
- Employees and contractors should understand and how it relates to their work
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Auditor's Objective Evidence
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On your portal
- Take a digital version and publish it on the portal
- To ensure it is being read and understood, create a small test about the Quality Policy
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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
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Auditor's Objective Evidence
- Risks identified (per company process) focusing on context & interested parties
- Actions planned with evaluation of effectiveness
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On your portal
- Use our CAPA system
- In a Document how risks are processed and what interested parties are affected
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6.2 Quality Objectives And Planning
- What are the objectives?
- Consistent with Quality Policy
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Auditor's Objective Evidence
- Is there documented information about the Quality Policy and its objectives
- How are the objectives communicated
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On your portal
- Communicated via portal's collaboration system
- Quality Objectives and Procedures are saved in the Document Management System
- A test to show it was read and understood
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7.1.3 Infrastructure
- IT & Communication technology
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Auditor's Objective Evidence
- Look at the IT / Communication Systems
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On your portal
- Show the portal as part of the information and communication technology and
- how it relates to the MS
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7.1.4 Environment For Operation
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Auditor's Objective Evidence
- Look for evidence of proper work environment for laboratories (Temp, humidity…), inspection areas, computer network rooms…
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On your portal
- The collaboration tool is used as a social platform for employees
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7.1.5.1 Monitoring And Measurement
- Ensure valid and reliable results to verify conformity of products and services to requirements.
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Auditor's Objective Evidence
- Retain appropriate documented information of fitness for purpose
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On your portal
- The Document Management system provides a method to retain appropriate documentation
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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
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Auditor's Objective Evidence
- Work Instruction & procedures as determined necessary
- Verification of access
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On your portal
- Provide both employee and supervisor access to the portal to the auditor
- Auditor can "see" what is available
- Auditor can review the work instructions (can access off site to reduce audit costs)
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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
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Auditor's Objective Evidence
- Training Needs / Competency requirements matrix or equivalent – Who needs what?
- Records of competency
- Related to work instructions (OJT is common)
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On your portal
- Document training procedures, needs and matrix
- Retain Job Descriptions on portal link job description to portal training courses
- Use the testing tool to show actual training results
- Use the testing tool to show employee evaluation
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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
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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
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On your portal
- Document Management can retain and provide access to the Quality Policy and statements of effectiveness and implications of QMS
- A Simple test can ensure the employee or contractor has read and understands the Quality Policy
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7.4 Communication - Internal communications
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Auditor's Objective Evidence
Evidence of
- Training
- Company meetings
- postings…
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On your portal
- The collaboration system shows a wall of notifications
- The collaboration system group discussions shows all communication and minutes of meeting by department
- The training system can be used to send notification of course completion and test results
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7.5 Documented Information
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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
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On your portal
- The document management systems has all the controls needed to verify 7.5
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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
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Auditor's Objective Evidence
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On your portal
- Document management system - Create the policy and procedure for handling external provider property
- Create short test on the policy and verify understanding
- Use the forms manager to log customer property and its disposition
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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
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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
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On your portal
- Use the built in CAPA system to identify a process that created a non-conforming products
- Use the forms tool to log the Nonconformity
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9.1.2 Customer Satisfaction
- Surveys, interviews (Would need record for review)
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Auditor's Objective Evidence
- Surveys, interviews (Would need record for review)
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On your portal
- Use the survey system to keep and maintain customer satisfaction results
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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
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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
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On your portal
- Use the built in CAPA system to identify and log N/C processes
- Show reports showing repeat N/Cs, timely resolutions
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