2. The Intent
(Optimizing the Transition)
• Minimize redundancy
• Minimize rework
• Involve key players in the QMS
• Instill ownership
• Eliminate “signature-only” approvals
• Maximize understanding of ISO 9001 requirements
• Avoid the unnecessary full-system gap analysis
3. Who is involved in an efficient
transition?
• Facilitator – Keeps senior leaders, process owners,
internal auditors on task
• Senior leaders
1. Define the context of the organization
2. Determine how to evaluate system
effectiveness
3. Involved in the risk mitigation process
4. Ensure they meet “Leadership requirements”
from ISO 9001
• Process owners - Define process inputs, outputs,
methods, criteria, resources, responsibilities…
• Internal auditors – Small scale gap analyses
4. Clause 4
Context
Clauses 9.1
and 6.2
Objectives
Clause 6.1
Risk
mitigation
Clause 5
Leadership
Process definitions
Clause 4.4.1 a, b, c, d, e, f, g, h
Internal audit / Corrective action cycle
(Gap analysis of all other clauses)
Senior Leadership
Process Owners
Internal Auditors
6. Clause 4
Context
Clauses 9.1
and 6.2
Objectives
Clause 6.1
Risk
mitigation
Clause 5
Leadership
Process definitions
Clause 4.4.1 a, b, c, d, e, f, g, h
Internal audit / Corrective action cycle
(Gap analysis of all other clauses)
7. Clause 4, Context
Senior Leadership
• Given the organization’s purpose and strategy,
what are its “issues”? And who monitors what,
with what frequency? Make sure updates are
reported in management review (9.3.2(b)).
• For purposes of the system, who are the
stakeholders and what are their needs? And who
monitors what, with what frequency?
• Determine system boundaries. What is included?
Excluded?
• What are the QMS processes? What is their
sequence and interaction?
8. Clauses 9.1 & 6.2, Evaluation and Objectives
Senior Leadership
• Q: Why does Senior Leadership need to be
involved in determining how the organization
measures the effectiveness of the quality
management system?
• A1: Leadership is accountable for it (5.1.1(a)).
• A2: A management system is a set of interrelated
processes that work together to achieve objectives.
(All of the activities required by ISO 9001 should
assist the organization in meeting its objectives.)
• Review / update organizational objectives.
9. Clause 6.1, Risk Mitigation
Senior Leadership +
• Determine the risks that need to be addressed.
• Plan action; take action; evaluate for effectiveness.
10. Clause 5, Leadership
Senior Leadership
• HOW DO Senior Leaders…
• Ensure the integration of QMS requirements
into the business processes?
• Promote the use of process-based thinking?
• Promote the use of risk-based thinking?
• Promote improvement?
• Support other managers to demonstrate
leadership as it applies to their scope of
responsibility?
• Ensure customer focus?
11. Clause 4
Context
Clauses 9.1
and 6.2
Objectives
Clause 6.1
Risk
mitigation
Clause 5
Leadership
Process definitions
Clause 4.4.1 a, b, c, d, e, f, g, h
Internal audit / Corrective action cycle
(Gap analysis of all other clauses)
12. Clause 4.4.1
Process Owners
For each key process identified as part of the QMS,
a) Determine expected inputs and outputs
c) Determine (and apply) criteria and methods
d) Determine and provide resources
e) Assign responsibilities and authorities
f) Address risks and opportunities
g) Evaluate process; ensure processes meet
intended results
h) Improve processes (and therefore the QMS)
14. Clauses 9.2 and 10.2
Internal Auditors & C/A assignees
• Internal audits and corrective action (1st)
• Planning of changes (2nd)
• All of the support processes (clause 7), including
“document and records control”
• Management review
• All of the operations processes (clause 8)
• Continual improvement (and improvement, gen.)
• QMS documents and records (clause 4.4.2)
15. Benefits
• Avoids wasteful full-system gap analysis
• Minimizes redundancy
• Involves multiple functions throughout the
organization (including senior leaders)
• Provides activity-based or workshop-style training
(not a 1-hour PowerPoint overview of ISO
9001:2015) for leadership, process owners and
their teams, internal auditors, and those assigned
corrective actions
