Process Audit - ISO9001:2008

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

PROCESS AUDITED

• Process name

• Related processes & process interactions

• Picture of process map

  Media

• Sketch of process map

  Drawing

AUDITEES

• Names of personnel audited

RECORDS

• List all relevant records that were examined?

PROCEDURES

• Relevant procedures & other documents

• Revisions valid?

  C

  NI

  NC

  NA

• Responsibilities defined & correct?

  C

  NI

  NC

  NA

• Procedures approved?

  C

  NI

  NC

  NA

• Does actual practice match documented procedures?

  C

  NI

  NC

  NA

• Are outsourced activities referenced?

  C

  NI

  NC

  NA

ASSESS

• Planning?

  C

  NI

  NC

  NA

• Communication?

  C

  NI

  NC

  NA

• Work environment?

  C

  NI

  NC

  NA

• Infrastructure?

  C

  NI

  NC

  NA

• Preventive maintenance?

  C

  NI

  NC

  NA

• Resources?

  C

  NI

  NC

  NA

• Training?

  C

  NI

  NC

  NA

• NAME - POSITION - TRAINING - EDUCATION - EXPERIENCE - SKILLS

• Identification of nonconformity?

  C

  NI

  NC

  NA

• Disposition of nonconformity?

  C

  NI

  NC

  NA

• Change management?

  C

  NI

  NC

  NA

• ID & Traceability?

  C

  NI

  NC

  NA

• Customer owned property?

  C

  NI

  NC

  NA

• Preservation?

  C

  NI

  NC

  NA

• Calibration?

  C

  NI

  NC

  NA

• INSTRUMENT TYPE - ID - LOCATION - CALIB FREQ - STATUS - TRACEABLE?

• Inspection & test?

  C

  NI

  NC

  NA

• Design inputs?

  C

  NI

  NC

  NA

• Design verification of outputs vs requirements?

  C

  NI

  NC

  NA

• Design verification vs plan?

  C

  NI

  NC

  NA

• Design validation?

  C

  NI

  NC

  NA

• Design reviews?

  C

  NI

  NC

  NA

• Design addresses statutory, regulatory & other requirements?

  C

  NI

  NC

  NA

• Design changes?

  C

  NI

  NC

  NA

OBJECTIVES, TARGETS, KPIs

• Quality policy understood?

  C

  NI

  NC

  NA

• O&T understood?

  C

  NI

  NC

  NA

• KPIs consistent with O&Ts?

  C

  NI

  NC

  NA

• KPI - TARGET - ACTUAL - ACTION PLAN

• Examples of CI?

  C

  NI

  NC

  NA

• Overall process efficiency, effectiveness & effectiveness of interactions with other processes

  Select Outstanding Very good Good Fair Poor Extremely weak

  • Outstanding
  • Very good
  • Good
  • Fair
  • Poor
  • Extremely weak

FINDINGS

• Deficiencies / CARs