Standard Blitz
Updated 3/23/23: Want a quick exercise for initial auditor training or a refresher for your veteran audit team members? This quick and simple "ISO scavenger hunt" will help your auditors quickly locate key requirements.
Exercise: In a small group, locate each of the following requirements or keywords in ISO 9001 and ISO/TS 16949. Record the number of times the keyword is mentioned, the clause numbers and the title/description on easel pads. It is also recommended that you record all of these findings using the table of contents in the front of your standard.
Documented procedures
Records
Effective (ness/ly)
Efficient (cy)
Customer satisfaction
Business plan
Cost
Risk
EXERCISE ANSWER KEY
DOCUMENTED PROCEDURES (7)
*4.2.1/4.2.2 (mentions requirements)
Control of Documents (4.2.3)
Control of Records (4.2.4)
Training (6.2.2.2)
Internal Audits (8.2.2)
Control of Nonconformities (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
RECORDS (26)
*Several mentions of record in general prior to 4.2.3)
4.2.3.1 - Engineering specification changes
5.6.1 - Management review records
6.2.2 (e) - Education, training, skills & experience
7.1 (d) - Product & realization processes evidence (plan vs. actual)
7.2.2 - Product requirements review (feasibility)
7.3.2 - Design & development input
7.3.4 - Design & development review
7.3.5 - Design & development verification
7.3.6 - Design & development validation
7.3.7 - Design & development changes
7.4.1 - Supplier evaluations & actions
7.5.2 - Validation records
7.5.3 - Product identification & traceability
7.5.4 - Lost, damaged or unusable customer property
7.6a - Basis for calibration (in case of no standard method)
7.6 (under e) - Calibration & verification records
7.6.2 - Calibration & verification records
8.2.2 - Internal audit records
8.2.3.1 - Significant process events
8.2.3.1 - Records of effective dates of process changes
8.2.4 - Product conformity & person(s) releasing records
8.3 - Nonconforming material (nature, actions, concessions)
8.3.4 - Expiration date or quantity authorized under concession
8.5.2 - Results of corrective actions
8.5.2.4 - Records of rejected product test/analyses
8.5.3 - Results of preventive actions
EFFECTIVE(NESS)(LY) (ISO = 26 & TS = 36)
0.2 – Introduction - Process approach (twice)
0.2c – Introduction - Process approach
0.3 – Introduction - Relationship with ISO 9004
1.1b - Scope - General
4.1 – General requirements
4.1c – General requirements
4.2.1d - Documentation requirements – general
4.2.4 – Control of records
5.1 – Management commitment
5.1.1 – Process efficiency
5.3b – Quality policy
5.5.3 – Internal communication
5.6.1 – Management review – General
5.6.3a – Management review – Review output
6.1a – Provision of resources
6.2.2c – Competence, awareness & training
6.3.1 – Plant, facility & equipment planning (& Note)
7.2.3 – Customer communication
7.3.1 – Design & development planning
7.4.1 – Purchasing Process (Note 2)
7.5.1.4 – Preventive & predictive maintenance (twice)
7.5.1.8 – Service agreement with customer
8.1c – Measurement, analysis & improvement – general
8.2.2b – Internal audit
8.2.2.2 – Manufacturing process audit
8.2.3 – Monitoring & measurement of processes (Note)
8.2.3.1 - Monitoring & measurement of manufacturing processes
8.4 – Analysis of data (twice)
8.5.1 – Continual improvement
8.5.2f – Corrective action
8.5.2.4 – Rejected product test/analysis (Note)
8.5.3e – Preventive action
EFFICIENT(CY) (3) – None in ISO 9001, but 3 in ISO/TS 16949
5.1.1 - Process efficiency
7.5.1.4 - Preventive and predictive maintenance
8.2.1.1 - Customer satisfaction — Supplemental
CUSTOMER SATISFACTION (9)
0.2 - Introduction - Process approach (twice)
1.1b - Scope – General
5.2 - Customer focus
5.6.1.1 - QMS performance
6.1b - Provision of resources
8.2.1 - Monitoring & Measurement – Customer satisfaction
8.2.1.1 - Customer Satisfaction - Supplement
8.4a - Analysis of data
BUSINESS PLAN (2)
5.4.1.1 - Quality objectives - Supplemental
5.6.1.1 - Quality management system performance
MANAGING COSTS & RISKS (0)
None in 9001 however… ISO 9004, Introduction – General (0.1)
COST (5)
3.1.9 - Premium freight
5.6.1.1 - Quality management system performance
7.3.2.1 - Product design input
7.3.4.1 - Manufacturing process design input
7.3.4.1 - Monitoring (Note)
RISK (7)
0.1a - Introduction - General
0.4 - Compatibility with other management systems
6.4.1 - Personnel safety to achieve conformity to product requirements
7.2.2.2 - Organization manufacturing feasibility
7.3.1.1 - Multidisciplinary approach
7.3.2.2 - Manufacturing process design input
7.3.4.1 - Design & development review - Monitoring