Who it’s for
Who should attend
Quality managers and quality engineers, design and manufacturing engineers, process owners, internal auditors, management representatives, and suppliers to regulated industries. Suitable for anyone new to management systems as well as those needing a structured refresher.
Curriculum
Course modules
- Purpose and structure of ISO 9001; the Annex SL high-level structure
- Quality management principles, the process approach and PDCA
- Risk-based thinking
- Clause 4: Context of the organization, interested parties, scope, QMS processes
- Clause 5: Leadership, policy, roles and responsibilities
- Clause 6: Planning, risks and opportunities, quality objectives, planning of changes
- Clause 7, Support: resources, competence, awareness, communication, documented information
- Clause 8, Operation: planning and control, requirements for products and services, design and development, external providers, production and service provision, release, nonconforming output
- Clause 9, Performance evaluation: monitoring and measurement, customer satisfaction, analysis, internal audit, management review
- Clause 10: Improvement, nonconformity and corrective action, continual improvement
Outcomes
What you’ll be able to do
- Interpret each ISO 9001 requirement and what evidence demonstrates conformity
- Apply the process approach to your own organization
- Identify gaps between existing practice and the standard
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Quality Management Systems (QMS)”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.