What are the required or mandatory procedures for ISO 9001? The latest version of ISO 9001:2015 does not require mandatory procedures as such, but contains 7 clauses of requirements for documents and records.
The Seven ISO 9001 Clauses With Requirements
- General Quality Management System Requirements
- Performance Evaluation
Learn more about the ISO 9001 Clauses.
ISO 9001 Requirements - Documents and Records
- Monitoring and measuring equipment calibration records
- Records of training, skills, experience and qualifications
- Product/service requirements review records
- Record about design and development outputs review
- Record about design and development inputs
- Records of design and development controls
- Records of design and development outputs
- Design and development changes records
- Characteristics of product to be produced and service to be provided
- Records about customer property
- Production/service provision change control records
- Record of conformity of product/service with acceptance criteria
- Record of nonconforming outputs
- Monitoring measurement results
- Internal audit program
- Results of internal audits
- Results of the management review
- Results of corrective actions
Learn more about the ISO 9001 Requirements.
How Many Procedures Should I Document?
It is up to you how many procedures you document, there are no hard and fast rules for ISO 9001.
Some companies like to document all their operating procedures - we've seen documentation with more than 40 procedures - but beware, the more procedures you document the more work and internal audits you are creating for yourself and your company.
We recommend documenting the following procedures, which satisfies all the latest requirements:
- Control of Documented Information
- Control of Risks & Opportunities
- Control of Competence & Awareness
- Control of Calibrated Equipment
- Control of Design & Development
- Control of Purchasing & Procurement
- Control of Non-conformity & Corrective Action
- Control of Customer Satisfaction
- Control of Internal Audits
- Control of Management Reviews
Free download - Control of Calibrated Equipment procedure (ISO 9001)
The above free download will give you an idea of the current level of documentation required for an ISO 9001 procedure.
What Were The Old ISO 9001:2008 Mandatory Procedures?
- Document control procedure 4.2.3
- Control of records procedure 4.2.4
- Internal audit procedure 8.2.2
- Control of non-conformance procedure 10.2
- Corrective action procedure 8.5.2
- Preventive action procedure 8.5.3
- Requirements for other documents: the minimum you feel are necessary to demonstrate control
All the current ISO 9001 mandatory procedures are documented and explained in our Quality Manual Template.