ISO 9001 is an international standard for quality management systems (QMS) belonging to the ISO 9000 family, based on the seven quality management principles. ISO 9001 quality management has ten essential clauses that companies need to comply with to be certified to ISO 9001. Each clause is in one of four action groups (Plan, Do, Check, and Act). A JAS ANZ accredited certification body like Best Practice can help your company achieve ISO 9001 certification.
The Seven Principles of a QMS
We have listed the seven principles of the ISO approach to building a quality management system below.
- Customer focus
- Engagement of people
- Process approach
- Evidence-based decision making
- Relationship management
The Ten Clauses of ISO 9001
We’ve listed the ten clauses of the ISO 9001 standard under their action headings.
The first six clauses of the ISO 9001 standard deal with fall under the planning phase and deal with the initial planning.
- Clause 1: Scope
- Clause 2: Normative approaches
- Clause 3 Terms and definitions
- Clause 4: Context of the organisation
- Clause 5: Leadership
- Clause 6: Planning
Clauses seven and eight refer to the actions you need to take to maintain an efficient business and ensure a consistent and quality output. Clause seven deals with items such as monitoring and measuring resources and company infrastructure. Clause eight deals with your business’s operational aspects like design and development of products and services and planning and control of operations.
- Clause 7: Support
- Clause 8: Operation
Clause nine deals with performance evaluation and includes measurement and evaluation of criteria such as customer satisfaction. Clause 9.3 refers to the need for internal audit, and clause 9.4 calls for a regular top management review.
Clause ten deals with the corrective actions needed for continuous improvement.
Documentation for ISO 9001 Certification
There are mandatory and non-mandatory documents for ISO 9001 certification. Records are mandatory documents used to demonstrate your compliance with ISO 9000 standards and achieve certification. Although it is helpful to submit procedure documents for review, especially in the gap analysis stage, it isn’t mandatory. The quality manual that ISO 9001 2008 called for is no longer needed for ISO 9001 2015 but still helpful to your company as the base document for your QMS.
- 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 the 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
- Procedure for determining the context of the organisation and interested parties
- Procedure for addressing risks and opportunities
- Procedure for competence, training, and awareness
- The procedure of equipment maintenance and measuring equipment
- Procedure for document and record control
- Sales procedure
- Procedure for design and development
- Procedure for production and service provision
- Warehousing procedure
- Procedure for management of nonconformities and corrective actions
- Procedure for monitoring customer satisfaction
- Procedure for internal audit
- Procedure for management review
ISO 9001 is a process-based QMS, and understanding the processes is an important part of implementing them. It is not always easy to understand a text-based system, especially if you have an integrated management system. Creating visual representations like process maps makes the processes easy to follow, resulting in a more efficient QMS.
A process map shows the entire process from beginning to end and includes:
- process inputs and outputs
- activities and responsibility
- pathways, parallel processes, and process loops
- decision points
- key measures, metrics, objectives, and targets
- interaction with other processes
Although achieving an ISO 9000 certification seems like a daunting procedure, most companies already have most of the procedures and records in place. A gap analysis from a certification body helps to determine what needs to be changed or implemented. Once this is done, creating your ISO 9000 QMS becomes easy.