Create procedural education for QM
In one Procedure instructions (VA)Also called standard operating procedure (sop) or description of the process, companies determine their processes, for example how they develop products or provide services.
Standards such as ISO 9001 and ISO 13485 require these procedural instructions. Companies can establish these requirements directly in the quality management manual or in independent documents.
With the free download of an example for procedural education.
1. Process instructions: Introduction, Definitions
a) Definition
ISO 9000 defines a procedure as follows:
“Defined way to carry out an activity or process”
Those: ISO 9000: 2015 3.4.5
A process is defined in the is an is Ise 9000 as follows:
“The phrase of contiguous or mutual activities that use inputs to obtain an expected result”
Those: ISO 9000: 2015 3.4.1
A procedural education therefore documents the way in which a company (e.g. a manufacturer) wishes to carry out a single activity or a process (phrase of activity). The terms procedural instructions and procedural description must be understood in a synonym way.
In English we talk about one Standard Operational Procedure (Sop).
b) differentiation of process instructions and procedural instructions
If you take on the above definitions, a procedural education when describing various contiguous or mutually influencing activities must be equated to a description of the process.
A Description of the process It includes the entire Z process. B. The software development process. Defines phases, roles and activities. For example, he asks for a software system test at the end of development. How, i.e. with what activity these tests are performed (e.g. with equivalence classes), part of a reference work or Procedure To be.
c) differences in work instructions and procedural instructions
Work and procedural instructions differ in different aspects:
| I wait | Procedure | Work instructions |
| Roles interested | Mostly different | Mainly a |
| Granularity | Many work steps. For the individual passage, the procedural instructions refer to work education. They quote the tools to be used without describing their operation. | Granular description of a work phase that includes precise instructions on how to use the tools. |
| Duration of the activity | The procedure cannot often be completed in a single step and without interruption. | A work education describes an activity that can be completed without interruptions and addictions. |
| responsibility | Owner of the process | People who carry out activities. |
| Training and use | The procedure instructions are trained. They serve as a reference to understand the processes. | The work instructions are available in the position of the activity. |
Example 1: software development
Die Procedure The “software development” describes the activities, their order and addictions and responsible roles. One of these activities is to create software architecture.
A Work instructions It could now describe how to model software architectures with the help of an instrument such as Enterprise Architect, how to use the tool and what best practices should be observed during modeling.
Example 2: post-market surveillance
Another Procedure “Post-market surveillance” provides an overview of the activities in “monitoring after the market arrangement”.
One associated Work instructions It describes how to look for BFARM security database and how to document and evaluate the results of the research.
d) differences in instructions and procedural plans
The development of products must follow instructions and procedural plans. These are regulatory requirements.
The procedural instructions (e.g. SOC Development) differ from the plans (development plans) as procedural instructions in general apply to create the product in particular with respect to the development plans.
2. What procedural education should include
a) Content
Procedural education must describe
- Which Rolle(N),
- Which Activity
- In what type (Method) ,,
- with AIDS AND Tools,
- in which Series (for example sequential, parallel) performed and in the process
- Which Input,
- in which Output Transferred.
If the description of the method for an activity is more extensive, it is advisable in A Work instructions to outsource.
Contrary to a work education, a procedural education usually describes a sequence required of activities that are often through several People are provided.
b) Meta information
Good procedural education should describe at the level of the destination:
- Call identification of procedural instructions e.g. B. document and title ID
- Version
- Author (EN)
- Responsibility
- Flow
- Objective
- Change the story
3. Content of the procedural instructions
a) structure of the chapter
The consultants of the Johner Institute usually use the following structure of the chapter
- Meta -Information
- Scope
- flow
- Responsibility
- Recipient
- Distributor
- Owner of the process
- training
- Key figures
- General (optional)
- Description of the process
- Overview (e.g. expiration diagram)
- Step 1
- Entrance
- Description of the activity
- Production
- Passages 2 – n (analog)
- Attachment
- Reference documents
- Versionshistorie
Use expiration diagrams. This allows you to have a quick overview.
b) example of procedural education
The following file shows the structure of procedural education. It can be downloaded directly (words format) and used for your projects.
c) Description of the processes
Graphic description
Various modeling languages are ideal such as Diagrams of UML, BPMN and classic flow diagrams. Numerous tools are available, including free (e.g. draw.io).
Tabular description
An alternative representation are the tables. These are suitable only for sequential processes.
| Step | Entrance | Task | Production | Rolle | Comment |
| 1 | Use scenarios Stakeholders requirements |
Specifications of the SW requirements | Specification of software requirements. | User interface designer |
4. List of procedural instructions
a) overview of regulatory requirements
The requirements of which procedural instructions must determine and follow the producers can be found in these regulations:
- ISO 13485
- Ordinance of the MDR medical device
- FDA 21 CFR Part 820 (which refers again to ISO 13485)
b) ISO 13485
Standards such as ISO 13485 require companies to determine procedures such as the steering of documents, the design and planning of development, contracts, corrective measures, etc.
ISO 13485: 2016 regulated the list of procedural instructions necessary for its predecessor version. The mental map above contains a precise consideration of the required procedures.
Here is a much more coarse list of the prescribed procedures (in English):
- Validation of the application of computer software used in the quality management system
- Control of documents
- Record control
- Revision of management
- Design and development including the transfer of design, development and control of design and development
- Purchase
- Procedures and methods for production control
- Service (if applicable)
- Validation of processes for the supply of production and service including validation of the application of computer software
- Sterilization validation and sterile barrier systems (if applicable)
- Product identification
- Traceability.
- Preserve the compliance of the product
- Control of monitoring and measurement equipment of the validation of the computer software application
- Feedback
- Management of complaints
- Reporting to the regulatory authorities
- Internal audit
- Monitoring and measurement of the product
- Control of non -compliant products
- Data analysis
- Corrective actions
- Preventive shares
In fact, standard such as B. ISO 13485 that producers all the above methods
- establish,
- document (in writing! This is exactly the procedural education),
- tool,
- schools e
- maintain.
Note that ISO 13485 requires many other activities, but this must not necessarily be described by procedural education.
b) MDR and IVDR against ISO 13485
On the one hand, the MDR or IVDR requires a fewer procedural instructions compared to ISIS 13485. At least not explicitly. On the other hand, there are procedures that producers must determine according to MDR, which ISO 13485 does not explicitly call how, for example, risk management.
It should be noted that ISO 13485 requires risk management very well as a business.
Conclusion: If you act in accordance with the current problem of ISO 13485, it essentially meets the requirements for quality management that MDR and IVDR ZB required in article 10 and in Appendix IX.
5. Other
a) Process instructions as part of the QM manual?
There are topics that speak to integrate the procedural instructions directly in the QM manual and there are those that speak against it. The topics that speak against the integration of procedural instructions and the quality management manual are:
- Separation of the confidential and non -confidential content
Some producers want to proudly present their QM manual to the outside world. If this manual contains the company’s internal know-how, this is not possible. The problem does not occur in the case of separate procedural instructions. - Interaction of procedural instructions
In particular, development services providers are often forced to develop according to the needs of their customers. This is simpler if the customer is used that of the customer rather than your procedural instructions. The QM manual remains unchanged. - Faster release
The changes to the procedural instructions are easier because it is not necessary to release the QM manual, in particular for large companies, and are necessary for large companies. The separation of the components sometimes makes sense in the panorama of the document.
Separate the QM manual and the sips is not always the best solution. Small companies with only one or some products sometimes get along with an integrated set of documents.
Are you not sure what variant is better for you? So contact us. We are happy to help.
b) abbreviations in procedural instructions
Common abbreviations are often used in procedural education to make the document clearer. All abbreviations used should be noted separately in a document. Examples:
- GF: Management
- UB: Environmental officer
- A: Environmental management
- Va: Procedure
- AA: Work instructions
- QM: Quality management
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Change the story
- 2025-04-16: chapter 1.b) integrated with examples; Chapter 1.c) reinserted; Chapter 3.B) inserted with download and then modified the following numbering; Note on the download at the beginning of the integrated article
- 2023-08-16: Transcriptions included in Chapter 2
- 2023-05-31: editorial changes
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In one Procedure instructions (VA)Also called standard operating procedure (sop) or description of the process, companies determine their processes, for example how they develop products or provide services. Standards such as ISO 9001 and ISO 13485 require these procedural instructions. Companies can establish these requirements directly in the quality management manual or in independent documents.…