At this point the ISO 13485 Standard differs himsekf from the ISO 9001 Standard. In other  more realistic words, thing are getting more complicated. From chapter 7.5.1 until chapter 7.5 (includes) there are "extra" requirements that the organization must follow. this "extra" requirements are presented as sub paragraphs to the original as you may see for your self:

Paragraph 7.5.1 (the ISO 9001 Standard) - Control of production and service provision 
Paragraph 7.5.1.1 (the ISO 13485 Standard) - Control of production and service provision – general requirements 

The organization is required to plan and perform production and service provision under controlled conditions. The control must be performed and achieved according to the planning requirements specified within chapter 7.1 (product realization). The control would apply the line of manufacturing or service provision, and would include activities such as:
Production activities
Product release activities
Replication activities
Sterilization processes
Delivery activities
Transporting activities
Installation activities
Maintenance activities (support and services)
Operation activities
So, if the medical device is to be sold in a sterile condition, it must be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated.
In order to maintain the required control over the realization processes, the organization shall refer the next issues (as much as applicable):

This chapter deals with the controls over the different elements that combine the production processes. The chapter specifies the requirements for achieving well controlled productions conditions necessary to ensure conformance to the medical device specifications. The control shall be planned in accordance with the medical device requirements and specifications. Which requirements? So many requirements all over the Standard… The exact ones that were specified in chapter 7.1 – product realization. The organization, the customer and the local authority decided upon certain requirements and specifications for the medical device. Now it's time to ensure that the medical device conforms its specifications. And what is a better way than a well controlled production process?

The requirements for a controlled process, according the ISO organization, shall include the next basic demands:

Infrastructure –
The infrastructures related to the product realization must be under control. The requirements for the controls are specified on chapter 6.3.

Medical device's specifications –

At any stage of the production (no matter what the production includes), the characteristics of the medical device are available for any relevant employee: The main purpose is that the employee could measure himself whether the output of the process is according to the specifications. 
Production requirements –

The ISO 9001 Standard requires maintaining the work instructions at the work stations as specified. The ISO 13485 Standard requires the organization to supply any related documentation to the realization process as appropriate. At any stage of the production (no matter what the production includes), the specification of the production processes are available for any relevant employee: documented instructions, standard operating procedures, flowcharts, routing charts and methods that define and control the production. This requirement includes regulatory requirements. If the organization produces medical device under any regulatory requirement, the operational requirements (related to the product realization processes) are to be available to the employees just like any other documentation.

The main purpose is to supply the employee the maximum knowledge and information in order for him to produce the optimal medical device. In generally, the ISO 13485 Standard has more documentation requirements than its cousin the ISO 9001 Standard. Now, it is important to ensure that all this documentation would be available where required (periods, functions and locations).

Control of product's measurements –

Do not get confused. It is not about controlling the measurement devices. It is about controlling the measurements themselves. The measurements activities are to be defined and the available to the relevant functions as well as the equipment for measurements. The purpose is to measure the production processes in order to control them and detect any non conformities.

Records, Records and once again Records

The required documentation to ensure the activities and controls mentioned above shall be defined and maintained. These records shall be submitted to your records control process. In other words, these records are part of your quality management documentation and needed to be documented in the records control procedure. 

Next additional requirement is for packaging and labeling activities. While the ISO 9001 Standard does not refer to the issue, the ISO 13485 Standard specifically requires defining the activities. The organization must define how, when, whom and where, during the realization process, the product should be labeled and packed. This requirement resulted by the traceability requirements. Later on the ISO 13485 Standard requires maintaining a strict traceability requirement. This requirement would have to be documented. More on this subject would be delivered on paragraph 7.5.3.

Next additional requirements relates to batches of medical devices. Each batch record should include the next issues:

• First, the organization is required to document the batch according to the traceability requirements as specified in paragraph 7.5.3.
• Second requirement is to document the amount of medical devices manufactured in each batch.
• Thirds requirement is to document, out of the batch manufactured, how many medical devices were approved for use.

This documentation shall be included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure. 

Paragraph 7.5.1.2 - Control of production and service provision — Specific requirements

This paragraph is an extension requirement.  It is divided into two requirements:

7.5.1.2.1 Cleanliness of product and contamination control

It is required that the organization shall establish a documented procedure indicating the cleanliness of products when the next terms occur:

1. When the medical device is required to be cleaned by the organization before it is subjected for a sterilization process (internal or external) or delivered for use.
2. The medical device supplied is required to be cleaned before it is subjected to a sterilization process.
3. The medical device is delivered sterilized and is required to be sterilized during or after use.
4. The medical device is required to be cleaned of any remnants from the production processes.

When cases mentioned in paragraph A-B are applicable, the organization is required to document the health, cleanliness, personal behavior and clothing requirements (as mentioned in paragraph 6.4 a) and to maintain documented requirements such as procedures or work instruction, which would assure monitoring and control of the work environment, when the work environment can affect the product's quality (as mentioned in paragraph 6.4 b) only after the cleanliness process and not before.

We are still under the process control requirements. Some medical devices are required to be cleaned after manufacturing or before they are submitted to the next process or are to be sold in a sterile condition. The ISO 13485 Standard requires maintaining a set of documented procedures. The ISO 13485 Standard suggests four different states of medical device's sterilization. When a medical device is required to be cleaned according to the cases mentioned in paragraphs A-D, the organization shall maintain documented requirements describing the cleanliness processes. The documentation shall indicate employees' behavior and operations of substructure. The requirement here does not apply for a procedure (although I recommend it highly), but a documentation of the requirements. That may appear as forms, routing cards, work instructions etc. In any case, the organization is required to define and to document the performance of the cleanliness processes.

7.5.1.2.2 Installation activities

When appropriate the organization shall define the criteria and the requirements for installing the medical devices. These criteria shall assure, verify and approve that the medical device would be installed according to prior requirements and/or criteria.

When customer's requirements for installment are different from the organization requirements or criteria (for installation), these requirements would be documented, assured and verified.

Documentation of the requirements, the verification and approval shall be included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure as specified in paragraph 4.2.4 – control of records. 

Some medical devices require installation. The ISO 13485 Standard regards the installation as direct element of the medical device. Therefore, the installation requirements are to be defined and documented. There are cases, where installation is performed by a third party. In these cases the organization must also document the installation requirements and criteria, the responsibilities, and authorities during the installation process.

The next stage is to verify and approve that the installation was performed according to the requirements. That means that any installation should be evaluated and examined according to the requirements. The performance the evaluation and the examination must be documented. 

Let's review it again to understand it better:

1. Definition of requirements – the requirements and criteria for installation must be defined as part of the medical device. The installation requirements and criteria must be documented. It is not required to document it as a procedure (although it is always highly recommended). It can be documented as a form, product portfolio or anything that suits your organization and your processes.
2. Installation - The installation of the medical device is performed according to the defined and documented requirements.
3. Verification – the installation is evaluated and examined that it was performed according to the requirements and criteria defined. The verification must be documented. 
4. Approval – the installation and verification must be approved for use. The approval provides the assurance that the medical device was delivered according to the requirements and criteria.

Customer's requirements for installation –

In some cases the customer's requirements for installation are different from the organization's requirements or it can be that the installation is varied from one customer to another.  In this case the special installation requirements would be documented (on an order, a contract, a special form etc.). Of course, the customer must approve these requirements. The approval must be documented. 

The next step is to perform the installation according to the customer's requirements. After installation it is required to verify and approve that the installation was performed according to the customer's requirements. That means that any installation should be evaluated and examined according to the customer's requirements. The performance the evaluation and the examination must be documented. 

Let's review it again to understand it better:

1. Definition of requirements – your customer defines the special requirements the installation of the medical device. These requirements must be documented on an order, a contract, a special form etc.
2. Installation - The installation of the medical device is performed according to the defined and documented customer's requirements.
3. Verification – the installation is evaluated and examined that it was performed according to the customer's requirements. The verification must be documented. 
4. Approval – the installation and verification must be approved for use by the customer. The approval provides the assurance that the medical device was delivered according to the requirements.

Of course, whether you forgot it or not, when regulatory requirements indicate or specify installation demands, they are to be implemented into the other installation requirements.

In any kind of requirements (organizational or customers'), documentation of the requirements, verification and approval shall be included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure as specified in paragraph 4.2.4 – control of records. 

7.5.1.2.3 Servicing activities

Where service is required as part of the product (repairs or maintenance for example), it is required to establish and maintain a documented set of procedures, work instructions, reference material, and any required documented material to perform the servicing activities. The activities must include verification activities that the service provided is according to the specified requirements. 

The ISO 13485 Standard requires documenting the process of the service provision;

• Where, when, and how the customer applies for service provision.
• Who how and where must provide the service.
• Which is the equipment or other accessories required to provide the service.
• What is the service scope; what is required to be done as first aid and when the organization representative shall accept approval (and from who must he accept the approval) before he carries out unusual activities. Try to remember. In some cases people's life would depend on this medical device.
• How can the service provider validate the service activities. In other words what are the validation activities that ensure the organization that the medical device is functional and meets the prior requirements and specifications again. These activities are required to be documented. 
• The information derives from the service activities are required to be recorded and submitted to the records control process.

Documentation of the service provision shall be included under the records control procedure. That means that these records are part of your quality management system documentation and needed to be included under the records control procedure as specified in paragraph 4.2.4 – control of records. 

When an organization produces a medical device that is not perishable, it is required, usually, to maintain service activities after delivering and/or installing the device. When service is required after delivering the product, the ISO 13485 Standard requires, in this case, that the service activities would be planned to follow the requirements. The service provided after delivering the device must be defined as part of the product. How? 

First by definition that after the medical device was delivered and/or installed, a service is required and who is responsible for the service provision. Naturally this definition would be included under the contract or any order specifications.      

Second, defining a set of documentation to defines and describes the services processes and activities. The documentation may include (as the ISO 13485 Standard indicates):

• Procedures
• Work instructions
• Reference material
• Reference measuring procedures

Third, defining the information needed to record the service activities. If your organization provides any services activities to the medical devices, it is required to document the service as specified above. The next details are just a suggestion:

• The name of medical device
• Any identifications and information used
• The date of the service
• The individual who are responsible to provide the service
• The service provided or performed.
• The tests and inspections which confirm the service reached its purposes (validation processes).

The service activities are required to include verification activities. What must the organization verify? The service was provided according to prior requirements. Which prior requirements? The ones are defined and documented as required above.

The next is a recommendation and not a requirement. Service maintenance can use as leverage activities for the continuous improvement or correctional actions. Think about it. A non conformity was detected on the medical device. This is a chance to initiate something…

7.5.1.3 - Particular requirements for sterile medical devices

Where required or applicable, the organization shall maintain a set of documentation for sterilizing processes.  The processes should apply to any manufactured batch.  The documentation shall achieve the requirements at paragraph 7.5.1.1.

Documentation of the sterilizing processes shall be included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure as specified in paragraph 4.2.4 – control of records. 

This small paragraph contains more than it appears. The purpose of sterilization processes is to inactivate any microbiological contaminants and thereby transform the non-sterile device into a sterile one.  Sterilization could be required due to regulatory requirements such as regulatory health requirements, Standard requirements such as ISO 10993 - Biological Evaluation of Medical Devices Package, or by customer's requirements. In any case the sterilization requirements shall be defined and documented. The organization must, on the basis of any sterilization requirements, establish and maintain a set of documentation that describes the sterilization processes as required. The documentation may include:

• Procedures
• Work instructions
• Measurement procedures
• Flow charts
• Etc.

The sterilization processes shall include the requirements from paragraph 7.5.1.1 of the ISO 13485 Standard:

• The information regarding the medical device and its sterilization requirements must be available to any related employee.
• Any documentation regarding the sterilization process must be available to any related employee at any relevant workstation.
• Processes for sterilizing activities are implemented according to prior plans or requirements.
• The equipment used (for sterilizing the medical device) is suitable and maintained accordingly. The equipments must be reviewed according to prior plans and eligible knowledge.
• The use of for monitoring and measuring devices to control the sterilizing processes is implemented according to prior plan or requirements.

And almost as always, the documentation of the sterilization processes shall be included under the records control procedure. That means that these records are part of your quality management documentation and needed to be documented in the records control procedure as specified in paragraph 4.2.4 – control of records. 

Read the next article about the ISO 13485 Standard validation of processes for prodcution and service provision requirements