SFS-EN ISO 22716

Soveltamisala

Tässä kansainvälisessä standardissa esitetään kosmeettisten valmisteiden tuotantoa, tarkastusta, varastointia ja toimittamista koskevia ohjeita.
Ohjeet kattavat tuotteen laatunäkökohdat, mutta ne eivät kata tuotantolaitoksessa työskentelevän henkilöstön turvallisuusnäkökohtia kokonaisuudessaan eivätkä ympäristönsuojeluun liittyviä näkökohtia. Turvallisuus- ja ympäristönäkökohdat
ovat yritykselle luontaisesti kuuluvia vastuita, joita saattavat ohjata paikallinen lainsäädäntö ja määräykset.
Nämä ohjeet eivät koske tutkimus- ja kehitystoimintaa eivätkä lopputuotteiden jakelua.

Tämän julkaisun valmistelusta Suomessa vastaa Kemesta ry, puh. 040 820 4888.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Personnel

3.1 Principle
3.2 Organization
3.3 Key responsibilities
3.4 Training
3.5 Personnel hygiene and health
3.6 Visitors and untrained personnel

4 Premises

4.1 Principle
4.2 Types of area
4.3 Space
4.4 Flow
4.5 Floors, walls, ceilings, windows
4.6 Washing and toilet facilities
4.7 Lighting
4.8 Ventilation
4.9 Pipework, drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest control

5 Equipment

5.1 Principle
5.2 Equipment design
5.3 Installation
5.4 Calibration
5.5 Cleaning and sanitization
5.6 Maintenance
5.7 Consumables
5.8 Authorizations
5.9 Back-up systems

6 Raw materials and packaging materials

6.1 Principle
6.2 Purchasing
6.3 Receipt
6.4 Identification and status
6.5 Release
6.6 Storage
6.7 Re-evaluation
6.8 Quality of water used in production

7 Production

7.1 Principle
7.2 Manufacturing operations
7.3 Packaging operations

8 Finished products

8.1 Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns

9 Quality control laboratory

9.1 Principle
9.2 Test methods
9.3 Acceptance criteria
9.4 Results
9.5 Out-of-specification results
9.6 Reagents, solutions, reference standards, culture media
9.7 Sampling
9.8 Retain sample

10 Treatment of product that is out of specification

10.1 Rejected finished products, bulk products, raw materials and packaging materials
10.2 Reprocessed finished products and bulk products

11 Wastes

11.1 Principle
11.2 Types of waste
11.3 Flow
11.4 Containers
11.5 Disposal

12 Subcontracting

12.1 Principle
12.2 Types of subcontracting
12.3 Contract giver
12.4 Contract acceptor
12.5 Contract

13 Deviations
14 Complaints and recalls

14.1 Principle
14.2 Product complaints
14.3 Product recalls

15 Change control
16 Internal audit

16.1 Principle
16.2 Approach
16.3 Follow-up

17 Documentation

17.1 Principle
17.2 Type of document
17.3 Writing, approval and distribution
17.4 Revision
17.5 Archiving

Näytä kaikki

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Personnel

3.1 Principle
3.2 Organization
3.3 Key responsibilities
3.4 Training
3.5 Personnel hygiene and health
3.6 Visitors and untrained personnel

4 Premises

4.1 Principle
4.2 Types of area
4.3 Space
4.4 Flow
4.5 Floors, walls, ceilings, windows
4.6 Washing and toilet facilities
4.7 Lighting
4.8 Ventilation
4.9 Pipework, drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest control

5 Equipment

5.1 Principle
5.2 Equipment design
5.3 Installation
5.4 Calibration
5.5 Cleaning and sanitization
5.6 Maintenance
5.7 Consumables
5.8 Authorizations
5.9 Back-up systems

6 Raw materials and packaging materials

6.1 Principle
6.2 Purchasing
6.3 Receipt
6.4 Identification and status
6.5 Release
6.6 Storage
6.7 Re-evaluation
6.8 Quality of water used in production

7 Production

7.1 Principle
7.2 Manufacturing operations
7.3 Packaging operations

8 Finished products

8.1 Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns

9 Quality control laboratory

9.1 Principle
9.2 Test methods
9.3 Acceptance criteria
9.4 Results
9.5 Out-of-specification results
9.6 Reagents, solutions, reference standards, culture media
9.7 Sampling
9.8 Retain sample

10 Treatment of product that is out of specification

10.1 Rejected finished products, bulk products, raw materials and packaging materials
10.2 Reprocessed finished products and bulk products

11 Wastes

11.1 Principle
11.2 Types of waste
11.3 Flow
11.4 Containers
11.5 Disposal

12 Subcontracting

12.1 Principle
12.2 Types of subcontracting
12.3 Contract giver
12.4 Contract acceptor
12.5 Contract

13 Deviations
14 Complaints and recalls

14.1 Principle
14.2 Product complaints
14.3 Product recalls

15 Change control
16 Internal audit

16.1 Principle
16.2 Approach
16.3 Follow-up

17 Documentation

17.1 Principle
17.2 Type of document
17.3 Writing, approval and distribution
17.4 Revision
17.5 Archiving

Tuoteryhmä(t)

71.100.70 Kosmetiikka. Hygieniatarvikkeet »

Sidokset

Velvoittavat viittaukset

Tässä julkaisussa ei ole velvoittavia viittauksia

Tekninen komitea

CEN/TC 392 Cosmetics »

Direktiivi

1223/2009 Kosmeettisista valmisteista

http://ec.europa.eu »

Vahvistuspäivä

12.05.2008

Julkaisupäivä

12.12.2008

Painos

1

Sivumäärä

50

Julkaisun kieli

suomi/englanti