What is a ‘standard’?
A standard is a normative document for voluntary use, which is generally available and has been approved by a recognized standards body.
A standard sets forth rules, guidelines or characteristics applicable to various types of activities or results thereof; it is approved on a consensual basis and intended for general and repeated use, accepted by all parties concerned as an advantage for all, and it introduces a code of best practice and rules of rational behaviour in the context of the current state of the art.
Provisions of a standard should:
- be based on scientific research and data reviewed for its technical, economic and operational appropriateness;
- take into account the state of the art and the level of technology achieved or achievable in the foreseeable future;
- be feasible and absolutely verifiable.
How is a standard developed?
The process of development of a standard consist of the following stages:
- evaluation and approval of a topic described in a new topic sheet,
- drafting of the standard,
- a targeted and a public enquiry,
- examination of comments and agreement on the content of the standard,
- approval of the standard,
- publication of the standard.
What is the purpose of a standard?
The purpose of a standard is to facilitate implementation of tasks resulting from social and economic needs by establishing model solutions in the following fields:
- human, environmental and material safety,
- elimination of barriers to trade,
- consolidation of the technological development,
- propagation of the technological development,
- efficiency improvement in the economy,
- providing a basis for resolution of disputes between a supplier and a customer,
- providing a reference basis for contracts concluded under the civil law.
What is a Polish standardization document?
A Polish Standardization Document is a standardization document identified by a reference number starting with a ‘PKN’ symbol.
Until 2002, the Standardization Act authorized the Polish Committee for Standardization to develop the Polish Standards only. Under an amendment of 2002 to this Act, the Polish Committee for Standardization was granted the competence to develop other standardization documents as well.
Each standardization organization develops standardization documents with a rank lower than that of a standard,
agrees its content only at the level of working bodies and publishes it as a document identified by a number containing the organization’s symbol – (PKN, CEN, ISO etc.). The competence ensured by the 2002 amendment to the Standardization Act was exercised in that a new type of document was adopted by the PKN – the so-called Polish Standardization Document (PDN), which is identified by a number starting with the ‘PKN’ symbol.
A Polish Standardization Document may transpose European or international standardization documents other than a standard, and standardization documents published by EU or NATO Member States. It may also be a national input (a so-called ‘own’ Polish Standardization Document).
The most frequent standardization documents:
TS (Technical Specification)
– a normative document which is developed in order to: present
information on the characteristics of the subject matter of the documents which are relevant for market development; provide users with guidelines on properties or methods of research; introduce experimental properties or technologies; publish the results of works on a draft of a standard where the support for such draft during the voting has been insufficient.
TR (Technical Report) – an informative text which is developed in order to convey information on topics other than usually published as a standard.
CWA (Workshop Agreement) – a document containing technical arrangements, developed as a result of an agreement between parties participating in a workshop, but not within a TC.
Guide – an informative document in the form of a set of rules, methods and guidelines.
PAS (Publicly Available Specification) – a document published in response to an urgent demand on the market.
What method is used in order to transpose the European Standards to the body of the Polish Standards?
In order to transpose the European Standards to the PN body, the PKN recognizes a specific European Standard as a Polish Standard and publishes it in the original language, with national pages added, including: a PN title page, a national preface, and national annexes.
A Polish language version of a PN-EN is developed after such need is reported by stakeholder circles in the form of a standardization topic proposal sheet (with a reference to the sources of funding), and after the proposal is adopted by the TC.
What documents are used as a basis for development of the Polish Standards?
The Polish Standards are developed on the basis of R2 procedures described in the PKN’s quality assurance system.
What is a dated reference and an undated reference?
A dated reference to a standard in a normative document (i.e. a regulation, standard, code of conduct, technical specification) means that a standard is referred to by identifying it through its reference number, which also includes the year of publication (in the PNs since January 2013, also the month of publication). In the light of such reference, no further amendment to the standard referred to or modification thereof is applicable. A dated reference is used in particular where a specific chapter, table or drawing included in a specific publication of a standard must be referred to. An undated reference to a standard in a normative text means that a standard is referred to by identifying it through its number, without mentioning a year of publication. Where such reference to a standard is used, the latest publication of the standard referred to (as amended) is applicable.
Does withdrawal of a standard imply its cancellation?
Withdrawal of a standard should not be understood to imply its cancellation, which was a characteristic of the previous standardization system. Cancellation of a standard used to have to a direct legal effect, which was a prohibition of the use of the cancelled standard, on pain of criminal sanctions. It also led to withdrawal of the standard concerned from the body of standards, which only comprised legitimate standards. Once withdrawn, such standard would then be of archival significance only.
In a normalization system based on voluntary application, withdrawal of a standard means that it is withdrawn from the body of up-to-date standards due to the fact that its content has become outdated.
How often will the PKN’s Work Program at the PKN’s website be updated?
The PKN’s Work Program at the PKN’s website is always up to date. Each new topic, each case where the implementation of an existing topic is discontinued, or any amendments to the Work Program are updated automatically. This is facilitated by a direct link between the Work Program and the IT system.
Why are there so few topics in the work program related to development of own polish standards?
The PKN’s priority is the transposition of the European Standards to the PNs. Most funds are allocated to this purpose. Own standards are developed with an active financial participation of stakeholder circles interested in the development of a specific standard. Adding of such topic to the Work Program should be preceded by developing a new topic sheet, and the topic itself should be notified to the CEN/CENELEC.
What is a standstill?
It is a period of suspension from the date when a standard is notified until the date when it its released. During this period, standardization works are withheld, and the proposed topic is reviewed – whether or not it poses a barrier to trade, or whether or not it is in conflict with standardization works at the European level.
How many members may serve on a Technical Committee/Project Committee/Technical Subcommittee, and who may be a TC/PC/SC member?
Technical Committee (KT)/ Project Committee (KZ)/ Technical Subcommittee (PK) members are entities operating and registered in the territory of the Republic of Poland, interested in the thematic field of a specific KT/KZ/PK.
The number of members (entities) should not be:
- lower than 5 for a KT;
- lower than 3 for a KZ;
- lower than 3for a PK.
In justified cases, the President of the PKN may consent to a KT composed of less than 5 entities. KT/KZ members (entities) are appointed by the President of the PKN for an indefinite period, and KZ members are appointed for the project’s duration. KT/KZ/PK members perform their works through their representatives.
Pursuant to the Standardization Act of 12 September 2002, a KT/KZ/PK is composed of: experts – the entities’ representatives, and a PKN employee.
Within a single KT/KZ/PK, each individual may only represent one member.
How to become a KT/KZ/PK member?
To become member of Technical Committee (KT)/ Project Committee (KZ)/Technical Subcommittee (PK) entity need:
• meet the requirements of Article 23 (2) of the Standardization Act of 12 September 2002;
• operate and be registered in the Republic of Poland;
• have competences in thematic scope of KT/ KZ/PK which they want to join.
Membership in KT/KZ/PK is voluntary and free. The applying procedure consists of submitting the required documents to PKN.
Detailed regulations, including a list of required documents, are available on the site: Jak zostać członkiem KT/KZ/PK, as well as in the procedure Z2-P3. The entity interested in membership can get support in the Standardization Activities Administration Department the PKN (WAN).
Are the European Standards and drafts of the European Standards available? Where are they sold?
The European Standards and drafts of the European Standards are only made available for the purpose of standardization works, to experts cooperating with the technical committees.
An European Standard may not be sold before it has been implemented at the national level. In Poland, such documents are marked as ‘PN-EN’, ‘PN-ETS’, ‘PN-ETSI EN’, ‘PN-HD’, ‘PN-ENV’, and ‘PN-CR’. They can be purchased from the Sales Department.
Other countries’ implementations may be purchased via the Sales Department
Are the ISO and IEC International Standards available?
The ISO and IEC International Standards are made available to readers at the Standards Reading Rooms in Warsaw, Łódź and Katowice. They can also be purchased via the Sales Department in Warsaw.
What is the ICS?
The ICS – the International Classification for Standards – is used for indexing standards, standardization documents, and drafts thereof. The ICS serves as a basis for classification of standards in international, European and national catalogues, databases, libraries and standards subscriptions. The ICS is a three-level hierarchical classification. It covers 40 fields of activity in standardization. These fields are subdivided into groups, marked by a two-digit field notation and a three-digit group notation. A group may be further divided into subgroups, e.g. 43.060.50.
What is the status of BN industry standards?
1. Industry standards (BN) are one of the types of technical normative documents which used to be developed by bodies beyond the control of the Polish Committee for Standardization, i.e. by entrepreneurs, academia, ministries etc. They were standards applied by companies in a specific industry. Pursuant to Article 28 of the Standardization Act of 12 September 2002 (consolidated version: Journal of Laws of 2015, item 1483), the PKN ceased to maintain the body of industry standards as of the effective date of the Act. The then-existing bodies of standards – Industry Standards (BN) and Military Industry Standards (WBN) – were transferred by the PKN to the Central Archives of Modern Records (Archiwum Akt Nowych).
2. Pursuant to Article 16(1) of the National Archive Resources and Archives Act of 14 July 1983 (Journal of Laws of 2016, item 1506), each citizen and organizational unit has the right to consult archive resources, which are made available free of charge for research, cultural, technological and economic purposes.
3. Industrial Standards published before the effective date of the Standardization Act are available at the Central Archive of Modern Records and may be applied voluntarily. Nevertheless, it has to be emphasized that they may contain outdated data. It is safer to rely on a Polish Standard, whose technical data is up to date.
Is there any other way of consulting a PN than to buy it?
The standards may be consulted free of charge at the PKN’s stationary reading rooms in Warsaw, Katowice, and Łódź.
Are the Polish Standards available for sale online?
The PN may be purchased via the online shop.
What protections does a Polish Standard have?
Where are errata, amendments and modifications of the Polish Standards available?
Just as the PNs themselves, errata, amendments and modifications of the Polish Standards form a body of documents, and they are available wherever the PN body is available, that is at the PKN’s stationary reading rooms in Warsaw, Katowice, and Łódź. Modifications may be purchased at the online shop, indirectly via the Wiedza website, or at the PKN’s distribution outlets. Amendments and errata may be downloaded free of charge from the online shop. As far as access services are concerned, all modifications, amendments and errata are added automatically to the sets of standards purchased.
What is the CE mark?
Are the Polish Standards available for subscription?
Yes. PN subscription for a specific year, based on the latest edition of the International Classification for Standards, is offered by the PKN’s Sales Department. Subscriptions are offered for the Polish Standards and for modifications of the Polish Standards and the Polish Standardization Documents PDN (published as separate documents) printed in a specific year.
Can the Polish Standards be copied?
Pursuant to Article 5(5) of the Standardization Act of 12 September 2002 (Journal of Laws of 2015, item 1483), which entered into force on 1 January 2003, the Polish Standards are protected like literary works, and the author’s economic rights belong to the national standards body, the Polish Committee for Standardization.
No copies of the standards can be made.
The Polish Standards may only be reproduced with the PKN’s official consent, and only with regard to specific fragments thereof (tables, drawings etc.), up to 30% of the standard’s volume. Specific terms and conditions of granting consent to the reproduction of the Polish Standards are described in the Rules of consent to the use of copyrights to the Polish Standards and other standardization documents. Proceedings related to consents to the reproduction of the PNs and national, international, European and foreign standardization publications are conducted by the External Relations Department.
For all information on copyrights to the Polish Standards under the Standardization Act and the Copyrights and Related Rights Act, please email the PKN’s Legal Team firstname.lastname@example.org.
How to check whether there is a standard on a specific topic, and how much it costs?
In the event that the Polish Standard number is unknown, you can use the shop search engine or the search engine at the Wiedza website. The relevant fields should be completed with known information on the standard.
Is application of standards mandatory?
Are all Polish Standards available in Polish?
No. The Standardization Act authorizes publication of the Polish Standards in the language of the original. Such standards are marked in the search engine as an English version, a German version, a French version, which indicates that the standard has not been translated into Polish. In order to place an order, one of the available language versions must be selected: English, German or French one.
Is the content of a Polish Standard available for sale in electronic form?
All Polish Standards (except for special standards with original appendices) are available in electronic form – as PDF files (CD, downloadable file, emailed file).
We also offer other publications and standardization products in electronic form.
Where can drafts of the Polish Standards be consulted?
PN drafts are available for consultation free of charge at the PKN’s reading rooms (Warsaw, Łódź, Katowice). They are also available for sale at the PKN’s distribution outlets.
A list of drafts for public enquiry, offering the possibility to submit comments, is available at General Enquiry on Polish Standard Drafts.
What are harmonized standards?
Harmonized standards are the European Standards developed by European Standards Organizations in response to a mandate granted by the European Commission after consultation with the Member States. They are published in the Official Journal of the European Union (C series). They take into account the essential requirements of directives and regulations, and they are the simplest measure for a manufacturer/importer to prove implied conformity of their product with the relevant directive/regulation.
While application of harmonized standards is voluntary, the priority is to meet requirements applicable to a specific product. Harmonized PN-EN standards are available at the ‘Standard and the Law’ page, ‘Directives, regulations and standards’ tag. The knowledge of harmonized standards is recommended even where the manufacturer has decided not to apply them. Harmonized standards are not a component of the European law.
What is the PN eACCESS service?
What is the Normy on-line service?
Are the Polish Standards regarded as public information?
No. Pursuant to Article 5(7) of the Standardization Act, the Polish Standards are not regarded as public information and they are not to be made available in the manner prescribed by the Access to Public Information Act of 6 September 2001 (consolidated version: Journal of Laws of 2022, item 902).
Is application of a Polish Standard mandatory when referred to in a regulation by a responsible minister?
Is a PN certificate required in order to apply the CE mark on a product?
It is not required. The PN certificate is a voluntary certificate which confirms that the requirements of a specific standard are met. Products subject to CE marking must meet essential requirements specified in the so-called New Approach directives. The easiest way to prove conformity to essential requirements is to meet the requirements of harmonized standards for relevant directives. Depending on the conformity assessment module provided for in a directive, the conformity assessment is conducted without or with the presence of a notified body for a relevant directive – in the latter case, a so-called certificate of conformity to essential requirements of the directive, issued by the notified body after a positive assessment, must be obtained.
A PN certificate, in turn, will always confirm an additional value of a product determined by voluntary compliance with all requirements of a relevant standard – a value verified in a certification process conducted by the PKN or by a product certification entity authorized by the PKN.
What does it mean when an organization holds a PN-EN ISO 9001:2009 declaration/certificate of conformity? What does it not mean?
It means that the organization has implemented a quality assurance system and that it is able to supply, on a continuous basis, a product which meets the customer’s requirements and the requirements of applicable legislation and other regulations.
It does not mean that a product/service offered meets the requirements of the PN-EN ISO 9001:2009 standard, because this standard does not apply to product.
Similarly, it does not mean that the organization’s products/services offer 100% conformity, but that the management system procedures in place ensure supervision over their conformity.
What is the PKN’s ISMS (SZBI) certificate?
It is a document which confirms the implementation and effective functioning of an information security management system at an organization cooperating with the PKN under a cooperation agreement. It confirms that the organization meets the requirements of the PN-ISO/IEC 27001:2014-12 standard.
How is a conformity assessment to essential requirements different from certification?
A conformity assessment to essential requirements is a mandatory measure required by the provision of law. The provision determines clearly how the assessment should be conducted and confirmed. Depending on the legal requirements, the assessment may be conducted by the manufacturer independently, or with voluntary or mandatory participation of a third party (a notified body).
Certification is always an assessment of conformity of the certification object with a reference document, conducted by an independent third party. Certification may be mandatory – imposed by the law – or voluntary – conducted at the manufacturer’s discretion.
A conformity assessment always concludes with a declaration of conformity to essential requirements. Certification concludes with a certificate. While a certificate is not a declaration of conformity, it may serve as a basis for the manufacturer to issue such declaration. Should this be the case, the certificate should be referred to in the declaration.
What is accreditation, and what kind of entities does it refer to?
Accreditation is a confirmation of the competence of an entity – (a body certifying products, services, people, systems), a laboratory (a testing laboratory, a calibration laboratory, etc.), an inspection body – to perform activities in a specific area. The scope of accreditation is an annex to the accreditation certificate and it describes in detail the area of confirmed competence.
Poland’s only accreditation body is the Polish Centre for Accreditation.
Within the EU, accreditation is of ‘cross-border’ nature, which means that a body accredited in Poland to certify, for instance, management systems for conformity to the PN-EN ISO 9001 standard by the PCA, may, on the basis of this accreditation, operate in every EU Member State.
Accreditation in the area of voluntary certification is not mandatory. Accreditation is required, as a matter of exception, in the event that a notification is applied for. Nevertheless, it is in the customer’s interest to use accredited bodies’ services in view of their confirmed competence, and in view of the supervision over their activities ensured by the PCA or other national accreditation body.
What is a notified body and a notified laboratory?
A notified body is a body assessing conformity, notified to the European Commission and on the list of notified bodies for a relevant directive. A unique identification number is assigned to such body. A notified body is authorized to conduct conformity assessments and issue certificates of conformity to type. A manufacturer whose product have to be assessed for conformity with the participation of a third party must use the services of a notified body of his choice.
A notified laboratory is a body authorized, in the manner described above, to test a product for conformity to relevant harmonized standards. The laboratory may issue a product’s research report to the manufacturer, but it is not a ‘substitute’ of, and does not replace a certificate of conformity to type.
How a declaration of conformity to essential requirements may be checked for accuracy?
A declaration of conformity to essential requirements is always issued by the product’s manufacturer, or by its authorized representative where the manufacturer is established beyond the EU. Its content is specified in an applicable directive. The relevant provisions have been transposed to the Polish law in the form of legal acts implementing such directives. They are available at the PKN’s website.
The first verification of a declaration of conformity should involve checking whether all provisions of the relevant legislation have been included in the verified document. When in doubt, a market supervision body should be consulted (for instance the Office of Competition and Consumer Protection). NOTE: Pursuant to Article 7 of the Standardization Act of 12 September 2002, the manufacturer may, on a voluntary basis and on its own responsibility, issue a declaration of conformity to a Polish Standard. Such declaration is in no way a ‘substitute’ or an equivalent of a declaration of conformity to essential requirements.
What are directives?
Directives are regulatory provisions the implementation of which is mandatory for all EU Member States. Directives are developed by the European Commission in order to create a uniform body of provisions to enable elimination of barriers to trade and to ensure a free movement of goods, meeting essential requirements with regard to safety of products for people and for the environment. Poland’s key legal act transposing directives to the domestic law is the Conformity Assessment System Act of 30 August 2002 (Journal of Laws of 2021, item 1344), provisions of the act of 13 April 2016 on conformity systems and market supervision (Journal of Laws of 2022, item 5) and the Act of 12 December 2003 on General Product Safety (Journal of Laws of 2021, item 222).
Provisions of the act on exercising compliance with medical articles, also for agri-food products and animal nutrition. Some directives take into account the key elements of research and certification and the rules of designation of bodies participating in the product assessment; they also harmonize the rules of application of the CE mark. Directives apply to products which are to be placed on the market or put into service for the first time. The manufacturer is responsible for meeting essential requirements, declares the product’s conformity to the requirements on its own, and remains responsible for its accuracy. The manner in which essential requirements are to be met is entirely at the manufacturer’s discretion. The PKN wishes to emphasise that the manufacturer has a choice; it may manufacture its product and verify its conformity directly with regard to a directive, or it may manufacture its product in accordance with the requirements of a harmonized standard, the result being that the product’s conformity to the directive’s essential requirements is merely implied. For more information on the Directives visit the European Commission’s website.
What is a Notice of the President of the PKN?
A Notice of the President of the PKN is an announcement, in the Monitor Polski official gazette, of a list of the published Polish Standards (PN) transposing European Standards (EN) harmonized on the basis of directives, together with the implementations of such directives to Polish legal acts.
The Notices are published twice a year, with lists valid as at 30 June and as at 31 December, in accordance with Article 13(3) of the Conformity Assessment System Act of 30 August 2002 (Journal of Laws of 2021, item 1344), provisions of the act of 13 April 2016 on conformity systems and market supervision (Journal of Laws of 2022, item 5) and the Act of 12 December 2003 on General Product Safety (Journal of Laws of 2021, item 222).