CAS-0 PSA Conformity Assessment Schemes

Introduction

 

The Conformity Assessment scheme provides the CAB with certification information based on the following requirements and general standards,
PSA has used a combination of world-class schemes in various stages of product certification to design the CAS and solve the problems of the Iran industry to keep Alignment with the international market..

issue a COC (certificate of conformity ), we saw the solution. we have divided the scheme into sectors defined in our ISIRI
is certifed and use the world’s most popular scheme for each sector, such as MSC, which comprehensively talks about aqua natural resources. Has provided responsible solutions for safety fishery products. .

All of the above requirements should be covered as essential requirements in the relevant conformity assessment standard
Although used in all schemes ISO 17021 requirements)Considered as the main standard. And PSA has seen the principles of this standard in its 17065 QM
In CAS 0-20, in accordance with the type and scope of activity, the conformity assessment has been carried out as much as possible with the requirements specified in the SCHEME related to the conformity assessment.

ISO/IEC Guide 53	Conformity assessment – Guidance on the use of an organization’s quality management system in product certification
[2]	ISO/IEC Guide 28:2004	Conformity assessment – Guidance on a third-party certification system for products
[3]	ISO 31000	Risk management – Principles and guidelines
[4]	ISO/IEC 17007	Conformity assessment – Guidance for drafting normative documents suitable for use for conformity assessment
[5]	ISO/IEC 17030	Conformity assessment – General requirements for third-party marks of conformity
[6]	ISO 10576-1	Statistical methods – Guidelines for the evaluation of conformity with specified requirements – Part 1: General principles (
[7]	ISO 2859-10	Sampling procedures for inspection by attributes – Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes (
[8]	ISO 3951-1	Sampling procedures for inspection by variables – Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL
[9]	ISO 22514-1	Statistical methods in process management – Capability and performance – Part 1: General principles and concepts
[10]	ISO/IEC 17025	General requirements for the competence of testing and calibration laboratories
[11]	ISO/IEC 17020	Conformity assessment – Requirements for the operation of various types of bodies performing inspection
[12]	ISO/IEC 17021	Conformity assessment – Requirements for bodies providing audit and certification of management systems
[13]	ISO Guide 27:1983	Guidelines for corrective action to be taken by a certification body in the event of either misapplication of its mark of conformity to a product, or products which bear the mark of the certification body being found to subject persons or property to risk
[14]	ISO/IEC Guide 68	Arrangements for the recognition and acceptance of conformity assessment results
	ISIRI STANDRADS

1.CERTIFICATION BODY

1.1The Certification Body of PSA carries out various certification of products according to its own certification programs as well as worldwide for business with Iran markets . The owners of international programs are agreements between Testing and Certification Bodies from various countries,
principles and guidance given in clauses 4 and 5 of the document ISO/IEC 17007 “Conformity assessment – Guidance for drafting normative documents suitable for use for conformity assessment” is followed.

Refer to our certification programs, PSA as the Certification Body is accredited by the NACI Accreditation Center, that received the acceptance of the international organizations, issued on the basis on carrying out mutual assessment.

On the basis of a positive result of the certification process, including product testing, evaluation of production conditions and subsequent supervision, we issue a certificate with the right to use on the products registered PSA trademarks. This type of certification is defined as types according to ISO/IEC 17067.

products certification according to the ISO 17065 types program, limited to confirming that product meets the requirements of the ISIRI or another international like codex standard and/or technical specification referred to in the certificate. We carry out such certification within our own programs as well as PSA programs. The latter two enable the manufacturer to obtain national certification in other countries, on the marks of units, that are signatories to PSA agreements.

1.2 The Conformity Assessment Scheme for market/stakeholder acceptance, .Looking at the seventeen principles of the United Nations until 2030 its sectors of PSA CAS includes:

• 1. Food Manufacturing-products.
• 2.Animal Feed Production
• 3.Farming Production
• 4(Retail and Wholesal ) Super &hyper marke
• 5.Restaurants and Caterings
• 6.Fish and marine
• 7.Transport and  Storage
• 8. waste & recycling
• 9.Paper &CELLULOSE
• 10.ELECTRICAL APPLIANCE

  11.CONSTRUCTION

  12.chemical & petrochemical

  13 .Oil &gas

  14.mine and stones

  15.insurance industry

  16.bank industry

  17.Medical Equipment

  18.BIOMASS & BIO-FUELS

  19.FLY ASH, LIME, CEMENT & SAND

• 20 Building Materials

• 21  PUBLIC HEALTH & VACCINES A BIOLOGIC DRUGS IN VETERINARY

   

• 1.3 The PSA certificate in the  Scheme ownership is based on the principle of mutual recognition by members of the international organization of test results and national certificates issued on the basis of conformity assessment with internationals standards (or their national equivalents) that accept by ISIRI.

These organizations requirements   is described under the general heading “Conformity Assessment Process Requirements”.
they Develop and follow the functional approach to conformity assessment, which provides a framework of basic conformity assessment functions and their relationships. PSA select and uses  functions that applicable to certain conformity assessment activities such as inspections as standalone activity.

P S A Flow chart of references use for certification products

1.4 Selection of conformity assessment, including selecting specified requirements to be assessed and planning information collection and sampling activities for targets:

1.4.1 Compliance to Customs Union Technical Regulations is required when exporting to the Eurasian Economic Union – EAEU (former Customs Union). Member states are: Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.

GOST certification systems for individual member states are being gradually replaced by certification to the Customs Union Technical Regulations (CU TR).

Technical Regulations are similar to Directives, covering the requirements to the entire product’s life cycle. Each TR is supported by GOSTs and other standards in terms of product-specific requirements and testing methods

CIS-LEGISLATION.

Applicable conformity assessment documents have to be in place for the Customs clearance and for sale and/or marketing within the member states.

The manufacturer of the products submitted for certification in the PSA program should have:

equipment enabling repetitive production of products
the possibility of performing routine checks of manufactured products (
implemented management system according to ISO 9001 (not necessarily certified), including in particular the production of certified product. In the case of a non-certified system, it will be subject to an assessment carried out periodically by ISIRI

Federal law “On technical regulating” has fundamentally changed an approach to conditions and a mechanism of Conformity Assurance to specified requirements. It establishes Conformity Assurance as a documentary attestation of conformity of products or other subjects, technological processes, processes of use, storage, transportation, realization and utilization, work or services to Technical Regulation requirements, Standard provisions or Contractual provisions.

  Conformity Assurance is carried out for the purposes of:

• attesting conformity of products or other subjects, technological processes, processes of use, storage, transportation, realization and utilization, work or services to Technical Regulations, Standards or Contractual provisions;
• helping purchasers in competent choice of products, work or services;
• increasing competitiveness of products, work or services in Russian and International markets;
• creating conditions for providing free movement of goods over the territory of the Russian Federation as well as International economic, scientific and technical cooperation and trade.

  Unlike other ways of assessment Conformity Assurance is applied on pre-market products stage and can be carried out by both manufacturers, that is the first party (conformity declaration), and independent of manufacturers and consumers bodies, that is the third party (certification).

  Conformity Assurance in the territory of the Russian Federation may be voluntary or mandatory.

  Conformity Declaration and Conformity Certificate both have equal legal effect independently of mandatory conformity assurance plans and are valid over all the territory of the Russian Federation.

.

1.4.2.National certification

When we certify a product or service that all stages of design, construction, service provision and consumer goods are covered by the national standard logo or ISIRI accredited certificates.

1.4.3 . International requirements covered by international schemes mainly related to Quality , and therefore are safe and do not pose a threat to the people and the environment. Certification of conformity according to the PSA program is a certification of 6 type , covering testing and assessment of the product, pre-license inspection, and management systems sampling from open market as well as annual surveillance at the place of production and manufactured products collected from the producer and/or from the market.

2.CERTIFICATE REGISTRY

TYPE OF PRODUCTS CERTIFICATIONS SCHEMES. ISO/IEC 17067

PSA certification program is defined as a certification system related to specified products, to which the well known international scheme owner requirements, specific rules and procedures apply.

Certain certification programs may include preliminary test of the product and pre-license inspection or assessment of quality management systems at the production site, followed by surveillance including periodic testing or inspection of samples taken from production and / or the market.

Other programs consist of a preliminary test and surveillance tests, and still others may include only product type testing, limited to testing the provided sample.

For an easy and unambiguous recognition of differences between individual certification programs ISO / IEC 17067 introduced the concept of program type, digitally highlighted, assigning to each of them a specific share of individual functions and conformity assessment activities in the product certification system.

Types of certification programs for products have been classified from 1 to 6, whereas the type 6 program applies only in Intangible products.

Below, there is presented the lists of conformity assessment activities that are to be performed in a given certification program of a given type

These requirements may vary depending on the declaration of ownership of the international project. PSA, however, considers the requirements of ISIRI and IAF for compliance

Of course, a specific table has been prepared for each sector with reference to IAF- accepted sources.
Which is regularly adapted by the technical managers of the company to the needs of Iranian stakeholders. /

 

Table 1 Type of product certification scheme PSA ISO/IEC 17067
Conformity assessment functions and activities within product certification schemes	Type of product certification scheme *
	1a	1b	2	3	4	5
Activities for issuing the certificate
Product evaluation – type test acc.	X	X	X	X	X	X
–  pre Approval pre-license inspection in factory				X	X	X
Review	X	X	X	X	X	X
Decision on certification	X	X	X	X	X	X
Certification documents	X	X	X	X	X	X
Certificate of conformity	X	X	X	X	X	X
License – granting the right to use marks of conformity		X	X	X	X	X
Certification of a batch		X
Surveillance after issuing a certificate
Testing of samples  from the open market			X		X	X
Testing of samples  from the factory/fram				X	X	X
Assessment of the production, the delivery of the service				X	X	X
Management system audits  combined with random tests or inspections						X
* The program type 6 for processes

It can be seen that in all types of programs there is a product evaluation carried out by testing a product sample to demonstrate compliance with specified requirements.

In programs with the surveillance and certification of conformity of a batch, in addition to the certificate of conformity, a document entitling to use a certified certification mark for the certified product is issued. Such a document is called a license
PSA methods and procedure, criteria for evaluation as well as reporting requirements is decided by the technical managers responsible for conformity assessment and ensured that the same are followed by the PSA engaged for the same, for ensuring integrity and consistency of the outcome of the process of conformity assessment. The technical manager should make use of the provisions described in the respective conformity assessment standards for elaborating the same. Additional guidance / requirements with respect to time required for evaluation tasks, transfer of certificates, multi site considerations and impartiality requirements for PSA is described, for stakeholders in impartiality committee.

.

Scheme type 1a
In this scheme, one or more samples of the product are subject to the determination activities. A certificate of conformity or other statement of conformity (e.g. a letter) is issued for the product type, the characteristics of which are detailed in the certificate or a document referred to in the certificate. Subsequent production items  are not covered by the certification body’s attestation of conformity.

The sample are representative of subsequent production items which could be referred to by the manufacturer as being manufactured in accordance with the certified type.

The certification  body may grant to the manufacturer the right to use the type certificate or other statement of conformity (e.g. a letter) as a basis for the manufacturer to declare that subsequent production items confirm to the specified requirements.

Scheme type 1b
This scheme type involves  the certification of a whole batch of products, following selection and determination as specified in the scheme. The proportion to be tested, which can include testing of all the units in the batch (100% testing), would be based, for example, on the homogeneity of the items in the batch and the application of sampling plan, where appropriate. If the outcome of determination, review and decision is positive, all items in the batch may described as certified  and may have a mark of conformity affixed, if that is included in the scheme.

This type of certification is preferred in cases required by law, periodic nature of production and also at the recipient’s request.

Scheme type 2
In this program, the evaluation for the issuance of the certificate is limited to the product evaluation carried out by testing the product sample to demonstrate compliance with the specified requirements. The surveillance part of this scheme involves periodically taking samples of the product from the market and subjecting them to demonstration activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. This program does not provide for the assessment of production. It is preferred if there is no possibility and need to carry out a factory inspection. Usually used for the certification of imported products and also in cases where legal provisions require entities to purchase equipment that has the appropriate attestations or certificates, e.g. equipment for schools and facilities.

Schemes types 3, 4 & 5
In these programs, unlike the other types, at the stage before the certificate is issued, the assessment of production process is carried out. The assessment of production, by pre-license factory inspection, is aimed at demonstrating compliance with the technical and organizational conditions guaranteeing the maintenance of repeatable production of products at the level confirmed by the type test of the product. In programs that include this action, there is always a surveillance function after issuing the certificate. The surveillance part covers both periodic sampling of products, for conducting control tests as well as periodic factory inspections, often referred to as routine inspections. Product inspection tests are performed to check whether products manufactured after the issuance of the certificate still meet the specified requirements. The purpose of the routine inspection is to confirm the maintenance of the proper production process at a level confirmed by a pre-license inspection.

It can be concluded that the certification carried out in this type of program not only confirms the conformity of the type of product identified with the specified requirements, but also gives a high degree of confidence that the subsequent manufactured products (from current production) also meet these requirements. It should be noted, however, that the type 3 certification scheme, in which a sample for control tests is taken only from the place of production, does not provide any indication of the impact the distribution channel plays on conformity.

These types of certification programs bring the best measurable benefits to all interested parties.

3.BENEFITS OF VOLUNTARY CERTIFICATION

Type of scheme	Benefits
	For manufacturer	For recipient/user	For importer	For authorities and local governments
3, 4 i 5 These types of certification programs bring the best measurable benefits to all interested parties	·       confirmation of own constructional assessment and avoiding later losses due to complaints or non-compliance with legal requirements ·       full support for documenting the fulfillment of legal requirements for placing products on the market ·       getting a better position on the competitive domestic and foreign market, and thus facilitating sales ·       getting an advantage in tenders or public procurement	·       facilitating the right choice of the product ·       a high degree of confidence that the product meets the declared parameters ·       resignation from conducting own controls, transferring these costs to the certificate holder (manufacturer)	·       support for documenting the fulfillment of legal requirements for placing products on the market ·       getting a better position on the competitive domestic  market, and thus facilitating sales	·       greater efficiency and lowering the costs of market surveillance, bearing in mind that these products on the market are surveillanced by an independent, competent unit ·       facilitating the selection of the right products for public procurement ·       improving the safety of citizens and the environment ·       reduction of costs related to health and environmental protection
2	·       the ability to sell the products ·       getting an advantage in tenders or public procurement, opportunities to sell products	·       fulfillment of the legal requirements for purchased products, if applicable		·       improving the safety of citizens and the environment ·       reduction of costs related to health and environmental protection
1b	·       the possibility of selling the products, the use of which requires compliance with legal requirements ·       getting an advantage in tenders or public procurement	·       fulfillment of the legal requirements for purchased products, if applicable zastosowanie ·       transferring the costs of the assessment of products to the supplier		·       improving the safety of citizens and the environment
1a	·       confirmation of own constructional assessment and avoiding later losses due to the need to introduce changes in the construction of products and / or production processes ·       full support for documenting the fulfillment of legal requirements for placing products on the market	·       For this group of stakeholders, you cannot assign special benefits from certification in this program. As in the case of CE marking, confidence in the manufactured products is associated with having proper knowledge about the reliability of the manufacturer.		·       facilitating the process of assessing compliance with requirements for issuing a Declaration of Conformity

4.The conditions under which the client can use the statement of conformity or marks of conformity is specified in User logo guide and license contract .

4.1.Certification Contract QF4.12

4.2.User logo guide

Last update: 15 January 2023

طرح ارزیابی انطباق شرکت پایش سلامت اسیا را براساس الزامات و استانداردهای عمومی زیر ارائه شده است، پایش سلامت اسیا  ترکیبی از طرح‌های برتر جهانی در مراحل مختلف ارزیابی هماهنگ و  استفاده کرده است تا طرح CAS را طراحی کند و مشکلات صنعت ایران را برای حفظ همترازی با بازار جهانی حل کند. برای صدور گواهی بازرسی (COI)، راه حل را در این دیدم  که طرح را به بخش‌های تعریف شده در ISIRI تقسیم کنیم. و کمبود های ان را با استفاده از معتبر ترین طرح های جهان برای هر بخش، تضمین کنیم.	The Conformity Assessment scheme provides the PSA with certification information based on the following requirements and general standards, PSA has used a combination of world-class schemes in various stages of comformity assessment to design the CAS and solve the problems of the Iran industry to keep Alignment with the international market.. .To issue a COI (certificate of inspection ), we saw the solution. we have divided the scheme into sectors defined in ISIRI is certifed and use the world’s most popular scheme for each sector,