5.15 Sector-Specific Manuals


5.15 Sector-Specific Manuals

5.15.1 The Accreditation Board Requirements

5.15.1.1 Purpose

Although it is unnecessary to be certified to ISO 9000 by an accredited registrar, accredited certifications are generally desirable due to their international recognition [33]. Unaccredited certification appears to be a choice for those who feel that ISO 9001:2000 is not viable for their organization but wish to continue their certification with a well-established registrar. A discussion of the accreditation process is covered in several texts, and any accredited registrar would welcome questions on this subject [34]. As a result, our purpose in this text is not to cover the details of accreditation but to instruct the reader in the ways accreditation board requirements affect the manual's structure.

5.15.1.2 Sector-Specific Requirements

Accreditation boards impact a supplier's certification process via sector-specific requirements that are passed on to the accredited registrar by means of memoranda backed up by a series of parallel standards. For example:

  • EN45012: General Criteria for Certification Bodies Operating Quality System Certification;

  • EN46001: Quality Systems—Medical Devices (particular requirements for the application of EN 29001; soon to be replaced by ISO 13485).

For example, requirements of this nature strongly affect certifications in the medical industry and to some degree in software design and manufacturing. In addition, the customer and/or the U.S. government can declare sector-specific conditions (e.g., as in the automotive industry's QS-9000 requirements). In the case of QS-9000, GM, Ford, and Chrysler-Daimler operate as a team with the accreditation boards because the QS-9000 certification is impressed upon a certified ISO 9000 system.

5.15.1.3 Direct Applicability

What we wish to demonstrate is that all of the processes and methods discussed throughout our text are directly applicable to sector-specific assessments. In every case, the sequence and configuration techniques described previously will hold exactly in a sector-specific manual. In other words, the manner in which the Standard drives the lower level documents holds true regardless of the form of the Standard. The Standard could be ISO 9001, QS-9000, FDA/CGMP, or any other. It is still necessary to respond to each requirement.

5.15.2 Sector-Specific Quality Policy Statements

5.15.2.1 QS-9000 Example

The standard Quality System Requirements QS-9000 was developed by the Chrysler/Ford/General Motors Supplier Quality Requirements Task Force to harmonize the several quality documents already in use by those companies. This standard is more than an interpretive guide in the assessment of automotive manufacturers. It must be adhered to in order for a company to receive a joint ISO 9001 or ISO 9002 and QS-9000 certification. The QS-9000 standard, which will require ISO 9001:2000 registration, is scheduled for revision to a new document in 2003 that carries the present identifier ISO/ Draft TS 16949:2002 [35]. The technique demonstrated is invariant under this change.

The degree to which this automotive standard is to be applied is at the discretion of the registrar and their accreditation board based on interpretations provided by the International Automotive Sector Group (IASG) sanctioned by the Chrysler/Ford/General Motors. Such interpretations are published as special supplements in Quality Systems Update, a publication of the McGraw-Hill Companies, Fairfax, VA.

5.15.2.2 Specific QS-9000 SHALL

We will now consider a specific QS-9000 requirement and a typical response:

Section II: Sector-Specific Requirements—Production Part Approval Process—General 1.1 states that suppliers are to fully comply with all requirements that are described in the production part approval process (PPAP) manual.

Notice that there is only one SHALL, but it is a big one. In fact, the rest of the requirement gives some general direction as to the protocols for subcontracted material, questions of part need, and approval. But it is necessary to go to the PPAP itself to determine the scope of the response. This is a 51-page document published by the Automotive Industry Action Group (AIAG), and we must assume that the supplier is extremely familiar with its content.

We can now write our quality policy statements in response to the PPAP directives. To do this, we first determine where the directives belong within the manual. This turns out to be easy, as it can go readily into an additional Section 9, entitled "Sector-Specific Requirements" (see boxed text).

Our response would then be found under Section 9 of the manual and would look something like the boxed text below, which should be an acceptable quality policy statement. In practice, a similar approach was fully accepted.

5.15.3 Current Good Manufacturing Practices Example

FDA/CGMP 21 CFR Part 820, Part VII, Quality System Regulation, Department of Health and Human Services, is a mixture of ISO 9001 and the previous Part 820. It is an integral part of any accredited assessment that involves medical devices. The degree to which this Standard is applied depends both on the class of devices manufactured and the discretion of the registrar and their accreditation board.

We will examine one of the Current Good Manufacturing Practices (CGMP) requirements and create a quality policy statement in response.

Section 820.70 Production and process controls.

  • (d) Personnel. Each manufacturer SHALL establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.

When we analyze the requirement we see that there is only one SHALL but there are eight directives:

start sidebar
Excellent Corporation's Automotive Quality Policy Manual

Section 9: Sector-Specific Requirements

Production Part Approval Process

Procedure: Excellent's Standard practices and procedures used in the production part approval process (PPAP) is described in SOP# MNFG-2-21-001, entitled, "Production Part Approval Process." All procedures are based directly upon the AIAG publication entitled "Production Part Approval Process." Excellent contacts their customers directly when clarification is required with regard to this directive.

Responsibility: Excellent's quality assurance manager and quality control supervisor are responsible for the coordination and completion of the PPAP activity. This activity includes completion of the required documentation and submission of the appropriate PPAP documents to the customer.

Process: At Excellent, production part approval is always required prior to the first shipment of new parts, correction of discrepancies in shipped parts, and for modified parts managed and recorded within the ECO process. Notification of the customer by Excellent when parts are submitted for approval, unless waived by the customer, is the direct responsibility of the quality assurance manager. Excellent customers specify the submission level they require for each part on their initial purchase order. When no submission is specified, Excellent defaults to levels specified in the PPAP.

Submissions: Documents used in a PPAP submission include the part number, change level, drawing date, and identification as an Excellent part. Measurement system variation studies are conducted in accord with customer requirements. Special characteristics are referred to as critical, key, safety, significant, major, and minor. A Ppk index is used to determine acceptable levels of preliminary process capability.

Quality: Excellent's quality control department provides dimensional analysis, material tests, and performance test analysis based on the AIAG publication "Fundamental Statistical Process Control."

Records: The quality control department maintains all process records, engineering changes, and retains master samples."

end sidebar

  1. Establish requirements for the health;

  2. Establish requirements for the cleanliness;

  3. Establish requirements for the personal practices;

  4. Establish requirements for the clothing;

  5. Maintain requirements for the health;

  6. Maintain requirements for the cleanliness;

  7. Maintain requirements for the personal practices;

  8. Maintain requirements for the clothing.

We can now write our quality policy statements in response to the eight directives. To do this, we first determine where the directives belong within the manual. The Subpart G under which this requirement resides is entitled "Production and Process Controls," so it obviously belongs under 7.5.1 Control of Production and Service Provision of the Standard (see boxed text).

Our response would then be found under Section 7.5.1 of the manual and would look something like the boxed text below. Notice that we have responded in reasonable detail to all eight directives.

5.15.4 EN46001/ISO 13485 Example

The EN46001 Standard is published as a European standard and is entitled "Quality Systems—Medical Devices—Particular Requirements for the Application of EN ISO 9001." It is to be replaced in the near future by the ISO 13485 Standard published by the ISO Technical Committee 210. This new document is entitled "Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001" [36]. The Standards are required as part of medical device certification for recognition by foreign parties (e.g., a requirement for CE marking or acceptance by Health Canada).

Both the EN46001and the ISO 13485 Standards require the same requirement for a medical device file. We will examine this particular requirement and create a quality policy statement in response.

The 46001/13485 requirement under quality planning requires us to establish and maintain a file containing documents that define product specifications and quality system requirements—both process and quality assurance—for manufacturing, installation, and servicing activities, as they are appropriate—for each type or model of a medical device. Alternately, the reader can be referred to the location of the various documents.

start sidebar
Excellent Corporation's Medical Device Quality Policy Manual

Section 7.5.1: Production and Process Control

Personnel: The Excellent Corporation Standards for health, cleanliness, personal practices, and use of clothing apply to all personnel in contact with either medical components or finished goods in the clean room. SOP# Mnfg-2-07-011, entitled "Clean Room Dress Code and Regulations," defines the necessary procedures to ensure that these Standards are implemented and maintained overall by the manufacturing manager.

Dress Code: Company-issued uniforms are worn by all personnel while working with the components and products. For safety as well as sanitary reasons, strict rules apply with regard to shoes worn in manufacturing, assembly, packaging, warehouse, and laboratory areas. Also, strict rules apply with regard to hair and beard covers and the use of make-up and hand cream. The clean room supervisor is responsible for the strict adherence by all clean room employees to this Standard.

Facilities: Locker, wash, and coat rooms—all employees and visitors to the manufacturing and assembly areas use approved entrances and exits. Lockers are available so that street clothes and personal items can be stored before entering the manufacturing areas. Personal cleanliness is required after rest room use. Area supervisors monitor and enforce all aspects of this Standard.

end sidebar

When we analyze this requirement we see that there is only one SHALL, but there are three directives with six subdirectives—or nine total directives. That is, the file is to contain (or reference) documents that define the following for each medical device with regard to manufacturing, installation, and servicing, as appropriate:

  1. Product specifications to manufacture;

  2. Product specifications to install;

  3. Product specifications to service;

  4. Quality system process requirements to manufacture;

  5. Quality system process requirements to install;

  6. Quality system process requirements to service;

  7. Quality-assurance requirements to manufacture;

  8. Quality-assurance requirements to install;

  9. Quality-assurance requirements to service.

We can now write our quality policy statements in response to the nine directives. To do this, we first determine where the directives belong within the manual.

The technical file (as it is usually referred to) can be described in either section 4 as a record or in Section 7 as part of the design phase. Because it is actually a collection of documents, we choose to include it in Clause 4.2.4: Control of Records.

Our response would then be found under Clause 4.2.4 of the manual and would look something like the boxed text below. Notice that we have responded in reasonable detail to all nine directives (i.e., we cover manufacturing, installation, and service as a function of the design, manufacturing, and quality-assurance processes).

[33]ISO 9000 astute purchasing agents, who are already on guard because it is not unusual for an ISO 9000-certified company to ship nonconforming product (the complexity of real-life shipping schedules and rapid technical changes are always with us), may tend to value less a nonaccredited registration. However, in most cases, purchasing agents tend to do what is best for their companies and get what they need when they need it. There are no simple answers in this case.

[34]See, for example, Tiratto, Joseph, "Registrar Accreditation," The ISO 9000 Handbook, Second Edition, Fairfax, VA: McGraw-Hill Companies. Another McGraw-Hill publication, ISO 9000 Registered Company Directory, North America, provides a running list of accredited and unaccredited registrars on a quarterly basis.

[35]Munro, Dr. Roderick A., "Future of APQP and PPAP in Doubt," Quality, January 2002, p. 28, at http://www.qualitymag.com, "Next TS 16495 to Require ISO 9001:2000 Registration," Quality Systems Update, October 2001, p. 1, and "The New Global Automotive Quality Management Standard ISO/TS 16949," May 2002, p. 17, at http://www.qsuonline.com.

[36]ISO 9000 and 13485 Essentials: A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers, Second Edition, CSA, Ontario, Canada, tel: (800) 463-6727.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

flylib.com © 2008-2017.
If you may any questions please contact us: flylib@qtcs.net